125742 S1 M5 CRF c4591001 1120 11201002

Document text

Page 1 of 249
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version30 JUN 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
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Page 2 of 249
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jul/29/2020
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Page 3 of 249
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Demography
1.Subject ID [11201002]
2.Birth Date: /1955
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):BLACK OR AFRICAN AMERICAN
6.Racial Designation:
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(b) (6)
(b) (4)
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Page 4 of 249
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jul/29/2020
2.Erroneous Visit
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Page 5 of 249
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion
criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55
years, inclusive, 65 and 85 years, inclusive, or 18 and 85 years,
inclusive, at randomization (dependent upon study stage)
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all
scheduled visits, vaccination plan, laboratory tests, lifestyle
considerations, and other study procedures
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN02A00
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history,
physical examination, and clinical judgment of the investigator
to be eligible for inclusion in the study
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN03A00
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Page 6 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which
includes compliance with the requirements and restrictions
listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN04A00
Exclusion Criteria
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past
year) or active suicidal ideation/behavior/lab abnormality that
may increase the risk of study participation
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX01A00
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV),
hepatitis C virus (HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX02A00
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Page 7 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine
and/or severe allergic reaction (eg, anaphylaxis) to any
component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX04A00
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected
immunodeficiency, as determined by history and/or
laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX08A00
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Page 8 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged
bleeding that would, in the opinion of the investigator,
contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX11A00
2.hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as
cytotoxic agents or systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX13A01
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Page 9 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60
days before study intervention administration or planned
receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX14A01
2.kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention
within 28 days prior to study entry and/or during study
participation
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study
intervention containing lipid nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX16A01
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(b) (4)
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Page 10 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in
the conduct of the study, site staff otherwise supervised by the
investigator, and their respective family members
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX21A01
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(b) (4)
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Page 11 of 249
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathJul/29/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
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Page 12 of 249
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Diabetes Mellitus Type II]
Start Date: UNK/UNK/1986
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypertension]
Start Date: UNK/UNK/1995
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypercholesterolemia]
Start Date: UNK/UNK/2010
Ongoing: YES
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(b) (4)
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Page 13 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Laminectomy Lumbar]
Start Date: Feb/7/2020
Ongoing: NO
End Date:
Feb/7/2020
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Onychomycosis toe nails]
Start Date: Apr/UNK/2020
Ongoing: YES
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(b) (4)
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Page 14 of 249
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Jul/29/2020
2.Weight: [86.0]
3.Unit: kg
4.Height: [165.0]
5.Unit: cm
6.Body Mass Index: [31.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: ORAL CAVITY
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(b) (4)
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Page 15 of 249
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jul/29/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
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Page 16 of 249
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Jul/29/2020
2.Randomization Number: [220363]
3.Randomization Group: [ ]
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(b) (4)
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Page 17 of 249
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jul/29/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP5R31]
5.bSample ID [BP5R32]
5.cSample ID [BP5R33]
5.dSample ID [BPR2VB]
5.eSample ID [BPR2VC]
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(b) (4)
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Page 18 of 249
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jul/29/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP5R34]
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(b) (4)
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Page 19 of 249
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Jul/29/2020 20:33
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
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(b) (4)
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Page 20 of 249
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
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(b) (4)
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***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/19/2020
2.Erroneous Visit
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***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
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(b) (4)
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***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
3.Injection Site Location: DELTOID MUSCLE
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(b) (4)
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***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798307
Page 25 of 249
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Aug/19/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
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(b) (4)
FDA-CBER-2021-5683-0798308
Page 26 of 249
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/19/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798309
Page 27 of 249
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/19/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP8VD3]
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798310
Page 28 of 249
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/19/2020 11:57
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798311
Page 29 of 249
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/16/2020
2.Erroneous Visit
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798312
Page 30 of 249
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798313
Page 31 of 249
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
3.Injection Site Location: DELTOID MUSCLE
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798314
Page 32 of 249
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798315
Page 33 of 249
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/16/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM50V4]
5.bSample ID [BPR2MF]
5.cSample ID [BPR2MG]
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798316
Page 34 of 249
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798317
Page 35 of 249
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/10/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BHVSS9]
5.bSample ID [BHDKVL]
5.cSample ID [BHDKVM]
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798318
Page 36 of 249
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798319
Page 37 of 249
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798320
Page 38 of 249
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798321
Page 39 of 249
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798322
Page 40 of 249
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798323
Page 41 of 249
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798324
Page 42 of 249
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798325
Page 43 of 249
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798326
Page 44 of 249
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798327
Page 45 of 249
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798328
Page 46 of 249
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798329
Page 47 of 249
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798330
Page 48 of 249
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798331
Page 49 of 249
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Unplanned Assessments
1.Assessments
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798332
Page 50 of 249
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Sep/16/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798333
Page 51 of 249
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798334
Page 52 of 249
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB
- New Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798335
Page 53 of 249
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB
- New Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798336
Page 54 of 249
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#CategoryAE Iden
tifierAdverse
EventStart DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  fibroids  Dec/27/2020 U
NK:UNK NO
End Date Time:
Jan/26/2021 UNK:
UNK
 Repeating
Pages
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798337
Page 55 of 249
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[fibroids]
4.Start Date Time: Dec/27/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/26/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798338
Page 56 of 249
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798339
Page 57 of 249
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021148932]
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798340
Page 58 of 249
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798341
Page 59 of 249
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with
Study Treatment:
6.Was a Concomitant
Medication given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error
cause the subject to be
discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798342
Page 60 of 249
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.[ ]      [ ]    Repeating
Pages
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798343
Page 61 of 249
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798344
Page 62 of 249
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798345
Page 63 of 249
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798346
Page 64 of 249
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798347
Page 65 of 249
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment
Identifier?[ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798348
Page 66 of 249
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798349
Page 67 of 249
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798350
Page 68 of 249
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798351
Page 69 of 249
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798352
Page 70 of 249
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798353
Page 71 of 249
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Vaccination
1.Was there a temporary
delay of vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798354
Page 72 of 249
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798355
Page 73 of 249
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798356
Page 74 of 249
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798357
Page 75 of 249
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798358
Page 76 of 249
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798359
Page 77 of 249
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798360
Page 78 of 249
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798361
Page 79 of 249
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798362
Page 80 of 249
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/10/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798363
Page 81 of 249
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent
Date :Not Done
//Comments
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798364
Page 82 of 249
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection /
Notification of Death:Not Done
//Comments
Cause of Death
2.Cause of Death Status: Not Done
Cause of Death: Not Done
[ ]
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798365
Page 83 of 249
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798366
Page 84 of 249
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Informed Consent - Further Vaccination
1.Consent Was:
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798367
Page 85 of 249
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not Met
Exclusion Criteria Met
2.Description of Exclusion
Criterion Met
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798368
Page 86 of 249
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798369
Page 87 of 249
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/16/2020
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798370
Page 88 of 249
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798371
Page 89 of 249
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798372
Page 90 of 249
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormFeb-24-2021 09:22:31 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0798373
Page 91 of 249
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Feb-24-2021 09:22:31 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0798374
Page 92 of 249
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormFeb-24-2021 09:22:45 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0798375
Page 93 of 249
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Feb-24-2021 09:22:45 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0798376
Page 94 of 249
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Feb-11-2021 14:01:17 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul
Bradley Approved Sep-17-2020 15:30:12 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulBradley, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Sep-16-2020 16:05:38 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798377
Page 95 of 249
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Affidavit:
N/A
Paul
Bradley Approved Sep-01-2020 16:49:08 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulBradley, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798378
Page 96 of 249
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Jul-30-2020
12:21:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Jul-30-2020
12:21:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798379
Page 97 of 249
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Jul-30-2020
12:21:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Jul/29/2020Initial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798380
Page 98 of 249
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Subject ID
Date Location User Value Reason
Jul-30-2020
12:21:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11201002Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Jul-30-2020
12:21:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1955Enrollment
Entry
3. Sex:
Date Location User Value Reason
Jul-30-2020
12:21:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798381
Page 99 of 249
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Jul-30-2020
12:21:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Jul-30-2020
12:21:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLACK OR AFRIC
AN AMERICANInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798382
Page 100 of 249
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Jul-30-2020
12:22:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jul/29/2020Initial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798383
Page 101 of 249
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.a
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Incl
usio
n N
um
ber:1
Crit
erio
n D
escr
ipti
on:Male or femal
e participants
between the ag
es of 18 and 5
5 years, inclusi
ve, 65 and 85
years, inclusiv
e, or 18 and 85
years, inclusiv
e, at randomiz
ation (depende
nt upon study
stage)
Crit
erio
n m
et?:YESInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798384
Page 102 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Crit
erio
n I
D: (
For
Pfiz
er u
se o
nly)
:IN01A00
1.a Inclusion Number:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Male or female parti
cipants between the
ages of 18 and 55 ye
ars, inclusive, 65 and
85 years, inclusive, o
r 18 and 85 years, in
clusive, at randomiza
tion (dependent upon
study stage)Initial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798385
Page 103 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.a Criterion met?
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Incl
usio
n N
umb
er:2Initial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798386
Page 104 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Crit
erio
n De
scri
ptio
n:Participants w
ho are willing
and able to co
mply with all
scheduled visi
ts, vaccination
plan, laborator
y tests, lifestyl
e consideratio
ns, and other s
tudy procedur
es
Crit
erio
n m
et?:YES
Crit
erio
n ID
: (F
or P
fizer
use
only
):IN02A00
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798387
Page 105 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.b Inclusion Number:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participants who are
willing and able to c
omply with all sched
uled visits, vaccinati
on plan, laboratory te
sts, lifestyle consider
ations, and other stud
y proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798388
Page 106 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Incl
usio
n N
umb
er:3
Crit
erio
n De
scri
ptio
n:Healthy partic
ipants who are
determined by
medical histor
y, physical exa
mination, and
clinical judgm
ent of the inve
stigator to be e
ligible for incl
usion in the st
udy
Crit
erio
n m
et?:YESInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798389
Page 107 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Crit
erio
n ID
: (F
or P
fizer
use
only
):IN03A00
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798390
Page 108 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.c Inclusion Number:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Healthy participants
who are determined
by medical history, p
hysical examination,
and clinical judgmen
t of the investigator t
o be eligible for incl
usion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798391
Page 109 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Incl
usio
n N
umb
er:4
Crit
erio
n De
scri
ptio
n:Capable of giv
ing personal si
gned informed
consent, whic
h includes co
mpliance with
the requireme
nts and restrict
ions listed in t
he ICD and in
this protocol
Crit
erio
n m
et?:YESInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798392
Page 110 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Crit
erio
n ID
: (F
or P
fizer
use
only
):IN04A00
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798393
Page 111 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.d Inclusion Number:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Capable of giving pe
rsonal signed inform
ed consent, which in
cludes compliance w
ith the requirements
and restrictions listed
in the ICD and in thi
s protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798394
Page 112 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Excl
usio
n N
um
ber:1
Crit
erio
n D
escr
ipti
on:Other medical
or psychiatric
condition incl.
recent (within
past year) or a
ctive suicidal i
deation/behavi
or/lab abnorm
ality that may
increase the ri
sk of study par
ticipation
Crit
erio
n m
et?:NOInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798395
Page 113 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Crit
erio
n ID
: (F
or P
fize
r us
e on
ly):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Other medical or psy
chiatric condition inc
l. recent (within past
year) or active suicid
al ideation/behavior/l
ab abnormality that
may increase the risk
of study participationInitial Entry
2.a Criterion met?
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798396
Page 114 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Excl
usion
Num
ber:2Initial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798397
Page 115 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Crite
rion
Desc
ripti
on:Known infect
ion with hum
an immunode
ficiency virus
(HIV), hepati
tis C virus (H
CV), or hepat
itis B virus (
HBV)
Crite
rion
met?
:NO
Crite
rion
ID: (
For
Pfize
r use
only)
:EX02A00
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798398
Page 116 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.b Exclusion Number:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Known infection wit
h human immunodef
iciency virus (HIV),
hepatitis C virus (HC
V), or hepatitis B vir
us (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798399
Page 117 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Excl
usio
n N
umb
er:3
Crit
erio
n De
scri
ptio
n:History of sev
ere adverse re
action associat
ed with a vacc
ine and/or sev
ere allergic re
action (eg, ana
phylaxis) to a
ny component
of the study in
tervention(s)
Crit
erio
n m
et?:NOInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798400
Page 118 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Crit
erio
n ID
: (F
or P
fizer
use
only
):EX03A00
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798401
Page 119 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.c Exclusion Number:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
History of severe ad
verse reaction associ
ated with a vaccine a
nd/or severe allergic
reaction (eg, anaphyl
axis) to any compon
ent of the study inter
vention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798402
Page 120 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:4
Criteri
on Desc
ription:Receipt of
medication
s intended
to prevent
COVID-19
Criteri
on met
?:NO
Criteri
on ID: (
For Pfi
zer use
only):EX04A00Initial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798403
Page 121 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.d Exclusion Number:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Receipt of medicatio
ns intended to preve
nt COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020
12:22:37ACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798404
Page 122 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00)
Eastern Time (US
& Canada)
2.e
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:8
Crit
erio
n De
scri
ptio
n:Immunocomp
romised indivi
duals with kn
own or suspec
ted immunode
ficiency, as de
termined by hi
story and/or la
boratory/physi
cal examinati
on
Crit
erio
n me
t?:NOInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798405
Page 123 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX08A00
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798406
Page 124 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.e Exclusion Number:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Immunocompromise
d individuals with kn
own or suspected im
munodeficiency, as d
etermined by history
and/or laboratory/ph
ysical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798407
Page 125 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Excl
usio
n N
umb
er:10
Crit
erio
n De
scri
ptio
n:Bleeding diath
esis or conditi
on associated
with prolonge
d bleeding tha
t would, in the
opinion of the
investigator, c
ontraindicate i
ntramuscular i
njection
Crit
erio
n m
et?:NOInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798408
Page 126 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX10A00
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798409
Page 127 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.f Exclusion Number:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Bleeding diathesis or
condition associated
with prolonged bleed
ing that would, in the
opinion of the investi
gator, contraindicate
intramuscular injecti
onInitial Entry
2.f Criterion met?
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798410
Page 128 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:11
Criterio
n Descri
ption:Women w
ho are pre
gnant or b
reastfeedi
ng
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only
):EX11A00Initial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798411
Page 129 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.g Exclusion Number:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Women who are preg
nant or breastfeedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020
12:22:37ACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798412
Page 130 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00)
Eastern Time (US
& Canada)
2.h
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:12
Criterio
n Descr
iption:Previous v
accination
with any c
oronavirus
vaccine
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX12A00Initial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798413
Page 131 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.h Exclusion Number:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Previous vaccination
with any coronavirus
vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020
12:22:37ACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798414
Page 132 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00)
Eastern Time (US
& Canada)
2.i
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Exclu
sion
Num
ber:13
Crite
rion
Descr
iptio
n:Subjects who
receive imm
unosuppressi
ve therapy, s
uch as cytoto
xic agents or
systemic cort
icosteroids
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer u
se onl
y):EX13A01Initial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798415
Page 133 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.i Exclusion Number:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Subjects who receive
immunosuppressive t
herapy, such as cytot
oxic agents or syste
mic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798416
Page 134 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Excl
usio
n N
umb
er:15
Crit
erio
n De
scri
ptio
n:Receipt of blo
od/plasma pro
ducts or immu
noglobulin, fr
om 60 days be
fore study inte
rvention admi
nistration or p
lanned receipt
throughout the
study
Crit
erio
n m
et?:NOInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798417
Page 135 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX14A01
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798418
Page 136 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.j Exclusion Number:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Receipt of blood/plas
ma products or imm
unoglobulin, from 60
days before study int
ervention administrat
ion or planned receip
t throughout the stud
yInitial Entry
2.j Criterion met?
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798419
Page 137 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798420
Page 138 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
2.k
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:16
Crit
erio
n De
scrip
tion:Participation
in other studi
es involving
study interve
ntion within
28 days prior
to study entry
and/or during
study particip
ation
Crit
erio
n me
t?:NO
Crit
erio
n ID
: (Fo
r Pfi
zer u
se on
ly):EX15A01Initial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798421
Page 139 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.k Exclusion Number:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participation in othe
r studies involving st
udy intervention wit
hin 28 days prior to
study entry and/or d
uring study participa
tionInitial Entry
2.k Criterion met?
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798422
Page 140 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Exclu
sion
Num
ber:17
Crite
rion
Descr
iption
:Previous par
ticipation in
other studies
involving st
udy interven
tion containi
ng lipid nan
oparticles
Crite
rion
met?:NOInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798423
Page 141 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Crite
rion I
D: (F
or Pfi
zer u
se onl
y):EX16A01
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798424
Page 142 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.l Exclusion Number:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Previous participatio
n in other studies in
volving study interv
ention containing lip
id nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798425
Page 143 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Exc
lusi
on
Nu
mbe
r:22
Crit
erio
n D
escr
ipti
on:Investigator si
te staff or Pfiz
er employees
directly involv
ed in the cond
uct of the stud
y, site staff oth
erwise supervi
sed by the inv
estigator, and t
heir respective
family membe
rs
Crit
erio
n m
et?:NOInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798426
Page 144 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Crit
erio
n I
D: (
For
Pfiz
er u
se o
nly)
:EX21A01
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798427
Page 145 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.m Exclusion Number:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Investigator site staf
f or Pfizer employee
s directly involved i
n the conduct of the
study, site staff other
wise supervised by t
he investigator, and t
heir respective famil
y membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798428
Page 146 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020
12:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798429
Page 147 of 249
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Jul-30-2020
12:22:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jul/29/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jul-30-2020
12:22:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Jul-30-2020
12:22:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798430
Page 148 of 249
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.a
Date Location User Value Reason
Jul-30-2020
13:22:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Line/M
H Num
ber:1
Medical
History
Term:Diabetes
Mellitus
Type II
Start D
ate:UNK/U
NK/198
6
Ongoin
g:YESTranscription
Error
Jul-30-2020
13:21:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:1
Medical
History
Term:Dbetes
Mellitus
Type II
Start Da
te:UNK/U
NK/198
6
Ongoing
:YESInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798431
Page 149 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.a Line/MH Number:
Date Location User Value Reason
Jul-30-2020
13:21:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-30-2020
13:22:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Diabetes Mellitus T
ype IITranscription
Error
Jul-30-2020
13:21:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dbetes Mellitus Ty
pe IIInitial Entry
1.a Start Date:
Date Location User Value Reason
Jul-30-2020
13:21:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1986Initial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798432
Page 150 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.a Ongoing:
Date Location User Value Reason
Jul-30-2020
13:21:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Jul-30-2020
13:23:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:Hyperte
nsion
Start Date: UNK/U
NK/199
5
Ongoing: YESInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798433
Page 151 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.b Line/MH Number:
Date Location User Value Reason
Jul-30-2020
13:23:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-30-2020
13:23:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
1.b Start Date:
Date Location User Value Reason
Jul-30-2020
13:23:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1995Initial Entry
1.b Ongoing:
Date Location User Value Reason
Jul-30-2020
13:23:30ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798434
Page 152 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00)
Eastern Time (US
& Canada)
1.c
Date Location User Value Reason
Jul-30-2020
13:24:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical H
istory Ter
m:Hypercho
lesterolem
ia
Start Date
:UNK/UN
K/2010
Ongoing: YESInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0798435
Page 153 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.c Line/MH Number:
Date Location User Value Reason
Jul-30-2020
13:24:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-30-2020
13:24:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Hypercholesterolemi
aInitial Entry
1.c Start Date:
Date Location User Value Reason
Jul-30-2020
13:24:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.c Ongoing:
Date Location User Value Reason
Jul-30-2020
13:24:12ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798436
Page 154 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00)
Eastern Time (US
& Canada)
1.d
Date Location User Value Reason
Jul-30-2020
13:36:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/M
H Num
ber:4
Medical
History
Term:Laminect
omy Lum
bar
Start D
ate:Feb/7/20
20
Ongoin
g:NO
End Da
te:
Feb/7/
2020Transcription
Error
Jul-30-2020
13:34:27
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:4
Medical
History
Term:Laminec
tomy Lu
mbar
Start Da
te:Feb/7/2
020Initial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798437
Page 155 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Ongoing
:YES
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798438
Page 156 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.d Line/MH Number:
Date Location User Value Reason
Jul-30-2020
13:34:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-30-2020
13:34:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Laminectomy Lumb
arInitial Entry
1.d Start Date:
Date Location User Value Reason
Jul-30-2020
13:34:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/7/2020Initial Entry
1.d Ongoing:
Date Location User Value Reason
Jul-30-2020
13:36:06ACV0PFEINFP6000  Data Entry:
NOTranscription
Error
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798439
Page 157 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
Feb/7/2020
Jul-30-2020
13:34:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Jul-30-2020
13:35:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:5
Medical
History T
erm:Onychomy
cosis toe n
ails
Start Date
:Apr/UNK/
2020
Ongoing: YESInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798440
Page 158 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.e Line/MH Number:
Date Location User Value Reason
Jul-30-2020
13:35:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-30-2020
13:35:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Onychomycosis toe
nailsInitial Entry
1.e Start Date:
Date Location User Value Reason
Jul-30-2020
13:35:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Apr/UNK/2020Initial Entry
1.e Ongoing:
Date Location User Value Reason
Jul-30-2020
13:35:36ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798441
Page 159 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0798442
Page 160 of 249
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Jul-30-2020
13:36:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jul/29/2020Initial Entry
2. Weight:
Date Location User Value Reason
Jul-30-2020
13:36:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
86.0Initial Entry
3. Unit:
Date Location User Value Reason
Jul-30-2020
13:36:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798443
Page 161 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Jul-30-2020
13:36:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
165.0Initial Entry
5. Unit:
Date Location User Value Reason
Jul-30-2020
13:36:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Jul-30-2020
13:36:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
31.6Initial Entry
7.a
Date Location User Value Reason
Jul-30-2020
13:36:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.6Initial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798444
Page 162 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Jul-30-2020
13:36:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Jul-30-2020
13:36:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.6Initial Entry
7.a Unit:
Date Location User Value Reason
Jul-30-2020
13:36:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798445
Page 163 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
7.a Temperature Location:
Date Location User Value Reason
Jul-30-2020
13:36:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798446
Page 164 of 249
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jul-30-2020
13:46:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jul-30-2020
13:46:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jul-30-2020
13:46:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jul/29/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798447
Page 165 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Jul-30-2020
13:46:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jul-30-2020
13:46:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Jul-30-2020
13:38:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result::
Not Done
::NOT DON
EInitial Entry
6.a Sponsor ID:
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798448
Page 166 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Jul-30-2020
13:38:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jul-30-2020
13:38:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Jul-30-2020
13:38:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798449
Page 167 of 249
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Jul-30-2020
13:41:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jul/29/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Jul-30-2020
13:41:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
220363Initial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798450
Page 168 of 249
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Jul-30-2020
13:42:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jul-30-2020
13:42:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jul-30-2020
13:42:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jul-30-2020
13:42:11
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798451
Page 169 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Jul-30-2020
13:42:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Jul/29/2020Initial Entry
5.a
Date Location User Value Reason
Jul-30-2020
13:42:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP5R3
1Initial Entry
5.a Sample ID
Date Location User Value Reason
Jul-30-2020
13:42:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP5R31Initial Entry
5.b
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798452
Page 170 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Jul-30-2020
13:43:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP5R3
2Initial Entry
5.b Sample ID
Date Location User Value Reason
Jul-30-2020
13:43:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP5R32Initial Entry
5.c
Date Location User Value Reason
Jul-30-2020
13:43:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP5R3
3Initial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798453
Page 171 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.c Sample ID
Date Location User Value Reason
Jul-30-2020
13:43:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP5R33Initial Entry
5.d
Date Location User Value Reason
Jul-30-2020
13:43:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPR2V
BInitial Entry
5.d Sample ID
Date Location User Value Reason
Jul-30-2020
13:43:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPR2VBInitial Entry
5.e
Date Location User Value Reason
Jul-30-2020
13:43:49ACV0PFEINFP6000  Data Entry:
Sample I BPR2VInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798454
Page 172 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00)
Eastern Time (US
& Canada)D: C
5.e Sample ID
Date Location User Value Reason
Jul-30-2020
13:43:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPR2VCInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798455
Page 173 of 249
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Jul-30-2020
13:44:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jul-30-2020
13:44:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jul-30-2020
13:44:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jul-30-2020
13:44:22
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798456
Page 174 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Jul-30-2020
13:44:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Jul/29/2020Initial Entry
5.a
Date Location User Value Reason
Jul-30-2020
13:44:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP5R3
4Initial Entry
5.a Sample ID
Date Location User Value Reason
Jul-30-2020
13:44:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP5R34Initial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798457
Page 175 of 249
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jul-30-2020
13:45:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jul-30-2020
13:45:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Jul-30-2020
13:45:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798458
Page 176 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-13-2020
02:56:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies
query
Aug-12-2020
16:46:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered Original
value is
correct
Aug-11-2020
21:56:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened Please can
you review
the time
subject was
dosed as it
appears to be
later than
expected?
Thank you
Jul-30-2020
13:45:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jul/29/2020 20:33Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jul-30-2020
13:45:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798459
Page 177 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
6. Body Side:
Date Location User Value Reason
Jul-30-2020
13:45:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jul-30-2020
13:45:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jul-30-2020
13:45:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Jul-30-2020
13:45:18ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798460
Page 178 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0798461
Page 179 of 249
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Jul-30-2020
13:45:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGE
NICITY E-DIARY
COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798462
Page 180 of 249
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-19-2020
16:41:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/19/2020Initial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798463
Page 181 of 249
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: F
E
V
E
R
Were fever or sy
stemic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798464
Page 182 of 249
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:N
OInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798465
Page 183 of 249
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.b Symptom:
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HEInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798466
Page 184 of 249
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:NO
2.c Symptom:
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
Symptom:: C
HIInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798467
Page 185 of 249
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time (US
& Canada)L
LS
Were fever or sy
stemic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:N
O
2.d Symptom:
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798468
Page 186 of 249
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or s
ystemic sympto
ms present on t
he last day the S
ubject Diary wa
s completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798469
Page 187 of 249
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
OInitial Entry
2.f Symptom:
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798470
Page 188 of 249
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.g
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUSC
LE PA
IN
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary w
as completed
?:NOInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798471
Page 189 of 249
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.g Symptom:
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENE
D MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED J
OINT
PAINInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798472
Page 190 of 249
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary wa
s completed?
:NO
2.h Symptom:
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENE
D JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Aug-19-2020 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798473
Page 191 of 249
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)(autocalc) DELTOID MUSCLE
4. Injection Site Body Side:
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Re
action::RE
D
NE
SS
Were injection si
te reactions pres
ent on the last d
ay the Subject D
iary was comple
ted?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798474
Page 192 of 249
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site R
eaction::SW
EL
LI
NG
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:NOInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798475
Page 193 of 249
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTI
ON S
ITEInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798476
Page 194 of 249
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Were injectio
n site reaction
s present on t
he last day the
Subject Diary
was complete
d?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION
SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-19-2020
16:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798477
Page 195 of 249
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Aug-19-2020
16:42:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/19/2020Initial Entry
2.a
Date Location User Value Reason
Aug-19-2020
16:42:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatur
e:36.9
Temperatur
e Unit:C
Temperatur
e Location:
:ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-19-2020
16:42:00
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798478
Page 196 of 249
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
& Canada)
2.a Temperature:
Date Location User Value Reason
Aug-19-2020
16:42:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
36.9Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-19-2020
16:42:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Aug-19-2020
16:42:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798479
Page 197 of 249
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-19-2020
16:42:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-19-2020
16:42:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-19-2020
16:42:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/19/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798480
Page 198 of 249
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-19-2020
16:42:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-19-2020
16:42:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-19-2020
16:42:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result::
Not Done
::NOT DON
EInitial Entry
6.a Sponsor ID:
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798481
Page 199 of 249
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Aug-19-2020
16:42:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-19-2020
16:42:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-19-2020
16:42:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798482
Page 200 of 249
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-19-2020
16:42:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-19-2020
16:42:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-20-2020
08:48:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-20-2020
03:33:13
(UTC-05:00)ACV0PFEINFP6000  Query 1: Opened DM query:
'Sample
Collected?' is
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798483
Page 201 of 249
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Thank you.
Aug-19-2020
16:42:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-19-2020
16:42:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Aug/19/2020Initial Entry
5.a
Date Location User Value Reason
Aug-20-2020
08:48:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BP8VD
3Initial Entry
5.a Sample ID
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798484
Page 202 of 249
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Aug-20-2020
08:48:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP8VD3Initial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798485
Page 203 of 249
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-19-2020
16:42:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-19-2020
16:42:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-19-2020
16:42:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798486
Page 204 of 249
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-19-2020
16:42:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/19/2020 11:57Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-19-2020
16:42:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-19-2020
16:42:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-19-2020
16:42:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798487
Page 205 of 249
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-19-2020
16:42:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-19-2020
16:42:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798488
Page 206 of 249
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-16-2020
16:05:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798489
Page 207 of 249
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: F
E
V
E
R
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was comple
ted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798490
Page 208 of 249
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:N
OInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798491
Page 209 of 249
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.b Symptom:
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HEInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798492
Page 210 of 249
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:NO
2.c Symptom:
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
Symptom:: C
HIInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798493
Page 211 of 249
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time (US
& Canada)L
LS
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:N
O
2.d Symptom:
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798494
Page 212 of 249
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798495
Page 213 of 249
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or sy
stemic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798496
Page 214 of 249
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.g
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUSC
LE PA
IN
Were fever or
systemic sym
ptoms presen
t on the last d
ay the Subjec
t Diary was c
ompleted?:NOInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798497
Page 215 of 249
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.g Symptom:
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENE
D MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED J
OINT
PAINInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798498
Page 216 of 249
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Were fever or
systemic sym
ptoms presen
t on the last d
ay the Subjec
t Diary was c
ompleted?:NO
2.h Symptom:
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENE
D JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-16-2020
16:06:31ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798499
Page 217 of 249
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00)
Eastern Time (US
& Canada)
4. Injection Site Body Side:
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Re
action::RE
D
NE
SS
Were injection si
te reactions prese
nt on the last day
the Subject Diar
y was completed
?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798500
Page 218 of 249
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Re
action::SW
EL
LI
NG
Were injection si
te reactions pres
ent on the last d
ay the Subject D
iary was comple
ted?:NOInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798501
Page 219 of 249
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTIO
N SI
TEInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798502
Page 220 of 249
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Were injection
site reactions p
resent on the l
ast day the Su
bject Diary wa
s completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION
SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-16-2020
16:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798503
Page 221 of 249
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020
16:07:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020
16:07:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-16-2020
16:07:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-16-2020
16:07:08
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798504
Page 222 of 249
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-16-2020
16:07:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/16/2020Initial Entry
5.a
Date Location User Value Reason
Sep-16-2020
16:07:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM50V4Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-16-2020
16:07:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BM50V4Initial Entry
5.b
Date Location User Value Reason
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798505
Page 223 of 249
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep-16-2020
16:07:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPR2MFInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-16-2020
16:07:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPR2MFInitial Entry
5.c
Date Location User Value Reason
Sep-16-2020
16:07:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPR2M
GInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-16-2020
16:07:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPR2MGInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798506
Page 224 of 249
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-11-2021
14:01:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/10/2021Initial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798507
Page 225 of 249
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-16-2021
15:17:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-16-2021
15:17:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-16-2021
15:18:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-16-2021
15:17:16
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798508
Page 226 of 249
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-16-2021
15:17:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/10/2021Initial Entry
5.a
Date Location User Value Reason
Feb-16-2021
15:18:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BHVSS9Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-16-2021
15:18:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BHVSS9Initial Entry
5.b
Date Location User Value Reason
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798509
Page 227 of 249
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Feb-16-2021
15:18:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BHDKV
LInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-16-2021
15:18:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BHDKVLInitial Entry
5.c
Date Location User Value Reason
Feb-16-2021
15:18:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BHDKV
MInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-16-2021
15:18:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BHDKVMInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798510
Page 228 of 249
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Sep-17-2020
12:59:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-17-2020
12:59:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-17-2020
12:59:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3ff9\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798511
Page 229 of 249
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Feb-15-2021
14:06:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6
…[truncated]