125742 S1 M5 5351 c4591001 fa interim sample crf

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Annotated Stud y Book for Stud y Desi gn: C4591001
Stud y Desi gn Version: 11.0
Sponsor: Pfizer
Protocol: C4591001
Sponsor Dru g Name: BLINDED THERAPY
C4591001 - COVID19
Generated by Central Designer TM
October 12, 2020 8:47AMPage 1 of 101 Annotated Study Book - C4591001
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C4591001: ADVERSE EVENT REPORT (AE) - Repeating Form
#C a t e g o r y A E  
IdentifierAdverse 
EventStart 
DateIs the 
Adverse 
Event 
Still 
OngoingToxicity 
GradeSerious Is AE a 
Result of a 
Medication 
ErrorRelationship 
to Study 
TreatmentAction 
Taken 
with 
Study 
TreatmentConcomitant 
Medication 
GivenNon-Drug 
Treatment 
GivenOutcome Caused Study 
DiscontinuationSerious 
Adverse 
Event 
Number
1
Adverse Event Report
1. Category:
[Category] 
ADVERSE EVEN T
2. AE ID:
[AE Identifier] 
3. Adverse Event: 
(If possible specify 
diagnosis, not 
individual 
symptoms) 
[Adverse Event] 
4. Start Date Time:
[Start Date] 
/ 
  / 
: 
  24-hour clock
5. Is the adverse event 
still ongoing?
[Is the Adverse 
Event Still Ongoing] 
YES
NO
End Date Time:
 / 
  / 
 : 
  24-hour clock
6. Toxicity Grade:
[Toxicity Grade] 
1
2
3
4
7. Is the adverse event 
ser ous? 
If Yes, NOTIFY 
PFIZER 
IMMEDIATELY.
Fatal; Life-
threatening; 
Inpatient 
hosp talization or 
prolongat on of 
existing 
hosp talization; 
Persistent or 
signif cant 
disabil ty/incapac ty; 
Congenital 
anomaly/birth 
defect; Important 
med cal event (i.e. 
may jeopardize 
subject and may require 
med cal/surgical 
intervention to 
prevent above 
outcomes).
[Serious] 
YES
Is this ser ous event associated with con genital anomal y or birth defect ?
YES
NO
Did this serious event result in death ?
YES
NO
Did this serious event re quire or prolong hospitalization ?
YES
NO
Did this serious event result in persistent or si gnificant disabil t y/incapac ty?
YES
NO
Is this ser ous event life threatenin g?
YES
NO
Other med call y important ser ous even t
YES
NO
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. 
[Is AE a Result of a Medication Error] 
YES
NO
9. Is this event related 
to study treatment:[Relat onship to 
Study Treatment] 
NOT RELATE D
If Not Related to stud y treatment (s), this event is due to:
CONCOMITANT DRUG TREATMEN T
CONCOMITANT NON-DRUG TREATMENT
OTHER
If Other, specify:
RELATE D
10. Latest Action Taken 
with Study 
DRUG WITHDRAW N
NOT APPLICABL EPage 2 of 101 Annotated Study Book - C4591001
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Treatment:
[Act on Taken with 
Study Treatment] 
11. Was a Concomitant 
Medication given?[Concom tant 
Med cat on Given] 
YES
NO
12. Was a Non-Drug 
Treatment given?
[Non-Drug 
Treatment Given] 
YES
NO
13. What was the 
outcome of this adverse event?:
[Outcome] 
FATAL
NOT RECOVERED/NOT RESOLVE D
RECOVERED/RESOLVE D
RECOVERED/RESOLVED WITH SEQUELA E
RECOVERING/RESOLVING
UNKNOW N
14. D d the adverse 
event cause the 
subject to be 
discontinued from the study?
[Caused Study 
Discontinuat on] 
YES
NO
15. Ser ous Adverse 
Event Number: For Pfizer Use Only
[Serious Adverse 
Event Number] 
16. Comparison Term 
[hidden][Comparison Term] 
17. Lowest Level Term 
[hidden][Lowest Level Term] 
18. Lowest Level Term 
Code [hidden]
[Lowest Level Term 
Code] 
19. D ctionary-Derived 
Term [hidden]
[D ctionary-Derived Term] 
20. Preferred Term 
Code [hidden]
[Preferred Term 
Code] 
21. High Level Term 
[hidden][High Level Term] 
22. High Level Term 
Code [hidden]
[High Level Term 
Code] 
23. High Level Group 
Term [hidden]
[High Level Group Term] 
24. High Level Group 
Term Code [hidden]
[High Level Group 
Term Code] 
25. Primary System 
Organ Class [hidden]
[Primary System 
Organ Class] 
26. Primary System 
Organ Class Code 
[hidden]
[Primary System 
Organ Class Code] Page 3 of 101 Annotated Study Book - C4591001
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C4591001: LABORATORY DATA - HEMATOLOGY (CD4)
Laboratory Data Hematology
1. Lab Panel:
[Category for Lab Test] 
HEMATOLOG Y
2. Laboratory Name and Address
[Vendor Name (DERIVED)] 
3. Collection Date:
[Collect on Date:] 
 / 
 / 
4. Specimen Type:
[Specimen Type] 
BLOO D
Lab Result
# Sponsor-Defined Identifier Test: Result: Not Done: Lab Normal Range
5.a CD4_PX4722
Lab Result Entry5.1 Sponsor ID:
[Sponsor-Defined Identifier] 
5.2 Test:
[Test:] 
CD4_PX4722
5.3 Result:
[Result:] 
5.4 Not Done: [hidden]
[Not Done:] 
NOT DONE
5.5 LNMT
[Lab Normal Range] Low
High
Un t
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C4591001: COHORT SELECTION (COHORT SEL)
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 version
[Trigger Response 1] 
2. Select appropriate response -
What cohort does the subject belong to?
[Trigger Response 10] 
STAGE 1 SENTINEL COHORTS
STAGE 1 NONSENTINEL COHORTS
STAGE 2 COHORTS
STAGE 3 COHORTSPage 5 of 101 Annotated Study Book - C4591001
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C4591001: CONCOMITANT MEDICATIONS - BASELINE (CONMED BSL) - Repeating Form
#S p o n s o r - D e f i n e d  
IdentifierCategory for 
MedicationConcomitant Medications Pre-
specifiedName of 
MedicationDose 
DescriptionDose 
UnitDose 
FrequencyRoute Start 
Date
1
Concomitant Medications
1. What is the medication dentifier?
[Sponsor-Defined Identifier] 
2. Category:
[Category for Medication] 
GENERAL CONCOMITANT MEDICATIONS
3. Concomitant Medications Pre-specified:
[Concom tant Medications Pre-specified] 
NO
4. Med cation:
Prov de the complete gener c drug name 
(including salt form, where applicable). Where 
generic name is unknown, enter the full trade or 
proprietary name. Include clarifying information in the Med cat on text (e.g., Ingredient(s), 
route, use, formulation).
[Name of Medication] 
5. Dose:
[Dose Description] 
6. Dose Unit:
[Dose Unit] 
7. Dose Frequency:
[Dose Frequency] 
8. Route:
[Route] 
9. Start Date:
[Start Date] 
 / 
 / 
10. Comparison Term [hidden]
[Comparison Term] 
11. Standardized Med cat on Name - Dict onary 
derived. [hidden]
[Standardized Med cat on Name] 
12. Standardized Med cat on Code - D ctionary 
derived [hidden]
[Standardized Med cat on Code] Page 6 of 101 Annotated Study Book - C4591001
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C4591001: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS (CONMED VAX) - Repeating Form
# Sponsor-Defined Identifier Category for Medication Concomitant Medications Pre-specified Name of Medication Start Date
1
Concomitant Medications
1. What is the medication identifier?
[Sponsor-Defined Identifier] 
2. Category:
[Category for Med cat on] 
VACCINATIONS
3. Concomitant Medications Pre-specified:
[Concomitant Medications Pre-specified] 
NO
4. Medication:
Provide the complete gener c drug name 
(including salt form, where applicable). Where 
generic name is unknown, enter the full trade 
or proprietary name. Include clarifying 
information in the Med cat on text (e.g., Ingredient(s), route, use, formulation).
[Name of Medication] 
5. Date:
[Start Date] 
 / 
 / 
6. Comparison Term [hidden]
[Comparison Term] 
7. Standardized Medicat on Name - Dict onary 
derived. [hidden]
[Standardized Med cat on Name] 
8. Standardized Med cat on Code - Dictionary 
derived [hidden]
[Standardized Med cat on Code] Page 7 of 101 Annotated Study Book - C4591001
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C4591001: MAIN INFORMED CONSENT (CONSENT)
Informed Consent
1. Consent Was:
[Consent Was:] 
OBTAINE D
Date Written Consent Obtained
/ 
  / 
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C4591001: CONTACT OUTCOME - MONTH 1 (CONTACT 1M)
Contact Outcome
1. Follow-Up Contact Category 
[hidden]
[Follow Up Contact Category] 
CONTACT OUTCOM E
2. Contact Type:
[Type of Contact/Visit] 
CLINIC VISIT
TELEHEALTH VISIT
3. Was contact made?
[Was Contact Made] 
YES
Date of Contact:
 / 
 / 
NO
If No, why?
4. Comments:
[Comments/Findings/Details] Page 9 of 101 Annotated Study Book - C4591001
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C4591001: CONTACT OUTCOME - MONTH 6 (CONTACT 6M)
Contact Outcome
1. Follow-Up Contact Category 
[hidden]
[Follow Up Contact Category] 
CONTACT OUTCOM E
2. Contact Type:
[Type of Contact/Visit] 
CLINIC VISIT
TELEHEALTH VISIT
3. Was contact made?
[Was Contact Made] 
YES
Date of Contact:
 / 
 / 
NO
If No, why?
4. Comments:
[Comments/Findings/Details] Page 1 0of 101 Annotated Study Book - C4591001
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C4591001: CONTACT OUTCOME (CONTACT SV)
Contact Outcome
1. Follow-Up Contact Category 
[hidden]
[Follow Up Contact Category] 
CONTACT OUTCOM E
2. Contact Type:
[Type of Contact/Visit] 
TELEPHONE VISIT
3. Was contact made?
[Was Contact Made] 
YES
Date of Contact:
 / 
 / 
NOIf No, why?
4. Comments:
[Comments/Findings/Details] Page 11 of 101 Annotated Study Book - C4591001
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C4591001: CONTACT OUTCOME - UNPLANNED (CONTACT UV)
Contact Outcome
1. Follow-Up Contact Category 
[hidden]
[Follow Up Contact Category] 
CONTACT OUTCOM E
2. Contact Type:
[Type of Contact/Visit] 
TELEPHONE VISIT
3. Was contact made?
[Was Contact Made] 
YES
Date of Contact:
 / 
 / 
Contact Outcome:
VISIT ARRANGE D
VISIT ARRANGED, BUT NOT ATTENDE D
VISIT NOT ARRANGED, REACTION NO LONGER PRESEN T
VISIT NOT ARRANGED, UNABLE TO ATTEN D
VISIT NOT REQUIRED, DATA ENTRY ERROR IN E-DIAR Y
VISIT NOT REQUIRED, INVESTIGATOR DECISIO N
NOIf No, why?
4. Comments:
[Comments/Findings/Details] Page 1 2of 101 Annotated Study Book - C4591001
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C4591001: MICROBIOLOGY SPECIMEN (COV19 SITE) - Repeating Form
# Date of Collection Specimen Type Assay Code and Description Device Type Result Comments:
1
Microbiology Specimen
1. Actual Date of Collection:
[Date of Collection] 
 / 
  / 
2. Specimen Type:
[Specimen Type] 
SERUM
BLOOD
PLASMA
3. Assay Code and Description:
[Assay Code and Description] 
SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
4. Device Type:
[Device Type] 
SARS-COV-2 DIAGNOSTIC TEST
5. Test Result:
[Result] 
POSITIVE
NEGATIV E
INDETERMINATE
6. Comments/Findings/Details:
[Comments:] Page 1 3of 101 Annotated Study Book - C4591001
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C4591001: MICROBIOLOGY SPECIMEN (COVID TEST) - Repeating Form
#D a t e  o f  
CollectionSpecimen 
TypeSpecimen Collection 
LocationAssay Code and 
DescriptionDevice 
TypeTrade 
NameResult Comments: Trade Name Other, 
Specify
1
Microbiology Specimen
1. Actual Date of Collection:
[Date of Collection] 
 / 
  / 
2. Specimen Type:
[Specimen Type] 
SWABBED MATERIA L
RESPIRATORY SECRETIONS
3. Specimen Collection Location:
[Specimen Collection Location] 
NASOPHARYNX
LOWER RESPIRATORY SYSTEM
THROAT
4. Assay Code and Description:
[Assay Code and Description] 
SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5. Device Type:
[Device Type] 
SARS-COV-2 DIAGNOSTIC TEST
6. Trade Name:
[Trade Name] 
7. Test Result:
[Result] 
POSITIV E
NEGATIVE
INDETERMINATE
8. Comments/Findings/Details:
[Comments:] 
9. Trade Name Other, Specify:
[Trade Name Other, Specify] Page 1 4of 101 Annotated Study Book - C4591001
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C4591001: DEATH DETAILS CODED (DEATH DTL)
Death Details
1. Date of Collect on / Notification 
of Death:
[Date of Collect on / Notif cat on 
of Death] 
 / 
  / 
Cause of Death Status Cause of Death
2.
Cause of Death Entry
2.1 Cause of Death Status:
[Cause of Death Status] 
PRIMARY CAUSE OF DEATH
SECONDARY CAUSE OF DEATH
2.2 Cause of Death:
[Cause of Death] 
2.3 Comparison Term [hidden]
[Comparison Term] 
2.4 Lowest Level Term [hidden]
[Lowest Level Term] 
2.5 Lowest Level Term Code 
[hidden]
[Lowest Level Term Code] 
2.6 Dict onary-Derived Term 
[hidden][Dictionary-Derived Term] 
2.7 Preferred Term Code [hidden]
[Preferred Term Code] 
2.8 High Level Term [hidden]
[High Level Term] 
2.9 High Level Term Code 
[hidden]
[High Level Term Code] 
2.10 High Level Group Term 
[hidden][High Level Group Term] 
2.11 High Level Group Term Code 
[hidden][High Level Group Term Code] 
2.12 Primary System Organ Class 
[hidden][Primary System Organ Class] 
2.13 Primary System Organ Class 
Code [hidden]
[Primary System Organ Class Code] Page 1 5of 101 Annotated Study Book - C4591001
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C4591001: DEMOGRAPHY (DEMOG)
Demography
1. Subject ID
[Subject ID] 
2. Birth Date:
[Birth Date] 
 / 
 / 
3. Sex:
[Sex] 
FEMAL E
MALE
4. Ethnicity:
[Ethnicity] 
HISPANIC OR LATINO (A) OR OF SPANISH ORIGI N
NOT HISPANIC OR LATINO (A) OR OF SPANISH ORIGI N
NOT REPORTE D
5. Race: (Check X all that apply):
[Race Of Subject] 
BLACK OR AFRICAN AMERICA N
AMERICAN INDIAN OR ALASKA NATIV E
ASIAN
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
WHIT E
NOT REPORTE DPage 1 6of 101 Annotated Study Book - C4591001
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C4591001: DISPOSITION - FOLLOW-UP (DISP FUP)
Disposition - Follow-Up
1. Date of Complet on/Discontinuation/Death :
[Date of Completion/Discontinuation/Death :] 
/ 
 / 
2. Phase of Disposition:
[Disposition Phase] 
FOLLO W-UP
3. Status:
[Status] 
4. Specify Status:
[Specify Status] Page 17 of 101 Annotated Study Book - C4591001
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C4591001: DISPOSITION - SCREENING (DISP SCR)
Disposition - Screening
1. Date of Complet on/Discontinuation/Death
[Date of Completion/Discontinuation/Death] 
/ 
 / 
2. Phase of Disposition:
[Disposition Phase] 
SCREENING
3. Status:
[Status] 
4. Specify Status:
[Specify Status] Page 18 of 101 Annotated Study Book - C4591001
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C4591001: DISPOSITION - TREATMENT (DISP TRT)
Disposition - Treatment
1. Date of Complet on/Discontinuation/Death :
[Date of Completion/Discontinuation/Death :] 
/ 
 / 
2. Phase of Disposition:
[Disposition Phase] 
VACCINATIO N
3. Status:
[Status] 
4. Specify Status:
[Specify Status] Page 19 of 101 Annotated Study Book - C4591001
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C4591001: DATE OF VISIT (DOV)
Date of Visit
1. Date of Visit
[Date of Visit] 
 / 
  / 
2. Erroneous Visit
[Visit Error] 
ERRONEOUS VISITPage 2 0of 101 Annotated Study Book - C4591001
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C4591001: DATE OF VISIT - ILLNESS CONVALESCENT (DOV CONV)
Date of Visit
1. Date of Visit
[Date of Visit] 
 / 
  / 
2. Erroneous Visit
[Visit Error] 
ERRONEOUS VISIT
COVID-19 Illness Visit3. COVID-19 Illness Visit:
[COVID-19 Illness Vis t] 
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C4591001: DATE OF VISIT - ILLNESS ONSET (DOV ILL)
Date of Visit
1. Date of Visit
[Date of Visit] 
 / 
  / 
2. Erroneous Visit
[Visit Error] 
ERRONEOUS VISIT
COVID-19 Illness Visit3. COVID-19 Illness Visit:
[COVID-19 Illness Vis t] 
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C4591001: DATE OF VISIT - REPEAT SWAB (DOV SWAB)
Date of Visit
1. Date of Visit
[Date of Visit] 
 / 
  / 
2. Erroneous Visit
[Visit Error] 
ERRONEOUS VISIT
COVID-19 Repeat Swab3. COVID-19 Repeat Swab:
[COVID-19 Repeat Swab] 
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C4591001: INFORM ENROLLMENT (ENROLL)
InForm Enrollment
1. Subject ID
[Subject ID] Page 2 4of 101 Annotated Study Book - C4591001
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C4591001: HIV STATUS (HIV)
HIV Status
1. Select appropriate response -
What is the subject HIV status?
[Trigger Response 2] 
The sub ject is known to be HIV POSITIV E
The subject is NOT known to be HIV POSITIVEPage 2 5of 101 Annotated Study Book - C4591001
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C4591001: LAB CHEMISTRY (HIV RNA)
Lab Chemistry Details
1. Lab Panel:
[Category for Lab Test] 
CLINICAL CHEMISTR Y
2. Laboratory Name and Address
[Vendor Name] 
3. Collection Date:
[Collect on Date:] 
 / 
 / 
4. Specimen Type:
[Specimen Type] 
BLOO D
Lab Result
# Sponsor-Defined Identifier Test: Result: Not Done: Lab Normal Range
5.a HIV RNA (Ultrasensitive)
Lab Result Entry5.1 Sponsor ID:
[Sponsor-Defined Identifier] 
5.2 Test:
[Test:] 
HIV RNA (Ultrasens tive)
5.3 Result:
[Result:] 
5.4 Not Done: [hidden]
[Not Done:] 
NOT DONE
5.5 LNMT
[Lab Normal Range] Low
High
Un t
/mLPage 2 6of 101 Annotated Study Book - C4591001
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C4591001: HEALTH CARE UTILIZATION (HLTHCARE)
Health Care Utilization
1. Evaluation Interval: [hidden]
[Evaluation Interval] 
SINCE THE START OF THE RESPIRATORY ILLNESS EPISOD E
2. Disease Name: [hidden]
[Disease Name] 
RESPIRATORY ILLNESS
Health Care Utilization
#
Pre-Specified Type of Practitioner Occurrence of Visits or Contacts
3.a YES SPECIALIST3.b YES EMERGENCY ROOM3.c YES PRIMARY CARE PHYSICIAN3.d YES URGENT CARE3.e YES TELEPHONE CONSULTATION3.f YES OTHER
Health Care Utilization Entry3.1 Pre-Specified: [hidden]
[Pre-Specified] 
YES
3.2 Physician or Healthcare 
Professional:
[Type of Practitioner] 
SPECIALIS T
EMERGENCY ROOM
PRIMARY CARE PHYSICIA N
URGENT CARE
TELEPHONE CONSULTATION
OTHER
3.3 Occurrence of Visits or 
Contacts:
[Occurrence of Vis ts or 
Contacts] 
YES
Number of Vis ts or Contacts:
NO
Health Care Utilization Other
4. Other Type of Pract tioner 
Specify:
[Other Type of Pract t oner 
Specify] 
Health Care Utilization
5. Has the subject been 
hospitalized due to potential 
COVID-19 illness?
[Been Hospitalized] 
YES
Has the subject been in intensive care due to potential COVID-19 illness?
YES
NO
NOPage 27 of 101 Annotated Study Book - C4591001
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C4591001: HOSPITALIZATION DETAILS (HOSP) - Repeating Form
# Hospitalization Category Hospitalization Term Admission Date Ongoing
1
Hospitalization Details
1. Hosp talization Category:
[Hospitalization Category] 
HOSPITALIZATION STATUS
2. Hosp talization Term:
[Hospitalization Term] 
ICU
HOSPITAL 
3. Admission Date:
[Admission Date] 
 / 
  / 
4. Ongoing?
[Ongoing] 
YES
NO
Dischar ge Date:
 / 
 / 
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C4591001: ILLNESS DETAILS (ILL POTEN)
Illness Details
1. Category of Clinical Event:
[Category of Clin cal Event:] 
POTENTIAL COVI D-19 ILLNESS
2. Was a diagnosis obtained for 
Potential COVID-19 Illness? 
[Diagnosis Obtained] 
YES
Respirator y Illness Dia gnosis:
Date of Dia gnosis:
/ 
  / 
NO
3. Toxicity Grade:
[Toxicity Grade] 
0
1
2
3
4
5
4. Comparison Term: [hidden]
[Comparison Term] 
5. Lowest Level Term [hidden]
[Lowest Level Term] 
6. Lowest Level Term Code 
[hidden]
[Lowest Level Term Code] 
7. D ctionary Derived Term 
[hidden][D ctionary Derived Term] 
8. Preferred Term Code [hidden]
[Preferred Term Code] 
9. High Level Term [hidden]
[High Level Term] 
10. High Level Term Code [hidden]
[High Level Term Code] 
11. High Level Group Term 
[hidden][High Level Group Term] 
12. High Level Group Term Code 
[hidden][High Level Group Term Code] 
13. Primary System Organ Class 
[hidden][Primary System Organ Class] 
14. Primary System Organ Class 
Code [hidden]
[Primary System Organ Class 
Code] Page 29 of 101 Annotated Study Book - C4591001
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C4591001: ILLNESS DETAILS - SEVERE (ILL SEVERE) - Repeating Form
# Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade
1
Illness Details
1. Category of Clinical Event:
[Category of Clin cal Event:] 
SEVERE COVI D-19 ILLNESS
2. Subcategory of Clin cal Event:
[Subcategory of Clin cal Event] 
SIGNIFICANT ACUTE RENAL DYSFUNCTIO N
SIGNIFICANT ACUTE HEPATIC DYSFUNCTIO N
SIGNIFICANT ACUTE NEUROLOGIC DYSFUNCTIO N
3. Was a diagnosis obtained? 
[Diagnosis Obtained] 
YES
Diagnosis:
Start Date:
/ 
  / 
Ongoing?:
YES
NO
End Date:
 / 
 / 
NO
4. Toxicity Grade:
[Toxicity Grade] 
1
2
3
4
5
5. Comparison Term: [hidden]
[Comparison Term] 
6. Lowest Level Term [hidden]
[Lowest Level Term] 
7. Lowest Level Term Code 
[hidden]
[Lowest Level Term Code] 
8. D ctionary Derived Term 
[hidden][D ctionary Derived Term] 
9. Preferred Term Code [hidden]
[Preferred Term Code] 
10. High Level Term [hidden]
[High Level Term] 
11. High Level Term Code [hidden]
[High Level Term Code] 
12. High Level Group Term 
[hidden][High Level Group Term] 
13. High Level Group Term Code 
[hidden][High Level Group Term Code] 
14. Primary System Organ Class 
[hidden][Primary System Organ Class] 
15. Primary System Organ Class 
Code [hidden]
[Primary System Organ Class Code] Page 3 0of 101 Annotated Study Book - C4591001
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C4591001: ILLNESS DETAILS - SEVERE (ILL SEVERE)
Illness Details
1. Category of Clinical Event:
[Category of Clin cal Event:] 
SEVERE COVI D-19 ILLNESS
2. Subcategory of Clin cal Event:
[Subcategory of Clin cal Event] 
SIGNIFICANT ACUTE RENAL DYSFUNCTIO N
SIGNIFICANT ACUTE HEPATIC DYSFUNCTIO N
SIGNIFICANT ACUTE NEUROLOGIC DYSFUNCTIO N
3. Was a diagnosis obtained? 
[Diagnosis Obtained] 
YES
Diagnosis:
Start Date:
/ 
  / 
Ongoing?:
YES
NO
End Date:
 / 
 / 
NO
4. Toxicity Grade:
[Toxicity Grade] 
1
2
3
4
5
5. Comparison Term: [hidden]
[Comparison Term] 
6. Lowest Level Term [hidden]
[Lowest Level Term] 
7. Lowest Level Term Code 
[hidden]
[Lowest Level Term Code] 
8. D ctionary Derived Term 
[hidden][D ctionary Derived Term] 
9. Preferred Term Code [hidden]
[Preferred Term Code] 
10. High Level Term [hidden]
[High Level Term] 
11. High Level Term Code [hidden]
[High Level Term Code] 
12. High Level Group Term 
[hidden][High Level Group Term] 
13. High Level Group Term Code 
[hidden][High Level Group Term Code] 
14. Primary System Organ Class 
[hidden][Primary System Organ Class] 
15. Primary System Organ Class 
Code [hidden]
[Primary System Organ Class 
Code] Page 31 of 101 Annotated Study Book - C4591001
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C4591001: IMAGING (IMAGING) - Repeating Form
# Date of Assessment Location of Assessment Imaging Method Overall Assessment
1
Imaging
1. Date of Assessment:
[Date of Assessment] 
 / 
  / 
2. Locat on of Assessment:
[Location of Assessment] 
CHEST
HEAD
OTHER
If other, specify:
3. Type of Imaging Exam:
[Imaging Method] 
CT SCA N
X-RAY
ULTRASOUN D
MRI
OTHERIf other, specify:
4. Assessment:
[Overall Assessment] 
ABNORMAL
If abnormal, specify findings:
INDETERMINATE
NORMA L
UNKNOWN
NOT EVALUABLEPage 3 2of 101 Annotated Study Book - C4591001
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C4591001: INCLUSION/EXCLUSION CRITERIA (IN EX STG3)
Study eligibility requires subjects to meet all inclus on criteria (YES) and Not meet exclusion criteria (NO). 
Inclusion Criteria
# Inclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
1.a 1 Male or female part cipants 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)IN01A00
1.b 2 Participants who are willing and able to comply w th all scheduled vis ts, vaccination plan, 
laboratory tests, lifestyle cons derat ons, and other study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and 
clinical judgment of the investigator to be eligible for inclusion in the studyIN03A00
1.d 4 Capable of giving personal signed informed  consent, which includes compliance with the 
requirements and restr ctions listed in the ICD and in this protocolIN04A00
Inclusion Criteria Entry
1.1 Inclusion Number:
[Inclusion Number] 
1
2
3
4
1.2 Cr terion Description:
[Criter on Descript on] 
1.3 Cr terion met?
[Criter on met?] 
YES
NO
Describe details if relevan t
1.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
IN01A00
IN02A0 0
IN03A00
IN04A00
Exclusion Criteria
# Exclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
2.a 1 Other medical or psychiatric condition incl. recent (within past year) or active suicidal 
deation/behavior/lab abnormal ty that may increase the risk of study participationEX01A00
2.b 2 Known infection w th human immunodeficiency virus (HIV), hepatitis C virus (HCV), or 
hepatitis B virus (HBV)EX02A00
2.c 3 History of severe adverse reaction associated with a vaccine and/or severe allergic 
reaction (eg, anaphylaxis) to any component of the study intervention(s)EX03A00
2.d 4 Receipt of medicat ons intended to prevent COVID-19 EX04A00
2.e 8 Immunocompromised indiv duals w th kn own or suspected immunodeficiency, as 
determined by history and/or laboratory/phys cal examinationEX08A00
2.f 9 Individuals with a history of autoimmune disease or an active autoimmune disease 
requiring therapeutic interventionEX09A00
2.g 10 Bleeding diathesis or condition associated  w th prolonged bleeding that would, in the 
opinion of the investigator, contraindicate intramuscular inject onEX10A00
2.h 11 Women who are pregnant or breastfeeding EX11A00
2.i 12 Previous vaccinat on with any coronavirus vaccine EX12A00
2.j 13 Individuals who receive immunosuppressive therapy, such as cytotoxic agents or 
systemic corticosteroids. Inhaled/nebulized, Intra-art cular, intrabursal, or topical 
cort costeroids are permittedEX13A00
2.k 14 Receipt of blood/plasma products or immunoglobulin, from 60 days before study 
intervention administrat on or planned receipt throughout the studyEX14A00
2.l 15 Participation in other studies involving study intervention w thin 28 days pr or to study 
entry and/or during study participationEX15A00
2.m 16 Previous part cipation in other studies involving study intervent on containing lip d 
nanopart clesEX16A00
2.n 21 Investigator s te staff or Pfizer employees directly involved in the conduct of the study, 
site staff otherwise supervised by the investigator, and their respective family membersEX21A00
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number] 
2.2 Cr terion Description:
[Criter on Descript on] 
2.3 Cr terion met?
[Criter on met?] 
YES
Describe details if relevan tPage 3 3of 101 Annotated Study Book - C4591001
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NO
2.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use only)] 
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C4591001: INCLUSION/EXCLUSION CRITERIA (IN EX STG3)
Study eligibility requires subjects to meet all inclus on criteria (YES) and Not meet exclusion criteria (NO). 
Inclusion Criteria
# Inclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
1.a 1 Male or female part cipants 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)IN01A00
1.b 2 Participants who are willing and able to comply w th all scheduled vis ts, vaccination plan, 
laboratory tests, lifestyle cons derat ons, and other study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and 
clinical judgment of the investigator to be eligible for inclusion in the studyIN03A00
1.d 4 Capable of giving personal signed informed  consent, which includes compliance with the 
requirements and restr ctions listed in the ICD and in this protocolIN04A00
Inclusion Criteria Entry
1.1 Inclusion Number:
[Inclusion Number] 
1
2
3
4
1.2 Cr terion Description:
[Criter on Descript on] 
1.3 Cr terion met?
[Criter on met?] 
YES
NO
Describe details if relevan t
1.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
IN01A00
IN02A0 0
IN03A00
IN04A00
Exclusion Criteria
# Exclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
2.a 1 Other medical or psychiatric condition incl. recent (within past year) or active suicidal 
deation/behavior/lab abnormal ty that may increase the risk of study participationEX01A00
2.b 2 Known infection w th human immunodeficiency virus (HIV), hepatitis C virus (HCV), or 
hepatitis B virus (HBV)EX02A00
2.c 3 History of severe adverse reaction associated with a vaccine and/or severe allergic 
reaction (eg, anaphylaxis) to any component of the study intervention(s)EX03A00
2.d 4 Receipt of medicat ons intended to prevent COVID-19 EX04A00
2.e 8 Immunocompromised indiv duals w th kn own or suspected immunodeficiency, as 
determined by history and/or laboratory/phys cal examinationEX08A00
2.f 10 Bleeding diathesis or condition associated  w th prolonged bleeding that would, in the 
opinion of the investigator, contraindicate intramuscular inject onEX10A00
2.g 11 Women who are pregnant or breastfeeding EX11A00
2.h 12 Previous vaccinat on with any coronavirus vaccine EX12A00
2.i 13 Subjects who receive immunosuppressive therapy, such as cytotox c agents or systemic 
cort costeroidsEX13A01
2.j 15 Receipt of blood/plasma products or immunoglobulin, from 60 days before study 
intervention administrat on or planned receipt throughout the studyEX14A01
2.k 16 Participation in other studies involving study intervention w thin 28 days pr or to study 
entry and/or during study participationEX15A01
2.l 17 Previous part cipation in other studies involving study intervent on containing lip d 
nanopart clesEX16A01
2.m 22 Investigator s te staff or Pfizer employees directly involved in the conduct of the study, 
site staff otherwise supervised by the investigator, and their respective family membersEX21A01
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number] 
2.2 Cr terion Description:
[Criter on Descript on] 
2.3 Cr terion met?
[Criter on met?] 
YES
Describe details if relevant
NO
2.4 Cr terion ID: (For Pfizer use Page 3 5of 101 Annotated Study Book - C4591001
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only)
[Criter on ID: (For Pfizer use 
only)] 
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C4591001: INCLUSION/EXCLUSION CRITERIA (IN EX STG3)
Study eligibility requires subjects to meet all inclus on criteria (YES) and Not meet exclusion criteria (NO). 
Inclusion Criteria
# Inclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
1.a 1 Male or female part cipants 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)IN01A00
1.b 2 Participants who are willing and able to comply w th all scheduled vis ts, vaccination plan, 
laboratory tests, lifestyle cons derat ons, and other study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and 
clinical judgment of the investigator to be eligible for inclusion in the studyIN03A00
1.d 4 Capable of giving personal signed informed  consent, which includes compliance with the 
requirements and restr ctions listed in the ICD and in this protocolIN04A00
Inclusion Criteria Entry
1.1 Inclusion Number:
[Inclusion Number] 
1
2
3
4
1.2 Cr terion Description:
[Criter on Descript on] 
1.3 Cr terion met?
[Criter on met?] 
YES
NO
Describe details if relevan t
1.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
IN01A00
IN02A0 0
IN03A00
IN04A00
Exclusion Criteria
# Exclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
2.a 1 Other medical or psychiatric condition incl. recent (within past year) or active suicidal 
deation/behavior/lab abnormal ty that may increase the risk of study participationEX01A00
2.b 2 Known infection w th human immunodeficiency virus (HIV), hepatitis C virus (HCV), or 
hepatitis B virus (HBV)EX02A00
2.c 3 History of severe adverse reaction associated with a vaccine and/or severe allergic 
reaction (eg, anaphylaxis) to any component of the study intervention(s)EX03A00
2.d 4 Receipt of medicat ons intended to prevent COVID-19 EX04A00
2.e 8 Immunocompromised indiv duals w th kn own or suspected immunodeficiency, as 
determined by history and/or laboratory/phys cal examinationEX08A00
2.f 9 Individuals with a history of autoimmune disease or an active autoimmune disease 
requiring therapeutic interventionEX09A00
2.g 10 Bleeding diathesis or condition associated  w th prolonged bleeding that would, in the 
opinion of the investigator, contraindicate intramuscular inject onEX10A00
2.h 11 Women who are pregnant or breastfeeding EX11A00
2.i 12 Previous vaccinat on with any coronavirus vaccine EX12A00
2.j 13 Subjects who receive immunosuppressive therapy, such as cytotox c agents or systemic 
cort costeroidsEX13A01
2.k 15 Receipt of blood/plasma products or immunoglobulin, from 60 days before study 
intervention administrat on or planned receipt throughout the studyEX14A01
2.l 16 Participation in other studies involving study intervention w thin 28 days pr or to study 
entry and/or during study participationEX15A01
2.m 17 Previous part cipation in other studies involving study intervent on containing lip d 
nanopart clesEX16A01
2.n 22 Investigator s te staff or Pfizer employees directly involved in the conduct of the study, 
site staff otherwise supervised by the investigator, and their respective family membersEX21A01
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number] 
2.2 Cr terion Description:
[Criter on Descript on] 
2.3 Cr terion met?
[Criter on met?] 
YES
Describe details if relevantPage 37 of 101 Annotated Study Book - C4591001
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NO
2.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
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C4591001: INCLUSION/EXCLUSION CRITERIA (INC EXC)
Criterion Description
1.
Inclusion Criteria Not Met Entry
1.1 Description of Inclusion 
Cr terion Not Met
[Criter on Descript on] 
Criterion Description
2.
Exclusion Criteria Met Entry
2.1 Description of Exclusion 
Cr terion Met
[Criter on Descript on] 
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C4591001: INCLUSION/EXCLUSION CRITERIA (INC EXC NS)
Study eligibility requires subjects to meet all inclus on criteria (YES) and Not meet exclusion criteria (NO). 
Inclusion Criteria
# Inclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
1.a 1 Male or female part cipants 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)IN01A00
1.b 2 Participants who are willing and able to comply w th all scheduled vis ts, vaccination plan, 
laboratory tests, lifestyle cons derat ons, and other study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and 
clinical judgment of the investigator to be eligible for inclusion in the studyIN03A00
1.d 4 Capable of giving personal signed informed  consent, which includes compliance with the 
requirements and restr ctions listed in the ICD and in this protocolIN04A00
Inclusion Criteria Entry
1.1 Inclusion Number:
[Inclusion Number] 
1
2
3
4
1.2 Cr terion Description:
[Criter on Descript on] 
1.3 Cr terion met?
[Criter on met?] 
YES
NO
Describe details if relevan t
1.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
IN01A00
IN02A0 0
IN03A00
IN04A00
Exclusion Criteria
# Exclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
2.a 1 Other medical or psychiatric condition incl. recent (within past year) or active suicidal 
deation/behavior/lab abnormal ty that may increase the risk of study participationEX01A00
2.b 2 Known infection w th human immunodeficiency virus (HIV), hepatitis C virus (HCV), or 
hepatitis B virus (HBV)EX02A00
2.c 3 History of severe adverse reaction associated with a vaccine and/or severe allergic 
reaction (eg, anaphylaxis) to any component of the study intervention(s)EX03A00
2.d 4 Receipt of medicat ons intended to prevent COVID-19 EX04A00
2.e 5 Stages 1 and 2 only: Prev ous clinical or microbiolog cal diagnosis of COVID-19 EX05A00
2.f 8 Immunocompromised indiv duals w th kn own or suspected immunodeficiency, as 
determined by history and/or laboratory/phys cal examinationEX08A00
2.g 10 Bleeding diathesis or condition associated  w th prolonged bleeding that would, in the 
opinion of the investigator, contraindicate intramuscular inject onEX10A00
2.h 11 Women who are pregnant or breastfeeding EX11A00
2.i 12 Previous vaccinat on with any coronavirus vaccine EX12A00
2.j 13 Subjects who receive immunosuppressive therapy, such as cytotox c agents or systemic 
cort costeroidsEX13A01
2.k 15 Receipt of blood/plasma products or immunoglobulin, from 60 days before study 
intervention administrat on or planned receipt throughout the studyEX14A01
2.l 16 Participation in other studies involving study intervention w thin 28 days pr or to study 
entry and/or during study participationEX15A01
2.m 17 Previous part cipation in other studies involving study intervent on containing lip d 
nanopart clesEX16A01
2.n 22 Investigator s te staff or Pfizer employees directly involved in the conduct of the study, 
site staff otherwise supervised by the investigator, and their respective family membersEX21A01
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number] 
2.2 Cr terion Description:
[Criter on Descript on] 
2.3 Cr terion met?
[Criter on met?] 
YES
Describe details if relevant
NOPage 4 0of 101 Annotated Study Book - C4591001
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2.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
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C4591001: INCLUSION/EXCLUSION CRITERIA (INC EXC NS)
Study eligibility requires subjects to meet all inclus on criteria (YES) and Not meet exclusion criteria (NO). 
Inclusion Criteria
# Inclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
1.a 1 Male or female part cipants 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)IN01A00
1.b 2 Participants who are willing and able to comply w th all scheduled vis ts, vaccination plan, 
laboratory tests, lifestyle cons derat ons, and other study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and 
clinical judgment of the investigator to be eligible for inclusion in the studyIN03A00
1.d 4 Capable of giving personal signed informed  consent, which includes compliance with the 
requirements and restr ctions listed in the ICD and in this protocolIN04A00
Inclusion Criteria Entry
1.1 Inclusion Number:
[Inclusion Number] 
1
2
3
4
1.2 Cr terion Description:
[Criter on Descript on] 
1.3 Cr terion met?
[Criter on met?] 
YES
NO
Describe details if relevan t
1.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
IN01A00
IN02A0 0
IN03A00
IN04A00
Exclusion Criteria
# Exclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
2.a 1 Other medical or psychiatric condition incl. recent (within past year) or active suicidal 
deation/behavior/lab abnormal ty that may increase the risk of study participationEX01A00
2.b 2 Known infection w th human immunodeficiency virus (HIV), hepatitis C virus (HCV), or 
hepatitis B virus (HBV)EX02A00
2.c 3 History of severe adverse reaction associated with a vaccine and/or severe allergic 
reaction (eg, anaphylaxis) to any component of the study intervention(s)EX03A00
2.d 4 Receipt of medicat ons intended to prevent COVID-19 EX04A00
2.e 5 Stages 1 and 2 only: Prev ous clinical or microbiolog cal diagnosis of COVID-19 EX05A00
2.f 8 Immunocompromised indiv duals w th kn own or suspected immunodeficiency, as 
determined by history and/or laboratory/phys cal examinationEX08A00
2.g 9 Individuals with a history of autoimmune disease or an active autoimmune disease 
requiring therapeutic interventionEX09A00
2.h 10 Bleeding diathesis or condition associated  w th prolonged bleeding that would, in the 
opinion of the investigator, contraindicate intramuscular inject onEX10A00
2.i 11 Women who are pregnant or breastfeeding EX11A00
2.j 12 Previous vaccinat on with any coronavirus vaccine EX12A00
2.k 13 Individuals who receive immunosuppressive therapy, such as cytotoxic agents or 
systemic corticosteroids. Inhaled/nebulized, Intra-art cular, intrabursal, or topical 
cort costeroids are permittedEX13A00
2.l 14 Receipt of blood/plasma products or immunoglobulin, from 60 days before study 
intervention administrat on or planned receipt throughout the studyEX14A00
2.m 15 Participation in other studies involving study intervention w thin 28 days pr or to study 
entry and/or during study participationEX15A00
2.n 16 Previous part cipation in other studies involving study intervent on containing lip d 
nanopart clesEX16A00
2.o 21 Investigator s te staff or Pfizer employees directly involved in the conduct of the study, 
site staff otherwise supervised by the investigator, and their respective family membersEX21A00
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number] 
2.2 Cr terion Description:
[Criter on Descript on] 
2.3 Cr terion met?
[Criter on met?] 
YES
Describe details if relevantPage 4 2of 101 Annotated Study Book - C4591001
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NO
2.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
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C4591001: INCLUSION/EXCLUSION CRITERIA (INC EXC NS)
Study eligibility requires subjects to meet all inclus on criteria (YES) and Not meet exclusion criteria (NO). 
Inclusion Criteria
# Inclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
1.a 1 Male or female part cipants 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)IN01A00
1.b 2 Participants who are willing and able to comply w th all scheduled vis ts, vaccination plan, 
laboratory tests, lifestyle cons derat ons, and other study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and 
clinical judgment of the investigator to be eligible for inclusion in the studyIN03A00
1.d 4 Capable of giving personal signed informed  consent, which includes compliance with the 
requirements and restr ctions listed in the ICD and in this protocolIN04A00
Inclusion Criteria Entry
1.1 Inclusion Number:
[Inclusion Number] 
1
2
3
4
1.2 Cr terion Description:
[Criter on Descript on] 
1.3 Cr terion met?
[Criter on met?] 
YES
NO
Describe details if relevan t
1.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
IN01A00
IN02A0 0
IN03A00
IN04A00
Exclusion Criteria
# Exclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
2.a 1 Other medical or psychiatric condition incl. recent (within past year) or active suicidal 
deation/behavior/lab abnormal ty that may increase the risk of study participationEX01A00
2.b 2 Known infection w th human immunodeficiency virus (HIV), hepatitis C virus (HCV), or 
hepatitis B virus (HBV)EX02A00
2.c 3 History of severe adverse reaction associated with a vaccine and/or severe allergic 
reaction (eg, anaphylaxis) to any component of the study intervention(s)EX03A00
2.d 4 Receipt of medicat ons intended to prevent COVID-19 EX04A00
2.e 5 Stages 1 and 2 only: Prev ous clinical or microbiolog cal diagnosis of COVID-19 EX05A00
2.f 8 Immunocompromised indiv duals w th kn own or suspected immunodeficiency, as 
determined by history and/or laboratory/phys cal examinationEX08A00
2.g 9 Individuals with a history of autoimmune disease or an active autoimmune disease 
requiring therapeutic interventionEX09A00
2.h 10 Bleeding diathesis or condition associated  w th prolonged bleeding that would, in the 
opinion of the investigator, contraindicate intramuscular inject onEX10A00
2.i 11 Women who are pregnant or breastfeeding EX11A00
2.j 12 Previous vaccinat on with any coronavirus vaccine EX12A00
2.k 13 Subjects who receive immunosuppressive therapy, such as cytotox c agents or systemic 
cort costeroidsEX13A01
2.l 15 Receipt of blood/plasma products or immunoglobulin, from 60 days before study 
intervention administrat on or planned receipt throughout the studyEX14A01
2.m 16 Participation in other studies involving study intervention w thin 28 days pr or to study 
entry and/or during study participationEX15A01
2.n 17 Previous part cipation in other studies involving study intervent on containing lip d 
nanopart clesEX16A01
2.o 22 Investigator s te staff or Pfizer employees directly involved in the conduct of the study, 
site staff otherwise supervised by the investigator, and their respective family membersEX21A01
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number] 
2.2 Cr terion Description:
[Criter on Descript on] 
2.3 Cr terion met?
[Criter on met?] 
YES
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NO
2.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
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C4591001: INCLUSION/EXCLUSION CRITERIA (INC EXC S)
Study eligibility requires subjects to meet all inclus on criteria (YES) and Not meet exclusion criteria (NO). 
Inclusion Criteria
# Inclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
1.a 1 Male or female part cipants 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)IN01A00
1.b 2 Participants who are willing and able to comply w th all scheduled vis ts, vaccination plan, 
laboratory tests, lifestyle cons derat ons, and other study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and 
clinical judgment of the investigator to be eligible for inclusion in the studyIN03A00
1.d 4 Capable of giving personal signed informed  consent, which includes compliance with the 
requirements and restr ctions listed in the ICD and in this protocolIN04A00
Inclusion Criteria Entry
1.1 Inclusion Number:
[Inclusion Number] 
1
2
3
4
1.2 Cr terion Description:
[Criter on Descript on] 
1.3 Cr terion met?
[Criter on met?] 
YES
NO
Describe details if relevan t
1.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
IN01A00
IN02A0 0
IN03A00
IN04A00
Exclusion Criteria
# Exclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
2.a 1 Other medical or psychiatric condition incl. recent (within past year) or active suicidal 
deation/behavior/lab abnormal ty that may increase the risk of study participationEX01A00
2.b 2 Known infection w th human immunodeficiency virus (HIV), hepatitis C virus (HCV), or 
hepatitis B virus (HBV)EX02A00
2.c 3 History of severe adverse reaction associated with a vaccine and/or severe allergic 
reaction (eg, anaphylaxis) to any component of the study intervention(s)EX03A00
2.d 4 Receipt of medicat ons intended to prevent COVID-19 EX04A00
2.e 5 Stages 1 and 2 only: Prev ous clinical or microbiolog cal diagnosis of COVID-19 EX05A00
2.f 6 Sentinel participants in Stage 1 only: Individuals at high risk for severe COVID-19 (full 
details in protocol)EX06A01
2.g 7 Sentinel participants in Stage 1 only: Individuals currently working in occupations with 
high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response 
personnel)EX07A00
2.h 8 Immunocompromised indiv duals w th kn own or suspected immunodeficiency, as 
determined by history and/or laboratory/phys cal examinat onEX08A00
2.i 9 Sentinel participants in Stage 1 only: Individuals w th a history of autoimmune disease or 
an active autoimmune disease requiring therapeut c interventionEX09A04
2.j 10 Bleeding diathesis or condition associated  w th prolonged bleeding that would, in the 
opinion of the investigator, contraindicate intramuscular inject onEX10A00
2.k 11 Women who are pregnant or breastfeeding EX11A00
2.l 12 Previous vaccinat on with any coronavirus vaccine EX12A00
2.m 13 Subjects who receive immunosuppressive therapy, such as cytotox c agents or systemic 
cort costeroidsEX13A01
2.n 14 Sentinel participants in Stage 1 only: Regular receipt of inhaled/nebulized corticosteroids EX22A01
2.o 15 Receipt of blood/plasma products or immunoglobulin, from 60 days before study 
intervention administrat on or planned receipt throughout the studyEX14A01
2.p 16 Participation in other studies involving study intervention w thin 28 days pr or to study 
entry and/or during study participationEX15A01
2.q 17 Previous part cipation in other studies involving study intervent on containing lip d 
nanopart clesEX16A01
2.r 18 Sentinel part cipants in Stage 1 only: Posi tive serological test for SARS-CoV-2 IgM and/or 
IgG antibodies at the screening visitEX17A01
2.s 19 Sentinel part cipants in Stage 1 only: Screening hematology/blood chemistry lab 
>=Grade 1 abnormality. Except Bilirubin, other stable Grade1 abnormalities may be considered eligible by InvestigatorEX18A01
2.t 20 Sentinel part cipants in Stage 1 only: Positive test for HIV, hepat tis B surface antigen EX19A01Page 4 6of 101 Annotated Study Book - C4591001
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(HBsAg), hepat tis B core antibodies (HBc Abs) , or hepatitis C virus antibodies (HCV Abs) 
at screening vis t
2.u 21 Sentinel participants in Stage 1 only: SARS-CoV-2 NAAT-positive nasal swab within 24 
hours before receipt of study interventionEX20A01
2.v 22 Investigator s te staff or Pfizer employees directly involved in the conduct of the study, 
site staff otherwise supervised by the investigator, and their respective family membersEX21A01
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number] 
2.2 Cr terion Description:
[Criter on Descript on] 
2.3 Cr terion met?
[Criter on met?] 
YES
Describe details if relevant
NO
2.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
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C4591001: INCLUSION/EXCLUSION CRITERIA (INC EXC S)
Study eligibility requires subjects to meet all inclus on criteria (YES) and Not meet exclusion criteria (NO). 
Inclusion Criteria
# Inclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
1.a 1 Male or female part cipants 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)IN01A00
1.b 2 Participants who are willing and able to comply w th all scheduled vis ts, vaccination plan, 
laboratory tests, lifestyle cons derat ons, and other study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and 
clinical judgment of the investigator to be eligible for inclusion in the studyIN03A00
1.d 4 Capable of giving personal signed informed  consent, which includes compliance with the 
requirements and restr ctions listed in the ICD and in this protocolIN04A00
Inclusion Criteria Entry
1.1 Inclusion Number:
[Inclusion Number] 
1
2
3
4
1.2 Cr terion Description:
[Criter on Descript on] 
1.3 Cr terion met?
[Criter on met?] 
YES
NO
Describe details if relevan t
1.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
IN01A00
IN02A0 0
IN03A00
IN04A00
Exclusion Criteria
# Exclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
2.a 1 Other medical or psychiatric condition incl. recent (within past year) or active suicidal 
deation/behavior/lab abnormal ty that may increase the risk of study participationEX01A00
2.b 2 Known infection w th human immunodeficiency virus (HIV), hepatitis C virus (HCV), or 
hepatitis B virus (HBV)EX02A00
2.c 3 History of severe adverse reaction associated with a vaccine and/or severe allergic 
reaction (eg, anaphylaxis) to any component of the study intervention(s)EX03A00
2.d 4 Receipt of medicat ons intended to prevent COVID-19 EX04A00
2.e 5 Stages 1 and 2 only: Prev ous clinical or microbiolog cal diagnosis of COVID-19 EX05A00
2.f 6 Sentinel participants in Stage 1 only: Individuals at high risk for severe COVID-19 EX06A00
2.g 7 Sentinel participants in Stage 1 only: Individuals currently working in occupations with 
high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response personnel)EX07A00
2.h 8 Immunocompromised indiv duals w th kn own or suspected immunodeficiency, as 
determined by history and/or laboratory/phys cal examinat onEX08A00
2.i 9 Individuals w th a history of autoimmune disease or an active autoimmune disease 
requiring therapeutic interventionEX09A00
2.j 10 Bleeding diathesis or condition associated  w th prolonged bleeding that would, in the 
opinion of the investigator, contraindicate intramuscular inject onEX10A00
2.k 11 Women who are pregnant or breastfeeding EX11A00
2.l 12 Previous vaccinat on with any coronavirus vaccine EX12A00
2.m 13 Individuals who receive immunosuppressive therapy, such as cytotoxic agents or 
systemic corticosteroids. Inhaled/nebulized, Intra-art cular, intrabursal, or topical cort costeroids are permittedEX13A00
2.n 14 Receipt of blood/plasma products or immunoglobulin, from 60 days before study 
intervention administrat on or planned receipt throughout the studyEX14A00
2.o 15 Participation in other studies involving study intervention w thin 28 days pr or to study 
entry and/or during study participationEX15A00
2.p 16 Previous part cipation in other studies involving study intervent on containing lip d 
nanopart clesEX16A00
2.q 17 Sentinel part cipants in Stage 1 only: Posi tive serological test for SARS-CoV-2 IgM and/or 
IgG antibodies at the screening visitEX17A00
2.r 18 Sentinel part cipants in Stage 1 only: Screening hematology/blood chemistry lab 
>=Grade 1 abnormality. Except Bilirubin, other stable Grade1 abnormalities may be 
considered eligible by InvestigatorEX18A00
2.s 19 Sentinel part cipants in Stage 1 only: Positive test for HIV, hepat tis B surface antigen 
(HBsAg), hepat tis B core antibodies (HBc Abs) , or hepatitis C virus antibodies (HCV Abs) 
at screening vis tEX19A00Page 48 of 101 Annotated Study Book - C4591001
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2.t 20 Sentinel participants in Stage 1 only: SARS-CoV-2 NAAT-positive nasal swab within 24 
hours before receipt of study interventionEX20A00
2.u 21 Investigator s te staff or Pfizer employees directly involved in the conduct of the study, 
site staff otherwise supervised by the investigator, and their respective family membersEX21A00
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number] 
2.2 Cr terion Description:
[Criter on Descript on] 
2.3 Cr terion met?
[Criter on met?] 
YES
Describe details if relevan t
NO
2.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
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C4591001: INCLUSION/EXCLUSION CRITERIA (INC EXC S)
Study eligibility requires subjects to meet all inclus on criteria (YES) and Not meet exclusion criteria (NO). 
Inclusion Criteria
# Inclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
1.a 1 Male or female part cipants 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)IN01A00
1.b 2 Participants who are willing and able to comply w th all scheduled vis ts, vaccination plan, 
laboratory tests, lifestyle cons derat ons, and other study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and 
clinical judgment of the investigator to be eligible for inclusion in the studyIN03A00
1.d 4 Capable of giving personal signed informed  consent, which includes compliance with the 
requirements and restr ctions listed in the ICD and in this protocolIN04A00
Inclusion Criteria Entry
1.1 Inclusion Number:
[Inclusion Number] 
1
2
3
4
1.2 Cr terion Description:
[Criter on Descript on] 
1.3 Cr terion met?
[Criter on met?] 
YES
NO
Describe details if relevan t
1.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
IN01A00
IN02A0 0
IN03A00
IN04A00
Exclusion Criteria
# Exclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
2.a 1 Other medical or psychiatric condition incl. recent (within past year) or active suicidal 
deation/behavior/lab abnormal ty that may increase the risk of study participationEX01A00
2.b 2 Known infection w th human immunodeficiency virus (HIV), hepatitis C virus (HCV), or 
hepatitis B virus (HBV)EX02A00
2.c 3 History of severe adverse reaction associated with a vaccine and/or severe allergic 
reaction (eg, anaphylaxis) to any component of the study intervention(s)EX03A00
2.d 4 Receipt of medicat ons intended to prevent COVID-19 EX04A00
2.e 5 Stages 1 and 2 only: Prev ous clinical or microbiolog cal diagnosis of COVID-19 EX05A00
2.f 6 Sentinel participants in Stage 1 only: Individuals at high risk for severe COVID-19 (full 
details in protocol)EX06A01
2.g 7 Sentinel participants in Stage 1 only: Individuals currently working in occupations with 
high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response 
personnel)EX07A00
2.h 8 Immunocompromised indiv duals w th kn own or suspected immunodeficiency, as 
determined by history and/or laboratory/phys cal examinat onEX08A00
2.i 9 Individuals w th a history of autoimmune disease or an active autoimmune disease 
requiring therapeutic interventionEX09A00
2.j 10 Bleeding diathesis or condition associated  w th prolonged bleeding that would, in the 
opinion of the investigator, contraindicate intramuscular inject onEX10A00
2.k 11 Women who are pregnant or breastfeeding EX11A00
2.l 12 Previous vaccinat on with any coronavirus vaccine EX12A00
2.m 13 Subjects who receive immunosuppressive therapy, such as cytotox c agents or systemic 
cort costeroidsEX13A01
2.n 14 Sentinel participants in Stage 1 only: Regular receipt of inhaled/nebulized corticosteroids EX22A01
2.o 15 Receipt of blood/plasma products or immunoglobulin, from 60 days before study 
intervention administrat on or planned receipt throughout the studyEX14A01
2.p 16 Participation in other studies involving study intervention w thin 28 days pr or to study 
entry and/or during study participationEX15A01
2.q 17 Previous part cipation in other studies involving study intervent on containing lip d 
nanopart clesEX16A01
2.r 18 Sentinel part cipants in Stage 1 only: Posi tive serological test for SARS-CoV-2 IgM and/or 
IgG antibodies at the screening visitEX17A01
2.s 19 Sentinel part cipants in Stage 1 only: Screening hematology/blood chemistry lab 
>=Grade 1 abnormality. Except Bilirubin, other stable Grade1 abnormalities may be considered eligible by InvestigatorEX18A01
2.t 20 Sentinel part cipants in Stage 1 only: Positive test for HIV, hepat tis B surface antigen EX19A01Page 5 0of 101 Annotated Study Book - C4591001
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(HBsAg), hepat tis B core antibodies (HBc Abs) , or hepatitis C virus antibodies (HCV Abs) 
at screening vis t
2.u 21 Sentinel participants in Stage 1 only: SARS-CoV-2 NAAT-positive nasal swab within 24 
hours before receipt of study interventionEX20A01
2.v 22 Investigator s te staff or Pfizer employees directly involved in the conduct of the study, 
site staff otherwise supervised by the investigator, and their respective family membersEX21A01
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number] 
2.2 Cr terion Description:
[Criter on Descript on] 
2.3 Cr terion met?
[Criter on met?] 
YES
Describe details if relevant
NO
2.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
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C4591001: CASEBOOK SIGNATURE FORM (INVSIG)
Casebook Signature Form
1. Casebook Signature
[Casebook Signature] 
Click Here to EnablePage 5 2of 101 Annotated Study Book - C4591001
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C4591001: CENTRAL LAB SAMPLE COLLECTION (LAB)
Central Lab Sample Collection
1. Collection Date:
[Collect on Date:] 
 / 
 / 
2. Specimen Type:
[Specimen Type] 
BLOO D
Lab Test
# Category for Lab Test Subcategory for Lab Test Lab Sub-Panel Collected
3.a CLINICAL CHEMISTRY BLOOD CHEMISTRY
3.b HEMATOLOGY DIFFERENTIAL
Lab Test Entry3.1 Lab Panel:
[Category for Lab Test] 
HEMATOLOGY
CLINICAL CHEMISTR Y
3.2 Lab Sub-Panel:
[Subcategory for Lab Test] 
DIFFERENTIAL
BLOOD CHEMISTRY
3.3 Was the lab sub-panel collected?:
[Lab Sub-Panel Collected] 
YES
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C4591001: CENTRAL LAB SAMPLE COLLECTION - BASELINE (LAB BSL)
Central Lab Sample Collection
1. Collection Date:
[Collect on Date:] 
 / 
 / 
2. Specimen Type:
[Specimen Type] 
BLOO D
Lab Test
# Category for Lab Test Subcategory for Lab Test Lab Sub-Panel Collected
3.a CLINICAL CHEMISTRY BLOOD CHEMISTRY
3.b CLINICAL CHEMISTRY VIROLOGY
3.c HEMATOLOGY DIFFERENTIAL
Lab Test Entry3.1 Lab Panel:
[Category for Lab Test] 
HEMATOLOGY
CLINICAL CHEMISTRY
3.2 Lab Sub-Panel:
[Subcategory for Lab Test] 
DIFFERENTIAL
BLOOD CHEMISTRY
VIROLOGY
3.3 Was the lab sub-panel collected?:
[Lab Sub-Panel Collected] 
YES
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C4591001: LOCAL LABORATORY DATA - REPEATING CHEMISTRY (LAB CHEM) - Repeating Form
# Category for Lab Test Vendor Name Collection Date: Specimen Type Lab Result
1
Lab Chemistry Details
1. Lab Panel:
[Category for Lab Test] 
CLINICAL CHEMISTR Y
2. Laboratory Name and Address
[Vendor Name] 
3. Collection Date:
[Collect on Date:] 
 / 
 / 
4. Specimen Type:
[Specimen Type] 
BLOO D
Lab Result
#
Sponsor-Defined Identifier Test: Result: Not Done: Lab Normal Range
5.a C Reactive Protein_PX329
Lab Result Entry5.1 Sponsor ID:
[Sponsor-Defined Identifier] 
5.2 Test:
[Test:] 
C Reactive Protein_PX329
5.3 Result:
[Result:] 
5.4 Not Done: [hidden]
[Not Done:] 
NOT DONE
5.5 LNMT
[Lab Normal Range] Low
High
Un t
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C4591001: LOCAL LABORATORY DATA - REPEATING CHEMISTRY (LAB CHEM) - Repeating Form
# Category for Lab Test Vendor Name Collection Date: Specimen Type Lab Result
1
Lab Chemistry Details
1. Lab Panel:
[Category for Lab Test] 
CLINICAL CHEMISTR Y
2. Laboratory Name and Address
[Vendor Name] 
3. Collection Date:
[Collect on Date:] 
 / 
 / 
4. Specimen Type:
[Specimen Type] 
BLOO D
Lab Result
#
Sponsor-Defined Identifier Test: Result: Not Done: Lab Normal Range
5.a C Reactive Protein_PX329
5.b Alanine Aminotransferase_PX30
5.c Aspartate Aminotransferase_PX28
5.d Alkaline Phosphatase_PX35
5.e Bilirubin_PX21
5.f Blood Urea Nitrogen_PX47
5.g Creatinine_PX48
Lab Result Entry5.1 Sponsor ID:
[Sponsor-Defined Identifier] 
5.2 Test:
[Test:] 
5.3 Result:
[Result:] 
5.4 Not Done:
[Not Done:] 
NOT DON E
5.5 LNMT
[Lab Normal Range] Low
High
Un t
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C4591001: LOCAL LABORATORY DATA - REPEATING Hematology (LAB HEM) - Repeating Form
# Category for Lab Test Vendor Name (DERIVED) Collection Date: Specimen Type Lab Result
1
Laboratory Data Hematology
1. Lab Panel:
[Category for Lab Test] 
HEMATOLOG Y
2. Laboratory Name and Address
[Vendor Name (DERIVED)] 
3. Collection Date:
[Collect on Date:] 
 / 
 / 
4. Specimen Type:
[Specimen Type] 
BLOO D
Lab Result
#
Sponsor-Defined Identifier Test: Result: Not Done: Lab Normal Range
5.a Hemoglobin_PX1
5.b Hematocrit_PX2
5.c Erythrocytes_PX3
5.d Platelets_PX5
5.e Leukocytes_PX7
5.f Neutrophils_PX608
5.g Eosinophils_PX609
5.h Monocytes_PX612
5.i Basophils_PX610
5.j Lymphocytes_PX611
Lab Result Entry5.1 Sponsor ID:
[Sponsor-Defined Identifier] 
5.2 Test:
[Test:] 
5.3 Result:
[Result:] 
5.4 Not Done:
[Not Done:] 
NOT DONE
5.5 LNMT
[Lab Normal Range] Low
High
Unt
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C4591001: LAB URINALYSIS - PREGNANCY TEST (LAB PREG)
Lab Urinalysis
1. Lab Panel:
[Category for Lab Test] 
URINALYSIS
2. Lab Sub-Panel:
[Subcategory for Lab Test] 
PREGNANC Y
3. Collection Date:
[Collect on Date:] 
 / 
 / 
4. Laboratory Name and Address (Derived) 
[Vendor Name (DERIVED)] 
5. Specimen Type:
[Specimen Type] 
URINE
Lab Result
# Sponsor-Defined Identifier Test: Result: Not Done:
6.a Chor ogonadotropin Beta_PX113
Lab Result Entry6.1 Sponsor ID:
[Sponsor-Defined Identifier] 
6.2 Test:
[Test:] 
Chor o gonadotro pin Beta_PX11 3
6.3 Result:
[Result:] 
NEGATIVE
POSITIV E
6.4 Not Done:
[Not Done:] 
NOT DONEPage 58 of 101 Annotated Study Book - C4591001
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C4591001: MEDICATION ERROR (MED ERROR) - Repeating Form
# Category Medication 
ErrorStart 
DateIs the medication 
error Still 
OngoingStudy 
Medication 
Errors ActionConcomitant 
Medication GivenNon-Drug 
Treatment 
GivenCaused Study 
DiscontinuationMedication Error 
Associated With 
AESerious 
Adverse Event 
Number
1
Medication Error
1. Category:
[Category] 
MEDICATION ERROR
2. Medication Error (Type 
of Medication Error):
[Med cat on Error] 
3. If this is a dispensing 
error, record the incorrect container 
number that was 
dispensed/administered 
to the subject: [hidden]
[Incorrect package ID] 
4. Start Date:
[Start Date] 
/ 
  / 
5. Is the med cation error 
still ongoing?
[Is the med cat on error 
Still Ongoing] 
YES
NO
End Date:
 / 
 / 
6. Latest Action Taken 
with Study Treatment:
[Study Medication 
Errors Act on] 
NO ACTION TAKEN
PERMANENTLY DISCONTINUED
7. Was a Concomitant 
Med cation given?[Concom tant 
Med cat on Given] 
YES
NO
8. Was a Non-Drug 
Treatment given?[Non-Drug Treatment 
Given] 
YES
NO
9. D d the Medication Error 
cause the subject to be 
discontinued from the 
study?
[Caused Study 
Discontinuat on] 
YES
NO
10. Was this medication 
error associated with any adverse events?
[Med cat on Error 
Associated With AE] 
YES
AE ID:
AE ID:
AE ID:
AE ID:
AE ID:
NO
11. Ser ous Adverse Event 
Number: For Pfizer Use 
Only
[Serious Adverse Event 
Number] 
12. Comparison Term 
[hidden]
[Comparison Term] 
13. Lowest Level Term 
[hidden]
[Lowest Level Term] 
14. Lowest Level Term 
Code [hidden]
[Lowest Level Term Code] 
15. D ctionary-Derived 
Term [hidden]
[D ctionary-Derived 
Term] Page 59 of 101 Annotated Study Book - C4591001
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16. Preferred Term Code 
[hidden]
[Preferred Term Code] 
17. High Level Term 
[hidden][High Level Term] 
18. High Level Term Code 
[hidden]
[High Level Term Code] 
19. High Level Group Term 
[hidden][High Level Group 
Term] 
20. High Level Group Term 
Code [hidden]
[High Level Group Term 
Code] 
21. Primary System Organ 
Class [hidden]
[Primary System Organ 
Class] 
22. Primary System Organ 
Class Code [hidden]
[Primary System Organ Class Code] Page 6 0of 101 Annotated Study Book - C4591001
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C4591001: GENERAL MEDICAL HISTORY (MEDHX)
Line/MH Number Medical History Term Start Date Ongoing
1.
Medical History Details Entry
1.1 Line/MH Number:
[Line/MH Number] 
1.2 Disease/Syndrome/Surgery/Non-
Drug Allergies/Drug Allergies:
[Medical History Term] 
1.3 Start Date:
[Start Date] 
/ 
  / 
1.4 Ongoing:
[Ongoing] 
YES
NO
End Date:
 / 
 / 
1.5 Comparison Term [hidden]
[Comparison Term] 
1.6 Lowest Level Term [hidden]
[Lowest Level Term] 
1.7 Lowest Level Term Code 
[hidden]
[Lowest Level Term Code] 
1.8 Dict onary Derived Term 
[hidden][Dictionary Derived Term] 
1.9 Preferred Term Code [hidden]
[Preferred Term Code] 
1.10 High Level Term [hidden]
[High Level Term] 
1.11 High Level Term Code [hidden]
[High Level Term Code] 
1.12 High Level Group Term [hidden]
[High Level Group Term] 
1.13 High Level Group Term Code 
[hidden]
[High Level Group Term Code] 
1.14 Primary System Organ Class 
[hidden][Primary System Organ Class] 
1.15 Primary System Organ Class 
Code [hidden]
[Primary System Organ Class 
Code] Page 61 of 101 Annotated Study Book - C4591001
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C4591001: OXYGENATION PARAMETERS (OXYGEN) - Repeating Form
# Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen)
1
Oxygenation Parameters
1. Date Time of Assessment:
[Date Time of Assessment] 
 / 
  / 
 : 
  24-hour clock
2. Arterial Blood Gases PaO2 
(mmHg):
[Arterial Blood Gases PaO2] 
3. FiO2 (Fract on of Inhaled 
Oxygen):[FiO2 (Fraction of Inhaled 
Oxygen)] Page 6 2of 101 Annotated Study Book - C4591001
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C4591001: PHYSICAL EXAMINATION (PHYS EXAM)
Physical Examination
1. Exam Date:
[Exam Date] 
 / 
  / 
Physical Examination Result
# Body System Examined Result
2.a GENERAL APPEARANCE2.b SKIN2.c HEAD2.d EYES2.e EARS2.f NOSE2.g THROAT2.h HEART2.i LUNGS2.j ABDOMEN2.k MUSCULOSKELETAL2.l EXTREMITIES2.m NEUROLOGICAL
2.n LYMPH NODES
Physical Examination Result Entry
2.1 Body System Examined:
[Body System Examined] 
2.2 Result:
[Result] 
NORMAL
ABNORMAL
If abnormal findings, specify: (If clinically signif cant, record on the Medical History or Adverse Event CRF as appropriate).
Are there clinically signif cant findings?
YES
NO
NOT DONEPage 6 3of 101 Annotated Study Book - C4591001
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C4591001: ELECTRONIC SAMPLE TRACKING - PRIOR COVID-19 INFECTION (PRIORCOV19)
Electronic Sample Tracking
1. Data Origin
[Data Origin] 
SITE
2. Sample Type
[Sample Type] 
SERUM
3. Sample Collected?
[Sample Collected] 
NO
YES
Date of Collect on:
 / 
 / 
4. If no sample was collected or 
sample was not collected 
according to protocol, please 
provide reason:
[Reason sample not collected] 
Sample ID
5.
Aliquot Entry
Please enter barcode for each aliquot.5.1 Sample ID
[Sample ID] Page 6 4of 101 Annotated Study Book - C4591001
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C4591001: CONCOMITANT MEDICATIONS - PROHIBITED (PROHIB CM) - Repeating Form
# Sponsor-Defined 
IdentifierCategory for 
MedicationConcomitant Medications Pre-
specifiedName of 
MedicationDose 
DescriptionDose 
UnitDose 
FrequencyRoute Start 
DateOngoing
1
Concomitant Medications
1. What is the medication dentifier?
[Sponsor-Defined Identifier] 
2. Category:
[Category for Medication] 
CONCOMITANT IMMUNOSUPPRESSIVE THERAP Y
CORTICOSTEROIDS
IMMUNOGLOBULINS
3. Concomitant Medications Pre-specified:
[Concom tant Medications Pre-specified] 
NO
4. Med cation:
Prov de the complete gener c drug name 
(including salt form, where applicable). Where 
generic name is unknown, enter the full trade or 
proprietary name. Include clarifying information 
in the Med cat on text (e.g., Ingredient(s), 
route, use, formulation).
[Name of Medication] 
5. Dose:
[Dose Description] 
6. Dose Unit:
[Dose Unit] 
7. Dose Frequency:
[Dose Frequency] 
8. Route:
[Route] 
9. Start Date:
[Start Date] 
 / 
 / 
10. Ongoing?
[Ongoing] 
YES
NO
End Date:
/ 
  / 
11. Comparison Term [hidden]
[Comparison Term] 
12. Standardized Med cat on Name - Dict onary 
derived. [hidden]
[Standardized Med cat on Name] 
13. Standardized Med cat on Code - D ctionary 
derived [hidden]
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C4591001: RADIATION TREATMENT (PROHIB ND) - Repeating Form
# Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Ongoing?
1
Radiation Treatment
1. Category:
[Category] 
RADIATION THERAP Y
2. What is the treatment Identifier?
[Treatment Identifier] 
3. Concomitant Non-drug Treatment Pre-specified:
[Con Non-Drug Treatments Pre-specified] 
YES
4. Treatment:
[Treatment] 
5. Start Date:
[Start Date] 
 / 
  / 
6. Ongoing?
[Ongoing?] 
YES
NO
End Date:
/ 
  / 
7. Comparison Term [hidden]
[Comparison Term] 
8. Lowest Level Term [hidden]
[Lowest Level Term] 
9. Lowest Level Term Code [hidden]
[Lowest Level Term Code] 
10. D ctionary Derived Term [hidden]
[D ctionary Derived Term] 
11. Preferred Term Code [hidden]
[Preferred Term Code] 
12. High Level Term [hidden]
[High Level Term] 
13. High Level Term Code [hidden]
[High Level Term Code] 
14. High Level Group Term [hidden]
[High Level Group Term] 
15. High Level Group Term Code [hidden]
[High Level Group Term Code] 
16. Primary System Organ Class [hidden]
[Primary System Organ Class] 
17. Primary System Organ Class Code [hidden]
[Primary System Organ Class Code] Page 6 6of 101 Annotated Study Book - C4591001
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C4591001: VITAL SIGNS - PULSE OX ROOM AIR (PULSE OX) - Repeating Form
#D ate: Vital Signs Details
1
Vital Signs
1. Date:
[Date:] 
 / 
  / 
Vital Signs Details
#
Record Identifier: Oxygen Saturation
2.a 1
Vital Signs Details Entry2.1 Record Identifier:
[Record Identifier:] 
1
2.2 SPO2 Pulse Oximetry %
[Oxygen Saturation] Page 67 of 101 Annotated Study Book - C4591001
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C4591001: RANDOMIZATION (RAND)
Disposition
1. Randomizat on Date :
[Randomization Date :] 
/ 
 / 
2. Randomizat on Number:
[Randomization Number] 
3. Randomizat on Group:
[Randomization Group] Page 68 of 101 Annotated Study Book - C4591001
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C4591001: REACTOGENICITY DIARY (REAC DIARY)
Reactogenicity Diary
1. Select appropriate response -
Reactogen c ty diary collection
[Trigger Response 9] 
YES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJEC T
NO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECTPage 69 of 101 Annotated Study Book - C4591001
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C4591001: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC EVENT (REACTION)
Unplanned Assessment Of Local Reaction
1. CISR Category [hidden]
[CISR Category] 
UNPLANNED ASSESSMENT OF LOCAL REACTION/SYSTEMIC EVEN T
2. Date of Assessment:
[Date of Assessment] 
 / 
  / 
3. Injection Site Location
[Injection S te Location] 
DELTOID MUSCL E
4. Injection Site Body S de:
[Injection S te Body Side] 
LEFT
RIGH T
Reaction
#R eaction: Reaction Present:
5.a REDNESS5.b SWELLING
Reaction Entry5.1 Reaction:
[React on:] 
REDNESS
SWELLING
5.2 Reaction Present:
[React on Present:] 
YES
Maximum Diameter (cm):
Minimum Diameter (cm):
Meets Grade 4 Reaction Cr teria:
YES
NO
NO
Symptom
#S ymptom: Symptom Present:
6.a PAIN AT INJECTION SITE
6.b FATIGUE/TIREDNESS6.c HEADACHE6.d VOMITING6.e DIARRHEA6.f NEW OR WORSENED MUSCLE PAIN6.g NEW OR WORSENED JOINT PAIN6.h CHILLS
Symptom Entry6.1 Symptom:
[Symptom:] 
6.2 Symptom Present:
[Symptom Present:] 
YES
Symptom Grade:
1
2
3
4
Event related to Stud y Treament ?
YES
NO
NOPage 7 0of 101 Annotated Study Book - C4591001
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C4591001: RESPIRATORY TREATMENT (RESP TX) - Repeating Form
# Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Ongoing?
1
Respiratory Treatment
1. What is the treatment Identifier?
[Treatment Identifier] 
2. Concomitant Non-drug Treatment Pre-specified:
[Con Non-Drug Treatments Pre-specified] 
YES
3. Treatment:
[Treatment] 
INTUBATIO N
NON-INVASIVE POSITIVE PRESSURE VENTILATION
CPAP
OXYGEN THERAP Y
4. Treatment:
[Treatment] 
5. Start Date:
[Start Date] 
 / 
  / 
6. Ongoing?
[Ongoing?] 
YES
NO
End Date:
/ 
 / 
7. Comparison Term [hidden]
[Comparison Term] 
8. Lowest Level Term [hidden]
[Lowest Level Term] 
9. Lowest Level Term Code [hidden]
[Lowest Level Term Code] 
10. D ctionary Derived Term [hidden]
[D ctionary Derived Term] 
11. Preferred Term Code [hidden]
[Preferred Term Code] 
12. High Level Term [hidden]
[High Level Term] 
13. High Level Term Code [hidden]
[High Level Term Code] 
14. High Level Group Term [hidden]
[High Level Group Term] 
15. High Level Group Term Code [hidden]
[High Level Group Term Code] 
16. Primary System Organ Class [hidden]
[Primary System Organ Class] 
17. Primary System Organ Class Code [hidden]
[Primary System Organ Class Code] Page 71 of 101 Annotated Study Book - C4591001
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C4591001: RESPIRATORY TREATMENT (RESP TX) - Repeating Form
# Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Ongoing?
1
Respiratory Treatment
1. What is the treatment Identifier?
[Treatment Identifier] 
2. Concomitant Non-drug Treatment Pre-specified:
[Con Non-Drug Treatments Pre-specified] 
YES
3. Treatment:
[Treatment] 
NON-INVASIVE POSITIVE PRESSURE VENTILATION
CPAP
MECHANICAL VENTILATIO N
EXTRACORPOREAL MEMBRANE OXYGENATIO N
HIGH FLOW OXYGEN THERAP Y
4. Treatment:
[Treatment] 
5. Start Date:
[Start Date] 
 / 
 / 
6. Ongoing?
[Ongoing?] 
YES
NO
End Date:
/ 
  / 
7. Comparison Term [hidden]
[Comparison Term] 
8. Lowest Level Term [hidden]
[Lowest Level Term] 
9. Lowest Level Term Code [hidden]
[Lowest Level Term Code] 
10. D ctionary Derived Term [hidden]
[D ctionary Derived Term] 
11. Preferred Term Code [hidden]
[Preferred Term Code] 
12. High Level Term [hidden]
[High Level Term] 
13. High Level Term Code [hidden]
[High Level Term Code] 
14. High Level Group Term [hidden]
[High Level Group Term] 
15. High Level Group Term Code [hidden]
[High Level Group Term Code] 
16. Primary System Organ Class [hidden]
[Primary System Organ Class] 
17. Primary System Organ Class Code [hidden]
[Primary System Organ Class Code] Page 7 2of 101 Annotated Study Book - C4591001
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C4591001: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB (RSWAB)
Electronic Sample Tracking
1. Data Origin
[Data Origin] 
SITE
2. Sample Type
[Sample Type] 
NASAL_SWAB
NASAL_SWAB_SEL F
3. Sample Collected?
[Sample Collected] 
NO
YES
Date of Collect on:
 / 
 / 
4. If no sample was collected or 
sample was not collected 
according to protocol, please 
provide reason:
[Reason sample not collected] 
Sample ID
5.
Aliquot Entry
Please enter barcode for each aliquot.5.1 Sample ID
[Sample ID] Page 7 3of 101 Annotated Study Book - C4591001
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C4591001: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY (SAMP TRK)
Electronic Sample Tracking
1. Data Origin
[Data Origin] 
SITE
2. Sample Type
[Sample Type] 
SERUM
3. Sample Collected?
[Sample Collected] 
NO
YES
Date of Collect on:
 / 
 / 
4. If no sample was collected or 
sample was not collected 
according to protocol, please 
provide reason:
[Reason sample not collected] 
Sample ID
5.
Aliquot Entry
Please enter barcode for each aliquot.5.1 Sample ID
[Sample ID] Page 7 4of 101 Annotated Study Book - C4591001
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C4591001: INFORM SCREENING (SCREEN)
InForm Screening
1. InForm Initials [hidden]
[InForm Initials] 
2. Birth Date:
[Birth Year] 
 / 
  / 
Page 7 5of 101 Annotated Study Book - C4591001
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C4591001: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF (SELF SWAB)
Electronic Sample Tracking
1. Data Origin
[Data Origin] 
SITE
2. Sample Type
[Sample Type] 
NASAL_SWAB_SELF
3. Sample Collected?
[Sample Collected] 
NO
YES
Date of Collect on:
 / 
 / 
4. If no sample was collected or 
sample was not collected 
according to protocol, please 
provide reason:
[Reason sample not collected] 
Sample ID
5.
Aliquot Entry
Please enter barcode for each aliquot.5.1 Sample ID
[Sample ID] Page 7 6of 101 Annotated Study Book - C4591001
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C4591001: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 (SOD)
Signs and Symptoms
1. Date of Assessment:
[Date of assessment] 
 / 
  / 
2. Date of First Symptom Started:
[First Symptom Started Date] 
 / 
  / 
3. Symptoms Ongoing?
[Symptoms Ongoing] 
YES
NO
Date of Last Symptom Resolved:
 / 
 / 
Symptoms
#
Event Pre-specified Symptoms Symptom Present
4.a YES FEVER
4.b YES LOSS OF TASTE/SMELL4.c YES NEW OR INCREASED COUGH 4.d YES NEW OR INCREASED NASAL CONGESTION4.e YES NEW OR INCREASED NASAL DISCHARGE4.f YES NEW OR INCREASED SHORTNESS OF BREATH4.g YES NEW OR INCREASED SORE THROAT4.h YES NEW OR INCREASED SPUTUM PRODUCTION4.i YES NEW OR INCREASED WHEEZING
Symptoms Entry4.1 Event Pre-specified: [hidden]
[Event Pre-specified] 
YES
4.2 Symptoms:
[Symptoms] 
4.3 Was symptom present?
[Symptom Present] 
YES
NO
Symptoms - Other
5.

Symptoms - Other Entry5.1 Symptoms - Other Text:
[Symptoms - Other] 
5.2 Comparison Term: [hidden]
[Comparison Term] 
5.3 Lowest Level Term [hidden]
[Lowest Level Term] 
5.4 Lowest Level Term Code 
[hidden]
[Lowest Level Term Code] 
5.5 Dict onary Derived Term 
[hidden][Dictionary Derived Term] 
5.6 Preferred Term Code [hidden]
[Preferred Term Code] 
5.7 High Level Term [hidden]
[High Level Term] 
5.8 High Level Term Code 
[hidden][High Level Term Code] 
5.9 High Level Group Term 
[hidden][High Level Group Term] 
5.10 High Level Group Term Code 
[hidden]
[High Level Group Term Code] 
5.11 Primary System Organ Class 
[hidden][Primary System Organ Class] 
5.12 Primary System Organ Class 
Code [hidden]
[Primary System Organ Class Page 77 of 101 Annotated Study Book - C4591001
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Code] Page 78 of 101 Annotated Study Book - C4591001
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C4591001: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 (SOD)
Signs and Symptoms
1. Date of Assessment:
[Date of assessment] 
 / 
  / 
2. Date of First Symptom Started:
[First Symptom Started Date] 
 / 
  / 
3. Symptoms Ongoing?
[Symptoms Ongoing] 
YES
NO
Date of Last Symptom Resolved:
 / 
 / 
Symptoms
#
Event Pre-specified Symptoms Symptom Present
4.a YES FEVER
4.b YES NEW OR INCREASED COUGH 4.c YES NEW OR INCREASED SHORTNESS OF BREATH4.d YES CHILLS4.e YES NEW OR INCREASED MUSCLE PAIN4.f YES NEW LOSS OF TASTE OR SMELL4.g YES NEW OR INCREASED SORE THROAT4.h YES DIARRHEA4.i YES VOMITING
Symptoms Entry4.1 Event Pre-specified: [hidden]
[Event Pre-specified] 
YES
4.2 Symptoms:
[Symptoms] 
4.3 Was symptom present?
[Symptom Present] 
YES
NO
Symptoms - Other
5.

Symptoms - Other Entry5.1 Symptoms - Other Text:
[Symptoms - Other] 
5.2 Comparison Term: [hidden]
[Comparison Term] 
5.3 Lowest Level Term [hidden]
[Lowest Level Term] 
5.4 Lowest Level Term Code 
[hidden]
[Lowest Level Term Code] 
5.5 Dict onary Derived Term 
[hidden][Dictionary Derived Term] 
5.6 Preferred Term Code [hidden]
[Preferred Term Code] 
5.7 High Level Term [hidden]
[High Level Term] 
5.8 High Level Term Code 
[hidden][High Level Term Code] 
5.9 High Level Group Term 
[hidden][High Level Group Term] 
5.10 High Level Group Term Code 
[hidden]
[High Level Group Term Code] 
5.11 Primary System Organ Class 
[hidden][Primary System Organ Class] 
5.12 Primary System Organ Class 
Code [hidden]
[Primary System Organ Class Page 79 of 101 Annotated Study Book - C4591001
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Code] Page 8 0of 101 Annotated Study Book - C4591001
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C4591001: STRATIFICATION (STRAT)
Stratification
1. Select appropriate response -
Randomizat on Stage
[Trigger Response 3] 
Non-Sentinel Sta ge 1
2. Select appropriate response -
Randomizat on Age Group
[Trigger Response 4] 
Age 18 to 55
Age 65 to 85
3. Select appropriate response -
Randomizat on Dose[Trigger Response 5] 
10 mcg
20 mc g
30 mcg
4. Select appropriate response -
Randomizat on Dose Group[Trigger Response 8] 
21 Day
60 Day
5. Select appropriate response -
BNT Number[Trigger Response 7] 
(BNT162b1 or PBO)
(BNT162b2 or PBO)
(BNT162b3 or PBO)Page 81 of 101 Annotated Study Book - C4591001
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C4591001: STRATIFICATION (STRAT)
Stratification
1. Select appropriate response -
Randomizat on Stage
[Trigger Response 3] 
Stage 1
Stage 2
2. Select appropriate response -
Randomizat on Age Group
[Trigger Response 4] 
Age 18 to 55
Age 56 to 85
Age 65 to 8 5
3. Select appropriate response -
Randomizat on Dose
[Trigger Response 5] 
Low dose level (3mcg)
Medium dose level (10mcg)
High dose level (30mcg)
Low dose level (10mcg)
Medium dose level (30mc g)
High dose level (100mcg)
Low dose level (0.1mcg)
Medium dose level (0.3mcg)
High dose level (1mcg)
Mid-High dose level (50mc g)
Low-Mid dose level (20mcg)
4. Select appropriate response -
Randomizat on Dose Group 
[hidden]
[Trigger Response 6] 
21 Da y 2-dose group
60 Day 2-dose group
1-dose group
5. Select appropriate response -
Randomizat on Dose Group
[Trigger Response 8] 
21 Da y
60 Day
6. Select appropriate response -
BNT Number[Trigger Response 7] 
(BNT162a1 or PBO)
(BNT162b1 or PBO)
(BNT162b2 or PBO )
(BNT162c2 or PBO)
(BNT162b3 or PBO )Page 8 2of 101 Annotated Study Book - C4591001
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C4591001: STRATIFICATION (STRAT)
Stratification
1. Select appropriate response -
Randomizat on Stage
[Trigger Response 3] 
Stage 2
2. Select appropriate response -
Randomizat on Age Group
[Trigger Response 4] 
Age 18 to 55
Age 56 to 85
3. Select appropriate response -
Randomizat on Dose[Trigger Response 5] 
10 mcg
20 mc g
30 mcg
4. Select appropriate response -
BNT Number[Trigger Response 7] 
(BNT162b1 or PBO)
(BNT162b2 or PBO)
(BNT162b3 or PBO)Page 8 3of 101 Annotated Study Book - C4591001
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C4591001: SUBJECT STATUS (SUB STATU)
Subject Status
1. Subject Status
[Subject Status] 
2. Subject Status Date
[Status Date] 
 / 
  / 
Page 8 4of 101 Annotated Study Book - C4591001
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C4591001: ELECTRONIC SAMPLE TRACKING - NASAL SWAB (SWAB PFE)
Electronic Sample Tracking
1. Data Origin
[Data Origin] 
SITE
2. Sample Type
[Sample Type] 
NASAL_SWAB
3. Sample Collected?
[Sample Collected] 
NO
YES
Date of Collect on:
 / 
 / 
4. If no sample was collected or 
sample was not collected 
according to protocol, please 
provide reason:
[Reason sample not collected] 
Sample ID
5.
Aliquot Entry
Please enter barcode for each aliquot.5.1 Sample ID
[Sample ID] Page 8 5of 101 Annotated Study Book - C4591001
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C4591001: MICROBIOLOGY SPECIMEN (SWAB SITE) - Repeating Form
# Date of Collection Specimen Type Specimen Collection Location Assay Code and Description Device Type Trade Name Result Comments:
1
Microbiology Specimen
1. Actual Date of Collection:
[Date of Collection] 
 / 
  / 
2. Specimen Type:
[Specimen Type] 
SWABBED MATERIAL
3. Specimen Collection Location:
[Specimen Collection Location] 
NASAL CAVITY
4. Assay Code and Description:
[Assay Code and Description] 
SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5. Device Type:
[Device Type] 
SARS-CO V-2 DIAGNOSTIC TES T
6. Trade Name:
[Trade Name] 
CEPHEID XPERT XPRESS SARS-COV-2 TEST
7. Test Result:
[Result] 
POSITIVE
NEGATIVE
INDETERMINATE
8. Comments/Findings/Details:
[Comments:] Page 8 6of 101 Annotated Study Book - C4591001
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C4591001: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES (SYMPRDATE)
Vaccination Symptoms Diary - Symptom Resolved Dates
1. Were medications to treat 
fever/pain given on the last day 
the Subject Diary was 
completed?[Fever/Pain Medication on Last 
Diary Day] 
YES
Ongoing?
YES
NO
Stop Date:
/ 
  / 
NO
# Symptom: Were fever or systemic symptoms present on the last day the Subject Diary was completed?
2.a FEVER
2.b FATIGUE2.c HEADACHE2.d CHILLS2.e VOMITING2.f DIARRHEA2.g NEW OR WORSENED MUSCLE PAIN2.h NEW OR WORSENED JOINT PAIN
2.1 Symptom:
[Symptom:] 
2.2 Were fever or system c 
symptoms present on the last 
day the Subject Diary was 
completed?
[Were fever or systemic 
symptoms present on the last 
day the Subject Diary was 
completed?] 
YES
Ongoing?
YES
NOStop Date:
/ 
  / 
NO
3. Injection Site Location:
[Injection S te Location:] 
DELTOID MUSCLE
4. Injection Site Body S de:
[Injection S te Body Side:] 
LEFT
RIGHT
# Injection Site Reaction: Were injection site reactions present on the last day the Subject Diary was completed?
5.a REDNESS
5.b SWELLING5.c PAIN AT INJECTION SITE
5.1 Injection Site React on:
[Injection Site Reaction:] 
REDNESS
SWELLING
PAIN AT INJECTION SITE
5.2 Were injection s te reactions 
present on the last day the 
Subject Diary was completed?
[Were inject on site reactions 
present on the last day the 
Subject Diary was completed?] 
YES
Ongoing?
YES
NOStop Date:
/ 
  / 
NOPage 87 of 101 Annotated Study Book - C4591001
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C4591001: TRANSFUSIONS (TRANSFUSE) - Repeating Form
#T ransfusion Type Date of Transfusion
1
1. Transfus on Type:
[Transfus on Type] 
PACKED RBC
PLATELETS
WHOLE BLOOD
PLASM A
OTHER
Specify:
2. Date of Transfus on:
[Date of Transfusion] 
 / 
  / 
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C4591001: TREATMENT UNBLINDED (TRN UNBLN)
Treatment Unblinded
1. Date Treatment Unblinded :
[Date Treatment Unblinded :] 
/ 
 / 
2. Primary Reason for Unblinding:
[Primary Reason for Unblinding] 
SUBJECT SAFETY CONCER N
OTHER 
If other, s pecify:Page 89 of 101 Annotated Study Book - C4591001
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C4591001: UNPLANNED VISIT (UNPL)
Unplanned Assessments
1. Assessments
[Assessments] 
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C4591001: VACCINATION (VACIN TRT)
Vaccination
1. Was there a 
temporary 
delay of 
vaccinat on?[Temporary 
Delay of 
Vaccination] 
YES
Date of First Delay:
 / 
  / 
Reason (s) for Tem porary Delay of Vaccination
FEVER OR ACUTE ILLNESS
RECENT SYSTEMIC CORTICOSTEROID TREATMEN T
RECENT NO N-STUDY VACCINATION
ANTICIPATED NO N-STUDY VACCINATION
NO
2. Treatment 
Name
[Treatment 
Name] 
3. Formulat on:
[Formulat on:] 
INJECTION
4. Dose Date 
Time:[Dose Date 
Time:] 
 / 
 / 
 : 
 24-hour clock
5. Anatomical 
Locat on:[Anatomical 
Locat on:] 
DELTOID MUSCLE
6. Body Side:
[Body S de:] 
LEFT
RIGHT
7. Route:
[Route:] 
INTRAMUSCULAR
8. Container 
Number: [hidden]
[PAC / K t 
Number:] 
9. Actual Dose:
[Actual Dose:] 
10. Unit:
[Unit:] 
mL
11. Timeframe 
Subject Was 
Observed
[Timeframe 
Subject Was 
Observed] 
THE PROTOCOL SPECIFIED OBSERVATION PERIO D
12. Was the 
subject 
observed for at 
least the 
protocol 
specified 
observation 
period after 
investigational 
product 
administration?
[Observed Post 
Dose For 
Specified Time] 
YES
NO
If No, specify reason:
13. Comparison 
Term [hidden]
[Comparison 
Term] 
14. Standardized 
Med cation Name -
D ctionary 
Derived. 
[hidden]
[Standardized 
Med cation 
Name] 
15. Standardized 
Med cation 
Code -
D ctionary 
Derived 
[hidden]Page 91 of 101 Annotated Study Book - C4591001
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[Standardized 
Med cation 
Code] Page 9 2of 101 Annotated Study Book - C4591001
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C4591001: VACCINATION (VACIN TRT)
Vaccination
1. Was there a 
temporary 
delay of 
vaccinat on?[Temporary 
Delay of 
Vaccination] 
YES
Date of First Delay:
 / 
  / 
Reason (s) for Tem porary Delay of Vaccination
FEVER OR ACUTE ILLNESS
RECENT SYSTEMIC CORTICOSTEROID TREATMEN T
RECENT NO N-STUDY VACCINATION
ANTICIPATED NO N-STUDY VACCINATION
NO
2. Treatment 
Name
[Treatment 
Name] 
3. Formulat on:
[Formulat on:] 
INJECTION
4. Dose Date 
Time:[Dose Date 
Time:] 
 / 
 / 
 : 
 24-hour clock
5. Anatomical 
Locat on:[Anatomical 
Locat on:] 
DELTOID MUSCLE
6. Body Side:
[Body S de:] 
LEFT
RIGHT
7. Route:
[Route:] 
INTRAMUSCULAR
8. Planned Dose:
[Planned Dose] 
9. Planned Dose 
Unit:[Planned Dose 
Unit] 
ug
10. Actual Dose:
[Actual Dose:] 
11. Unit:
[Unit:] 
ug
12. Was the Actual 
Dose adjusted from planned?
[Dose Adjusted 
From Planned] 
YES
What was the reason the dose was adjusted?
ADVERSE EVENT (S)
INSUFFICIENT CLINICAL RESPONS E
OTHER SPECIF Y
If other, s pecify:
NO
13. Timeframe 
Subject Was 
Observed
[Timeframe 
Subject Was 
Observed] 
THE PROTOCOL SPECIFIED OBSERVATION PERIOD
14. Was the 
subject observed for at 
least the 
protocol 
specified 
observation 
period after 
investigational 
product administration?
[Observed Post 
Dose For 
Specified Time] 
YES
NO
If No, specify reason:
15. Comparison 
Term [hidden]
[Comparison 
Term] 
16. Standardized 
Med cation 
Name -Page 9 3of 101 Annotated Study Book - C4591001
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D ctionary 
Derived. 
[hidden]
[Standardized 
Med cation 
Name] 
17. Standardized 
Med cation 
Code -
D ctionary 
Derived 
[hidden]
[Standardized 
Med cation 
Code] Page 9 4of 101 Annotated Study Book - C4591001
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C4591001: CONCOMITANT MEDICATIONS - VASOPRESSORS (VASOPRESS) - Repeating Form
# Sponsor-Defined Identifier Category for Medication Concomitant Medications Pre-specified Name of Medication Start Date Ongoing
1
Concomitant Medications
1. What is the medication identifier?
[Sponsor-Defined Identifier] 
2. Category:
[Category for Med cat on] 
GENERAL CONCOMITANT MEDICATIONS
3. Concomitant Medications Pre-specified:
[Concomitant Medications Pre-specified] 
NO
4. Medication:
Provide the complete gener c drug name 
(including salt form, where applicable). Where 
generic name is unknown, enter the full trade 
or proprietary name. Include clarifying 
information in the Med cat on text (e.g., Ingredient(s), route, use, formulation).
[Name of Medication] 
5. Start Date:
[Start Date] 
 / 
 / 
6. Ongoing?
[Ongoing] 
YES
NO
End Date:
/ 
  / 
7. Comparison Term [hidden]
[Comparison Term] 
8. Standardized Medicat on Name - Dict onary 
derived. [hidden]
[Standardized Med cat on Name] 
9. Standardized Med cat on Code - Dictionary 
derived [hidden]
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C4591001: VITAL SIGNS - TEMP (VITAL TEMP)
Vital Signs
1. Date:
[Date:] 
 / 
  / 
Vital Signs Details
# Record Identifier: Temperature Temperature Unit Temperature Location:
2.a 1
Vital Signs Details Entry2.1 Record Identifier:
[Record Identifier:] 
1
2.2 Temperature:
[Temperature] 
2.3 Unit:
[Temperature Unit] 
F
C
2.4 Temperature Location:
[Temperature Location:] 
ORAL CAVITY
EAR
RECTU M
AXILLA
FOREHEADPage 9 6of 101 Annotated Study Book - C4591001
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C4591001: VITAL SIGNS - BASELINE (VITALS BSL)
Vital Signs
1. Date:
[Date:] 
 / 
  / 
2. Weight:
[Weight] 
3. Un t:
[Weight Unit] 
kg
LB
4. Height:
[Height] 
5. Un t:
[Height Un t] 
cm
in
6. Body Mass Index:
[Body Mass Index] 
Vital Signs Details
# Record Identifier: Temperature Temperature Unit Temperature Location:
7.a 1
Vital Signs Details Entry7.1 Record Identifier:
[Record Identifier:] 
1
7.2 Temperature:
[Temperature] 
7.3 Unit:
[Temperature Unit] 
C
F
7.4 Temperature Location:
[Temperature Location:] 
ORAL CAVITY
EAR
RECTUM
AXILL A
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C4591001: VITAL SIGNS - BASELINE (VITALS BSL)
Vital Signs
1. Date:
[Date:] 
 / 
  / 
2. Weight:
[Weight] 
3. Un t:
[Weight Unit] 
kg
LB
4. Height:
[Height] 
5. Un t:
[Height Un t] 
cm
in
6. Body Mass Index:
[Body Mass Index] 
Vital Signs Details
# Record Identifier: Temperature Temperature Unit Temperature Location: Systolic: Diastolic: BP Position Pulse:
7.a 1 SITTING
Vital Signs Details Entry7.1 Record Identifier:
[Record Identifier:] 
1
7.2 Temperature:
[Temperature] 
7.3 Unit:
[Temperature Unit] 
C
F
7.4 Temperature Location:
[Temperature Location:] 
ORAL CAVITY
EAR
RECTUM
AXILL A
FOREHEAD
7.5 Systol c:
[Systolic:] 
7.6 Diastol c:
[Diastol c:] 
7.7 BP Posit on:
[BP Position] 
SITTING
7.8 Pulse:
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C4591001: VITAL SIGNS - COVID (VITALS COV) - Repeating Form
#D ate: Vital Signs Details
1
Vital Signs
1. Date:
[Date:] 
 / 
  / 
Vital Signs Details
#
Record Identifier: Systolic: Diastolic: Respiratory Rate in respirations/minute Heart Rate in beats/minute
2.a 1
Vital Signs Details Entry2.1 Record Identifier:
[Record Identifier:] 
1
2.2 Systol c:
[Systolic:] 
2.3 Diastol c:
[Diastol c:] 
2.4 Respiratory Rate in 
respirations/minute:
[Respiratory Rate in 
respirations/minute] 
2.5 Heart Rate in beats/minute:
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C4591001: VITAL SIGNS (VITALS FUP)
Vital Signs
1. Date:
[Date:] 
 / 
  / 
Vital Signs Details
# Record Identifier: Temperature Temperature Unit Temperature Location: Systolic: Diastolic: BP Position Pulse:
2.a 1 SITTING
Vital Signs Details Entry2.1 Record Identifier:
[Record Identifier:] 
1
2.2 Temperature:
[Temperature] 
2.3 Unit:
[Temperature Unit] 
F
C
2.4 Temperature Location:
[Temperature Location:] 
ORAL CAVITY
EAR
RECTU M
AXILLA
FOREHEAD
2.5 Systol c:
[Systolic:] 
2.6 Diastol c:
[Diastol c:] 
2.7 BP Posit on:
[BP Position] 
SITTING
2.8 Pulse:
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C4591001: WITHDRAWAL OF CONSENT (WOC)
Withdrawal Of Consent
1. Withdrawal of Consent Date :
[Withdrawal of Consent Date :] 
/ 
 / 
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A-1426 -0086 /  App Subject Facing Screen Report  26-OCT -2020  
C4591001 -Post -12-July-2020  English (USA) enUS  Version 4 
 
Page 1 of 57 A-1426 -0086 / C4591001 -Post -12-July-
2020  
App Subject Facing Screen Report  
Localized texts are displayed in English (US).  
Contents  
1 Notifications / Subject card ................................ ................................ ................................ .. 2 
2 Common  ................................ ................................ ................................ ...........................  5 
3 Form: Vaccination Diary  ................................ ................................ ................................ .....22 
4 Form: COVID -19 Illness Diary  ................................ ................................ .............................. 37 
5 Form: Patient main menu  ................................ ................................ ................................ ...40 
6 Form: Subject training diary  ................................ ................................ ................................ 47 
7 Form: Settings  ................................ ................................ ................................ .................. 54 
8 Form: Security question  ................................ ................................ ................................ .....55 
 
 
 
 
 
 
 
 
 
 
 
 
 
Localized months and days of the week will display throughtout the app.  
Month  January  February  March  April  May  June  July August  September  October  November  December  
Abbr.  Jan Feb Mar  Apr May  Jun Jul Aug Sep Oct Nov Dec 
 Days  Monday  Tuesday  Wednesday  Thursday  Friday  Saturday  Sunday  
Abbr.  Mon  Tue Wed  Thu Fri Sat Sun 
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Page 2 of 57 Note : Text below the screens/messages is for information purposes only and gives instruction on 
when particular wording on a screen/message may display or what a computed value may display  
 
1 Notifications / Subject card  
 
Email notification/ Subject card to provisioned device subjects : 
 
Welcome to the C4591001 -Post -12-July-2020  study!  
 
Email notification only: [ Hello, ] 
 
The information below will guide you on how to start using the TrialMax App.  
 
On the phone provided to you by the study clinic, open the TrialMax  App and type in the 
following code to activate it:  
[Activation Code]  
 
Then log in with your temporary PIN provided by your study clinic personnel. You will be asked to 
change the PIN to a new personal one.  
 
During your study clinic visit, the study person nel will help you with any questions related to the 
TrialMax App activation.  
 
You must activate the App with the provided activation code during your study clinic visit. If you 
need any help with the activation, contact your study clinic or the Helpdesk.  
 
If you contact your study clinic or the Helpdesk, you may need to give the following information:  
 
Subject card only: [ Participant number: XXXXXXXX ] 
 
Subject card only: [ Site number: XXXX ] 
 
Trial ID: C4591001 -Post -12-July-2020  
 
 
Email notification only: [ ----------  
This is an automatic e -mail message sent by Signant Health, an electronic patient diary provider 
for clinical trials. This email message and its contents are for the sole use of the intended 
recipient(s) and may contai n confidential and privileged information. Any unauthorized review, 
use, disclosure or distribution is strictly prohibited. Please do not reply to this email; the email 
address cannot receive messages. If you need any assistance, please contact the Helpdes k. ] 
 
 
 
 
 
SMS Body for Provisioned Devices : 
Welcome to the C4591001 -Post -12-July-2020 Study! Activate the TrialMax App with code:  
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Page 3 of 57 [Activation Code]  
 
 
 
Email notification/Subject card to BYOD subjects:  
 
Welcome to the C4591001 -Post -12-July-2020  study!  
 
Email notification only: [ Hello,  ] 
 
The information below will guide you on how to install the TrialMax App onto your cell phone 
and how to start using the TrialMax App after the installation.  
 
Email notification only: [ To install the TrialMax App, tap the link below and follow the on -screen 
instructions.  ] 
 
Subject card only: [ To install the TrialMax App, tap the link in the installation text message (SMS) 
or email you will receive in a few mi nutes, and follow the on -screen instructions.  
 
If you have not received the text message or email, enter the following internet address into the 
web browser of your device:  ] 
[Link]  
 
After the installation has completed, open the TrialMax App and type in the following code to 
activate it:  
[Activation Code]  
 
Then log in with your temporary PIN provided by your study clinic personnel. You will be asked to 
change the PIN to a new personal  one.  
 
During your study clinic visit, the study clinic personnel will help you with any questions related 
to the TrialMax App installation.  
 
You must activate the App with the provided activation code during your study clinic visit. If you 
need any help w ith the installation, contact your study clinic or the Helpdesk.  
 
If you contact your study clinic or the Helpdesk, you may need to give the following information:  
 
Subject card only: [ Participant number: XXXXXXXX ] 
 
Subject card only: [ Site number: XXXX  ] 
 
Trial ID: C4591001 -Post -12-July-2020  
 
Email notification only: [ ----------  
This is an automatic e -mail message sent by Signant Health, an electronic patient diary provider 
for clinical trials. This email message and its contents are for the sole use of the intended 
recipient(s) and may contain confidential and privileged informat ion. Any unauthorized review, 
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Page 4 of 57 use, disclosure or distribution is strictly prohibited. Please do not reply to this email; the email 
address cannot receive messages. If you need any assistance, please contact the Helpdesk. ] 
 
 
 
 
 
SMS  Body  for BYOD subjects:  
 
Welcome to the C4591001 -Post -12-July-2020  Study!  To install the TrialMax App, select the link :  
[Link]  
Activate the TrialMax App with code:  
[Activation Code]  
 
 
 
App notification:  
 
Please fill in your diary!  
 
 
 
 
Email notification subject : 
COVID -19 Illness Diary Reminder  
 
Email and SMS Body for COVID -19 Illness Diary Reminder : 
 
Please continue to complete the illness diary weekly or if you experience COVID -19 symptoms or 
have a COVID -19 diagnosis. Contact your study doctor with any suspected COVID -19 symptoms.  
 
Email notification only: [ ----------  
This is an automatic e -mail me ssage sent by Signant Health, an electronic patient diary provider 
for clinical trials. This email message and its contents are for the sole use of the intended 
recipient(s) and may contain confidential and privileged information. Any unauthorized review, 
use, disclosure or distribution is strictly prohibited. Please do not reply to this email; the email 
address cannot receive messages. If you need any assistance, please contact the Helpdesk. ] 
 
 
 
 
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Page 5 of 57 2 Common  
 
 
Screen 1   
Screen 2  
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Screen 3   
Screen 4  
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Screen 5   
Screen 6  
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Screen 7    
Screen 8  
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Screen 9   
Screen 10  
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Screen 11  
  
Screen 12  
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Screen 13   
Screen 14  
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Screen 15   
Screen 16  
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Screen 17   
Screen 18  
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Screen 19   
Screen 20  
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Screen 21  
 
Screen 22  
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Screen 23   
Screen 24  
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Screen 25   
Screen 26  
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Screen 27  
  
Screen 28  
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Screen 29  
 
Screen 30  
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Screen 31   
Screen 32  
 
 
 
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Page 21 of 57 Message 1  
 Note: Other messages that could appear on 
the device include : 
‘Invalid PIN’  
‘Installing study questions’  
‘Securing study questions’  
 ‘Unsent answers’  
‘There are a lot of unsent study answers. Please 
make sure your device is connected to the 
Internet.’  
‘The limit of unsent study answers has been 
reached. Please connect your device to the 
Internet to fill in the diary again.’  
‘Oops!’  
‘Something went wrong, please try again or 
contact the Help desk.’  
‘Unsuccessful sending’  
‘Cannot safely send the study answers, please 
contact the Help desk.’  
‘Study ended’  
‘You no longer need to fill in the diary. Thank 
you for your help. ’ 
‘Updating’  
‘Syste m is updating, please try again later.’  
‘Connection error’  
‘No Internet connection. Please check your 
Internet connection and try again.’  
‘Time out’  
‘Please check your Internet connection and try 
again.’  
‘Low storage space’  
‘Your device is running out of available storage. 
Please free some storage space and try again.’  
‘Error’  
‘Something went wrong, please contact the 
Help desk or click OK to try again. ’ 
 
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Page 22 of 57 3 Form: Vaccination Diary  
 
Screen 1  
[Computed] Text will display “ Hello, welcome to 
the vaccination diary. You will be answering the 
following questions about how you have been 
feeling since your vaccination on {1}. You will 
answer these questions for {2} day(s) .” 
{1} Will display a date  
{2} Will display a number of days.  
Example: Hello, welcome to the vaccination 
diary. You will be answering the following 
questions about how you have been feeling 
since your vaccination on Mar -27-2020. You will 
answer these questions for 7 day(s).   
Message 1  
 
  
Screen 3  
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Message 1   
Message 2  
 
Message 3   
Screen 4  
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Message 3   
Screen 5  
[Computed] will display the temperature 
selected on Screen 3 or Screen 4  
 
 
Message 1   
Screen 6  
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Message 2   
Screen 7  
 
Message 2   
Screen 8  
[Computed] will display the number selected on 
Screen 7.  
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Screen 9   
Screen 10  
 
Screen 11  
[Computed] will display the number selected on 
Screen 10.   
Screen 12  
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Screen 13   
Screen 14  
 
Message 2   
Message 4  
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Screen 15   
Screen 16  
 
Screen 17   
Screen 18  
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Message 2   
Screen 19  
 
Screen 20   
Screen 21  
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Screen 22   
Screen 23  
 
Screen 24   
Screen 25  
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Screen 26   
Message 2  
 
Screen 27   
Screen 28  
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Screen 29   
Screen 30  
 
Message 2   
Screen 31  
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Screen 32   
Screen 33  
 
Screen 34   
Screen 35  
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Screen 36   
Screen 37  
 
Screen 38   
Screen 39  
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Screen 40   
Screen 41  
 
Screen 42   
Screen 43  
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Screen 44   
Message 2  
 
Screen 45  
[Computed] will display “Please continue to fill 
out your diary for the next {1} day(s).”  
Where {1} = a number of days  
Example: Please continue to fill out your diary 
for the next 4 day(s).   
Screen 46  
[Computed] will display “Please continue to fill 
out your diary for the next {1} day(s).”  
Where {1} = a number of days  
Example: Please continue to fill out your diary 
for the next 4 day(s).  
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Page 37 of 57 4 Form: COVID -19 Illness Diar y 
 
Screen 1   
Message 1  
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Message 2   
Message 3  
 
Screen 2   
Message 1  
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Message 2   
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Page 40 of 57 5 Form: Patient main menu  
 
Screen 1   
Message 1  
 
Screen 2   
Message 1  
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Screen 3  
First [Computed] will show ‘ Old reminder time:  
{1}’ where {1} will be the old reminder time  
Second [Computed] will show ‘ New reminder 
time: {1} ’ where {1} will be the new reminder 
time   
Screen 4  
First [Computed] text below Hello, will either 
display:  “<b>You are being reminded to 
complete your weekly COVID -19 Illness 
Diary.</b> ” or “<b>You are being reminded to 
complete your daily <u>Vaccination 
Diary</u>.</b> ” 
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Page 42 of 57  
 Second [Computed] text below Hello, will either 
display:  “You have completed today's 
Vaccination Diary. ”,  “You have completed 
today's Vaccination Diary. Please remember t o 
log in again tomorrow. " or “Please fill in your 
daily Vaccination Diary before midnight. ” 
[Computed] text within the button will read: 
“Update Symptoms” or “ <b>Vaccination 
Diary</b> ” 
 
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Message 1  
Device text will format out the leading 0’s and 
seconds. Actual popup will read “6:00 PM and 
11:59 PM”   
Message 2  
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Screen 5   
 
Message 2  
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Message 3   
 
Message 5  
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Message 9   
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Page 47 of 57 6 Form: Subject training diary  
 
Screen 1   
Message 1  
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Screen 2   
 
Screen 3  
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Screen 4  
[Computed] will display ‘Your reminder time is 
{1}.’, where {1} will be the selected diary 
reminder time .  
Screen 5  
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Screen 6   
Screen 7  
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Screen 8   
Screen 9  
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Message 1   
Screen 10  
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Screen 11   
Screen 12  
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Page 54 of 57 7 Form: Settings  
 
Screen 1   
Popup input 1  
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Page 55 of 57 8 Form: Security question  
 
Screen 1  
[Computed] will show one of the following:  
‘Your oldest sibling’s birth year (YY)’  
‘Your mother’s birth year (YY)’  
‘Last two digits of your childhood phone number’  
‘Day of the month of your father’s birthday’  
‘Day of the  month of your mother’s birthday’  
‘Childhood home door number (2 digits only)’  
‘How old were you when you passed your driving 
test?’  
‘The year you got married (YY)’   
Message 1  
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Message 2   
Screen 2  
[Computed] will display  
‘Your question:<br/><br/><b><i>{1}</i></b>’  
 {1} will show the question selected on Screen 1  
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Popup input 1   
Message 1  
 
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Page 158
Screen Report Approval A-1426-0086-5270SR
Version: 3 Date: 2-Oct-2020
Confidential © 2020 Signant Health.  Template Version: 4 Page 1 of 1
SCREEN REPORT APPROVAL 
Content for Approval
Language English for United States
Subject screen report A-1426-0086-5270SR_enUS Version 3 Date 02-Oct- 2020
CUSTOMER
Approval
Name and Title: Kimberly Rarrick Signature:
Company: Pfizer Role: Study Manager Date:
SIGNANT HEALTH
Approval
Name: Brittany Hayes Signature:
Title: Project Manager III Date:
  	 

  	 

090177e19533c1ac\Approved\Approved On: 12-Oct-2020 12:43 (GMT) 
Page 159
FDA-CBER-2021-5683-0024440
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 English (USA) enUS  Version 2 
 
Page 1 of 52 ǦͳͶʹ͸ǦͲͲͺʹȀͶͷͻͳͲͲͳ
’’—„Œ‡…–	ƒ…‹‰…”‡‡‡’‘”–
Localized texts are displayed in English (US). 
Contents 
 
1 Notifications / Subject card ................................ ............................................................... ................... 2 
2 Common ..................................................................................................................... .......................... 5 
3 Form: Vaccination Diary ..................................... ............................................................... ................. 22 
4 Form: Patient Main Menu ..................................... ............................................................... .............. 37 
5 Form: Subject training diary ................................ ............................................................... ................ 42 
6 Form: Settings .............................................. ............................................................... ....................... 49 
7 Form: Security  question ..................................... ............................................................... ................. 50 
 
 
  
 
 
 
  
 
 
 
 
Localized months and days of the  week will display throughtout the app. 
Month January February March April May June July August September October November December  
Abbr. Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 
 
Note : Text below the screens/messages is for information purposes o nly and gives instruction on 
when particular wording on a screen/message may display or what  a computed value may display Days Monday Tuesday Wednesday Thursday Friday Saturday Sunday 
Abbr. Mon Tue Wed Thu Fri Sat Sun 
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Page 2 of 52 1 Notifications / Subject card 
 
Email notification/ Subject card to provisioned device subjects: 
 
Welcome to the C4591001 study! 
 
Email notification only: [ Hello, ] 
 
The information below will guide you on how to start using the TrialMax App. 
 
On the phone provided to you by the study clinic, open the TrialMax App and type in the 
following code to activate it:  
[Activation Code]  
 
Then log in with your temporary PIN provided by your study clin ic personnel. You will be asked to 
change the PIN to a new personal one. During your study clinic visit, the study
 personnel will help you with any questions related to the 
TrialMax App activation. 
 
You must activate the App with the provided activation code dur ing your study clinic visit. If you 
need any help with the activation, contact your study clinic or the Helpdesk. 
 
If you contact your study clinic or the Helpdesk, you may need to give the following information: 
 Subject
 card only: [ Participant number: XXXXXXXX ] 
 
Subject  card only: [ Site number: XXXX ] 
 
Trial ID:  C4591001 
 
 Email notification only: [ 
---------- 
This is an automatic e -mail message sent by Signant Health, an electronic patient diary provider 
for clinical trials. This email message and its contents  are for the sole use of the intended 
recipient(s) and may contain confidential and privileged inform ation. Any unauthorized review, 
use, disclosure or distribution is strictly prohibited. Please do not reply to this email; the email 
address cannot receive  messages. If you need any assistance, please contact the Helpd esk. ] 
 
    
SMS 
Body for Provisioned Devices: 
Welcome to the C4591001 Study! Activate the TrialMax App with c ode:  
[Activation Code]  
 
 
 
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Page 3 of 52 Email notificati on/Subject card to BYOD subjects:  
 
Welcome to the C4591001 study! 
 
Email notification only: [ Hello, ] 
 
The information below will guide you on how to install the Tria lMax App onto your cell phone 
and how to start using the TrialMax App after the installation.  
 
Email notification only: [ To install the TrialMax App, tap the link below and follow the on-screen 
instructions.  ] 
 
Subject  card only: [ To install the TrialMax App, tap  the link in the installation t ext message (SMS) 
or email you will receive in a few minutes, and follow the on-screen instructions. 
 
If you have not received the text message or email, enter the f ollowing internet address into the 
web browser of your device:  ] 
[Link]  
 
After the installation has completed, open the TrialMax App and type in the following code to 
activate it:  
[Activation Code]  
 
Then log in with your temporary PIN provided by your study clin ic personnel. You will be asked to 
change the PIN to a new personal one.  
 
During your study clinic visit, the study clinic personnel will  help you with any questions related 
to the TrialMax App installation.  
 
You must activate the App with the provided activation code dur ing your study clinic visit. If you 
need any help with the installati on, contact your study clinic or the Helpdesk.  
 
If you contact your study clinic or the Helpdesk, you may need to give the following information: 
 Subject
 card only: [ Participant number: XXXXXXXX ] 
 
Subject  card only: [ Site number: XXXX ] 
 
Trial ID: C4591001  
 
Email notification only: [ ---------- 
This is an automatic e -mail message sent by Signant Health, an electronic patient diar y provider 
for clinical trials. This email message and its contents are for the sole use of the intended 
recipient(s) and may contain confidential and privileged inform ation. Any unauthorized review, 
use, disclosure or distribution is strictly prohibited. Please do not reply to this email; the email 
address cannot receive messages. If you need any assistance, please contact the Helpdes k. ] 
 
   
 
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Page 4 of 52 SMS Body for BYOD subjects: 
 
Welcome to the C4591001 Study!  To install the TrialMax App, select the link:  
[Link] 
Activate the TrialMax App with code:  
[Activation Code] 
 
  App notification
: 
 
Please fill in you r vaccination diary!  
 
 
 
  
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Page 5 of 52 2 Common  
 
 
Screen 1  
Screen 2 
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Screen 3  
Screen 4 
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Screen 5  
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Screen 7   
Screen 8 
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Screen 11 
  
Screen 12 
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Screen 13  
Screen 14 
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Screen 15  
Screen 16 
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Screen 17  
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Screen 19  
Screen 20 
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Screen 21 
 
Screen 22 
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Screen 23  
Screen 24 
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Screen 25  
Screen 26 
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Screen 27  
Screen 28 
   
 
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Screen 29  
Screen 30 
  
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Screen 31 Message 1 
 
  
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Page 21 of 52 Note: Other messages that could appear on the 
device include: 
‘Invalid PIN’ 
‘Installing study questions’ 
‘Securing study questions’ 
 ‘Unsent answers’ 
‘There are a lot of unsent study answers. Please 
make sure your device is connected to the 
Internet.’ 
‘The limit of unsent study answers has been 
reached. Please connect your device to the 
Internet to fill in the diary again.’ 
‘Oops!’ 
‘Something went wrong, please try again or 
contact the Help desk.’ 
‘Unsuccessful sending’ 
‘Cannot safely send the study answers, please 
contact the Help desk.’ 
‘Study ended’  
‘You no longer need to fill in the diary. Thank 
you for your help.’ 
‘Updating’ 
‘System is updating, please try again later.’ 
‘Connection error’ 
‘No Internet connection. Please check your 
Internet connection and try again.’ 
‘Time out’ 
‘Please check your Internet connection and try 
again.’ 
‘Low storage space’ 
‘Your device is running out of available storage. 
Please free some storage space and try again.’ 
‘Error’ 
‘Something went wrong, please contact the Help 
desk or click OK to try again.’  
 
 
 
 
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Page 22 of 52 3 Form: Vaccination Diary 
 
Screen 1 
 [Computed] Text will display “Hello, welcome 
to the vaccination diary. You will be answering 
the following questions about how you have 
been feeling since your vaccination on {1}. You 
will answer these questions for {2} more day(s).” 
{1} Will display a date 
{2} Will display a number of days. 
Example: Hello, welcome to the vaccination 
diary. You will be answering the following 
questions about how you have been feeling 
since your vaccination on Mar -27-2020. You will 
answer these questions for 7 more day(s).  
Message 1 
 
Screen 2   
Message 1 
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Message 2 
  
Message 3 
 
Screen 3 
[Computed] will display the temperature 
selected on Screen 2. 
 
  
Message 1  
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Screen 4 
  
Message 2 
 
Screen 5  
Message 2 
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Screen 6 
[Computed] will display the number selected on 
Screen 5.  
Screen 7 
 
Screen 8 
  
Screen 9 
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Screen 10 
  
Screen 11 
  
Screen 12 
  
Message 2 
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Message 4  
Screen 13 
 
Screen 14  
Screen 15 
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Screen 16  
Message 2 
 
Screen 17  
Screen 18 
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Screen 19  
Screen 20 
 
Screen 21  
Screen 23 
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Screen 23  
Screen 24 
 
Message 2  
Screen 25 
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Screen 26  
Screen 27 
 
Screen 28  
Message 2 
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Screen 29  
Screen 30 
 
Screen 31  
Screen 32 
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Screen 33  
Screen 34 
 
Screen 35  
Screen 36 
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Message 2  
Screen 37 
 
Screen 38  
Screen 39 
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Screen 40  
Screen 41 
 
Screen 42  
Message 2 
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Screen 43 
[Computed] will display “Please continue to fill 
out your diary for the next {1} day(s).” 
Where {1} = a number of days 
Example: Please continue to fill out your diary 
for the next 4 day(s).  
Screen 44  
[Computed] will display “Please continue to fill 
out your diary for the next {1} day(s).” 
Where {1} = a number of days 
Example: Please continue to fill out your diary 
for the next 4 day(s). 
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Page 37 of 52 4 Form: Patient Main Menu 
 
 
Screen 1  
Message 1 
 
Screen 2  
Message 1 
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Screen 3 
First [Computed] will show ‘Old reminder time: 
{1}’ where {1} will be the old reminder time 
Second [Computed] will show ‘New reminder 
time: {1} ’ where {1} will be the new reminder 
time  
Screen 4  
[Computed] text below Hello, will either display: 
“There are no Vaccination Diaries expected”, 
“You have completed today’s Vaccination 
Diary.”  “You have completed today’s 
Vaccination Diary. Please remember to log in 
again tomorrow.”, or Please fill in your 
Vaccination Diary before midnight”. The 
[Computed] text within the button will read 
“Update Symptoms” or “Vaccination Diary” 
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Message 1 
Device text will format out the leading 0’s and 
seconds. Actual popup will read “6:00 PM and 
11:59 PM”  
Message 2 
 
 
 
 
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Screen 5  
Message 2 
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Message 4  
Message 8 
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Page 42 of 52 5 Form: Subject training diary 
 
 
Screen 1  
Message 1 
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Screen 2  
 
Screen 3 
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Screen 4 
[Computed] will display ‘Your daily reminder 
time is {1}.’, where {1} will be the selected diary 
reminder time.  
Screen 5 
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Screen 6  
Screen 7 
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Screen 8  
Screen 9 
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Message 1  
Screen 10 
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Screen 11  
Screen 12 
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Page 49 of 52 6 Form: Settings 
 
 
Screen 1  
Popup input 1 
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Page 50 of 52 7 Form: Security question 
 
 
 
Screen 1 
[Computed] will show one of the following: 
‘Your oldest sibling’s birth year (YY)’ 
‘Your mother’s b irth year (YY)’ 
‘Last two digits of your c hildhood phone number’ 
‘Day of the month of your father’s birthday’ 
‘Day of the month of your mother’s birthday’  
‘Childhood home door num ber (2 digits only)’ 
‘How old were you when you passed your driving 
test?’ 
‘The year you got married (YY)’   
Message 1 
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Message 2  
Screen 2 
 [Computed] will display  
‘Your question:<br/><br/><b><i>{1}</i></b>’  
 {1} will show the question selected on Screen 1 
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Popup input 1  
Message 1 
 
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Approval A-1426-0082_5270SR_enUS_v2
Version: 1 Date: 3-Apr-2020
Confidential © 2020 Signant Health.  Template Version: 4 Page 1 of 1
SCREEN REPORT APPROVAL 
Content for Approval
Language English for United States
Site Screen Report A-1426-0082_5270SR_enUS_v2 Version 2 Date 03-Apr- 2020
CUSTOMER
Approval
Name and Title: Kathleen Snyder Signature:
Company: Pfizer Role: Study Manager Date:
SIGNANT HEALTH
Approval
Name: Brittany Hayes Signature:
Title: Project Manager II Date:

   
	
   
	
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