Document text
Annotated Stud y Book for Stud y Desi gn: C4591001
Study Design Version: 16.0
Sponsor: Pfizer
Protocol: C4591001
Sponsor Dru g Name: BLINDED THERAPY
C4591001 - COVID1 9
Generated by Central Designer TM
Februar y 22, 2021 8:10AMPage 1 of 11 5 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 EVENT
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 cloc k
6. Toxicity Grade:
[Tox c ty Grade]
1
2
3
4
7. Is the adverse event
serious?
If Yes, NOTIFY
PFIZER
IMMEDIATELY.
Fatal; Life-
threatening; Inpatient
hospitalization or
prolongat on of existing hospitalization; Persistent or
significant
disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e.
may jeopardize subject and may require medical/surgical
intervention to
prevent above outcomes).[Serious]
YES
Is this serious event associated w th congenital anomaly or birth defect?
YES
NO
D d this ser ous event result in death ?
YES
NO
Did this ser ous event require or prolong hospitalization ?
YES
NO
Did this ser ous event result in persistent or significant disabil ty/incapacity?
YES
NO
Is this serious event life threatening ?
YES
NO
Other med cally important ser ous event
YES
NO
NO
8. Is this adverse
YESPage 2 of 11 5 Annotated Study Book - C4591001
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event the result of a
study Medication Error? If Yes, record the type of med cation
error on the
Medicat on Error Log. [Is AE a Result of a Medicat on Error]
NO
9. Is this event related
to study treatment:[Relationship to Study Treatment]
NOT RELATED
If Not Related to study treatment(s), this event is due to :
CONCOMITANT DRUG TREATMENT
CONCOMITANT NON-DRUG TREATMENT
OTHER
If Other, specify :
RELATED
10. Latest Action Taken
with Study
Treatment:
[Action Taken w th Study Treatment]
DRUG WITHDRAWN
NOT APPLICABLE
11. Was a Concomitant
Medicat on given?
[Concom tant Medicat 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 RESOLVED
RECOVERED/RESOLVED
RECOVERED/RESOLVED WITH SEQUELAE
RECOVERING/RESOLVING
UNKNOWN
14. Did the adverse
event cause the subject to be discontinued from
the study?
[Caused Study Discontinuat on]
YES
NO
15. Serious Adverse
Event Number: For Pfizer Use Only[Serious Adverse
Event Number]
16. Comparison Term
[hidden]
[Comparison Term]
17. Lowest Level Term
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[Lowest Level Term]
18. Lowest Level Term
Code [hidden]
[Lowest Level Term
Code]
19. Dict onary-Derived
Term [hidden]
[Dict onary-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 4 of 11 5 Annotated Study Book - C4591001
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C4591001: INFORMED CONSENT - BOOSTER (BOOST CONS)
Informed Consent - Booster
1. Consent Was:
[Consent Was:]
OBTAINED
Date Written Consent Obtaine d
/
/
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C4591001: INCLUSION/EXCLUSION CRITERIA - BOOSTER (BOOST IE)
Criterion Description
1.
Inclusion Criteria Not Met Entry
1.1 Description of Inclus on Cr terion Not Met
[Criter on Description]
Criterion Description
2.
Exclusion Criteria Met Entry
2.1 Description of Exclusion Cr terion Met
[Criter on Description]
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C4591001: BOOSTER DOSE TRIGGER FORM (BOOST TRIG)
Booster Dose Trigger Form
1. Select appropriate response - Will the
participant return for consent/eligibility
assessment for the booster dose vis t?
[Trigger Response 13]
The participant will return for consent/eligibility assessment for the booster dose vis t
The participant will NOT return for consent/eligibil ty assessment for the booster dose visitPage 7 of 11 5 Annotated Study Book - C4591001
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C4591001: LABORATORY DATA - HEMATOLOGY (CD4)
Laboratory Da ta Hematology
1. Lab Panel:
[Category for Lab Test]
HEMATOLOGY
2. Laboratory Name and Address
[Vendor Name (DERIVED)]
3. Collect on Date:
[Collection Date:]
/
/
4. Specimen Type:
[Specimen Type]
BLOOD
Lab Result
# Sponsor-Defined Identifier Test: Result: Not Done: Lab Normal Range
5.a CD4_PX4722
Lab Result Entry
5.1 Sponsor ID:
[Sponsor-Defined Identifier]
5.2 Test:
[Test:]
CD4_PX472 2
5.3 Result:
[Result:]
5.4 Not Done: [hidden]
[Not Done:]
NOT DONE
5.5 LNMT
[Lab Normal Range] Low
High
Unit
10^3/mm3
/uL
%Page 8 of 11 5 Annotated Study Book - C4591001
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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 COHORT S
STAGE 1 NONSENTINEL COHORT S
STAGE 2 COHORT S
STAGE 3 COHORT SPage 9 of 11 5 Annotated Study Book - C4591001
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C4591001: CONCOMITANT MEDICATIONS - BASELINE (CONMED BSL) - Repeating Form
# Sponsor-Defined Identifier Category for Medication Concomitant Medications Pre-specified Name of Medication Dose Description Dose U nit Dose Frequency Route Start Date
1
Concomitant Medications
1. What is the med cation dentifier?
[Sponsor-Defined Identifier]
2. Category:
[Category for Medication]
GENERAL CONCOMITANT MEDICATIONS
3. Concomitant Med cat ons Pre-specified:
[Concom tant Medicat ons Pre-specified]
NO
4. Medicat on:
Provide the complete gener c drug name (including salt form,
where applicable). Where gener c name is unknown, enter the
full trade or proprietary name. Include clarifying information in
the Medication 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 Medication Name - Dictionary derived. [hidden]
[Standardized Medication Name]
12. Standardized Medication Code - Dict onary derived [hidden]
[Standardized Medication Code] Page 1 0of 11 5 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 med cation dentifier?
[Sponsor-Defined Identifier]
2. Category:
[Category for Medication]
VACCINATIONS
3. Concomitant Medications Pre-specified:
[Concom tant Medicat ons Pre-specified]
NO
4. Medicat on:
Provide the complete gener c drug name (including salt form,
where applicable). Where gener c name is unknown, enter the
full trade or proprietary name. Include clarifying information in
the Med cation text (e.g., Ingredient(s), route, use, formulation).[Name of Medication]
5. Date:
[Start Date]
/
/
6. Comparison Term [hidden]
[Comparison Term]
7. Standardized Medication Name - D ctionary derived. [hidden]
[Standardized Medication Name]
8. Standardized Medication Code - Dictionary derived [hidden]
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C4591001: MAIN INFORMED CONSENT (CONSENT)
Informed Consent
1. Consent Was:
[Consent Was:]
OBTAINED
Date Written Consent Obtaine d
/
/
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C4591001: CONTACT OUTCOME - MONTH 1 (CONTACT 1M)
Contact Outcome
1. Follow-Up Contact Category [hidden]
[Follow Up Contact Category]
CONTACT OUTCOME
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 3of 11 5 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 OUTCOME
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:
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C4591001: CONTACT OUTCOME (CONTACT SV)
Contact Outcome
1. Follow-Up Contact Category [hidden]
[Follow Up Contact Category]
CONTACT OUTCOME
2. Contact Type:
[Type of Contact/Visit]
TELEPHONE VISIT
3. Was contact made?
[Was Contact Made]
YES
Date of Contact :
/
/
NO
If No, why ?
4. Comments:
[Comments/Findings/Details] Page 1 5of 11 5 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 OUTCOME
2. Contact Type:
[Type of Contact/Visit]
TELEPHONE VISIT
3. Was contact made?
[Was Contact Made]
YES
Date of Contact :
/
/
Contact Outcome :
VISIT ARRANGED
VISIT ARRANGED, BUT NOT ATTENDED
VISIT NOT ARRANGED, REACTION NO LONGER PRESENT
VISIT NOT ARRANGED, UNABLE TO ATTEND
VISIT NOT REQUIRED, DATA ENTRY ERROR IN E-DIARY
VISIT NOT REQUIRED, INVESTIGATOR DECISION
NO
If No, why ?
4. Comments:
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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 Collect on:
[Date of Collect on]
/
/
2. Specimen Type:
[Specimen Type]
SERUM
BLOOD
PLASM A
3. Assay Code and Description:
[Assay Code and Description]
SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
4. Dev ce Type:
[Dev ce Type]
SARS-COV-2 DIAGNOSTIC TEST
5. Test Result:
[Result]
POSITIVE
NEGATIVE
INDETERMINATE
6. Comments/Findings/Details:
[Comments:] Page 17 of 11 5 Annotated Study Book - C4591001
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C4591001: MICROBIOLOGY SPECIMEN (COVID TEST) - Repeating Form
# Date of Collection Specimen Type Specimen Collection Location Assay Code and Description Device Type Trade Name Result Comments: Trade Name Other, Specify
1
Microbiology Specimen
1. Actual Date of Collect on:
[Date of Collect on]
/
/
2. Specimen Type:
[Specimen Type]
SWABBED MATERIAL
RESPIRATORY SECRETION S
3. Specimen Collect on Location:
[Specimen Collection Location]
NASOPHARYN X
LOWER RESPIRATORY SYSTEM
THROAT
4. Assay Code and Description:
[Assay Code and Description]
SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5. Dev ce Type:
[Dev ce Type]
SARS-COV-2 DIAGNOSTIC TEST
6. Trade Name:
[Trade Name]
7. Test Result:
[Result]
POSITIVE
NEGATIVE
INDETERMINATE
8. Comments/Findings/Details:
[Comments:]
9. Trade Name Other, Specify:
[Trade Name Other, Specify] Page 18 of 11 5 Annotated Study Book - C4591001
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C4591001: DEATH DETAILS CODED (DEATH DTL)
Death Details
1. Date of Collection / Notif cation of Death:
[Date of Collect on / Notif cation of Death]
/
/
Cause of Death Status Cause of Death
2.
Cause of Death Entry2.1 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 D ctionary-Derived Term [hidden]
[D ctionary-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 19 of 11 5 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]
FEMALE
MALE
4. Ethnicity:
[Ethn c ty]
HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
NOT REPORTED
5. Race: (Check X all that apply):
[Race Of Subject]
BLACK OR AFRICAN AMERICAN
AMERICAN INDIAN OR ALASKA NATIVE
ASIAN
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDE R
WHITE
NOT REPORTED
6. Racial Designation:
[Racial Designation]
JAPANESE
OTHE RPage 2 0of 11 5 Annotated Study Book - C4591001
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C4591001: DISPOSITION - SCREENING FOR BOOSTER DOSE (DISP BOOST)
Disposition - Screening for Booster Dose
1. Date of Completion/Discontinuation/Death :
[Date of Completion/Discontinuat on/Death :]
/
/
2. Phase of Disposit on:
[Disposition Phase]
REPEAT SCREENING 2
3. Status:
[Status]
4. Specify Status:
[Specify Status] Page 21 of 11 5 Annotated Study Book - C4591001
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C4591001: DISPOSITION - FOLLOW-UP (DISP FUP)
Disposition - Follow-Up
1. Date of Completion/Discontinuation/Death :
[Date of Completion/Discontinuat on/Death :]
/
/
2. Phase of Disposit on:
[Disposition Phase]
FOLLO W-UP
3. Status:
[Status]
4. Specify Status:
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C4591001: DISPOSITION - SCREENING FOR FURTHER VACCINATION (DISP RESCR)
Disposition - Screening for Further Vaccination
1. Date of Completion/Discontinuation/Death :
[Date of Completion/Discontinuat on/Death :]
/
/
2. Phase of Disposit on:
[Disposition Phase]
REPEAT SCREENING 1
3. Status:
[Status]
4. Specify Status:
[Specify Status] Page 2 3of 11 5 Annotated Study Book - C4591001
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C4591001: DISPOSITION - SCREENING (DISP SCR)
Disposition - Screening
1. Date of Completion/Discontinuation/Death
[Date of Completion/Discontinuat on/Death]
/
/
2. Phase of Disposit on:
[Disposition Phase]
SCREENIN G
3. Status:
[Status]
4. Specify Status:
[Specify Status] Page 2 4of 11 5 Annotated Study Book - C4591001
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C4591001: DISPOSITION - TREATMENT (DISP TRT)
Disposition - Treatment
1. Date of Completion/Discontinuation/Death :
[Date of Completion/Discontinuat on/Death :]
/
/
2. Phase of Disposit on:
[Disposition Phase]
VACCINATION
OPEN LABEL TREATMENT
SUBSTUDY
3. Status:
[Status]
4. Specify Status:
[Specify Status] Page 2 5of 11 5 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
[Vis t Error]
ERRONEOUS VISITPage 2 6of 11 5 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
[Vis t Error]
ERRONEOUS VISIT
COVID-19 Illness Visit3. COVID-19 Illness Vis t:
[COVID-19 Illness Visit]
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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
[Vis t Error]
ERRONEOUS VISIT
COVID-19 Illness Visit3. COVID-19 Illness Vis t:
[COVID-19 Illness Visit]
Page 28 of 11 5 Annotated Study Book - C4591001
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C4591001: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE (DOV SURV)
Date of Visit
1. Date of Visit
[Date of Visit]
/
/
2. Erroneous Visit
[Vis t Error]
ERRONEOUS VISIT
COVID-19 Surveillance Visit3. COVID-19 Surveillance Vis t:
[COVID-19 Surveillance 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
[Vis t 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 31 of 11 5 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 subject is known to be HIV POSITIVE
The subject is NOT known to be HIV POSITIVEPage 3 2of 11 5 Annotated Study Book - C4591001
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C4591001: LAB CHEMISTRY (HIV RNA)
Lab Chemistry Details
1. Lab Panel:
[Category for Lab Test]
CLINICAL CHEMISTRY
2. Laboratory Name and Address
[Vendor Name]
3. Collect on Date:
[Collection Date:]
/
/
4. Specimen Type:
[Specimen Type]
BLOOD
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
Unit
/mLPage 3 3of 11 5 Annotated Study Book - C4591001
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C4591001: HEALTH CARE UTILIZATION (HLTHCARE)
Health Care Utilization
1. Evaluation Interval: [hidden]
[Evaluat on Interval]
SINCE THE START OF THE RESPIRATORY ILLNESS EPISODE
2. Disease Name: [hidden]
[Disease Name]
RESPIRATORY ILLNES S
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 PHYSICIAN
3.d YES URGENT CARE
3.e YES TELEPHONE CONSULTATION3.f YES OTHER
Health Care Utilization Entry3.1 Pre-Specified: [hidden]
[Pre-Specified]
YES
3.2 Phys cian or Healthcare Professional:
[Type of Pract t oner]
SPECIALIST
EMERGENCY ROOM
PRIMARY CARE PHYSICIAN
URGENT CARE
TELEPHONE CONSULTATION
OTHE R
3.3 Occurrence of Visits or Contacts:
[Occurrence of Visits or Contacts]
YES
Number of Visits or Contacts :
NO
Health Care Utilization Other4. Other Type of Practit oner Specify:
[Other Type of Practitioner Specify]
Health Care Utilization5. Has the subject been hosp talized 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 3 4of 11 5 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. Hospitalization Category:
[Hospitalization Category]
HOSPITALIZATION STATU S
2. Hospitalization Term:
[Hospitalization Term]
ICU
HOSPITAL
3. Admission Date:
[Admission Date]
/
/
4. Ongoing?
[Ongoing]
YES
NO
Discharge Date :
/
/
Page 3 5of 11 5 Annotated Study Book - C4591001
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C4591001: ILLNESS DETAILS (ILL POTEN)
Illness Details
1. Category of Clinical Event:
[Category of Clinical Event:]
POTENTIAL COVID-19 ILLNES S
2. Was a diagnosis obtained for Potential
COVID-19 Illness?
[Diagnosis Obtained]
YES
Respiratory Illness Diagnosis :
Date of Diagnosis :
/
/
NO
3. Toxicity Grade:
[Tox c ty 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. Dict onary Derived Term [hidden]
[Dict onary 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 3 6of 11 5 Annotated Study Book - C4591001
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C4591001: ILLNESS DETAILS - SEVERE (ILL SEVERE)
Illness Details
1. Category of Clinical Event:
[Category of Clinical Event:]
SEVERE COVID-19 ILLNES S
2. Subcategory of Clinical Event:
[Subcategory of Clinical Event]
SIGNIFICANT ACUTE RENAL DYSFUNCTION
SIGNIFICANT ACUTE HEPATIC DYSFUNCTION
SIGNIFICANT ACUTE NEUROLOGIC DYSFUNCTION
3. Was a diagnosis obtained?
[Diagnosis Obtained]
YES
Diagnosis :
Start Date :
/
/
Ongoing? :
YES
NO
End Date :
/
/
NO
4. Toxicity Grade:
[Tox c ty 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. Dict onary Derived Term [hidden]
[Dict onary 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] Page 37 of 11 5 Annotated Study Book - C4591001
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15. Primary System Organ Class Code [hidden]
[Primary System Organ Class Code] Page 38 of 11 5 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 Clinical Event:]
SEVERE COVID-19 ILLNES S
2. Subcategory of Clinical Event:
[Subcategory of Clinical Event]
SIGNIFICANT ACUTE RENAL DYSFUNCTION
SIGNIFICANT ACUTE HEPATIC DYSFUNCTION
SIGNIFICANT ACUTE NEUROLOGIC DYSFUNCTION
3. Was a diagnosis obtained?
[Diagnosis Obtained]
YES
Diagnosis :
Start Date :
/
/
Ongoing? :
YES
NO
End Date :
/
/
NO
4. Toxicity Grade:
[Tox c ty 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. Dict onary Derived Term [hidden]
[Dict onary 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]Page 39 of 11 5 Annotated Study Book - C4591001
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[Primary System Organ Class]
15. Primary System Organ Class Code [hidden]
[Primary System Organ Class Code] Page 4 0of 11 5 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. Location of Assessment:
[Location of Assessment]
CHEST
HEAD
OTHE R
If other, specify :
3. Type of Imaging Exam:
[Imaging Method]
CT SCAN
X-RAY
ULTRASOUND
MRI
OTHE R
If other, specify :
4. Assessment:
[Overall Assessment]
ABNORMAL
If abnormal, specify findings :
INDETERMINATE
NORMAL
UNKNOWN
NOT EVALUABLEPage 41 of 11 5 Annotated Study Book - C4591001
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C4591001: INCLUSION/EXCLUSION CRITERIA (IN EX STG3)
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclus on 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 year s, 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 visits, vaccination plan, laboratory tests, lifestyle considerat ons, and other
study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and clin cal judgment of the investigator to be eligible for
inclus on in the studyIN03A00
1.d 4 Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in
this protocolIN04A00
Inclusion Criteria Entry1.1 Inclusion Number:
[Inclus on Number]
1
2
3
4
1.2 Criter on Description:
[Criter on Description]
1.3 Criter on met?
[Criter on met?]
YES
NO
Describe details if relevant
1.4 Criter on ID: (For Pfizer use only)
[Criter on ID: (For Pfizer use only)]
IN01A0 0
IN02A0 0
IN03A0 0
IN04A0 0
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 abnormality that may increase the
risk of study participationEX01A00
2.b 2 Known infect on with human immunodef ciency 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 compo nent of the study
intervention(s)EX03A00
2.d 4 Receipt of medications intended to prevent COVID-19 EX04A00
2.e 8 Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical
examinationEX08A00
2.f 9 Indiv duals with a history of autoimmune disease or an active autoimmune disease requiring therapeut c intervention EX09A00
2.g 10 Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contrai ndicate intramuscular
injectionEX10A00
2.h 11 Women who are pregnant or breastfeeding EX11A00
2.i 12 Prev ous vaccinat on with any coronavirus vaccine EX12A00
2.j 13 Indiv duals who receive immunosuppressive therapy, such as cytotoxic agents or systemic corticosteroids. Inhaled/nebulized , Intra-articular,
intrabursal, or topical corticosteroids are permittedEX13A00
2.k 14 Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervent on administration or planned receipt throughout the
studyEX14A00Page 4 2of 11 5 Annotated Study Book - C4591001
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2.l 15 Participation in other studies involving study intervention within 28 days prior to study entry and/or during study partic ipat on EX15A00
2.m 16 Prev ous participation in other studies involving study intervention containing lipid nanoparticles EX16A00
2.n 21 Investigator site staff or Pfizer employees directly involved in the conduct of the study, s te staff otherwise supervised by the investigator, and
their respective family membersEX21A00
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number]
2.2 Criter on Description:
[Criter on Description]
2.3 Criter on met?
[Criter on met?]
YES
Describe details if relevant
NO
2.4 Criter on 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 inclusion criteria (YES) and Not meet exclus on 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 year s, 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 visits, vaccination plan, laboratory tests, lifestyle considerat ons, and other
study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and clin cal judgment of the investigator to be eligible for
inclus on in the studyIN03A00
1.d 4 Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in
this protocolIN04A00
Inclusion Criteria Entry1.1 Inclusion Number:
[Inclus on Number]
1
2
3
4
1.2 Criter on Description:
[Criter on Description]
1.3 Criter on met?
[Criter on met?]
YES
NO
Describe details if relevant
1.4 Criter on ID: (For Pfizer use only)
[Criter on ID: (For Pfizer use only)]
IN01A0 0
IN02A0 0
IN03A0 0
IN04A0 0
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 abnormality that may increase the
risk of study participationEX01A00
2.b 2 Known infect on with human immunodef ciency 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 compo nent of the study
intervention(s)EX03A00
2.d 4 Receipt of medications intended to prevent COVID-19 EX04A00
2.e 8 Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical
examinationEX08A00
2.f 10 Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contrai ndicate intramuscular
injectionEX10A00
2.g 11 Women who are pregnant or breastfeeding EX11A00
2.h 12 Prev ous vaccinat on with any coronavirus vaccine EX12A00
2.i 13 Subjects who receive immunosuppressive therapy, such as cytotox c agents or system c corticosteroids EX13A01
2.j 15 Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervent on administration or planned receipt throughout the
studyEX14A01
2.k 16 Participation in other studies involving study intervention within 28 days prior to study entry and/or during study partic ipat on EX15A01
2.l 17 Previous participation in other studies involving study intervention containing lipid nanoparticles EX16A01Page 4 4of 11 5 Annotated Study Book - C4591001
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2.m 22 Investigator site staff or Pfizer employees directly involved in the conduct of the study, s te staff otherwise supervised by the investigator, and
their respective family membersEX21A01
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number]
2.2 Criter on Description:
[Criter on Description]
2.3 Criter on met?
[Criter on met?]
YES
Describe details if relevant
NO
2.4 Criter on 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 inclusion criteria (YES) and Not meet exclus on 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 year s, 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 visits, vaccination plan, laboratory tests, lifestyle considerat ons, and other
study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and clin cal judgment of the investigator to be eligible for
inclus on in the studyIN03A00
1.d 4 Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in
this protocolIN04A00
Inclusion Criteria Entry1.1 Inclusion Number:
[Inclus on Number]
1
2
3
4
1.2 Criter on Description:
[Criter on Description]
1.3 Criter on met?
[Criter on met?]
YES
NO
Describe details if relevant
1.4 Criter on ID: (For Pfizer use only)
[Criter on ID: (For Pfizer use only)]
IN01A0 0
IN02A0 0
IN03A0 0
IN04A0 0
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 abnormality that may increase the
risk of study participationEX01A00
2.b 2 Known infect on with human immunodef ciency 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 compo nent of the study
intervention(s)EX03A00
2.d 4 Receipt of medications intended to prevent COVID-19 EX04A00
2.e 8 Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical
examinationEX08A00
2.f 9 Indiv duals with a history of autoimmune disease or an active autoimmune disease requiring therapeut c intervention EX09A00
2.g 10 Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contrai ndicate intramuscular
injectionEX10A00
2.h 11 Women who are pregnant or breastfeeding EX11A00
2.i 12 Prev ous vaccinat on with any coronavirus vaccine EX12A00
2.j 13 Subjects who receive immunosuppressive therapy, such as cytotox c agents or system c corticosteroids EX13A01
2.k 15 Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervent on administration or planned receipt throughout the
studyEX14A01
2.l 16 Participation in other studies involving study intervention within 28 days prior to study entry and/or during study partic ipat on EX15A01Page 4 6of 11 5 Annotated Study Book - C4591001
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2.m 17 Prev ous participation in other studies involving study intervention containing lipid nanoparticles EX16A01
2.n 22 Investigator site staff or Pfizer employees directly involved in the conduct of the study, s te staff otherwise supervised by the investigator, and
their respective family membersEX21A01
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number]
2.2 Criter on Description:
[Criter on Description]
2.3 Criter on met?
[Criter on met?]
YES
Describe details if relevant
NO
2.4 Criter on 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 Inclus on Cr terion Not Met
[Criter on Description]
Criterion Description
2.
Exclusion Criteria Met Entry
2.1 Description of Exclusion Cr terion Met
[Criter on Description]
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C4591001: INCLUSION/EXCLUSION CRITERIA (INC EXC NS)
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclus on 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 year s, 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 visits, vaccination plan, laboratory tests, lifestyle considerat ons, and other
study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and clin cal judgment of the investigator to be eligible for
inclus on in the studyIN03A00
1.d 4 Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in
this protocolIN04A00
Inclusion Criteria Entry1.1 Inclusion Number:
[Inclus on Number]
1
2
3
4
1.2 Criter on Description:
[Criter on Description]
1.3 Criter on met?
[Criter on met?]
YES
NO
Describe details if relevant
1.4 Criter on ID: (For Pfizer use only)
[Criter on ID: (For Pfizer use only)]
IN01A0 0
IN02A0 0
IN03A0 0
IN04A0 0
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 abnormality that may increase the
risk of study participationEX01A00
2.b 2 Known infect on with human immunodef ciency 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 compo nent of the study
intervention(s)EX03A00
2.d 4 Receipt of medications intended to prevent COVID-19 EX04A00
2.e 5 Stages 1 and 2 only: Previous clin cal or microb olog cal diagnosis of COVID-19 EX05A00
2.f 8 Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical
examinationEX08A00
2.g 10 Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contrai ndicate intramuscular
injectionEX10A00
2.h 11 Women who are pregnant or breastfeeding EX11A00
2.i 12 Prev ous vaccinat on with any coronavirus vaccine EX12A00
2.j 13 Subjects who receive immunosuppressive therapy, such as cytotox c agents or system c corticosteroids EX13A01
2.k 15 Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervent on administration or planned receipt throughout the
studyEX14A01
2.l 16 Participation in other studies involving study intervention within 28 days prior to study entry and/or during study partic ipat on EX15A01Page 49 of 11 5 Annotated Study Book - C4591001
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2.m 17 Prev ous participation in other studies involving study intervention containing lipid nanoparticles EX16A01
2.n 22 Investigator site staff or Pfizer employees directly involved in the conduct of the study, s te staff otherwise supervised by the investigator, and
their respective family membersEX21A01
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number]
2.2 Criter on Description:
[Criter on Description]
2.3 Criter on met?
[Criter on met?]
YES
Describe details if relevant
NO
2.4 Criter on 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 inclusion criteria (YES) and Not meet exclus on 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 year s, 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 visits, vaccination plan, laboratory tests, lifestyle considerat ons, and other
study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and clin cal judgment of the investigator to be eligible for
inclus on in the studyIN03A00
1.d 4 Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in
this protocolIN04A00
Inclusion Criteria Entry1.1 Inclusion Number:
[Inclus on Number]
1
2
3
4
1.2 Criter on Description:
[Criter on Description]
1.3 Criter on met?
[Criter on met?]
YES
NO
Describe details if relevant
1.4 Criter on ID: (For Pfizer use only)
[Criter on ID: (For Pfizer use only)]
IN01A0 0
IN02A0 0
IN03A0 0
IN04A0 0
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 abnormality that may increase the
risk of study participationEX01A00
2.b 2 Known infect on with human immunodef ciency 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 compo nent of the study
intervention(s)EX03A00
2.d 4 Receipt of medications intended to prevent COVID-19 EX04A00
2.e 5 Stages 1 and 2 only: Previous clin cal or microb olog cal diagnosis of COVID-19 EX05A00
2.f 8 Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical
examinationEX08A00
2.g 9 Indiv duals with a history of autoimmune disease or an active autoimmune disease requiring therapeut c intervention EX09A00
2.h 10 Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contrai ndicate intramuscular
injectionEX10A00
2.i 11 Women who are pregnant or breastfeeding EX11A00
2.j 12 Prev ous vaccinat on with any coronavirus vaccine EX12A00
2.k 13 Subjects who receive immunosuppressive therapy, such as cytotox c agents or system c corticosteroids EX13A01
2.l 15 Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervent on administration or planned recei pt throughout the
studyEX14A01Page 51 of 11 5 Annotated Study Book - C4591001
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2.m 16 Participation in other studies involving study intervention within 28 days prior to study entry and/or during study partic ipat on EX15A01
2.n 17 Prev ous participation in other studies involving study intervention containing lipid nanoparticles EX16A01
2.o 22 Investigator site staff or Pfizer employees directly involved in the conduct of the study, s te staff otherwise supervised by the investigator, and
their respective family membersEX21A01
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number]
2.2 Criter on Description:
[Criter on Description]
2.3 Criter on met?
[Criter on met?]
YES
Describe details if relevant
NO
2.4 Criter on 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 inclusion criteria (YES) and Not meet exclus on 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 year s, 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 visits, vaccination plan, laboratory tests, lifestyle considerat ons, and other
study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and clin cal judgment of the investigator to be eligible for
inclus on in the studyIN03A00
1.d 4 Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in
this protocolIN04A00
Inclusion Criteria Entry1.1 Inclusion Number:
[Inclus on Number]
1
2
3
4
1.2 Criter on Description:
[Criter on Description]
1.3 Criter on met?
[Criter on met?]
YES
NO
Describe details if relevant
1.4 Criter on ID: (For Pfizer use only)
[Criter on ID: (For Pfizer use only)]
IN01A0 0
IN02A0 0
IN03A0 0
IN04A0 0
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 abnormality that may increase the
risk of study participationEX01A00
2.b 2 Known infect on with human immunodef ciency 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 compo nent of the study
intervention(s)EX03A00
2.d 4 Receipt of medications intended to prevent COVID-19 EX04A00
2.e 5 Stages 1 and 2 only: Previous clin cal or microb olog cal diagnosis of COVID-19 EX05A00
2.f 8 Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical
examinationEX08A00
2.g 9 Indiv duals with a history of autoimmune disease or an active autoimmune disease requiring therapeut c intervention EX09A00
2.h 10 Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contrai ndicate intramuscular
injectionEX10A00
2.i 11 Women who are pregnant or breastfeeding EX11A00
2.j 12 Prev ous vaccinat on with any coronavirus vaccine EX12A00
2.k 13 Indiv duals who receive immunosuppressive therapy, such as cytotoxic agents or systemic corticosteroids. Inhaled/nebulized , Intra-articular,
intrabursal, or topical corticosteroids are permittedEX13A00
2.l 14 Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervent on administration or planned recei pt throughout the EX14A00Page 5 3of 11 5 Annotated Study Book - C4591001
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study
2.m 15 Participation in other studies involving study intervention within 28 days prior to study entry and/or during study partic ipat on EX15A00
2.n 16 Prev ous participation in other studies involving study intervention containing lipid nanoparticles EX16A00
2.o 21 Investigator site staff or Pfizer employees directly involved in the conduct of the study, s te staff otherwise supervised by the investigator, and
their respective family membersEX21A00
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number]
2.2 Criter on Description:
[Criter on Description]
2.3 Criter on met?
[Criter on met?]
YES
Describe details if relevant
NO
2.4 Criter on 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 inclusion criteria (YES) and Not meet exclus on 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 year s, 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 visits, vaccination plan, laboratory tests, lifestyle considerat ons, and other
study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and clin cal judgment of the investigator to be eligible for
inclus on in the studyIN03A00
1.d 4 Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in
this protocolIN04A00
Inclusion Criteria Entry1.1 Inclusion Number:
[Inclus on Number]
1
2
3
4
1.2 Criter on Description:
[Criter on Description]
1.3 Criter on met?
[Criter on met?]
YES
NO
Describe details if relevant
1.4 Criter on ID: (For Pfizer use only)
[Criter on ID: (For Pfizer use only)]
IN01A0 0
IN02A0 0
IN03A0 0
IN04A0 0
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 abnormality that may increase the
risk of study participationEX01A00
2.b 2 Known infect on with human immunodef ciency 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 compo nent of the study
intervention(s)EX03A00
2.d 4 Receipt of medications intended to prevent COVID-19 EX04A00
2.e 5 Stages 1 and 2 only: Previous clin cal or microb olog cal diagnosis of COVID-19 EX05A00
2.f 6 Sentinel participants in Stage 1 only: Indiv duals at high risk for severe COVID-19 (full details in protocol) EX06A01
2.g 7 Sentinel participants in Stage 1 only: Indiv duals currently working in occupat ons with high risk of exposure to SARS-CoV- 2 (eg, healthcare
worker, emergency response personnel)EX07A00
2.h 8 Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical
examinationEX08A00
2.i 9 Sentinel participants in Stage 1 only: Indiv duals w th a history of autoimmune disease or an active autoimmune disease req uiring therapeutic
interventionEX09A04
2.j 10 Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contrai ndicate intramuscular
injectionEX10A00
2.k 11 Women who are pregnant or breastfeeding EX11A00Page 5 5of 11 5 Annotated Study Book - C4591001
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2.l 12 Prev ous vaccinat on with any coronavirus vaccine EX12A00
2.m 13 Subjects who receive immunosuppressive therapy, such as cytotox c agents or system c corticosteroids EX13A01
2.n 14 Sentinel participants in Stage 1 only: Regular receipt of inhaled/nebulized cort costeroids EX22A01
2.o 15 Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervent on administration or planned receipt throughout the
studyEX14A01
2.p 16 Participation in other studies involving study intervention within 28 days prior to study entry and/or during study partic ipat on EX15A01
2.q 17 Prev ous participation in other studies involving study intervention containing lipid nanoparticles EX16A01
2.r 18 Sentinel participants in Stage 1 only: Pos tive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit EX17A01
2.s 19 Sentinel participants in Stage 1 only: Screening hematology/blood chemistry lab >=Grade 1 abnormal ty. Except Bilirubin, o ther stable
Grade1 abnormal ties may be considered eligible by InvestigatorEX18A01
2.t 20 Sentinel participants in Stage 1 only: Pos tive test for HIV, hepat tis B surface antigen (HBsAg), hepat tis B core antibo dies (HBc Abs), or
hepatitis C virus antibodies (HCV Abs) at screening vis tEX19A01
2.u 21 Sentinel participants in Stage 1 only: SARS-CoV-2 NAAT-pos tive nasal swab w thin 24 hours before receipt of study interve nt on EX20A01
2.v 22 Investigator site staff or Pfizer employees directly involved in the conduct of the study, s te staff otherwise supervised by the investigator, and
their respective family membersEX21A01
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number]
2.2 Criter on Description:
[Criter on Description]
2.3 Criter on met?
[Criter on met?]
YES
Describe details if relevant
NO
2.4 Criter on 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 inclusion criteria (YES) and Not meet exclus on 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 year s, 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 visits, vaccination plan, laboratory tests, lifestyle considerat ons, and other
study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and clin cal judgment of the investigator to be eligible for
inclus on in the studyIN03A00
1.d 4 Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in
this protocolIN04A00
Inclusion Criteria Entry1.1 Inclusion Number:
[Inclus on Number]
1
2
3
4
1.2 Criter on Description:
[Criter on Description]
1.3 Criter on met?
[Criter on met?]
YES
NO
Describe details if relevant
1.4 Criter on ID: (For Pfizer use only)
[Criter on ID: (For Pfizer use only)]
IN01A0 0
IN02A0 0
IN03A0 0
IN04A0 0
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 abnormality that may increase the
risk of study participationEX01A00
2.b 2 Known infect on with human immunodef ciency 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 compo nent of the study
intervention(s)EX03A00
2.d 4 Receipt of medications intended to prevent COVID-19 EX04A00
2.e 5 Stages 1 and 2 only: Previous clin cal or microb olog cal diagnosis of COVID-19 EX05A00
2.f 6 Sentinel participants in Stage 1 only: Indiv duals at high risk for severe COVID-19 EX06A00
2.g 7 Sentinel participants in Stage 1 only: Indiv duals currently working in occupat ons with high risk of exposure to SARS-CoV- 2 (eg, healthcare
worker, emergency response personnel)EX07A00
2.h 8 Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical
examinationEX08A00
2.i 9 Indiv duals with a history of autoimmune disease or an active autoimmune disease requiring therapeut c intervention EX09A00
2.j 10 Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contrai ndicate intramuscular
injectionEX10A00
2.k 11 Women who are pregnant or breastfeeding EX11A00
2.l 12 Prev ous vaccinat on with any coronavirus vaccine EX12A00Page 57 of 11 5 Annotated Study Book - C4591001
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2.m 13 Indiv duals who receive immunosuppressive therapy, such as cytotoxic agents or systemic corticosteroids. Inhaled/nebulized , Intra-articular,
intrabursal, or topical corticosteroids are permittedEX13A00
2.n 14 Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervent on administration or planned receipt throughout the
studyEX14A00
2.o 15 Participation in other studies involving study intervention within 28 days prior to study entry and/or during study partic ipat on EX15A00
2.p 16 Prev ous participation in other studies involving study intervention containing lipid nanoparticles EX16A00
2.q 17 Sentinel participants in Stage 1 only: Pos tive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit EX17A00
2.r 18 Sentinel participants in Stage 1 only: Screening hematology/blood chemistry lab >=Grade 1 abnormal ty. Except Bilirubin, o ther stable
Grade1 abnormal ties may be considered eligible by InvestigatorEX18A00
2.s 19 Sentinel participants in Stage 1 only: Pos tive test for HIV, hepat tis B surface antigen (HBsAg), hepat tis B core antibo dies (HBc Abs), or
hepatitis C virus antibodies (HCV Abs) at screening vis tEX19A00
2.t 20 Sentinel participants in Stage 1 only: SARS-CoV-2 NAAT-pos tive nasal swab w thin 24 hours before receipt of study interve nt on EX20A00
2.u 21 Investigator site staff or Pfizer employees directly involved in the conduct of the study, s te staff otherwise supervised by the investigator, and
their respective family membersEX21A00
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number]
2.2 Criter on Description:
[Criter on Description]
2.3 Criter on met?
[Criter on met?]
YES
Describe details if relevant
NO
2.4 Criter on 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 inclusion criteria (YES) and Not meet exclus on 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 year s, 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 visits, vaccination plan, laboratory tests, lifestyle considerat ons, and other
study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and clin cal judgment of the investigator to be eligible for
inclus on in the studyIN03A00
1.d 4 Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in
this protocolIN04A00
Inclusion Criteria Entry1.1 Inclusion Number:
[Inclus on Number]
1
2
3
4
1.2 Criter on Description:
[Criter on Description]
1.3 Criter on met?
[Criter on met?]
YES
NO
Describe details if relevant
1.4 Criter on ID: (For Pfizer use only)
[Criter on ID: (For Pfizer use only)]
IN01A0 0
IN02A0 0
IN03A0 0
IN04A0 0
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 abnormality that may increase the
risk of study participationEX01A00
2.b 2 Known infect on with human immunodef ciency 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 compo nent of the study
intervention(s)EX03A00
2.d 4 Receipt of medications intended to prevent COVID-19 EX04A00
2.e 5 Stages 1 and 2 only: Previous clin cal or microb olog cal diagnosis of COVID-19 EX05A00
2.f 6 Sentinel participants in Stage 1 only: Indiv duals at high risk for severe COVID-19 (full details in protocol) EX06A01
2.g 7 Sentinel participants in Stage 1 only: Indiv duals currently working in occupat ons with high risk of exposure to SARS-CoV- 2 (eg, healthcare
worker, emergency response personnel)EX07A00
2.h 8 Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical
examinationEX08A00
2.i 9 Indiv duals with a history of autoimmune disease or an active autoimmune disease requiring therapeut c intervention EX09A00
2.j 10 Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contrai ndicate intramuscular
injectionEX10A00
2.k 11 Women who are pregnant or breastfeeding EX11A00
2.l 12 Prev ous vaccinat on with any coronavirus vaccine EX12A00Page 59 of 11 5 Annotated Study Book - C4591001
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2.m 13 Subjects who receive immunosuppressive therapy, such as cytotox c agents or system c corticosteroids EX13A01
2.n 14 Sentinel participants in Stage 1 only: Regular receipt of inhaled/nebulized cort costeroids EX22A01
2.o 15 Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervent on administration or planned receipt throughout the
studyEX14A01
2.p 16 Participation in other studies involving study intervention within 28 days prior to study entry and/or during study partic ipat on EX15A01
2.q 17 Prev ous participation in other studies involving study intervention containing lipid nanoparticles EX16A01
2.r 18 Sentinel participants in Stage 1 only: Pos tive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit EX17A01
2.s 19 Sentinel participants in Stage 1 only: Screening hematology/blood chemistry lab >=Grade 1 abnormal ty. Except Bilirubin, o ther stable
Grade1 abnormal ties may be considered eligible by InvestigatorEX18A01
2.t 20 Sentinel participants in Stage 1 only: Pos tive test for HIV, hepat tis B surface antigen (HBsAg), hepat tis B core antibo dies (HBc Abs), or
hepatitis C virus antibodies (HCV Abs) at screening vis tEX19A01
2.u 21 Sentinel participants in Stage 1 only: SARS-CoV-2 NAAT-pos tive nasal swab w thin 24 hours before receipt of study interve nt on EX20A01
2.v 22 Investigator site staff or Pfizer employees directly involved in the conduct of the study, s te staff otherwise supervised by the investigator, and
their respective family membersEX21A01
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number]
2.2 Criter on Description:
[Criter on Description]
2.3 Criter on met?
[Criter on met?]
YES
Describe details if relevant
NO
2.4 Criter on 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 61 of 11 5 Annotated Study Book - C4591001
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C4591001: CENTRAL LAB SAMPLE COLLECTION (LAB)
Central Lab Sample Collection
1. Collect on Date:
[Collection Date:]
/
/
2. Specimen Type:
[Specimen Type]
BLOOD
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 CHEMISTRY
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. Collect on Date:
[Collection Date:]
/
/
2. Specimen Type:
[Specimen Type]
BLOOD
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 CHEMISTRY
2. Laboratory Name and Address
[Vendor Name]
3. Collect on Date:
[Collection Date:]
/
/
4. Specimen Type:
[Specimen Type]
BLOOD
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 DONE
5.5 LNMT
[Lab Normal Range] Low
High
Unit
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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 CHEMISTRY
2. Laboratory Name and Address
[Vendor Name]
3. Collect on Date:
[Collection Date:]
/
/
4. Specimen Type:
[Specimen Type]
BLOOD
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_PX32 9
5.3 Result:
[Result:]
5.4 Not Done: [hidden]
[Not Done:]
NOT DONE
5.5 LNMT
[Lab Normal Range] Low
High
Unit
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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 Da ta Hematology
1. Lab Panel:
[Category for Lab Test]
HEMATOLOGY
2. Laboratory Name and Address
[Vendor Name (DERIVED)]
3. Collect on Date:
[Collection Date:]
/
/
4. Specimen Type:
[Specimen Type]
BLOOD
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 Entry
5.1 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
Unit
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C4591001: LAB URINALYSIS - PREGNANCY TEST (LAB PREG)
Lab Urinalysis
1. Lab Panel:
[Category for Lab Test]
URINALYSI S
2. Lab Sub-Panel:
[Subcategory for Lab Test]
PREGNANCY
3. Collect on Date:
[Collection 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 Choriogonadotropin Beta_PX113
Lab Result Entry
6.1 Sponsor ID:
[Sponsor-Defined Identifier]
6.2 Test:
[Test:]
Chor ogonadotropin Beta_PX113
6.3 Result:
[Result:]
NEGATIVE
POSITIVE
6.4 Not Done:
[Not Done:]
NOT DONEPage 67 of 11 5 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 ERRO R
2. Medicat on Error (Type
of Med cation Error):
[Medicat 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 medication error
still ongoing?[Is the med cation error Still Ongoing]
YES
NO
End Date :
/
/
6. Latest Action Taken
with Study Treatment:
[Study Medication
Errors Action]
NO ACTION TAKEN
PERMANENTLY DISCONTINUED
7. Was a Concomitant
Medicat on given?[Concom tant Medicat on Given]
YES
NO
8. Was a Non-Drug
Treatment given?
[Non-Drug Treatment
Given]
YES
NO
9. Did the Med cation Error
cause the subject to be
discontinued from the study?[Caused Study
Discontinuat on]
YES
NO
10. Was this medicat on
error associated w th
any adverse events?[Medicat on Error Associated With AE]
YES
AE ID:
AE ID:
AE ID:
AE ID:
AE ID:
NO
11. Serious Adverse Event Page 68 of 11 5 Annotated Study Book - C4591001
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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. Dict onary-Derived
Term [hidden]
[Dict onary-Derived
Term]
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 69 of 11 5 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 D ctionary Derived Term
[hidden]
[D ctionary 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 7 0of 11 5 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 cloc k
2. Arterial Blood Gases PaO2 (mmHg):
[Arterial Blood Gases PaO2]
3. FiO2 (Fract on of Inhaled Oxygen):
[FiO2 (Fract on of Inhaled Oxygen)] Page 71 of 11 5 Annotated Study Book - C4591001
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FDA-CBER-2021-5683-0035395
C4591001: PHYSICAL EXAMINATION (PHYS EXAM)
Physical Examination
1. Exam Date:
[Exam Date]
/
/
Physical Examination Result
# Body System Examined Result
2.a GENERAL APPEARANCE2.b SKIN
2.c HEAD
2.d EYES2.e EARS2.f NOSE2.g THROAT2.h HEART2.i LUNGS2.j ABDOMEN
2.k MUSCULOSKELETAL
2.l EXTREMITIES2.m NEUROLOGICAL2.n LYMPH NODES
Physical Examination Result Entry2.1 Body System Examined:
[Body System Examined]
2.2 Result:
[Result]
NORMAL
ABNORMAL
If abnormal findings, specify: (If clin cally signif cant, record on the Medical History or Adverse Event CRF as appropriate).
Are there clinically significant findings?
YES
NO
NOT DONEPage 7 2of 11 5 Annotated Study Book - C4591001
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FDA-CBER-2021-5683-0035396
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
prov de 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 11 5 Annotated Study Book - C4591001
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FDA-CBER-2021-5683-0035397
C4591001: CONCOMITANT MEDICATIONS - PROHIBITED (PROHIB CM) - Repeating Form
# Sponsor-Defined Identifier Category for Medication Concomitant Medications Pre-specified Name of Medication Dose Description Dose U nit Dose Frequency Route Start Date Ongoing
1
Concomitant Medications
1. What is the med cation dentifier?
[Sponsor-Defined Identifier]
2. Category:
[Category for Medication]
CONCOMITANT IMMUNOSUPPRESSIVE THERAPY
CORTICOSTEROIDS
IMMUNOGLOBULINS
3. Concomitant Med cat ons Pre-specified:
[Concom tant Medicat ons Pre-specified]
NO
4. Medicat on:
Provide the complete gener c drug name (including salt form,
where applicable). Where gener c name is unknown, enter the full trade or proprietary name. Include clarifying information in the Medication 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 Medication Name - Dictionary derived. [hidden]
[Standardized Medication Name]
13. Standardized Medication Code - Dict onary derived [hidden]
[Standardized Medication Code] Page 7 4of 11 5 Annotated Study Book - C4591001
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FDA-CBER-2021-5683-0035398
C4591001: RADIATION TREATMENT (PROHIB ND) - Repeating Form
# Category Treatment Identifier Con Non-Drug Trea tments Pre-specified Treatment Start Date Ongoing?
1
Radiation Treatment
1. Category:
[Category]
RADIATION THERAPY
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. Dict onary Derived Term [hidden]
[Dict onary 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 5of 11 5 Annotated Study Book - C4591001
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FDA-CBER-2021-5683-0035399
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 Entry
2.1 Record Identifier:
[Record Identifier:]
1
2.2 SPO2 Pulse Oximetry %
[Oxygen Saturat on] Page 7 6of 11 5 Annotated Study Book - C4591001
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FDA-CBER-2021-5683-0035400
C4591001: RANDOMIZATION (RAND)
Disposition
1. Randomizat on Date :
[Randomizat on Date :]
/
/
2. Randomizat on Number:
[Randomizat on Number]
3. Randomizat on Group:
[Randomizat on Group] Page 77 of 11 5 Annotated Study Book - C4591001
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FDA-CBER-2021-5683-0035401
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 SUBJECT
NO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECTPage 78 of 11 5 Annotated Study Book - C4591001
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FDA-CBER-2021-5683-0035402
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 EVENT
2. Date of Assessment:
[Date of Assessment]
/
/
3. Inject on S te Location
[Inject on S te Locat on]
DELTOID MUSCLE
4. Inject on Site Body Side:
[Inject on S te Body Side]
LEFT
RIGHT
Reaction
#R eaction: Reaction Present:
5.a REDNESS5.b SWELLING
Reaction Entry5.1 React on:
[Reaction:]
REDNESS
SWELLING
5.2 React on Present:
[Reaction Present:]
YES
Maximum Diameter (cm) :
Minimum Diameter (cm):
Meets Grade 4 Reaction Criteria :
YES
NO
NO
Symptom
# Symptom: Symptom Present:
6.a PAIN AT INJECTION SITE
6.b FATIGUE/TIREDNESS
6.c HEADACHE
6.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 Study Treament ?
YESPage 79 of 11 5 Annotated Study Book - C4591001
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FDA-CBER-2021-5683-0035403
NO
NOPage 8 0of 11 5 Annotated Study Book - C4591001
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FDA-CBER-2021-5683-0035404
C4591001: RESPIRATORY TREATMENT (RESP TX) - Repeating Form
# Treatment Identifier Con Non-Drug Treatments Pr e-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]
INTUBATION
NON-INVASIVE POSITIVE PRESSURE VENTILATION
CPAP
OXYGEN THERAPY
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. Dict onary Derived Term [hidden]
[Dict onary 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 81 of 11 5 Annotated Study Book - C4591001
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FDA-CBER-2021-5683-0035405
C4591001: RESPIRATORY TREATMENT (RESP TX) - Repeating Form
# Treatment Identifier Con Non-Drug Treatments Pr e-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 VENTILATION
EXTRACORPOREAL MEMBRANE OXYGENATION
HIGH FLOW OXYGEN THERAPY
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. Dict onary Derived Term [hidden]
[Dict onary 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 8 2of 11 5 Annotated Study Book - C4591001
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FDA-CBER-2021-5683-0035406
C4591001: FURTHER VACCINATION CONFIRMATION (REVAX CONF)
Further Vaccination Confirmation
1. Select appropriate response - Is part cipant
willing to return for Vaccination 3?
[Trigger Response 1]
Participant is willing to return for Vaccination 3
Participant is :
eligible per local/nat onal recommendat ons and confirmed to have received only placebo at Vaccination 1/ 2
eligible per other protocol allowance(s) and confirmed to have received only placebo at Vaccinat on 1/ 2
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
Participant is NOT willing to return for Vaccination 3 OR otherwise not eligiblePage 8 3of 11 5 Annotated Study Book - C4591001
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FDA-CBER-2021-5683-0035407
C4591001: INFORMED CONSENT - FURTHER VACCINATION (REVAX CONS)
Informed Consent - Further Vaccination
1. Consent Was:
[Consent Was:]
OBTAINED
Date Written Consent Obtaine d
/
/
Page 8 4of 11 5 Annotated Study Book - C4591001
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FDA-CBER-2021-5683-0035408
C4591001: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION (REVAX IE)
Criterion Description
1.
Inclusion Criteria Not Met Entry
1.1 Description of Inclus on Cr terion Not Met
[Criter on Description]
Criterion Description
2.
Exclusion Criteria Met Entry
2.1 Description of Exclusion Cr terion Met
[Criter on Description]
Page 8 5of 11 5 Annotated Study Book - C4591001
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FDA-CBER-2021-5683-0035409
C4591001: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB (RSWAB)
Electronic Sample Tracking
1. Data Origin
[Data Origin]
SITE
2. Sample Type
[Sample Type]
NASAL_SWA B
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
prov de reason:[Reason sample not collected]
Sample ID
5.
Aliquot Entry
Please enter barcode for each aliquot.5.1 Sample ID
[Sample ID] Page 8 6of 11 5 Annotated Study Book - C4591001
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FDA-CBER-2021-5683-0035410
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
prov de reason:
[Reason sample not collected]
Sample ID
5.
Aliquot Entry
Please enter barcode for each aliquot.
5.1 Sample ID
[Sample ID] Page 87 of 11 5 Annotated Study Book - C4591001
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FDA-CBER-2021-5683-0035411
C4591001: INFORM SCREENING (SCREEN)
InForm Screening
1. InForm Initials [hidden]
[InForm Initials]
2. Birth Date:
[Birth Year]
/
/
Page 88 of 11 5 Annotated Study Book - C4591001
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FDA-CBER-2021-5683-0035412
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_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
prov de reason:
[Reason sample not collected]
Sample ID
5.
Aliquot Entry
Please enter barcode for each aliquot.
5.1 Sample ID
[Sample ID] Page 89 of 11 5 Annotated Study Book - C4591001
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FDA-CBER-2021-5683-0035413
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 BREATH
4.d YES CHILLS
4.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 D ctionary Derived Term [hidden]
[D ctionary Derived Term] Page 9 0of 11 5 Annotated Study Book - C4591001
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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 Code] Page 91 of 11 5 Annotated Study Book - C4591001
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FDA-CBER-2021-5683-0035415
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 CONGESTION
4.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 D ctionary Derived Term [hidden]
[D ctionary Derived Term] Page 9 2of 11 5 Annotated Study Book - C4591001
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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 Code] Page 9 3of 11 5 Annotated Study Book - C4591001
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C4591001: STRATIFICATION (STRAT)
Stratification
1. Select appropriate response -
Randomizat on Stage
[Trigger Response 3]
Non-Sentinel Stage 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 mc g
20 mc g
30 mc g
4. Select appropriate response -
Randomizat on Dose Group[Trigger Response 8]
21 Da y
60 Da y
5. Select appropriate response - BNT Number
[Trigger Response 7]
(BNT162b1 or PBO )
(BNT162b2 or PBO )
(BNT162b3 or PBO )Page 9 4of 11 5 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 mc g
20 mc g
30 mc g
4. Select appropriate response - BNT Number
[Trigger Response 7]
(BNT162b1 or PBO )
(BNT162b2 or PBO )
(BNT162b3 or PBO )Page 9 5of 11 5 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 85
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 (30mcg )
High dose level (100mcg )
Low dose level (0.1mcg )
Medium dose level (0.3mcg )
High dose level (1mcg )
Mid-High dose level (50mcg )
Low-M d dose level (20mcg )
4. Select appropriate response -
Randomizat on Dose Group [hidden]
[Trigger Response 6]
21 Day 2-dose grou p
60 Day 2-dose grou p
1-dose grou p
5. Select appropriate response -
Randomizat on Dose Group[Trigger Response 8]
21 Da y
60 Da y
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 9 6of 11 5 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]
/
/
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C4591001: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE (SURV CONS)
Informed Consent - Asymptomatic Surveillance
1. Consent Was:
[Consent Was:]
OBTAINED
Date Written Consent Obtaine d
/
/
Page 98 of 11 5 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_SWA B
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
prov de reason:
[Reason sample not collected]
Sample ID
5.
Aliquot Entry
Please enter barcode for each aliquot.
5.1 Sample ID
[Sample ID] Page 99 of 11 5 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 Collect on:
[Date of Collect on]
/
/
2. Specimen Type:
[Specimen Type]
SWABBED MATERIAL
3. Specimen Collect on Location:
[Specimen Collection Location]
NASAL CAVITY
4. Assay Code and Description:
[Assay Code and Description]
SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5. Dev ce Type:
[Dev ce Type]
SARS-COV-2 DIAGNOSTIC TEST
6. Trade Name:
[Trade Name]
CEPHEID XPERT XPRESS SAR S-COV-2 TEST
7. Test Result:
[Result]
POSITIVE
NEGATIVE
INDETERMINATE
8. Comments/Findings/Details:
[Comments:] Page 10 0of 11 5 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 FATIGUE
2.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 systemic 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
NO
Stop Date:
/
/
NO
3. Inject on S te Location:
[Inject on S te Locat on:]
DELTOID MUSCLE
4. Inject on Site Body Side:
[Inject on 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 SWELLING
5.c PAIN AT INJECTION SITE
5.1 Injection Site Reaction:
[Injection Site Reaction:]
REDNESS
SWELLING
PAIN AT INJECTION SITE
5.2 Were injection site 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 101 of 11 5 Annotated Study Book - C4591001
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C4591001: TRANSFUSIONS (TRANSFUSE) - Repeating Form
# Transfusion Type Date of Transfusion
1
1. Transfusion Type:
[Transfusion Type]
PACKED RBC
PLATELET S
WHOLE BLOOD
PLASM A
OTHE R
Specify :
2. Date of Transfusion:
[Date of Transfus on]
/
/
Page 10 2of 11 5 Annotated Study Book - C4591001
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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 CONCERN
OTHE R
If other, specify :
ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATIONPage 10 3of 11 5 Annotated Study Book - C4591001
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C4591001: UNPLANNED VISIT (UNPL)
Unplanned Assessments
1. Assessments
[Assessments]
CONTACT OUTCOMEPage 10 4of 11 5 Annotated Study Book - C4591001
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C4591001: VACCINATION (VACIN TRT)
Vaccination
1. Was there a
temporary delay of
vaccination?
[Temporary Delay of
Vaccination]
YES
Date of First Delay :
/
/
Reason(s) for Temporary Delay of Vaccination
FEVER OR ACUTE ILLNES S
RECENT SYSTEMIC CORTICOSTEROID TREATMENT
RECENT NON-STUDY VACCINATION
ANTICIPATED NON-STUDY VACCINATION
NO
2. Treatment Name
[Treatment Name]
3. Formulat on:
[Formulat on:]
INJECTION
4. Dose Date Time:
[Dose Date Time:]
/
/
:
24-hour cloc k
5. Anatomical Locat on:
[Anatom cal
Location:]
DELTOID MUSCLE
6. Body S de:
[Body S de:]
LEFT
RIGHT
7. Route:
[Route:]
INTRAMUSCULA R
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 RESPONSE
OTHER SPECIFY
If other, specify:
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
YES
NO
If No, specify reason :Page 10 5of 11 5 Annotated Study Book - C4591001
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administration?
[Observed Post Dose For Specified Time]
15. Comparison Term
[hidden][Comparison Term]
16. Standardized
Medicat on Name -Dict onary Derived. [hidden][Standardized Medicat on Name]
17. Standardized
Medicat on Code -
Dict onary Derived
[hidden][Standardized Medicat on Code] Page 10 6of 11 5 Annotated Study Book - C4591001
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C4591001: VACCINATION (VACIN TRT)
Vaccination
1. Was there a
temporary delay of
vaccination?
[Temporary Delay of
Vaccination]
YES
Date of First Delay :
/
/
Reason(s) for Temporary Delay of Vaccination
FEVER OR ACUTE ILLNES S
RECENT SYSTEMIC CORTICOSTEROID TREATMENT
RECENT NON-STUDY VACCINATION
ANTICIPATED NON-STUDY VACCINATION
NO
2. Treatment Name
[Treatment Name]
3. Formulat on:
[Formulat on:]
INJECTION
4. Dose Date Time:
[Dose Date Time:]
/
/
:
24-hour cloc k
5. Anatomical Locat on:
[Anatom cal
Location:]
DELTOID MUSCLE
6. Body S de:
[Body S de:]
LEFT
RIGHT
7. Route:
[Route:]
INTRAMUSCULA R
8. Container Number:
[hidden]
[PAC / Kit Number:]
9. Actual Dose:
[Actual Dose:]
10. Unit:
[Unit:]
mL
ug
11. Timeframe Subject
Was Observed[Timeframe Subject Was Observed]
THE PROTOCOL SPECIFIED OBSERVATION PERIOD
30 MINUTE S
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 Page 107 of 11 5 Annotated Study Book - C4591001
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Medicat on Name -
Dict onary Derived. [hidden][Standardized Medicat on Name]
15. Standardized
Medicat on Code -Dict onary Derived [hidden][Standardized Medicat on Code] Page 108 of 11 5 Annotated Study Book - C4591001
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C4591001: CONCOMITANT MEDICATIONS - VASOPRESSORS (VASOPRESS) - Repeating Form
# Sponsor-Defined Identifier Category for Medication Concomitan t Medications Pre-specified Name of Medication Start Date Ongoing
1
Concomitant Medications
1. What is the med cation dentifier?
[Sponsor-Defined Identifier]
2. Category:
[Category for Medication]
GENERAL CONCOMITANT MEDICATIONS
3. Concomitant Medications Pre-specified:
[Concom tant Medicat ons Pre-specified]
NO
4. Medicat on:
Provide the complete gener c drug name (including salt form,
where applicable). Where gener c name is unknown, enter the
full trade or proprietary name. Include clarifying information in
the Med cation 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 Medication Name - D ctionary derived. [hidden]
[Standardized Medication Name]
9. Standardized Medication Code - Dictionary derived [hidden]
[Standardized Medication Code] Page 109 of 11 5 Annotated Study Book - C4591001
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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 Un t:
[Temperature Unit]
F
C
2.4 Temperature Location:
[Temperature Locat on:]
ORAL CAVITY
EAR
RECTUM
AXILL A
FOREHEADPage 11 0of 11 5 Annotated Study Book - C4591001
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C4591001: VITAL SIGNS - BASELINE (VITALS BSL)
Vital Signs
1. Date:
[Date:]
/
/
2. Weight:
[Weight]
3. Unit:
[Weight Unit]
kg
LB
4. Height:
[Height]
5. Unit:
[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 Un t:
[Temperature Unit]
C
F
7.4 Temperature Location:
[Temperature Locat on:]
ORAL CAVITY
EAR
RECTUM
AXILLA
FOREHEADPage 111 of 11 5 Annotated Study Book - C4591001
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C4591001: VITAL SIGNS - BASELINE (VITALS BSL)
Vital Signs
1. Date:
[Date:]
/
/
2. Weight:
[Weight]
3. Unit:
[Weight Unit]
kg
LB
4. Height:
[Height]
5. Unit:
[Height Un t]
cm
in
6. Body Mass Index:
[Body Mass Index]
Vital Signs Details
# Record Identifier: Temperature Temperature Unit Temper ature 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 Un t:
[Temperature Unit]
C
F
7.4 Temperature Location:
[Temperature Locat on:]
ORAL CAVITY
EAR
RECTUM
AXILLA
FOREHEAD
7.5 Systolic:
[Systolic:]
7.6 Diastol c:
[Diastolic:]
7.7 BP Position:
[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 Entry
2.1 Record Identifier:
[Record Identifier:]
1
2.2 Systolic:
[Systolic:]
2.3 Diastol c:
[Diastolic:]
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 Temper ature 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 Un t:
[Temperature Unit]
F
C
2.4 Temperature Location:
[Temperature Locat on:]
ORAL CAVITY
EAR
RECTUM
AXILL A
FOREHEAD
2.5 Systolic:
[Systolic:]
2.6 Diastol c:
[Diastolic:]
2.7 BP Position:
[BP Position]
SITTIN G
2.8 Pulse:
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Withdrawal Of Consent
1. W thdrawal of Consent Date :
[Withdrawal of Consent Date :]
/
/
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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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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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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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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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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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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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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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Screen 1
Popup input 1
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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 1 of 52 ǦͳͶʹǦͲͲͺʹȀͶͷͻͳͲͲͳ
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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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 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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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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English (USA) enUS Version 2
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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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English (USA) enUS Version 2
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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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