Document text
Annotated Stud y Book for Stud y Desi gn: C4591001
Stud y Desi gn Version: 19.0
Sponsor: Pfizer
Protocol: C4591001
Sponsor Dru g Name: BLINDED THERAPY
C4591001 - COVID19
Generated by Central Designer TM
March 30, 2021 10:56AM3DJH RI $QQRWDWHG 6WXG\%RRN &
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FDA-CBER-2022-5812-0228684
C4591001: ADVERSE EVENT REPORT (AE) - Repeating Form
#C a t e g o r y A E
IdentifierAdverse
EventStart
DateIs the
Adverse
Event
Still
OngoingToxicity
GradeSerious Is AE a
Result of a
Medication
ErrorRelationship
to Study
TreatmentAction
Taken
with
Study
TreatmentConcomitant
Medication
GivenNon-Drug
Treatment
GivenOutcome Caused Study
DiscontinuationSerious
Adverse
Event
Number
1
Adverse Event Report
1. Category:
[Category]
ADVERSE EVEN T
2. AE ID:
[AE Identifier]
3. Adverse Event:
(If possible specify
diagnosis, not
individual
symptoms)
[Adverse Event]
4. Start Date Time:
[Start Date]
/
/
:
24-hour clock
5. Is the adverse event
still ongoing?
[Is the Adverse
Event Still Ongoing]
YES
NO
End Date Time:
/
/
:
24-hour clock
6. Toxicity Grade:
[Toxicity Grade]
1
2
3
4
7. Is the adverse event
ser ous?
If Yes, NOTIFY
PFIZER
IMMEDIATELY.
Fatal; Life-
threatening;
Inpatient
hosp talization or
prolongat on of
existing
hosp talization;
Persistent or
signif cant
disabil ty/incapac ty;
Congenital
anomaly/birth
defect; Important
med cal event (i.e.
may jeopardize
subject and may require
med cal/surgical
intervention to
prevent above
outcomes).
[Serious]
YES
Is this ser ous event associated with con genital anomal y or birth defect ?
YES
NO
Did this serious event result in death ?
YES
NO
Did this serious event re quire or prolong hospitalization ?
YES
NO
Did this serious event result in persistent or si gnificant disabil t y/incapac ty?
YES
NO
Is this ser ous event life threatenin g?
YES
NO
Other med call y important ser ous even t
YES
NO
NO
8. Is this adverse
event the result of a study Medication
Error?
If Yes, record the
type of medication
error on the
Medication Error
Log.
[Is AE a Result of a Medication Error]
YES
NO
9. Is this event related
to study treatment:[Relat onship to
Study Treatment]
NOT RELATE D
If Not Related to stud y treatment (s), this event is due to:
CONCOMITANT DRUG TREATMEN T
CONCOMITANT NON-DRUG TREATMENT
OTHER
If Other, specify:
RELATE D
10. Latest Action Taken
with Study
DRUG WITHDRAW N
NOT APPLICABL E3DJH RI $QQRWDWHG 6WXG\%RRN &
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FDA-CBER-2022-5812-0228685
Treatment:
[Act on Taken with
Study Treatment]
11. Was a Concomitant
Medication given?[Concom tant
Med cation Given]
YES
NO
12. Was a Non-Drug
Treatment given?
[Non-Drug
Treatment Given]
YES
NO
13. What was the
outcome of this adverse event?:
[Outcome]
FATAL
NOT RECOVERED/NOT RESOLVE D
RECOVERED/RESOLVE D
RECOVERED/RESOLVED WITH SEQUELA E
RECOVERING/RESOLVING
UNKNOW N
14. D d the adverse
event cause the
subject to be
discontinued from the study?
[Caused Study
Discontinuat on]
YES
NO
15. Ser ous Adverse
Event Number: For Pfizer Use Only
[Serious Adverse
Event Number]
16. Comparison Term
[hidden][Comparison Term]
17. Lowest Level Term
[hidden][Lowest Level Term]
18. Lowest Level Term
Code [hidden]
[Lowest Level Term
Code]
19. D ctionary-Derived
Term [hidden]
[D ctionary-Derived Term]
20. Preferred Term
Code [hidden]
[Preferred Term
Code]
21. High Level Term
[hidden][High Level Term]
22. High Level Term
Code [hidden]
[High Level Term
Code]
23. High Level Group
Term [hidden]
[High Level Group Term]
24. High Level Group
Term Code [hidden]
[High Level Group
Term Code]
25. Primary System
Organ Class [hidden]
[Primary System
Organ Class]
26. Primary System
Organ Class Code
[hidden]
[Primary System
Organ Class Code] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
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FDA-CBER-2022-5812-0228686
C4591001: INFORMED CONSENT - BOOSTER (BOOST CONS)
Informed Consent - Booster
1. Consent Was:
[Consent Was:]
OBTAINE D
Date Written Consent Obtained
/
/
3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
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FDA-CBER-2022-5812-0228687
C4591001: INCLUSION/EXCLUSION CRITERIA - BOOSTER (BOOST IE)
Criterion Description
1.
Inclusion Criteria Not Met Entry
1.1 Description of Inclusion
Cr terion Not Met
[Criter on Descript on]
Criterion Description
2.
Exclusion Criteria Met Entry
2.1 Description of Exclusion
Cr terion Met
[Criter on Descript on]
3DJH RI $QQRWDWHG 6WXG\%RRN &
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FDA-CBER-2022-5812-0228688
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/eli gibility assessment for the booster dose visi t
The participant will NOT return for consent/eligibility assessment for the booster dose vis t
The participant will return for consent/eligibility assessment for the LOW DOSE booster dose visit (Select this option for part cipant returning for 5 or 10 mcg booster)3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
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FDA-CBER-2022-5812-0228689
C4591001: LABORATORY DATA - HEMATOLOGY (CD4)
Laboratory Data Hematology
1. Lab Panel:
[Category for Lab Test]
HEMATOLOG Y
2. Laboratory Name and Address
[Vendor Name (DERIVED)]
3. Collection Date:
[Collect on Date:]
/
/
4. Specimen Type:
[Specimen Type]
BLOOD
Lab Result
# Sponsor-Defined Identifier Test: Result: Not Done: Lab Normal Range
5.a CD4_PX4722
Lab Result Entry5.1 Sponsor ID:
[Sponsor-Defined Identifier]
5.2 Test:
[Test:]
CD4_PX4722
5.3 Result:
[Result:]
5.4 Not Done: [hidden]
[Not Done:]
NOT DONE
5.5 LNMT
[Lab Normal Range] Low
High
Un t
10^3/mm3
/uL
%3DJH RI $QQRWDWHG 6WXG\%RRN &
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FDA-CBER-2022-5812-0228690
C4591001: COHORT SELECTION (COHORT SEL)
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1. Select appropriate response -
Protocol version
[Trigger Response 1]
2. Select appropriate response -
What cohort does the subject belong to?
[Trigger Response 10]
STAGE 1 SENTINEL COHORTS
STAGE 1 NONSENTINEL COHORTS
STAGE 2 COHORTS
STAGE 3 COHORTS3DJH RI $QQRWDWHG 6WXG\%RRN &
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FDA-CBER-2022-5812-0228691
C4591001: CONCOMITANT MEDICATIONS - BASELINE (CONMED BSL) - Repeating Form
#S p o n s o r - D e f i n e d
IdentifierCategory for
MedicationConcomitant Medications Pre-
specifiedName of
MedicationDose
DescriptionDose
UnitDose
FrequencyRoute Start
Date
1
Concomitant Medications
1. What is the medication dentifier?
[Sponsor-Defined Identifier]
2. Category:
[Category for Medicat on]
GENERAL CONCOMITANT MEDICATIONS
3. Concomitant Medications Pre-specified:
[Concom tant Medications Pre-specified]
NO
4. Med cation:
Prov de the complete gener c drug name
(including salt form, where applicable). Where
generic name is unknown, enter the full trade or
proprietary name. Include clarifying information in the Med cat on text (e.g., Ingredient(s),
route, use, formulation).
[Name of Medication]
5. Dose:
[Dose Description]
6. Dose Unit:
[Dose Unit]
7. Dose Frequency:
[Dose Frequency]
8. Route:
[Route]
9. Start Date:
[Start Date]
/
/
10. Comparison Term [hidden]
[Comparison Term]
11. Standardized Med cation Name - Dict onary
derived. [hidden]
[Standardized Med cat on Name]
12. Standardized Med cat on Code - Dictionary
derived [hidden]
[Standardized Med cat on Code] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 9
FDA-CBER-2022-5812-0228692
C4591001: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS (CONMED VAX) - Repeating Form
# Sponsor-Defined Identifier Category for Medication Concomitant Medications Pre-specified Name of Medication Start Date
1
Concomitant Medications
1. What is the medication identifier?
[Sponsor-Defined Identifier]
2. Category:
[Category for Med cat on]
VACCINATIONS
3. Concomitant Medications Pre-specified:
[Concomitant Medications Pre-specified]
NO
4. Medication:
Provide the complete gener c drug name
(including salt form, where applicable). Where
generic name is unknown, enter the full trade
or proprietary name. Include clarifying
information in the Med cat on text (e.g., Ingredient(s), route, use, formulation).
[Name of Medication]
5. Date:
[Start Date]
/
/
6. Comparison Term [hidden]
[Comparison Term]
7. Standardized Medication Name - Dict onary
derived. [hidden]
[Standardized Med cat on Name]
8. Standardized Medicat on Code - Dictionary
derived [hidden]
[Standardized Med cat on Code] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
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FDA-CBER-2022-5812-0228693
C4591001: MAIN INFORMED CONSENT (CONSENT)
Informed Consent
1. Consent Was:
[Consent Was:]
OBTAINE D
Date Written Consent Obtained
/
/
3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
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FDA-CBER-2022-5812-0228694
C4591001: CONTACT OUTCOME - MONTH 1 (CONTACT 1M)
Contact Outcome
1. Follow-Up Contact Category
[hidden]
[Follow Up Contact Category]
CONTACT OUTCOM E
2. Contact Type:
[Type of Contact/Visit]
CLINIC VISIT
TELEHEALTH VISIT
3. Was contact made?
[Was Contact Made]
YES
Date of Contact:
/
/
NO
If No, why?
4. Comments:
[Comments/Findings/Details] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
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FDA-CBER-2022-5812-0228695
C4591001: CONTACT OUTCOME - MONTH 6 (CONTACT 6M)
Contact Outcome
1. Follow-Up Contact Category
[hidden]
[Follow Up Contact Category]
CONTACT OUTCOM E
2. Contact Type:
[Type of Contact/Visit]
CLINIC VISIT
TELEHEALTH VISIT
3. Was contact made?
[Was Contact Made]
YES
Date of Contact:
/
/
NO
If No, why?
4. Comments:
[Comments/Findings/Details] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
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FDA-CBER-2022-5812-0228696
C4591001: CONTACT OUTCOME (CONTACT SV)
Contact Outcome
1. Follow-Up Contact Category
[hidden]
[Follow Up Contact Category]
CONTACT OUTCOM E
2. Contact Type:
[Type of Contact/Visit]
TELEPHONE VISIT
3. Was contact made?
[Was Contact Made]
YES
Date of Contact:
/
/
NOIf No, why?
4. Comments:
[Comments/Findings/Details] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
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FDA-CBER-2022-5812-0228697
C4591001: CONTACT OUTCOME - UNPLANNED (CONTACT UV)
Contact Outcome
1. Follow-Up Contact Category
[hidden]
[Follow Up Contact Category]
CONTACT OUTCOM E
2. Contact Type:
[Type of Contact/Visit]
TELEPHONE VISIT
3. Was contact made?
[Was Contact Made]
YES
Date of Contact:
/
/
Contact Outcome:
VISIT ARRANGE D
VISIT ARRANGED, BUT NOT ATTENDE D
VISIT NOT ARRANGED, REACTION NO LONGER PRESEN T
VISIT NOT ARRANGED, UNABLE TO ATTEN D
VISIT NOT REQUIRED, DATA ENTRY ERROR IN E-DIARY
VISIT NOT REQUIRED, INVESTIGATOR DECISIO N
NOIf No, why?
4. Comments:
[Comments/Findings/Details] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
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FDA-CBER-2022-5812-0228698
C4591001: MICROBIOLOGY SPECIMEN (COV19 SITE) - Repeating Form
# Date of Collection Specimen Type Assay Code and Description Device Type Result Comments:
1
Microbiology Specimen
1. Actual Date of Collection:
[Date of Collect on]
/
/
2. Specimen Type:
[Specimen Type]
SERUM
BLOOD
PLASMA
3. Assay Code and Description:
[Assay Code and Description]
SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
4. Device Type:
[Device Type]
SARS-COV-2 DIAGNOSTIC TEST
5. Test Result:
[Result]
POSITIVE
NEGATIV E
INDETERMINATE
6. Comments/Findings/Details:
[Comments:] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 16
FDA-CBER-2022-5812-0228699
C4591001: MICROBIOLOGY SPECIMEN (COVID TEST) - Repeating Form
#D a t e o f
CollectionSpecimen
TypeSpecimen Collection
LocationAssay Code and
DescriptionDevice
TypeTrade
NameResult Comments: Trade Name Other,
Specify
1
Microbiology Specimen
1. Actual Date of Collection:
[Date of Collect on]
/
/
2. Specimen Type:
[Specimen Type]
SWABBED MATERIA L
RESPIRATORY SECRETIONS
3. Specimen Collection Location:
[Specimen Collection Location]
NASOPHARYNX
LOWER RESPIRATORY SYSTEM
THROAT
4. Assay Code and Description:
[Assay Code and Description]
SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5. Device Type:
[Device Type]
SARS-COV-2 DIAGNOSTIC TEST
6. Trade Name:
[Trade Name]
7. Test Result:
[Result]
POSITIV E
NEGATIVE
INDETERMINATE
8. Comments/Findings/Details:
[Comments:]
9. Trade Name Other, Specify:
[Trade Name Other, Specify] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 17
FDA-CBER-2022-5812-0228700
C4591001: DEATH DETAILS CODED (DEATH DTL)
Death Details
1. Date of Collect on / Notification
of Death:
[Date of Collect on / Notif cat on
of Death]
/
/
Cause of Death Status Cause of Death
2.
Cause of Death Entry
2.1 Cause of Death Status:
[Cause of Death Status]
PRIMARY CAUSE OF DEATH
SECONDARY CAUSE OF DEATH
2.2 Cause of Death:
[Cause of Death]
2.3 Comparison Term [hidden]
[Comparison Term]
2.4 Lowest Level Term [hidden]
[Lowest Level Term]
2.5 Lowest Level Term Code
[hidden]
[Lowest Level Term Code]
2.6 Dict onary-Derived Term
[hidden][Dictionary-Derived Term]
2.7 Preferred Term Code [hidden]
[Preferred Term Code]
2.8 High Level Term [hidden]
[High Level Term]
2.9 High Level Term Code
[hidden]
[High Level Term Code]
2.10 High Level Group Term
[hidden][High Level Group Term]
2.11 High Level Group Term Code
[hidden][High Level Group Term Code]
2.12 Primary System Organ Class
[hidden][Primary System Organ Class]
2.13 Primary System Organ Class
Code [hidden]
[Primary System Organ Class Code] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 18
FDA-CBER-2022-5812-0228701
C4591001: DEMOGRAPHY (DEMOG)
Demography
1. Subject ID
[Subject ID]
2. Birth Date:
[Birth Date]
/
/
3. Sex:
[Sex]
FEMALE
MALE
4. Ethnicity:
[Ethnicity]
HISPANIC OR LATINO (A) OR OF SPANISH ORIGI N
NOT HISPANIC OR LATINO (A) OR OF SPANISH ORIGI N
NOT REPORTE D
5. Race: (Check X all that apply):
[Race Of Subject]
BLACK OR AFRICAN AMERICA N
AMERICAN INDIAN OR ALASKA NATIV E
ASIAN
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
WHITE
NOT REPORTE D
6. Racial Designation:
[Racial Designat on]
JAPANES E
OTHER3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 19
FDA-CBER-2022-5812-0228702
C4591001: DISPOSITION - SCREENING FOR BOOSTER DOSE (DISP BOOST)
Disposition - Screening for Booster Dose
1. Date of Complet on/Discontinuation/Death :
[Date of Completion/Discontinuation/Death :]
/
/
2. Phase of Disposition:
[Disposition Phase]
REPEAT SCREENING 2
3. Status:
[Status]
4. Specify Status:
[Specify Status] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 20
FDA-CBER-2022-5812-0228703
C4591001: DISPOSITION - FOLLOW-UP (DISP FUP)
Disposition - Follow-Up
1. Date of Complet on/Discontinuation/Death :
[Date of Completion/Discontinuation/Death :]
/
/
2. Phase of Disposition:
[Disposition Phase]
FOLLOW-UP
3. Status:
[Status]
4. Specify Status:
[Specify Status] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 21
FDA-CBER-2022-5812-0228704
C4591001: DISPOSITION - SCREENING FOR FURTHER VACCINATION (DISP RESCR)
Disposition - Screening for Further Vaccination
1. Date of Complet on/Discontinuation/Death :
[Date of Completion/Discontinuation/Death :]
/
/
2. Phase of Disposition:
[Disposition Phase]
REPEAT SCREENING 1
3. Status:
[Status]
4. Specify Status:
[Specify Status] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 22
FDA-CBER-2022-5812-0228705
C4591001: DISPOSITION - SCREENING (DISP SCR)
Disposition - Screening
1. Date of Complet on/Discontinuation/Death
[Date of Completion/Discontinuation/Death]
/
/
2. Phase of Disposition:
[Disposition Phase]
SCREENING
3. Status:
[Status]
4. Specify Status:
[Specify Status] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 23
FDA-CBER-2022-5812-0228706
C4591001: DISPOSITION - TREATMENT (DISP TRT)
Disposition - Treatment
1. Date of Complet on/Discontinuation/Death :
[Date of Completion/Discontinuation/Death :]
/
/
2. Phase of Disposition:
[Disposition Phase]
VACCINATIO N
OPEN LABEL TREATMEN T
SUBSTUD Y
3. Status:
[Status]
4. Specify Status:
[Specify Status] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 24
FDA-CBER-2022-5812-0228707
C4591001: DATE OF VISIT (DOV)
Date of Visit
1. Date of Visit
[Date of Visit]
/
/
2. Erroneous Visit
[Visit Error]
ERRONEOUS VISIT3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 25
FDA-CBER-2022-5812-0228708
C4591001: DATE OF VISIT - ILLNESS CONVALESCENT (DOV CONV)
Date of Visit
1. Date of Visit
[Date of Visit]
/
/
2. Erroneous Visit
[Visit Error]
ERRONEOUS VISIT
COVID-19 Illness Visit3. COVID-19 Illness Visit:
[COVID-19 Illness Vis t]
3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 26
FDA-CBER-2022-5812-0228709
C4591001: DATE OF VISIT - ILLNESS ONSET (DOV ILL)
Date of Visit
1. Date of Visit
[Date of Visit]
/
/
2. Erroneous Visit
[Visit Error]
ERRONEOUS VISIT
COVID-19 Illness Visit3. COVID-19 Illness Visit:
[COVID-19 Illness Vis t]
3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 27
FDA-CBER-2022-5812-0228710
C4591001: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE (DOV SURV)
Date of Visit
1. Date of Visit
[Date of Visit]
/
/
2. Erroneous Visit
[Visit Error]
ERRONEOUS VISIT
COVID-19 Surveillance Visit3. COVID-19 Surveillance Vis t:
[COVID-19 Surveillance Visit]
3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 28
FDA-CBER-2022-5812-0228711
C4591001: DATE OF VISIT - REPEAT SWAB (DOV SWAB)
Date of Visit
1. Date of Visit
[Date of Visit]
/
/
2. Erroneous Visit
[Visit Error]
ERRONEOUS VISIT
COVID-19 Repeat Swab3. COVID-19 Repeat Swab:
[COVID-19 Repeat Swab]
3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 29
FDA-CBER-2022-5812-0228712
C4591001: INFORM ENROLLMENT (ENROLL)
InForm Enrollment
1. Subject ID
[Subject ID] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 30
FDA-CBER-2022-5812-0228713
C4591001: HIV STATUS (HIV)
HIV Status
1. Select appropriate response -
What is the subject HIV status?
[Trigger Response 2]
The sub ject is known to be HIV POSITIV E
The subject is NOT known to be HIV POSITIVE3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 31
FDA-CBER-2022-5812-0228714
C4591001: LAB CHEMISTRY (HIV RNA)
Lab Chemistry Details
1. Lab Panel:
[Category for Lab Test]
CLINICAL CHEMISTR Y
2. Laboratory Name and Address
[Vendor Name]
3. Collection Date:
[Collect on Date:]
/
/
4. Specimen Type:
[Specimen Type]
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
Un t
/mL3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 32
FDA-CBER-2022-5812-0228715
C4591001: ELECTRONIC SAMPLE TRACKING - HLA (HLA)
Electronic Sample Tracking
1. Data Origin
[Data Origin]
SITE
2. Sample Type
[Sample Type]
WHOLE_BLOOD
3. Sample Collected?
[Sample Collected]
NO
YES
Date of Collect on:
/
/
4. If no sample was collected or
sample was not collected
according to protocol, please
provide reason:
[Reason sample not collected]
Sample ID
5.
Aliquot Entry
Please enter barcode for each aliquot.5.1 Sample ID
[Sample ID] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 33
FDA-CBER-2022-5812-0228716
C4591001: HEALTH CARE UTILIZATION (HLTHCARE)
Health Care Utilization
1. Evaluation Interval: [hidden]
[Evaluation Interval]
SINCE THE START OF THE RESPIRATORY ILLNESS EPISOD E
2. Disease Name: [hidden]
[Disease Name]
RESPIRATORY ILLNESS
Health Care Utilization
#
DPre-Specified Type of Practitioner Occurrence of Visits or Contacts
3.a YES SPECIALIST
3.b YES EMERGENCY ROOM
3.c YES PRIMARY CARE PHYSICIAN
3.d YES URGENT CARE
3.e YES TELEPHONE CONSULTATION
3.f YES OTHER
Health Care Utilization Entry3.1 Pre-Specified: [hidden]
[Pre-Specified]
YES
3.2 Physician or Healthcare
Professional:
[Type of Practitioner]
SPECIALIS T
EMERGENCY ROOM
PRIMARY CARE PHYSICIA N
URGENT CARE
TELEPHONE CONSULTATION
OTHER
3.3 Occurrence of Visits or
Contacts:
[Occurrence of Vis ts or
Contacts]
YES
Number of Vis ts or Contacts:
NO
Health Care Utilization Other
4. Other Type of Pract tioner
Specify:
[Other Type of Pract t oner
Specify]
Health Care Utilization
5. Has the subject been
hospitalized due to potential
COVID-19 illness?
[Been Hospitalized]
YES
Has the subject been in intensive care due to potential COVID-19 illness?
YES
NO
NO3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 34
FDA-CBER-2022-5812-0228717
C4591001: HOSPITALIZATION DETAILS (HOSP) - Repeating Form
# Hospitalization Category Hospitalization Term Admission Date Ongoing
1
Hospitalization Details
1. Hosp talization Category:
[Hospitalization Category]
HOSPITALIZATION STATUS
2. Hosp talization Term:
[Hospitalization Term]
ICU
HOSPITAL
3. Admission Date:
[Admission Date]
/
/
4. Ongoing?
[Ongoing]
YES
NO
Dischar ge Date:
/
/
3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 35
FDA-CBER-2022-5812-0228718
C4591001: ILLNESS DETAILS (ILL POTEN)
Illness Details
1. Category of Clinical Event:
[Category of Clin cal Event:]
POTENTIAL COVI D-19 ILLNESS
2. Was a diagnosis obtained for
Potential COVID-19 Illness?
[Diagnosis Obtained]
YES
Respiratory Illness Dia gnosis:
Date of Dia gnosis:
/
/
NO
3. Toxicity Grade:
[Toxicity Grade]
0
1
2
3
4
5
4. Comparison Term: [hidden]
[Comparison Term]
5. Lowest Level Term [hidden]
[Lowest Level Term]
6. Lowest Level Term Code
[hidden]
[Lowest Level Term Code]
7. D ctionary Derived Term
[hidden][D ctionary Derived Term]
8. Preferred Term Code [hidden]
[Preferred Term Code]
9. High Level Term [hidden]
[High Level Term]
10. High Level Term Code [hidden]
[High Level Term Code]
11. High Level Group Term
[hidden][High Level Group Term]
12. High Level Group Term Code
[hidden][High Level Group Term Code]
13. Primary System Organ Class
[hidden][Primary System Organ Class]
14. Primary System Organ Class
Code [hidden]
[Primary System Organ Class
Code] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 36
FDA-CBER-2022-5812-0228719
C4591001: ILLNESS DETAILS - SEVERE (ILL SEVERE)
Illness Details
1. Category of Clinical Event:
[Category of Clin cal Event:]
SEVERE COVI D-19 ILLNESS
2. Subcategory of Clin cal Event:
[Subcategory of Clin cal Event]
SIGNIFICANT ACUTE RENAL DYSFUNCTIO N
SIGNIFICANT ACUTE HEPATIC DYSFUNCTIO N
SIGNIFICANT ACUTE NEUROLOGIC DYSFUNCTIO N
3. Was a diagnosis obtained?
[Diagnosis Obtained]
YES
Diagnosis:
Start Date:
/
/
Ongoing?:
YES
NO
End Date:
/
/
NO
4. Toxicity Grade:
[Toxicity Grade]
1
2
3
4
5
5. Comparison Term: [hidden]
[Comparison Term]
6. Lowest Level Term [hidden]
[Lowest Level Term]
7. Lowest Level Term Code
[hidden]
[Lowest Level Term Code]
8. D ctionary Derived Term
[hidden][D ctionary Derived Term]
9. Preferred Term Code [hidden]
[Preferred Term Code]
10. High Level Term [hidden]
[High Level Term]
11. High Level Term Code [hidden]
[High Level Term Code]
12. High Level Group Term
[hidden][High Level Group Term]
13. High Level Group Term Code
[hidden][High Level Group Term Code]
14. Primary System Organ Class
[hidden][Primary System Organ Class]
15. Primary System Organ Class
Code [hidden]
[Primary System Organ Class
Code] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 37
FDA-CBER-2022-5812-0228720
C4591001: ILLNESS DETAILS - SEVERE (ILL SEVERE) - Repeating Form
# Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade
1
Illness Details
1. Category of Clinical Event:
[Category of Clin cal Event:]
SEVERE COVI D-19 ILLNESS
2. Subcategory of Clin cal Event:
[Subcategory of Clin cal Event]
SIGNIFICANT ACUTE RENAL DYSFUNCTIO N
SIGNIFICANT ACUTE HEPATIC DYSFUNCTIO N
SIGNIFICANT ACUTE NEUROLOGIC DYSFUNCTIO N
3. Was a diagnosis obtained?
[Diagnosis Obtained]
YES
Diagnosis:
Start Date:
/
/
Ongoing?:
YES
NO
End Date:
/
/
NO
4. Toxicity Grade:
[Toxicity Grade]
1
2
3
4
5
5. Comparison Term: [hidden]
[Comparison Term]
6. Lowest Level Term [hidden]
[Lowest Level Term]
7. Lowest Level Term Code
[hidden]
[Lowest Level Term Code]
8. D ctionary Derived Term
[hidden][D ctionary Derived Term]
9. Preferred Term Code [hidden]
[Preferred Term Code]
10. High Level Term [hidden]
[High Level Term]
11. High Level Term Code [hidden]
[High Level Term Code]
12. High Level Group Term
[hidden][High Level Group Term]
13. High Level Group Term Code
[hidden][High Level Group Term Code]
14. Primary System Organ Class
[hidden][Primary System Organ Class]
15. Primary System Organ Class
Code [hidden]
[Primary System Organ Class Code] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 38
FDA-CBER-2022-5812-0228721
C4591001: IMAGING (IMAGING) - Repeating Form
# Date of Assessment Location of Assessment Imaging Method Overall Assessment
1
Imaging
1. Date of Assessment:
[Date of Assessment]
/
/
2. Locat on of Assessment:
[Location of Assessment]
CHEST
HEAD
OTHER
If other, specify:
3. Type of Imaging Exam:
[Imaging Method]
CT SCA N
X-RAY
ULTRASOUN D
MRI
OTHERIf other, specify:
4. Assessment:
[Overall Assessment]
ABNORMAL
If abnormal, specify findings:
INDETERMINATE
NORMA L
UNKNOWN
NOT EVALUABLE3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 39
FDA-CBER-2022-5812-0228722
C4591001: INCLUSION/EXCLUSION CRITERIA (IN EX STG3)
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
# Inclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
1.a 1 Male or female part cipants between the ages of 18 and 55 years, inclusive, 65 and 85
years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study
stage)IN01A00
1.b 2 Participants who are willing and able to comply w th all scheduled visits, vaccination plan,
laboratory tests, lifestyle cons derat ons, and other study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and
clinical judgment of the investigator to be eligible for inclusion in the studyIN03A00
1.d 4 Capable of giving personal signed informed consent, which includes compliance with the
requirements and restr ctions listed in the ICD and in this protocolIN04A00
Inclusion Criteria Entry
1.1 Inclusion Number:
[Inclusion Number]
1
2
3
4
1.2 Cr terion Description:
[Criter on Descript on]
1.3 Cr terion met?
[Criter on met?]
YES
NO
Describe details if relevan t
1.4 Cr terion ID: (For Pfizer use
only)
[Criter on ID: (For Pfizer use
only)]
IN01A00
IN02A0 0
IN03A00
IN04A00
Exclusion Criteria
# Exclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
2.a 1 Other medical or psychiatric condition incl. recent (within past year) or active suicidal
deation/behavior/lab abnormal ty that may increase the risk of study participationEX01A00
2.b 2 Known infection w th human immunodeficiency virus (HIV), hepatitis C virus (HCV), or
hepatitis B virus (HBV)EX02A00
2.c 3 History of severe adverse reaction associated with a vaccine and/or severe allerg c
reaction (eg, anaphylaxis) to any component of the study intervent on(s)EX03A00
2.d 4 Receipt of med cat ons intended to prevent COVID-19 EX04A00
2.e 8 Immunocompromised indiv duals with known or suspected immunodeficiency, as
determined by history and/or laboratory/phys cal examinationEX08A00
2.f 9 Individuals with a history of autoimmune disease or an active autoimmune disease
requiring therapeutic interventionEX09A00
2.g 10 Bleeding diathesis or condition associated w th prolonged bleeding that would, in the
opinion of the investigator, contraindicate intramuscular inject onEX10A00
2.h 11 Women who are pregnant or breastfeeding EX11A00
2.i 12 Previous vaccinat on with any coronavirus vaccine EX12A00
2.j 13 Subjects who receive immunosuppressive therapy, such as cytotox c agents or system c
cort costeroidsEX13A01
2.k 15 Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administrat on or planned receipt throughout the studyEX14A01
2.l 16 Participation in other studies involving study intervention w thin 28 days pr or to study
entry and/or during study participat onEX15A01
2.m 17 Previous participation in other studies involving study intervent on containing lip d
nanopart clesEX16A01
2.n 22 Investigator s te staff or Pfizer employees directly involved in the conduct of the study,
site staff otherwise supervised by the investigator, and their respective family membersEX21A01
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number]
2.2 Cr terion Description:
[Criter on Descript on]
2.3 Cr terion met?
[Criter on met?]
YES
Describe details if relevant3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 40
FDA-CBER-2022-5812-0228723
NO
2.4 Cr terion ID: (For Pfizer use
only)
[Criter on ID: (For Pfizer use
only)]
3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 41
FDA-CBER-2022-5812-0228724
C4591001: INCLUSION/EXCLUSION CRITERIA (IN EX STG3)
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
# Inclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
1.a 1 Male or female part cipants between the ages of 18 and 55 years, inclusive, 65 and 85
years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study
stage)IN01A00
1.b 2 Participants who are willing and able to comply w th all scheduled visits, vaccination plan,
laboratory tests, lifestyle cons derat ons, and other study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and
clinical judgment of the investigator to be eligible for inclusion in the studyIN03A00
1.d 4 Capable of giving personal signed informed consent, which includes compliance with the
requirements and restr ctions listed in the ICD and in this protocolIN04A00
Inclusion Criteria Entry
1.1 Inclusion Number:
[Inclusion Number]
1
2
3
4
1.2 Cr terion Description:
[Criter on Descript on]
1.3 Cr terion met?
[Criter on met?]
YES
NO
Describe details if relevan t
1.4 Cr terion ID: (For Pfizer use
only)
[Criter on ID: (For Pfizer use
only)]
IN01A00
IN02A0 0
IN03A00
IN04A00
Exclusion Criteria
# Exclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
2.a 1 Other medical or psychiatric condition incl. recent (within past year) or active suicidal
deation/behavior/lab abnormal ty that may increase the risk of study participationEX01A00
2.b 2 Known infection w th human immunodeficiency virus (HIV), hepatitis C virus (HCV), or
hepatitis B virus (HBV)EX02A00
2.c 3 History of severe adverse reaction associated with a vaccine and/or severe allerg c
reaction (eg, anaphylaxis) to any component of the study intervent on(s)EX03A00
2.d 4 Receipt of med cat ons intended to prevent COVID-19 EX04A00
2.e 8 Immunocompromised indiv duals with known or suspected immunodeficiency, as
determined by history and/or laboratory/phys cal examinationEX08A00
2.f 10 Bleeding diathesis or condition associated w th prolonged bleeding that would, in the
opinion of the investigator, contraindicate intramuscular inject onEX10A00
2.g 11 Women who are pregnant or breastfeeding EX11A00
2.h 12 Previous vaccinat on with any coronavirus vaccine EX12A00
2.i 13 Subjects who receive immunosuppressive therapy, such as cytotox c agents or system c
cort costeroidsEX13A01
2.j 15 Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administrat on or planned receipt throughout the studyEX14A01
2.k 16 Participation in other studies involving study intervention within 28 days pr or to study
entry and/or during study participationEX15A01
2.l 17 Previous part cipation in other studies involving study intervent on containing lip d
nanopart clesEX16A01
2.m 22 Investigator s te staff or Pfizer employees directly involved in the conduct of the study,
site staff otherwise supervised by the investigator, and their respective family membersEX21A01
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number]
2.2 Cr terion Description:
[Criter on Descript on]
2.3 Cr terion met?
[Criter on met?]
YES
Describe details if relevant
NO
2.4 Cr terion ID: (For Pfizer use 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 42
FDA-CBER-2022-5812-0228725
only)
[Criter on ID: (For Pfizer use
only)]
3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 43
FDA-CBER-2022-5812-0228726
C4591001: INCLUSION/EXCLUSION CRITERIA (IN EX STG3)
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
# Inclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
1.a 1 Male or female part cipants between the ages of 18 and 55 years, inclusive, 65 and 85
years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study
stage)IN01A00
1.b 2 Participants who are willing and able to comply w th all scheduled visits, vaccination plan,
laboratory tests, lifestyle cons derat ons, and other study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and
clinical judgment of the investigator to be eligible for inclusion in the studyIN03A00
1.d 4 Capable of giving personal signed informed consent, which includes compliance with the
requirements and restr ctions listed in the ICD and in this protocolIN04A00
Inclusion Criteria Entry
1.1 Inclusion Number:
[Inclusion Number]
1
2
3
4
1.2 Cr terion Description:
[Criter on Descript on]
1.3 Cr terion met?
[Criter on met?]
YES
NO
Describe details if relevan t
1.4 Cr terion ID: (For Pfizer use
only)
[Criter on ID: (For Pfizer use
only)]
IN01A00
IN02A0 0
IN03A00
IN04A00
Exclusion Criteria
# Exclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
2.a 1 Other medical or psychiatric condition incl. recent (within past year) or active suicidal
deation/behavior/lab abnormal ty that may increase the risk of study participationEX01A00
2.b 2 Known infection w th human immunodeficiency virus (HIV), hepatitis C virus (HCV), or
hepatitis B virus (HBV)EX02A00
2.c 3 History of severe adverse reaction associated with a vaccine and/or severe allerg c
reaction (eg, anaphylaxis) to any component of the study intervent on(s)EX03A00
2.d 4 Receipt of med cat ons intended to prevent COVID-19 EX04A00
2.e 8 Immunocompromised indiv duals with known or suspected immunodeficiency, as
determined by history and/or laboratory/phys cal examinationEX08A00
2.f 9 Individuals with a history of autoimmune disease or an active autoimmune disease
requiring therapeutic interventionEX09A00
2.g 10 Bleeding diathesis or condition associated w th prolonged bleeding that would, in the
opinion of the investigator, contraindicate intramuscular inject onEX10A00
2.h 11 Women who are pregnant or breastfeeding EX11A00
2.i 12 Previous vaccinat on with any coronavirus vaccine EX12A00
2.j 13 Individuals who receive immunosuppressive therapy, such as cytotoxic agents or
systemic corticosteroids. Inhaled/nebulized, Intra-art cular, intrabursal, or topical
cort costeroids are perm ttedEX13A00
2.k 14 Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administrat on or planned receipt throughout the studyEX14A00
2.l 15 Participation in other studies involving study intervention w thin 28 days pr or to study
entry and/or during study participat onEX15A00
2.m 16 Previous participation in other studies involving study intervent on containing lip d
nanopart clesEX16A00
2.n 21 Investigator s te staff or Pfizer employees directly involved in the conduct of the study,
site staff otherwise supervised by the investigator, and their respective family membersEX21A00
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number]
2.2 Cr terion Description:
[Criter on Descript on]
2.3 Cr terion met?
[Criter on met?]
YES
Describe details if relevan t3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 44
FDA-CBER-2022-5812-0228727
NO
2.4 Cr terion ID: (For Pfizer use
only)
[Criter on ID: (For Pfizer use only)]
3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 45
FDA-CBER-2022-5812-0228728
C4591001: INCLUSION/EXCLUSION CRITERIA (INC EXC)
Criterion Description
1.
Inclusion Criteria Not Met Entry
1.1 Description of Inclusion
Cr terion Not Met
[Criter on Descript on]
Criterion Description
2.
Exclusion Criteria Met Entry
2.1 Description of Exclusion
Cr terion Met
[Criter on Descript on]
3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 46
FDA-CBER-2022-5812-0228729
C4591001: INCLUSION/EXCLUSION CRITERIA (INC EXC NS)
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
# Inclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
1.a 1 Male or female part cipants between the ages of 18 and 55 years, inclusive, 65 and 85
years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study
stage)IN01A00
1.b 2 Participants who are willing and able to comply w th all scheduled visits, vaccination plan,
laboratory tests, lifestyle cons derat ons, and other study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and
clinical judgment of the investigator to be eligible for inclusion in the studyIN03A00
1.d 4 Capable of giving personal signed informed consent, which includes compliance with the
requirements and restr ctions listed in the ICD and in this protocolIN04A00
Inclusion Criteria Entry
1.1 Inclusion Number:
[Inclusion Number]
1
2
3
4
1.2 Cr terion Description:
[Criter on Descript on]
1.3 Cr terion met?
[Criter on met?]
YES
NO
Describe details if relevan t
1.4 Cr terion ID: (For Pfizer use
only)
[Criter on ID: (For Pfizer use
only)]
IN01A00
IN02A0 0
IN03A00
IN04A00
Exclusion Criteria
# Exclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
2.a 1 Other medical or psychiatric condition incl. recent (within past year) or active suicidal
deation/behavior/lab abnormal ty that may increase the risk of study participationEX01A00
2.b 2 Known infection w th human immunodeficiency virus (HIV), hepatitis C virus (HCV), or
hepatitis B virus (HBV)EX02A00
2.c 3 History of severe adverse reaction associated with a vaccine and/or severe allerg c
reaction (eg, anaphylaxis) to any component of the study intervent on(s)EX03A00
2.d 4 Receipt of med cat ons intended to prevent COVID-19 EX04A00
2.e 5 Stages 1 and 2 only: Prev ous clinical or microbiolog cal diagnosis of COVID-19 EX05A00
2.f 8 Immunocompromised indiv duals w th known or suspected immunodeficiency, as
determined by history and/or laboratory/phys cal examinationEX08A00
2.g 10 Bleeding diathesis or condition associated w th prolonged bleeding that would, in the
opinion of the investigator, contraindicate intramuscular inject onEX10A00
2.h 11 Women who are pregnant or breastfeeding EX11A00
2.i 12 Previous vaccinat on with any coronavirus vaccine EX12A00
2.j 13 Subjects who receive immunosuppressive therapy, such as cytotox c agents or system c
cort costeroidsEX13A01
2.k 15 Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administrat on or planned receipt throughout the studyEX14A01
2.l 16 Participation in other studies involving study intervention within 28 days pr or to study
entry and/or during study participat onEX15A01
2.m 17 Previous participation in other studies involving study intervent on containing lip d
nanopart clesEX16A01
2.n 22 Investigator s te staff or Pfizer employees directly involved in the conduct of the study,
site staff otherwise supervised by the investigator, and their respective family membersEX21A01
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number]
2.2 Cr terion Description:
[Criter on Descript on]
2.3 Cr terion met?
[Criter on met?]
YES
Describe details if relevant
NO3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 47
FDA-CBER-2022-5812-0228730
2.4 Cr terion ID: (For Pfizer use
only)
[Criter on ID: (For Pfizer use
only)]
3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 48
FDA-CBER-2022-5812-0228731
C4591001: INCLUSION/EXCLUSION CRITERIA (INC EXC NS)
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
# Inclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
1.a 1 Male or female part cipants between the ages of 18 and 55 years, inclusive, 65 and 85
years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study
stage)IN01A00
1.b 2 Participants who are willing and able to comply w th all scheduled visits, vaccination plan,
laboratory tests, lifestyle cons derat ons, and other study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and
clinical judgment of the investigator to be eligible for inclusion in the studyIN03A00
1.d 4 Capable of giving personal signed informed consent, which includes compliance with the
requirements and restr ctions listed in the ICD and in this protocolIN04A00
Inclusion Criteria Entry
1.1 Inclusion Number:
[Inclusion Number]
1
2
3
4
1.2 Cr terion Description:
[Criter on Descript on]
1.3 Cr terion met?
[Criter on met?]
YES
NO
Describe details if relevan t
1.4 Cr terion ID: (For Pfizer use
only)
[Criter on ID: (For Pfizer use
only)]
IN01A00
IN02A0 0
IN03A00
IN04A00
Exclusion Criteria
# Exclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
2.a 1 Other medical or psychiatric condition incl. recent (within past year) or active suicidal
deation/behavior/lab abnormal ty that may increase the risk of study participationEX01A00
2.b 2 Known infection w th human immunodeficiency virus (HIV), hepatitis C virus (HCV), or
hepatitis B virus (HBV)EX02A00
2.c 3 History of severe adverse reaction associated with a vaccine and/or severe allerg c
reaction (eg, anaphylaxis) to any component of the study intervent on(s)EX03A00
2.d 4 Receipt of med cat ons intended to prevent COVID-19 EX04A00
2.e 5 Stages 1 and 2 only: Prev ous clinical or microbiolog cal diagnosis of COVID-19 EX05A00
2.f 8 Immunocompromised indiv duals w th known or suspected immunodeficiency, as
determined by history and/or laboratory/phys cal examinationEX08A00
2.g 9 Individuals with a history of autoimmune disease or an active autoimmune disease
requiring therapeutic interventionEX09A00
2.h 10 Bleeding diathesis or condition associated w th prolonged bleeding that would, in the
opinion of the investigator, contraindicate intramuscular inject onEX10A00
2.i 11 Women who are pregnant or breastfeeding EX11A00
2.j 12 Previous vaccinat on with any coronavirus vaccine EX12A00
2.k 13 Subjects who receive immunosuppressive therapy, such as cytotox c agents or system c
cort costeroidsEX13A01
2.l 15 Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administrat on or planned receipt throughout the studyEX14A01
2.m 16 Participation in other studies involving study intervention within 28 days pr or to study
entry and/or during study participationEX15A01
2.n 17 Previous participation in other studies involving study intervent on containing lip d
nanopart clesEX16A01
2.o 22 Investigator s te staff or Pfizer employees directly involved in the conduct of the study,
site staff otherwise supervised by the investigator, and their respective family membersEX21A01
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number]
2.2 Cr terion Description:
[Criter on Descript on]
2.3 Cr terion met?
[Criter on met?]
YES
Describe details if relevan t3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 49
FDA-CBER-2022-5812-0228732
NO
2.4 Cr terion ID: (For Pfizer use
only)
[Criter on ID: (For Pfizer use
only)]
3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 50
FDA-CBER-2022-5812-0228733
C4591001: INCLUSION/EXCLUSION CRITERIA (INC EXC NS)
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
# Inclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
1.a 1 Male or female part cipants between the ages of 18 and 55 years, inclusive, 65 and 85
years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study
stage)IN01A00
1.b 2 Participants who are willing and able to comply w th all scheduled visits, vaccination plan,
laboratory tests, lifestyle cons derat ons, and other study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and
clinical judgment of the investigator to be eligible for inclusion in the studyIN03A00
1.d 4 Capable of giving personal signed informed consent, which includes compliance with the
requirements and restr ctions listed in the ICD and in this protocolIN04A00
Inclusion Criteria Entry
1.1 Inclusion Number:
[Inclusion Number]
1
2
3
4
1.2 Cr terion Description:
[Criter on Descript on]
1.3 Cr terion met?
[Criter on met?]
YES
NO
Describe details if relevan t
1.4 Cr terion ID: (For Pfizer use
only)
[Criter on ID: (For Pfizer use
only)]
IN01A00
IN02A0 0
IN03A00
IN04A00
Exclusion Criteria
# Exclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
2.a 1 Other medical or psychiatric condition incl. recent (within past year) or active suicidal
deation/behavior/lab abnormal ty that may increase the risk of study participationEX01A00
2.b 2 Known infection w th human immunodeficiency virus (HIV), hepatitis C virus (HCV), or
hepatitis B virus (HBV)EX02A00
2.c 3 History of severe adverse reaction associated with a vaccine and/or severe allerg c
reaction (eg, anaphylaxis) to any component of the study intervent on(s)EX03A00
2.d 4 Receipt of med cat ons intended to prevent COVID-19 EX04A00
2.e 5 Stages 1 and 2 only: Prev ous clinical or microbiolog cal diagnosis of COVID-19 EX05A00
2.f 8 Immunocompromised indiv duals w th known or suspected immunodeficiency, as
determined by history and/or laboratory/phys cal examinationEX08A00
2.g 9 Individuals with a history of autoimmune disease or an active autoimmune disease
requiring therapeutic interventionEX09A00
2.h 10 Bleeding diathesis or condition associated w th prolonged bleeding that would, in the
opinion of the investigator, contraindicate intramuscular inject onEX10A00
2.i 11 Women who are pregnant or breastfeeding EX11A00
2.j 12 Previous vaccinat on with any coronavirus vaccine EX12A00
2.k 13 Individuals who receive immunosuppressive therapy, such as cytotoxic agents or
systemic corticosteroids. Inhaled/nebulized, Intra-art cular, intrabursal, or topical
cort costeroids are perm ttedEX13A00
2.l 14 Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administrat on or planned receipt throughout the studyEX14A00
2.m 15 Participation in other studies involving study intervention w thin 28 days pr or to study
entry and/or during study participationEX15A00
2.n 16 Previous part cipation in other studies involving study intervent on containing lip d
nanopart clesEX16A00
2.o 21 Investigator s te staff or Pfizer employees directly involved in the conduct of the study,
site staff otherwise supervised by the investigator, and their respective family membersEX21A00
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number]
2.2 Cr terion Description:
[Criter on Descript on]
2.3 Cr terion met?
[Criter on met?]
YES
Describe details if relevant3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 51
FDA-CBER-2022-5812-0228734
NO
2.4 Cr terion ID: (For Pfizer use
only)
[Criter on ID: (For Pfizer use
only)]
3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 52
FDA-CBER-2022-5812-0228735
C4591001: INCLUSION/EXCLUSION CRITERIA (INC EXC S)
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
# Inclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
1.a 1 Male or female part cipants between the ages of 18 and 55 years, inclusive, 65 and 85
years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study
stage)IN01A00
1.b 2 Participants who are willing and able to comply w th all scheduled visits, vaccination plan,
laboratory tests, lifestyle cons derat ons, and other study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and
clinical judgment of the investigator to be eligible for inclusion in the studyIN03A00
1.d 4 Capable of giving personal signed informed consent, which includes compliance with the
requirements and restr ctions listed in the ICD and in this protocolIN04A00
Inclusion Criteria Entry
1.1 Inclusion Number:
[Inclusion Number]
1
2
3
4
1.2 Cr terion Description:
[Criter on Descript on]
1.3 Cr terion met?
[Criter on met?]
YES
NO
Describe details if relevan t
1.4 Cr terion ID: (For Pfizer use
only)
[Criter on ID: (For Pfizer use
only)]
IN01A00
IN02A0 0
IN03A00
IN04A00
Exclusion Criteria
# Exclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
2.a 1 Other medical or psychiatric condition incl. recent (within past year) or active suicidal
deation/behavior/lab abnormal ty that may increase the risk of study participationEX01A00
2.b 2 Known infection w th human immunodeficiency virus (HIV), hepatitis C virus (HCV), or
hepatitis B virus (HBV)EX02A00
2.c 3 History of severe adverse reaction associated with a vaccine and/or severe allerg c
reaction (eg, anaphylaxis) to any component of the study intervent on(s)EX03A00
2.d 4 Receipt of med cat ons intended to prevent COVID-19 EX04A00
2.e 5 Stages 1 and 2 only: Prev ous clinical or microbiolog cal diagnosis of COVID-19 EX05A00
2.f 6 Sentinel participants in Stage 1 only: Individuals at high risk for severe COVID-19 (full
details in protocol)EX06A01
2.g 7 Sentinel participants in Stage 1 only: Individuals currently working in occupations with
high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response
personnel)EX07A00
2.h 8 Immunocompromised indiv duals with known or suspected immunodeficiency, as
determined by history and/or laboratory/phys cal examinationEX08A00
2.i 9 Sentinel participants in Stage 1 only: Individuals w th a history of autoimmune disease or
an active autoimmune disease requiring therapeut c interventionEX09A04
2.j 10 Bleeding diathesis or condition associated w th prolonged bleeding that would, in the
opinion of the investigator, contraindicate intramuscular inject onEX10A00
2.k 11 Women who are pregnant or breastfeeding EX11A00
2.l 12 Previous vaccinat on with any coronavirus vaccine EX12A00
2.m 13 Subjects who receive immunosuppressive therapy, such as cytotox c agents or system c
cort costeroidsEX13A01
2.n 14 Sentinel participants in Stage 1 only: Regular receipt of inhaled/nebulized corticosteroids EX22A01
2.o 15 Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administrat on or planned receipt throughout the studyEX14A01
2.p 16 Participation in other studies involving study intervention w thin 28 days pr or to study
entry and/or during study participationEX15A01
2.q 17 Previous part cipation in other studies involving study intervent on containing lip d
nanopart clesEX16A01
2.r 18 Sentinel participants in Stage 1 only: Positive serological test for SARS-CoV-2 IgM and/or
IgG antibodies at the screening visitEX17A01
2.s 19 Sentinel participants in Stage 1 only: Screening hematology/blood chemistry lab
>=Grade 1 abnormality. Except Bilirubin, other stable Grade1 abnormalities may be considered eligible by InvestigatorEX18A01
2.t 20 Sentinel participants in Stage 1 only: Positive test for HIV, hepat tis B surface antigen EX19A013DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 53
FDA-CBER-2022-5812-0228736
(HBsAg), hepat tis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs)
at screening vis t
2.u 21 Sentinel participants in Stage 1 only: SARS-CoV-2 NAAT-positive nasal swab within 24
hours before receipt of study interventionEX20A01
2.v 22 Investigator s te staff or Pfizer employees directly involved in the conduct of the study,
site staff otherwise supervised by the investigator, and their respective family membersEX21A01
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number]
2.2 Cr terion Description:
[Criter on Descript on]
2.3 Cr terion met?
[Criter on met?]
YES
Describe details if relevant
NO
2.4 Cr terion ID: (For Pfizer use
only)
[Criter on ID: (For Pfizer use
only)]
3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 54
FDA-CBER-2022-5812-0228737
C4591001: INCLUSION/EXCLUSION CRITERIA (INC EXC S)
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
# Inclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
1.a 1 Male or female part cipants between the ages of 18 and 55 years, inclusive, 65 and 85
years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study
stage)IN01A00
1.b 2 Participants who are willing and able to comply w th all scheduled visits, vaccination plan,
laboratory tests, lifestyle cons derat ons, and other study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and
clinical judgment of the investigator to be eligible for inclusion in the studyIN03A00
1.d 4 Capable of giving personal signed informed consent, which includes compliance with the
requirements and restr ctions listed in the ICD and in this protocolIN04A00
Inclusion Criteria Entry
1.1 Inclusion Number:
[Inclusion Number]
1
2
3
4
1.2 Cr terion Description:
[Criter on Descript on]
1.3 Cr terion met?
[Criter on met?]
YES
NO
Describe details if relevan t
1.4 Cr terion ID: (For Pfizer use
only)
[Criter on ID: (For Pfizer use
only)]
IN01A00
IN02A0 0
IN03A00
IN04A00
Exclusion Criteria
# Exclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
2.a 1 Other medical or psychiatric condition incl. recent (within past year) or active suicidal
deation/behavior/lab abnormal ty that may increase the risk of study participationEX01A00
2.b 2 Known infection w th human immunodeficiency virus (HIV), hepatitis C virus (HCV), or
hepatitis B virus (HBV)EX02A00
2.c 3 History of severe adverse reaction associated with a vaccine and/or severe allerg c
reaction (eg, anaphylaxis) to any component of the study intervent on(s)EX03A00
2.d 4 Receipt of med cat ons intended to prevent COVID-19 EX04A00
2.e 5 Stages 1 and 2 only: Prev ous clinical or microbiolog cal diagnosis of COVID-19 EX05A00
2.f 6 Sentinel participants in Stage 1 only: Individuals at high risk for severe COVID-19 EX06A00
2.g 7 Sentinel participants in Stage 1 only: Individuals currently working in occupations with
high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response personnel)EX07A00
2.h 8 Immunocompromised indiv duals with known or suspected immunodeficiency, as
determined by history and/or laboratory/phys cal examinationEX08A00
2.i 9 Individuals with a history of autoimmune disease or an active autoimmune disease
requiring therapeutic interventionEX09A00
2.j 10 Bleeding diathesis or condition associated w th prolonged bleeding that would, in the
opinion of the investigator, contraindicate intramuscular inject onEX10A00
2.k 11 Women who are pregnant or breastfeeding EX11A00
2.l 12 Previous vaccinat on with any coronavirus vaccine EX12A00
2.m 13 Individuals who receive immunosuppressive therapy, such as cytotoxic agents or
systemic corticosteroids. Inhaled/nebulized, Intra-art cular, intrabursal, or topical cort costeroids are perm ttedEX13A00
2.n 14 Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administrat on or planned receipt throughout the studyEX14A00
2.o 15 Participation in other studies involving study intervention w thin 28 days pr or to study
entry and/or during study participationEX15A00
2.p 16 Previous part cipation in other studies involving study intervent on containing lip d
nanopart clesEX16A00
2.q 17 Sentinel participants in Stage 1 only: Positive serological test for SARS-CoV-2 IgM and/or
IgG antibodies at the screening visitEX17A00
2.r 18 Sentinel participants in Stage 1 only: Screening hematology/blood chemistry lab
>=Grade 1 abnormality. Except Bilirubin, other stable Grade1 abnormalities may be
considered eligible by InvestigatorEX18A00
2.s 19 Sentinel participants in Stage 1 only: Positive test for HIV, hepatitis B surface antigen
(HBsAg), hepat tis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs) at screening vis tEX19A003DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 55
FDA-CBER-2022-5812-0228738
2.t 20 Sentinel participants in Stage 1 only: SARS-CoV-2 NAAT-positive nasal swab within 24
hours before receipt of study interventionEX20A00
2.u 21 Investigator s te staff or Pfizer employees directly involved in the conduct of the study,
site staff otherwise supervised by the investigator, and their respective family membersEX21A00
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number]
2.2 Cr terion Description:
[Criter on Descript on]
2.3 Cr terion met?
[Criter on met?]
YES
Describe details if relevan t
NO
2.4 Cr terion ID: (For Pfizer use
only)
[Criter on ID: (For Pfizer use
only)]
3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 56
FDA-CBER-2022-5812-0228739
C4591001: INCLUSION/EXCLUSION CRITERIA (INC EXC S)
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
# Inclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
1.a 1 Male or female part cipants between the ages of 18 and 55 years, inclusive, 65 and 85
years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study
stage)IN01A00
1.b 2 Participants who are willing and able to comply w th all scheduled visits, vaccination plan,
laboratory tests, lifestyle cons derat ons, and other study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and
clinical judgment of the investigator to be eligible for inclusion in the studyIN03A00
1.d 4 Capable of giving personal signed informed consent, which includes compliance with the
requirements and restr ctions listed in the ICD and in this protocolIN04A00
Inclusion Criteria Entry
1.1 Inclusion Number:
[Inclusion Number]
1
2
3
4
1.2 Cr terion Description:
[Criter on Descript on]
1.3 Cr terion met?
[Criter on met?]
YES
NO
Describe details if relevan t
1.4 Cr terion ID: (For Pfizer use
only)
[Criter on ID: (For Pfizer use
only)]
IN01A00
IN02A0 0
IN03A00
IN04A00
Exclusion Criteria
# Exclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
2.a 1 Other medical or psychiatric condition incl. recent (within past year) or active suicidal
deation/behavior/lab abnormal ty that may increase the risk of study participationEX01A00
2.b 2 Known infection w th human immunodeficiency virus (HIV), hepatitis C virus (HCV), or
hepatitis B virus (HBV)EX02A00
2.c 3 History of severe adverse reaction associated with a vaccine and/or severe allerg c
reaction (eg, anaphylaxis) to any component of the study intervent on(s)EX03A00
2.d 4 Receipt of med cat ons intended to prevent COVID-19 EX04A00
2.e 5 Stages 1 and 2 only: Prev ous clinical or microbiolog cal diagnosis of COVID-19 EX05A00
2.f 6 Sentinel participants in Stage 1 only: Individuals at high risk for severe COVID-19 (full
details in protocol)EX06A01
2.g 7 Sentinel participants in Stage 1 only: Individuals currently working in occupations with
high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response
personnel)EX07A00
2.h 8 Immunocompromised indiv duals with known or suspected immunodeficiency, as
determined by history and/or laboratory/phys cal examinationEX08A00
2.i 9 Individuals with a history of autoimmune disease or an active autoimmune disease
requiring therapeutic interventionEX09A00
2.j 10 Bleeding diathesis or condition associated w th prolonged bleeding that would, in the
opinion of the investigator, contraindicate intramuscular inject onEX10A00
2.k 11 Women who are pregnant or breastfeeding EX11A00
2.l 12 Previous vaccinat on with any coronavirus vaccine EX12A00
2.m 13 Subjects who receive immunosuppressive therapy, such as cytotox c agents or system c
cort costeroidsEX13A01
2.n 14 Sentinel participants in Stage 1 only: Regular receipt of inhaled/nebulized corticosteroids EX22A01
2.o 15 Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administrat on or planned receipt throughout the studyEX14A01
2.p 16 Participation in other studies involving study intervention w thin 28 days pr or to study
entry and/or during study participationEX15A01
2.q 17 Previous part cipation in other studies involving study intervent on containing lip d
nanopart clesEX16A01
2.r 18 Sentinel participants in Stage 1 only: Positive serological test for SARS-CoV-2 IgM and/or
IgG antibodies at the screening visitEX17A01
2.s 19 Sentinel participants in Stage 1 only: Screening hematology/blood chemistry lab
>=Grade 1 abnormality. Except Bilirubin, other stable Grade1 abnormalities may be considered eligible by InvestigatorEX18A01
2.t 20 Sentinel participants in Stage 1 only: Positive test for HIV, hepat tis B surface antigen EX19A013DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
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FDA-CBER-2022-5812-0228740
(HBsAg), hepat tis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs)
at screening vis t
2.u 21 Sentinel participants in Stage 1 only: SARS-CoV-2 NAAT-positive nasal swab within 24
hours before receipt of study interventionEX20A01
2.v 22 Investigator s te staff or Pfizer employees directly involved in the conduct of the study,
site staff otherwise supervised by the investigator, and their respective family membersEX21A01
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number]
2.2 Cr terion Description:
[Criter on Descript on]
2.3 Cr terion met?
[Criter on met?]
YES
Describe details if relevant
NO
2.4 Cr terion ID: (For Pfizer use
only)
[Criter on ID: (For Pfizer use
only)]
3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 58
FDA-CBER-2022-5812-0228741
C4591001: CASEBOOK SIGNATURE FORM (INVSIG)
Casebook Signature Form
1. Casebook Signature
[Casebook Signature]
Click Here to Enable3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
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FDA-CBER-2022-5812-0228742
C4591001: CENTRAL LAB SAMPLE COLLECTION (LAB)
Central Lab Sample Collection
1. Collection Date:
[Collect on 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 CHEMISTR Y
3.2 Lab Sub-Panel:
[Subcategory for Lab Test]
DIFFERENTIAL
BLOOD CHEMISTRY
3.3 Was the lab sub-panel collected?:
[Lab Sub-Panel Collected]
YES
NO3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 60
FDA-CBER-2022-5812-0228743
C4591001: CENTRAL LAB SAMPLE COLLECTION - BASELINE (LAB BSL)
Central Lab Sample Collection
1. Collection Date:
[Collect on 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
NO3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
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FDA-CBER-2022-5812-0228744
C4591001: LOCAL LABORATORY DATA - REPEATING CHEMISTRY (LAB CHEM) - Repeating Form
# Category for Lab Test Vendor Name Collection Date: Specimen Type Lab Result
1
Lab Chemistry Details
1. Lab Panel:
[Category for Lab Test]
CLINICAL CHEMISTR Y
2. Laboratory Name and Address
[Vendor Name]
3. Collection Date:
[Collect on Date:]
/
/
4. Specimen Type:
[Specimen Type]
BLOOD
Lab Result
#
DSponsor-Defined Identifier Test: Result: Not Done: Lab Normal Range
5.a C Reactive Protein_PX329
Lab Result Entry5.1 Sponsor ID:
[Sponsor-Defined Identifier]
5.2 Test:
[Test:]
C Reactive Protein_PX329
5.3 Result:
[Result:]
5.4 Not Done: [hidden]
[Not Done:]
NOT DONE
5.5 LNMT
[Lab Normal Range] Low
High
Un t
3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 62
FDA-CBER-2022-5812-0228745
C4591001: LOCAL LABORATORY DATA - REPEATING CHEMISTRY (LAB CHEM) - Repeating Form
# Category for Lab Test Vendor Name Collection Date: Specimen Type Lab Result
1
Lab Chemistry Details
1. Lab Panel:
[Category for Lab Test]
CLINICAL CHEMISTR Y
2. Laboratory Name and Address
[Vendor Name]
3. Collection Date:
[Collect on Date:]
/
/
4. Specimen Type:
[Specimen Type]
BLOOD
Lab Result
#
DSponsor-Defined Identifier Test: Result: Not Done: Lab Normal Range
5.a C Reactive Protein_PX329
5.b Alanine Aminotransferase_PX30
5.c Aspartate Aminotransferase_PX28
5.d Alkaline Phosphatase_PX35
5.e Bilirubin_PX21
5.f Blood Urea Nitrogen_PX47
5.g Creatinine_PX48
Lab Result Entry5.1 Sponsor ID:
[Sponsor-Defined Identifier]
5.2 Test:
[Test:]
5.3 Result:
[Result:]
5.4 Not Done:
[Not Done:]
NOT DON E
5.5 LNMT
[Lab Normal Range] Low
High
Un t
3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 63
FDA-CBER-2022-5812-0228746
C4591001: LOCAL LABORATORY DATA - REPEATING Hematology (LAB HEM) - Repeating Form
# Category for Lab Test Vendor Name (DERIVED) Collection Date: Specimen Type Lab Result
1
Laboratory Data Hematology
1. Lab Panel:
[Category for Lab Test]
HEMATOLOG Y
2. Laboratory Name and Address
[Vendor Name (DERIVED)]
3. Collection Date:
[Collect on Date:]
/
/
4. Specimen Type:
[Specimen Type]
BLOOD
Lab Result
#
DSponsor-Defined Identifier Test: Result: Not Done: Lab Normal Range
5.a Hemoglobin_PX1
5.b Hematocr t_PX2
5.c Erythrocytes_PX3
5.d Platelets_PX5
5.e Leukocytes_PX7
5.f Neutrophils_PX608
5.g Eosinophils_PX609
5.h Monocytes_PX612
5.i Basophils_PX610
5.j Lymphocytes_PX611
Lab Result Entry5.1 Sponsor ID:
[Sponsor-Defined Identifier]
5.2 Test:
[Test:]
5.3 Result:
[Result:]
5.4 Not Done:
[Not Done:]
NOT DONE
5.5 LNMT
[Lab Normal Range] Low
High
Unt
3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 64
FDA-CBER-2022-5812-0228747
C4591001: CENTRAL LAB SAMPLE COLLECTION - HLA (LAB HLA)
Central Lab Sample Collection
1. Collection Date:
[Collect on Date:]
/
/
2. Specimen Type:
[Specimen Type]
BLOOD
Lab Test
# Category for Lab Test Subcategory for Lab Test Lab Sub-Panel Collected
3.a HEMATOLOGY IMMUNOLOGY
Lab Test Entry3.1 Lab Panel:
[Category for Lab Test]
HEMATOLOGY
3.2 Lab Sub-Panel:
[Subcategory for Lab Test]
IMMUNOLOGY
3.3 Was the lab sub-panel collected?:
[Lab Sub-Panel Collected]
YES
NO3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 65
FDA-CBER-2022-5812-0228748
C4591001: CENTRAL LAB SAMPLE COLLECTION - PBMC (LAB PBMC)
Central Lab Sample Collection
1. Collection Date:
[Collect on Date:]
/
/
2. Specimen Type:
[Specimen Type]
BLOOD
Lab Test
# Category for Lab Test Subcategory for Lab Test Lab Sub-Panel Collected
3.a HEMATOLOGY IMMUNOLOGY
Lab Test Entry3.1 Lab Panel:
[Category for Lab Test]
HEMATOLOGY
3.2 Lab Sub-Panel:
[Subcategory for Lab Test]
IMMUNOLOGY
3.3 Was the lab sub-panel collected?:
[Lab Sub-Panel Collected]
YES
NO3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 66
FDA-CBER-2022-5812-0228749
C4591001: LAB URINALYSIS - PREGNANCY TEST (LAB PREG)
Lab Urinalysis
1. Lab Panel:
[Category for Lab Test]
URINALYSIS
2. Lab Sub-Panel:
[Subcategory for Lab Test]
PREGNANC Y
3. Collection Date:
[Collect on Date:]
/
/
4. Laboratory Name and Address (Derived)
[Vendor Name (DERIVED)]
5. Specimen Type:
[Specimen Type]
URINE
Lab Result
# Sponsor-Defined Identifier Test: Result: Not Done:
6.a Chor ogonadotropin Beta_PX113
Lab Result Entry6.1 Sponsor ID:
[Sponsor-Defined Identifier]
6.2 Test:
[Test:]
Chor ogonadotro pin Beta_PX11 3
6.3 Result:
[Result:]
NEGATIVE
POSITIV E
6.4 Not Done:
[Not Done:]
NOT DONE3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 67
FDA-CBER-2022-5812-0228750
C4591001: MEDICATION ERROR (MED ERROR) - Repeating Form
# Category Medication
ErrorStart
DateIs the medication
error Still
OngoingStudy
Medication
Errors ActionConcomitant
Medication GivenNon-Drug
Treatment
GivenCaused Study
DiscontinuationMedication Error
Associated With
AESerious
Adverse Event
Number
1
Medication Error
1. Category:
[Category]
MEDICATION ERROR
2. Medication Error (Type
of Medication Error):
[Med cat on Error]
3. If this is a dispensing
error, record the incorrect container
number that was
dispensed/administered
to the subject: [hidden]
[Incorrect package ID]
4. Start Date:
[Start Date]
/
/
5. Is the med cation error
still ongoing?
[Is the med cat on error
Still Ongoing]
YES
NO
End Date:
/
/
6. Latest Action Taken
with Study Treatment:
[Study Medication
Errors Act on]
NO ACTION TAKEN
PERMANENTLY DISCONTINUED
7. Was a Concomitant
Med cation given?[Concom tant
Med cat on Given]
YES
NO
8. Was a Non-Drug
Treatment given?[Non-Drug Treatment
Given]
YES
NO
9. D d the Medication Error
cause the subject to be
discontinued from the
study?
[Caused Study
Discontinuat on]
YES
NO
10. Was this medication
error associated with any adverse events?
[Med cat on Error
Associated With AE]
YES
AE ID:
AE ID:
AE ID:
AE ID:
AE ID:
NO
11. Ser ous Adverse Event
Number: For Pfizer Use
Only
[Serious Adverse Event
Number]
12. Comparison Term
[hidden]
[Comparison Term]
13. Lowest Level Term
[hidden]
[Lowest Level Term]
14. Lowest Level Term
Code [hidden]
[Lowest Level Term Code]
15. D ctionary-Derived
Term [hidden]
[D ctionary-Derived
Term] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
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FDA-CBER-2022-5812-0228751
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] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 69
FDA-CBER-2022-5812-0228752
C4591001: GENERAL MEDICAL HISTORY (MEDHX)
Line/MH Number Medical History Term Start Date Ongoing
1.
Medical History Details Entry
1.1 Line/MH Number:
[Line/MH Number]
1.2 Disease/Syndrome/Surgery/Non-
Drug Allergies/Drug Allergies:
[Medical History Term]
1.3 Start Date:
[Start Date]
/
/
1.4 Ongoing:
[Ongoing]
YES
NO
End Date:
/
/
1.5 Comparison Term [hidden]
[Comparison Term]
1.6 Lowest Level Term [hidden]
[Lowest Level Term]
1.7 Lowest Level Term Code
[hidden]
[Lowest Level Term Code]
1.8 Dict onary Derived Term
[hidden][Dictionary Derived Term]
1.9 Preferred Term Code [hidden]
[Preferred Term Code]
1.10 High Level Term [hidden]
[High Level Term]
1.11 High Level Term Code [hidden]
[High Level Term Code]
1.12 High Level Group Term [hidden]
[High Level Group Term]
1.13 High Level Group Term Code
[hidden]
[High Level Group Term Code]
1.14 Primary System Organ Class
[hidden][Primary System Organ Class]
1.15 Primary System Organ Class
Code [hidden]
[Primary System Organ Class
Code] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 70
FDA-CBER-2022-5812-0228753
C4591001: OXYGENATION PARAMETERS (OXYGEN) - Repeating Form
# Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen)
1
Oxygenation Parameters
1. Date Time of Assessment:
[Date Time of Assessment]
/
/
:
24-hour clock
2. Arterial Blood Gases PaO2
(mmHg):
[Arterial Blood Gases PaO2]
3. FiO2 (Fract on of Inhaled
Oxygen):[FiO2 (Fraction of Inhaled
Oxygen)] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 71
FDA-CBER-2022-5812-0228754
C4591001: PBMC/HLA BLOOD SAMPLE TRIGGER FORM (PBMC TRIG)
PBMC/HLA Blood Sample Trigger Form
1. Select appropriate response - Is
the participant part of the group
collecting blood samples for
PBMC isolation and HLA typing (select sites only)?
[Trigger Response 15]
Yes, the participant is part of the group collectin g blood sam ples for PBMC isolat on and HLA t yping
No, the part cipant is NOT part of the group collect ing blood samples for PBMC isolat on and HLA typing3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 72
FDA-CBER-2022-5812-0228755
C4591001: PHYSICAL EXAMINATION (PHYS EXAM)
Physical Examination
1. Exam Date:
[Exam Date]
/
/
Physical Examination Result
# Body System Examined Result
2.a GENERAL APPEARANCE2.b SKIN2.c HEAD2.d EYES2.e EARS2.f NOSE2.g THROAT2.h HEART2.i LUNGS2.j ABDOMEN
2.k MUSCULOSKELETAL
2.l EXTREMITIES2.m NEUROLOGICAL
2.n LYMPH NODES
Physical Examination Result Entry
2.1 Body System Examined:
[Body System Examined]
2.2 Result:
[Result]
NORMAL
ABNORMAL
If abnormal findings, specify: (If clinically significant, record on the Medical History or Adverse Event CRF as appropriate).
Are there clinically signif cant findings?
YES
NO
NOT DONE3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 73
FDA-CBER-2022-5812-0228756
C4591001: ELECTRONIC SAMPLE TRACKING - PRIOR COVID-19 INFECTION (PRIORCOV19)
Electronic Sample Tracking
1. Data Origin
[Data Origin]
SITE
2. Sample Type
[Sample Type]
SERUM
3. Sample Collected?
[Sample Collected]
NO
YES
Date of Collect on:
/
/
4. If no sample was collected or
sample was not collected
according to protocol, please
provide reason:
[Reason sample not collected]
Sample ID
5.
Aliquot Entry
Please enter barcode for each aliquot.5.1 Sample ID
[Sample ID] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
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FDA-CBER-2022-5812-0228757
C4591001: CONCOMITANT MEDICATIONS - PROHIBITED (PROHIB CM) - Repeating Form
# Sponsor-Defined
IdentifierCategory for
MedicationConcomitant Medications Pre-
specifiedName of
MedicationDose
DescriptionDose
UnitDose
FrequencyRoute Start
DateOngoing
1
Concomitant Medications
1. What is the medication dentifier?
[Sponsor-Defined Identifier]
2. Category:
[Category for Medicat on]
CONCOMITANT IMMUNOSUPPRESSIVE THERAP Y
CORTICOSTEROIDS
IMMUNOGLOBULINS
3. Concomitant Medications Pre-specified:
[Concom tant Medications Pre-specified]
NO
4. Med cation:
Prov de the complete gener c drug name
(including salt form, where applicable). Where
generic name is unknown, enter the full trade or
proprietary name. Include clarifying information
in the Med cat on text (e.g., Ingredient(s),
route, use, formulation).
[Name of Medication]
5. Dose:
[Dose Description]
6. Dose Unit:
[Dose Unit]
7. Dose Frequency:
[Dose Frequency]
8. Route:
[Route]
9. Start Date:
[Start Date]
/
/
10. Ongoing?
[Ongoing]
YES
NO
End Date:
/
/
11. Comparison Term [hidden]
[Comparison Term]
12. Standardized Med cation Name - Dict onary
derived. [hidden]
[Standardized Med cat on Name]
13. Standardized Med cat on Code - Dictionary
derived [hidden]
[Standardized Med cat on Code] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 75
FDA-CBER-2022-5812-0228758
C4591001: RADIATION TREATMENT (PROHIB ND) - Repeating Form
# Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Ongoing?
1
Radiation Treatment
1. Category:
[Category]
RADIATION THERAP Y
2. What is the treatment Identifier?
[Treatment Identifier]
3. Concomitant Non-drug Treatment Pre-specified:
[Con Non-Drug Treatments Pre-specified]
YES
4. Treatment:
[Treatment]
5. Start Date:
[Start Date]
/
/
6. Ongoing?
[Ongoing?]
YES
NO
End Date:
/
/
7. Comparison Term [hidden]
[Comparison Term]
8. Lowest Level Term [hidden]
[Lowest Level Term]
9. Lowest Level Term Code [hidden]
[Lowest Level Term Code]
10. D ctionary Derived Term [hidden]
[D ctionary Derived Term]
11. Preferred Term Code [hidden]
[Preferred Term Code]
12. High Level Term [hidden]
[High Level Term]
13. High Level Term Code [hidden]
[High Level Term Code]
14. High Level Group Term [hidden]
[High Level Group Term]
15. High Level Group Term Code [hidden]
[High Level Group Term Code]
16. Primary System Organ Class [hidden]
[Primary System Organ Class]
17. Primary System Organ Class Code [hidden]
[Primary System Organ Class Code] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 76
FDA-CBER-2022-5812-0228759
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
#
DRecord Identifier: Oxygen Saturation
2.a 1
Vital Signs Details Entry2.1 Record Identifier:
[Record Identifier:]
1
2.2 SPO2 Pulse Oximetry %
[Oxygen Saturation] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 77
FDA-CBER-2022-5812-0228760
C4591001: RANDOMIZATION (RAND)
Disposition
1. Randomizat on Date :
[Randomization Date :]
/
/
2. Randomizat on Number:
[Randomization Number]
3. Randomizat on Group:
[Randomization Group] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 78
FDA-CBER-2022-5812-0228761
C4591001: RANDOMIZATION - BOOSTER (RAND BOOST)
Disposition
1. Randomizat on Date :
[Randomization Date :]
/
/
2. Randomizat on Number:
[Randomization Number]
3. Rerandomization SSID:
[Rerandomizat on SSID] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 79
FDA-CBER-2022-5812-0228762
C4591001: REACTOGENICITY DIARY (REAC DIARY)
Reactogenicity Diary
1. Select appropriate response -
Reactogen c ty diary collection
[Trigger Response 9]
YES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJEC T
NO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 80
FDA-CBER-2022-5812-0228763
C4591001: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC EVENT (REACTION)
Unplanned Assessment Of Local Reaction
1. CISR Category [hidden]
[CISR Category]
UNPLANNED ASSESSMENT OF LOCAL REACTION/SYSTEMIC EVEN T
2. Date of Assessment:
[Date of Assessment]
/
/
3. Injection Site Location
[Injection S te Location]
DELTOID MUSCL E
4. Injection Site Body S de:
[Injection S te Body Side]
LEFT
RIGHT
Reaction
#R eaction: Reaction Present:
5.a REDNESS5.b SWELLING
Reaction Entry5.1 Reaction:
[React on:]
REDNESS
SWELLING
5.2 Reaction Present:
[React on Present:]
YES
Maximum Diameter (cm):
Minimum Diameter (cm):
Meets Grade 4 Reaction Cr teria:
YES
NO
NO
Symptom
#S ymptom: Symptom Present:
6.a PAIN AT INJECTION SITE
6.b FATIGUE/TIREDNESS6.c HEADACHE6.d VOMITING6.e DIARRHEA6.f NEW OR WORSENED MUSCLE PAIN6.g NEW OR WORSENED JOINT PAIN6.h CHILLS
Symptom Entry6.1 Symptom:
[Symptom:]
6.2 Symptom Present:
[Symptom Present:]
YES
Symptom Grade:
1
2
3
4
Event related to Stud y Treament ?
YES
NO
NO3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 81
FDA-CBER-2022-5812-0228764
C4591001: RESPIRATORY TREATMENT (RESP TX) - Repeating Form
# Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Ongoing?
1
Respiratory Treatment
1. What is the treatment Identifier?
[Treatment Identifier]
2. Concomitant Non-drug Treatment Pre-specified:
[Con Non-Drug Treatments Pre-specified]
YES
3. Treatment:
[Treatment]
INTUBATIO N
NON-INVASIVE POSITIVE PRESSURE VENTILATION
CPAP
OXYGEN THERAP Y
4. Treatment:
[Treatment]
5. Start Date:
[Start Date]
/
/
6. Ongoing?
[Ongoing?]
YES
NO
End Date:
/
/
7. Comparison Term [hidden]
[Comparison Term]
8. Lowest Level Term [hidden]
[Lowest Level Term]
9. Lowest Level Term Code [hidden]
[Lowest Level Term Code]
10. D ctionary Derived Term [hidden]
[D ctionary Derived Term]
11. Preferred Term Code [hidden]
[Preferred Term Code]
12. High Level Term [hidden]
[High Level Term]
13. High Level Term Code [hidden]
[High Level Term Code]
14. High Level Group Term [hidden]
[High Level Group Term]
15. High Level Group Term Code [hidden]
[High Level Group Term Code]
16. Primary System Organ Class [hidden]
[Primary System Organ Class]
17. Primary System Organ Class Code [hidden]
[Primary System Organ Class Code] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 82
FDA-CBER-2022-5812-0228765
C4591001: RESPIRATORY TREATMENT (RESP TX) - Repeating Form
# Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Ongoing?
1
Respiratory Treatment
1. What is the treatment Identifier?
[Treatment Identifier]
2. Concomitant Non-drug Treatment Pre-specified:
[Con Non-Drug Treatments Pre-specified]
YES
3. Treatment:
[Treatment]
NON-INVASIVE POSITIVE PRESSURE VENTILATION
CPAP
MECHANICAL VENTILATIO N
EXTRACORPOREAL MEMBRANE OXYGENATIO N
HIGH FLOW OXYGEN THERAP Y
4. Treatment:
[Treatment]
5. Start Date:
[Start Date]
/
/
6. Ongoing?
[Ongoing?]
YES
NO
End Date:
/
/
7. Comparison Term [hidden]
[Comparison Term]
8. Lowest Level Term [hidden]
[Lowest Level Term]
9. Lowest Level Term Code [hidden]
[Lowest Level Term Code]
10. D ctionary Derived Term [hidden]
[D ctionary Derived Term]
11. Preferred Term Code [hidden]
[Preferred Term Code]
12. High Level Term [hidden]
[High Level Term]
13. High Level Term Code [hidden]
[High Level Term Code]
14. High Level Group Term [hidden]
[High Level Group Term]
15. High Level Group Term Code [hidden]
[High Level Group Term Code]
16. Primary System Organ Class [hidden]
[Primary System Organ Class]
17. Primary System Organ Class Code [hidden]
[Primary System Organ Class Code] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 83
FDA-CBER-2022-5812-0228766
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 willin g to return for Vaccinat on 3
Participant is:
eligible per local/national recommendations and confirmed to have received onl y placebo at Vaccination 1/ 2
eligible per other protocol allowance (s) and confirmed to have received onl y placebo at Vaccination 1/ 2
eligible and NOT confirmed to have received onl y placebo at Vaccination 1/2
Participant is NOT willing to return for Vaccination 3 OR otherwise not eligible3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 84
FDA-CBER-2022-5812-0228767
C4591001: INFORMED CONSENT - FURTHER VACCINATION (REVAX CONS)
Informed Consent - Further Vaccination
1. Consent Was:
[Consent Was:]
OBTAINE D
Date Written Consent Obtained
/
/
3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 85
FDA-CBER-2022-5812-0228768
C4591001: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION (REVAX IE)
Criterion Description
1.
Inclusion Criteria Not Met Entry
1.1 Description of Inclusion
Cr terion Not Met
[Criter on Descript on]
Criterion Description
2.
Exclusion Criteria Met Entry
2.1 Description of Exclusion
Cr terion Met
[Criter on Descript on]
3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 86
FDA-CBER-2022-5812-0228769
C4591001: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB (RSWAB)
Electronic Sample Tracking
1. Data Origin
[Data Origin]
SITE
2. Sample Type
[Sample Type]
NASAL_SWAB
NASAL_SWAB_SEL F
3. Sample Collected?
[Sample Collected]
NO
YES
Date of Collect on:
/
/
4. If no sample was collected or
sample was not collected
according to protocol, please
provide reason:
[Reason sample not collected]
Sample ID
5.
Aliquot Entry
Please enter barcode for each aliquot.5.1 Sample ID
[Sample ID] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 87
FDA-CBER-2022-5812-0228770
C4591001: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY (SAMP TRK)
Electronic Sample Tracking
1. Data Origin
[Data Origin]
SITE
2. Sample Type
[Sample Type]
SERUM
3. Sample Collected?
[Sample Collected]
NO
YES
Date of Collect on:
/
/
4. If no sample was collected or
sample was not collected
according to protocol, please
provide reason:
[Reason sample not collected]
Sample ID
5.
Aliquot Entry
Please enter barcode for each aliquot.5.1 Sample ID
[Sample ID] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 88
FDA-CBER-2022-5812-0228771
C4591001: INFORM SCREENING (SCREEN)
InForm Screening
1. InForm Initials [hidden]
[InForm Initials]
2. Birth Date:
[Birth Year]
/
/
3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 89
FDA-CBER-2022-5812-0228772
C4591001: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF (SELF SWAB)
Electronic Sample Tracking
1. Data Origin
[Data Origin]
SITE
2. Sample Type
[Sample Type]
NASAL_SWAB_SELF
3. Sample Collected?
[Sample Collected]
NO
YES
Date of Collect on:
/
/
4. If no sample was collected or
sample was not collected
according to protocol, please
provide reason:
[Reason sample not collected]
Sample ID
5.
Aliquot Entry
Please enter barcode for each aliquot.5.1 Sample ID
[Sample ID] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 90
FDA-CBER-2022-5812-0228773
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
#
DEvent Pre-specified Symptoms Symptom Present
4.a YES FEVER
4.b YES LOSS OF TASTE/SMELL
4.c YES NEW OR INCREASED COUGH
4.d YES NEW OR INCREASED NASAL CONGESTION
4.e YES NEW OR INCREASED NASAL DISCHARGE
4.f YES NEW OR INCREASED SHORTNESS OF BREATH
4.g YES NEW OR INCREASED SORE THROAT
4.h YES NEW OR INCREASED SPUTUM PRODUCTION
4.i YES NEW OR INCREASED WHEEZING
Symptoms Entry
4.1 Event Pre-specified: [hidden]
[Event Pre-specified]
YES
4.2 Symptoms:
[Symptoms]
4.3 Was symptom present?
[Symptom Present]
YES
NO
Symptoms - Other
5.
D
Symptoms - Other Entry5.1 Symptoms - Other Text:
[Symptoms - Other]
5.2 Comparison Term: [hidden]
[Comparison Term]
5.3 Lowest Level Term [hidden]
[Lowest Level Term]
5.4 Lowest Level Term Code
[hidden]
[Lowest Level Term Code]
5.5 Dict onary Derived Term
[hidden][Dictionary Derived Term]
5.6 Preferred Term Code [hidden]
[Preferred Term Code]
5.7 High Level Term [hidden]
[High Level Term]
5.8 High Level Term Code
[hidden][High Level Term Code]
5.9 High Level Group Term
[hidden][High Level Group Term]
5.10 High Level Group Term Code
[hidden]
[High Level Group Term Code]
5.11 Primary System Organ Class
[hidden][Primary System Organ Class]
5.12 Primary System Organ Class
Code [hidden]
[Primary System Organ Class 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 91
FDA-CBER-2022-5812-0228774
Code] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 92
FDA-CBER-2022-5812-0228775
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
#
DEvent 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 PAIN
4.f YES NEW LOSS OF TASTE OR SMELL
4.g YES NEW OR INCREASED SORE THROAT
4.h YES DIARRHEA
4.i YES VOMITING
Symptoms Entry
4.1 Event Pre-specified: [hidden]
[Event Pre-specified]
YES
4.2 Symptoms:
[Symptoms]
4.3 Was symptom present?
[Symptom Present]
YES
NO
Symptoms - Other
5.
D
Symptoms - Other Entry5.1 Symptoms - Other Text:
[Symptoms - Other]
5.2 Comparison Term: [hidden]
[Comparison Term]
5.3 Lowest Level Term [hidden]
[Lowest Level Term]
5.4 Lowest Level Term Code
[hidden]
[Lowest Level Term Code]
5.5 Dict onary Derived Term
[hidden][Dictionary Derived Term]
5.6 Preferred Term Code [hidden]
[Preferred Term Code]
5.7 High Level Term [hidden]
[High Level Term]
5.8 High Level Term Code
[hidden][High Level Term Code]
5.9 High Level Group Term
[hidden][High Level Group Term]
5.10 High Level Group Term Code
[hidden]
[High Level Group Term Code]
5.11 Primary System Organ Class
[hidden][Primary System Organ Class]
5.12 Primary System Organ Class
Code [hidden]
[Primary System Organ Class 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 93
FDA-CBER-2022-5812-0228776
Code] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 94
FDA-CBER-2022-5812-0228777
C4591001: STRATIFICATION (STRAT)
Stratification
1. Select appropriate response -
Randomizat on Stage
[Trigger Response 3]
Non-Sentinel Sta ge 1
2. Select appropriate response -
Randomizat on Age Group
[Trigger Response 4]
Age 18 to 55
Age 65 to 85
3. Select appropriate response -
Randomizat on Dose[Trigger Response 5]
10 mcg
20 mcg
30 mcg
4. Select appropriate response -
Randomizat on Dose Group[Trigger Response 8]
21 Day
60 Day
5. Select appropriate response -
BNT Number[Trigger Response 7]
(BNT162b1 or PBO)
(BNT162b2 or PBO)
(BNT162b3 or PBO)3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 95
FDA-CBER-2022-5812-0228778
C4591001: STRATIFICATION (STRAT)
Stratification
1. Select appropriate response -
Randomizat on Stage
[Trigger Response 3]
Stage 1
Stage 2
2. Select appropriate response -
Randomizat on Age Group
[Trigger Response 4]
Age 18 to 55
Age 56 to 85
Age 65 to 8 5
3. Select appropriate response -
Randomizat on Dose
[Trigger Response 5]
Low dose level (3mcg)
Medium dose level (10mcg)
High dose level (30mcg)
Low dose level (10mcg)
Medium dose level (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-Mid dose level (20mcg)
4. Select appropriate response -
Randomizat on Dose Group
[hidden]
[Trigger Response 6]
21 Day 2-dose group
60 Day 2-dose group
1-dose group
5. Select appropriate response -
Randomizat on Dose Group
[Trigger Response 8]
21 Day
60 Day
6. Select appropriate response -
BNT Number[Trigger Response 7]
(BNT162a1 or PBO)
(BNT162b1 or PBO)
(BNT162b2 or PBO )
(BNT162c2 or PBO)
(BNT162b3 or PBO )3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 96
FDA-CBER-2022-5812-0228779
C4591001: STRATIFICATION (STRAT)
Stratification
1. Select appropriate response -
Randomizat on Stage
[Trigger Response 3]
Stage 2
2. Select appropriate response -
Randomizat on Age Group
[Trigger Response 4]
Age 18 to 55
Age 56 to 85
3. Select appropriate response -
Randomizat on Dose[Trigger Response 5]
10 mcg
20 mcg
30 mcg
4. Select appropriate response -
BNT Number[Trigger Response 7]
(BNT162b1 or PBO)
(BNT162b2 or PBO)
(BNT162b3 or PBO)3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 97
FDA-CBER-2022-5812-0228780
C4591001: SUBJECT STATUS (SUB STATU)
Subject Status
1. Subject Status
[Subject Status]
2. Subject Status Date
[Status Date]
/
/
3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 98
FDA-CBER-2022-5812-0228781
C4591001: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE (SURV CONS)
Informed Consent - Asymptomatic Surveillance
1. Consent Was:
[Consent Was:]
OBTAINE D
Date Written Consent Obtained
/
/
3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 99
FDA-CBER-2022-5812-0228782
C4591001: ELECTRONIC SAMPLE TRACKING - NASAL SWAB (SWAB PFE)
Electronic Sample Tracking
1. Data Origin
[Data Origin]
SITE
2. Sample Type
[Sample Type]
NASAL_SWAB
3. Sample Collected?
[Sample Collected]
NO
YES
Date of Collect on:
/
/
4. If no sample was collected or
sample was not collected
according to protocol, please
provide reason:
[Reason sample not collected]
Sample ID
5.
Aliquot Entry
Please enter barcode for each aliquot.5.1 Sample ID
[Sample ID] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 100
FDA-CBER-2022-5812-0228783
C4591001: MICROBIOLOGY SPECIMEN (SWAB SITE) - Repeating Form
# Date of Collection Specimen Type Specimen Collection Location Assay Code and Description Device Type Trade Name Result Comments:
1
Microbiology Specimen
1. Actual Date of Collection:
[Date of Collect on]
/
/
2. Specimen Type:
[Specimen Type]
SWABBED MATERIAL
3. Specimen Collection Location:
[Specimen Collection Location]
NASAL CAVITY
4. Assay Code and Description:
[Assay Code and Description]
SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5. Device Type:
[Device Type]
SARS-CO V-2 DIAGNOSTIC TES T
6. Trade Name:
[Trade Name]
CEPHEID XPERT XPRESS SARS-COV-2 TEST
7. Test Result:
[Result]
POSITIVE
NEGATIVE
INDETERMINATE
8. Comments/Findings/Details:
[Comments:] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 101
FDA-CBER-2022-5812-0228784
C4591001: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES (SYMPRDATE)
Vaccination Symptoms Diary - Symptom Resolved Dates
1. Were medications to treat
fever/pain given on the last day
the Subject Diary was
completed?[Fever/Pain Medication on Last
Diary Day]
YES
Ongoing?
YES
NO
Stop Date:
/
/
NO
# Symptom: Were fever or systemic symptoms present on the last day the Subject Diary was completed?
2.a FEVER
2.b FATIGUE2.c HEADACHE2.d CHILLS2.e VOMITING2.f DIARRHEA2.g NEW OR WORSENED MUSCLE PAIN2.h NEW OR WORSENED JOINT PAIN
2.1 Symptom:
[Symptom:]
2.2 Were fever or system c
symptoms present on the last
day the Subject Diary was
completed?
[Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?]
YES
Ongoing?
YES
NOStop Date:
/
/
NO
3. Injection Site Location:
[Injection S te Location:]
DELTOID MUSCLE
4. Injection Site Body S de:
[Injection S te Body Side:]
LEFT
RIGHT
# Injection Site Reaction: Were injection site reactions present on the last day the Subject Diary was completed?
5.a REDNESS
5.b SWELLING5.c PAIN AT INJECTION SITE
5.1 Injection Site React on:
[Injection Site Reaction:]
REDNESS
SWELLING
PAIN AT INJECTION SITE
5.2 Were injection s te reactions
present on the last day the
Subject Diary was completed?
[Were inject on site reactions
present on the last day the
Subject Diary was completed?]
YES
Ongoing?
YES
NOStop Date:
/
/
NO3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
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FDA-CBER-2022-5812-0228785
C4591001: TRANSFUSIONS (TRANSFUSE) - Repeating Form
#T ransfusion Type Date of Transfusion
1
1. Transfus on Type:
[Transfus on Type]
PACKED RBC
PLATELETS
WHOLE BLOOD
PLASMA
OTHER
Specify:
2. Date of Transfus on:
[Date of Transfusion]
/
/
3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
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FDA-CBER-2022-5812-0228786
C4591001: TREATMENT UNBLINDED (TRN UNBLN)
Treatment Unblinded
1. Date Treatment Unblinded :
[Date Treatment Unblinded :]
/
/
2. Primary Reason for Unblinding:
[Primary Reason for Unblinding]
SUBJECT SAFETY CONCER N
OTHER
If other, s pecify:
ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATIO N3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
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FDA-CBER-2022-5812-0228787
C4591001: TREATMENT UNBLINDED - BOOSTER (TRN UNBLNB)
Treatment Unblinded - Booster
1. Date Treatment Unblinded :
[Date Treatment Unblinded :]
/
/
2. Primary Reason for Unblinding:
[Primary Reason for Unblinding]
SUBJECT SAFETY CONCER N
OTHER
If other, s pecify:3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
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FDA-CBER-2022-5812-0228788
C4591001: UNPLANNED VISIT (UNPL)
Unplanned Assessments
1. Assessments
[Assessments]
CONTACT OUTCOM E3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 106
FDA-CBER-2022-5812-0228789
C4591001: VACCINATION (VACIN TRT)
Vaccination
1. Was there a
temporary
delay of
vaccinat on?[Temporary
Delay of
Vaccination]
YES
Date of First Delay:
/
/
Reason(s) for Tem porary Delay of Vaccination
FEVER OR ACUTE ILLNESS
RECENT SYSTEMIC CORTICOSTEROID TREATMEN T
RECENT NO N-STUDY VACCINATION
ANTICIPATED NO N-STUDY VACCINATION
NO
2. Treatment
Name
[Treatment
Name]
3. Formulat on:
[Formulat on:]
INJECTION
4. Dose Date
Time:[Dose Date
Time:]
/
/
:
24-hour clock
5. Anatomical
Locat on:[Anatomical
Locat on:]
DELTOID MUSCLE
6. Body Side:
[Body S de:]
LEFT
RIGHT
7. Route:
[Route:]
INTRAMUSCULAR
8. Planned Dose:
[Planned Dose]
9. Planned Dose
Unit:[Planned Dose
Unit]
ug
10. Actual Dose:
[Actual Dose:]
11. Unit:
[Unit:]
ug
12. Was the Actual
Dose adjusted from planned?
[Dose Adjusted
From Planned]
YES
What was the reason the dose was adjusted?
ADVERSE EVENT (S)
INSUFFICIENT CLINICAL RESPONS E
OTHER SPECIF Y
If other, s pecify:
NO
13. Timeframe
Subject Was
Observed
[Timeframe
Subject Was
Observed]
THE PROTOCOL SPECIFIED OBSERVATION PERIOD
14. Was the
subject observed for at
least the
protocol
specified
observation
period after
investigational
product administration?
[Observed Post
Dose For
Specified Time]
YES
NO
If No, specify reason:
15. Comparison
Term [hidden]
[Comparison
Term]
16. Standardized
Med cation
Name -3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
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FDA-CBER-2022-5812-0228790
D ctionary
Derived.
[hidden]
[Standardized
Med cation
Name]
17. Standardized
Med cation
Code -
D ctionary
Derived
[hidden]
[Standardized
Med cation
Code] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 108
FDA-CBER-2022-5812-0228791
C4591001: VACCINATION (VACIN TRT)
Vaccination
1. Was there a
temporary
delay of
vaccinat on?[Temporary
Delay of
Vaccination]
YES
Date of First Delay:
/
/
Reason(s) for Tem porary Delay of Vaccination
FEVER OR ACUTE ILLNESS
RECENT SYSTEMIC CORTICOSTEROID TREATMEN T
RECENT NO N-STUDY VACCINATION
ANTICIPATED NO N-STUDY VACCINATION
NO
2. Treatment
Name
[Treatment
Name]
3. Formulat on:
[Formulat on:]
INJECTION
4. Dose Date
Time:[Dose Date
Time:]
/
/
:
24-hour clock
5. Anatomical
Locat on:[Anatomical
Locat on:]
DELTOID MUSCLE
6. Body Side:
[Body S de:]
LEFT
RIGHT
7. Route:
[Route:]
INTRAMUSCULAR
8. Container
Number: [hidden]
[PAC / K t
Number:]
9. Actual Dose:
[Actual Dose:]
10. Unit:
[Unit:]
mL
ug
11. Timeframe
Subject Was
Observed
[Timeframe
Subject Was
Observed]
THE PROTOCOL SPECIFIED OBSERVATION PERIOD
30 MINUTES
12. Was the
subject observed for at
least the
protocol
specified
observation period after
investigational
product
administration?
[Observed Post
Dose For
Specified Time]
YES
NO
If No, specify reason:
13. Comparison
Term [hidden]
[Comparison
Term]
14. Standardized
Med cation
Name -
D ctionary
Derived.
[hidden]
[Standardized
Med cation
Name]
15. Standardized
Med cation Code -
D ctionary
Derived [hidden]3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
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FDA-CBER-2022-5812-0228792
[Standardized
Med cation
Code] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 110
FDA-CBER-2022-5812-0228793
C4591001: CONCOMITANT MEDICATIONS - VASOPRESSORS (VASOPRESS) - Repeating Form
# Sponsor-Defined Identifier Category for Medication Concomitant Medications Pre-specified Name of Medication Start Date Ongoing
1
Concomitant Medications
1. What is the medication identifier?
[Sponsor-Defined Identifier]
2. Category:
[Category for Med cat on]
GENERAL CONCOMITANT MEDICATIONS
3. Concomitant Medications Pre-specified:
[Concomitant Medications Pre-specified]
NO
4. Medication:
Provide the complete gener c drug name
(including salt form, where applicable). Where
generic name is unknown, enter the full trade
or proprietary name. Include clarifying
information in the Med cat on text (e.g., Ingredient(s), route, use, formulation).
[Name of Medication]
5. Start Date:
[Start Date]
/
/
6. Ongoing?
[Ongoing]
YES
NO
End Date:
/
/
7. Comparison Term [hidden]
[Comparison Term]
8. Standardized Medication Name - Dict onary
derived. [hidden]
[Standardized Med cat on Name]
9. Standardized Medicat on Code - Dictionary
derived [hidden]
[Standardized Med cat on Code] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
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FDA-CBER-2022-5812-0228794
C4591001: VACCINATION 4 TRIGGER FORM (VAX4 TRIG)
Vaccination 4 Trigger Form
1. Select appropriate response -
Has the part cipant been
selected to receive an add tional
(4th) dose of BNT162b2SA?[Trigger Response 14]
Yes, the participant has been selected to receive an add t onal (4th) dose of BNT162b2S A
No, the part cipant has NOT been selected to receive an add t onal (4th) dose of BNT162b2SA3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
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FDA-CBER-2022-5812-0228795
C4591001: VITAL SIGNS - TEMP (VITAL TEMP)
Vital Signs
1. Date:
[Date:]
/
/
Vital Signs Details
# Record Identifier: Temperature Temperature Unit Temperature Location:
2.a 1
Vital Signs Details Entry2.1 Record Identifier:
[Record Identifier:]
1
2.2 Temperature:
[Temperature]
2.3 Unit:
[Temperature Unit]
F
C
2.4 Temperature Location:
[Temperature Location:]
ORAL CAVITY
EAR
RECTUM
AXILLA
FOREHEAD3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
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FDA-CBER-2022-5812-0228796
C4591001: VITAL SIGNS - BASELINE (VITALS BSL)
Vital Signs
1. Date:
[Date:]
/
/
2. Weight:
[Weight]
3. Un t:
[Weight Unit]
kg
LB
4. Height:
[Height]
5. Un t:
[Height Un t]
cm
in
6. Body Mass Index:
[Body Mass Index]
Vital Signs Details
# Record Identifier: Temperature Temperature Unit Temperature Location: Systolic: Diastolic: BP Position Pulse:
7.a 1 SITTING
Vital Signs Details Entry7.1 Record Identifier:
[Record Identifier:]
1
7.2 Temperature:
[Temperature]
7.3 Unit:
[Temperature Unit]
C
F
7.4 Temperature Location:
[Temperature Location:]
ORAL CAVITY
EAR
RECTUM
AXILLA
FOREHEAD
7.5 Systol c:
[Systolic:]
7.6 Diastol c:
[Diastol c:]
7.7 BP Posit on:
[BP Position]
SITTING
7.8 Pulse:
[Pulse:] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
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FDA-CBER-2022-5812-0228797
C4591001: VITAL SIGNS - BASELINE (VITALS BSL)
Vital Signs
1. Date:
[Date:]
/
/
2. Weight:
[Weight]
3. Un t:
[Weight Unit]
kg
LB
4. Height:
[Height]
5. Un t:
[Height Un t]
cm
in
6. Body Mass Index:
[Body Mass Index]
Vital Signs Details
# Record Identifier: Temperature Temperature Unit Temperature Location:
7.a 1
Vital Signs Details Entry7.1 Record Identifier:
[Record Identifier:]
1
7.2 Temperature:
[Temperature]
7.3 Unit:
[Temperature Unit]
C
F
7.4 Temperature Location:
[Temperature Location:]
ORAL CAVITY
EAR
RECTUM
AXILLA
FOREHEAD3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
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FDA-CBER-2022-5812-0228798
C4591001: VITAL SIGNS - COVID (VITALS COV) - Repeating Form
#D ate: Vital Signs Details
1
Vital Signs
1. Date:
[Date:]
/
/
Vital Signs Details
#
DRecord Identifier: Systolic: Diastolic: Respiratory Rate in respirations/minute Heart Rate in beats/minute
2.a 1
Vital Signs Details Entry2.1 Record Identifier:
[Record Identifier:]
1
2.2 Systol c:
[Systolic:]
2.3 Diastol c:
[Diastol c:]
2.4 Respiratory Rate in
respirations/minute:
[Respiratory Rate in
respirations/minute]
2.5 Heart Rate in beats/minute:
[Heart Rate in beats/minute] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
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FDA-CBER-2022-5812-0228799
C4591001: VITAL SIGNS (VITALS FUP)
Vital Signs
1. Date:
[Date:]
/
/
Vital Signs Details
# Record Identifier: Temperature Temperature Unit Temperature Location: Systolic: Diastolic: BP Position Pulse:
2.a 1 SITTING
Vital Signs Details Entry2.1 Record Identifier:
[Record Identifier:]
1
2.2 Temperature:
[Temperature]
2.3 Unit:
[Temperature Unit]
F
C
2.4 Temperature Location:
[Temperature Location:]
ORAL CAVITY
EAR
RECTUM
AXILLA
FOREHEAD
2.5 Systol c:
[Systolic:]
2.6 Diastol c:
[Diastol c:]
2.7 BP Posit on:
[BP Position]
SITTING
2.8 Pulse:
[Pulse:] 3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
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FDA-CBER-2022-5812-0228800
C4591001: WITHDRAWAL OF CONSENT (WOC)
Withdrawal Of Consent
1. Withdrawal of Consent Date :
[Withdrawal of Consent Date :]
/
/
3DJH RI $QQRWDWHG 6WXG\%RRN &
ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT )
Page 118
FDA-CBER-2022-5812-0228801
A-1426-0086 / App Subject Facing Screen Report 26-OCT-2020
C4591001-Post-12-July-2020 English (USA) enUS Version 4
Page 1 of 57 ǦͳͶʹǦͲͲͺȀͶͷͻͳͲͲͳǦǦͳʹǦ
Ǧ
ʹͲʹͲ
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 ................................ ..............................................................3 7
5 Form: Patient main menu ...................................................................................................4 0
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 090177e198823706\A pproved\A pproved On: 04-Nov-2021 12:49 (GMT )
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C4591001-Post-12-July-2020 English (USA) enUS Version 4
Page 2 of 57 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
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 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 y ou 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-Post-12-July-2020
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 fo r 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, pl ease contact the Helpdes k. ]
SMS Body for Provisioned Devices:
Welcome to the C4591001-Post-12-July-2020 Study! Activate the TrialMax App with code: 090177e198823706\A pproved\A pproved On: 04-Nov-2021 12:49 (GMT )
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C4591001-Post-12-July-2020 English (USA) enUS Version 4
Page 3 of 57 [Activation Code]
Email notification/Subject card to BYOD subjects:
Welcome to the C4591001-Post-12-July-2020 study!
Email notification only: [ Hello, ]
The information below will guide you on how to install the 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 mi nutes, 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 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 diar y provider
for clinical trials. This email message and its contents are fo r the sole use of the intended
recipient(s) and may contain confidential and privileged inform ation. Any unauthorized review, 090177e198823706\A pproved\A pproved On: 04-Nov-2021 12:49 (GMT )
Page 121
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C4591001-Post-12-July-2020 English (USA) enUS Version 4
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, pl ease 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 COV ID-19 symptoms.
Email notification only: [ ----------
This is an automatic e -mail me ssage sent by Signant Health, an electronic patient diary provi der
for clinical trials. This email message and its contents are fo r 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, pl ease contact the Helpdesk. ]
090177e198823706\A pproved\A pproved On: 04-Nov-2021 12:49 (GMT )
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C4591001-Post-12-July-2020 English (USA) enUS Version 4
Page 5 of 57 2 Common
Screen 1
Screen 2
090177e198823706\A pproved\A pproved On: 04-Nov-2021 12:49 (GMT )
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Page 6 of 57
Screen 3
Screen 4
090177e198823706\A pproved\A pproved On: 04-Nov-2021 12:49 (GMT )
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Page 7 of 57
Screen 5
Screen 6
090177e198823706\A pproved\A pproved On: 04-Nov-2021 12:49 (GMT )
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Page 8 of 57
Screen 7
Screen 8
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Screen 9
Screen 10
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Screen 11
Screen 12
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FDA-CBER-2022-5812-0228811
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Screen 13
Screen 14
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FDA-CBER-2022-5812-0228812
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Screen 15
Screen 16
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FDA-CBER-2022-5812-0228813
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Screen 17
Screen 18
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FDA-CBER-2022-5812-0228814
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Screen 19
Screen 20
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FDA-CBER-2022-5812-0228815
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Screen 21
Screen 22
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FDA-CBER-2022-5812-0228816
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Screen 23
Screen 24
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FDA-CBER-2022-5812-0228817
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Screen 25
Screen 26
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FDA-CBER-2022-5812-0228818
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Screen 27
Screen 28
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FDA-CBER-2022-5812-0228819
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Screen 29
Screen 30
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FDA-CBER-2022-5812-0228820
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Screen 31
Screen 32
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FDA-CBER-2022-5812-0228821
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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’
‘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.
Pleas e free s ome s torage s pace and try again. ’
‘Error’
‘Something went wrong, please contact the
Help desk or click OK to try again.’
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FDA-CBER-2022-5812-0228822
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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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FDA-CBER-2022-5812-0228824
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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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FDA-CBER-2022-5812-0228825
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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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FDA-CBER-2022-5812-0228826
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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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FDA-CBER-2022-5812-0228827
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Screen 13
Screen 14
Message 2
Message 4
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FDA-CBER-2022-5812-0228828
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Screen 15
Screen 16
Screen 17
Screen 18
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FDA-CBER-2022-5812-0228829
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Message 2
Screen 19
Screen 20
Screen 21
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FDA-CBER-2022-5812-0228830
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Screen 22
Screen 23
Screen 24
Screen 25
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Page 148
FDA-CBER-2022-5812-0228831
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Screen 26
Message 2
Screen 27
Screen 28
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FDA-CBER-2022-5812-0228832
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Screen 29
Screen 30
Message 2
Screen 31
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FDA-CBER-2022-5812-0228833
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Screen 32
Screen 33
Screen 34
Screen 35
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Page 151
FDA-CBER-2022-5812-0228834
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C4591001-Post-12-July-2020 English (USA) enUS Version 4
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Screen 36
Screen 37
Screen 38
Screen 39
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Page 152
FDA-CBER-2022-5812-0228835
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C4591001-Post-12-July-2020 English (USA) enUS Version 4
Page 35 of 57
Screen 40
Screen 41
Screen 42
Screen 43
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FDA-CBER-2022-5812-0228836
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Screen 44
Message 2
Screen 45
[Computed] will display “Please continue to fill
out your diary for the next {1} day(s).”
Where {1} = a number of days
Example: Please continue to fill out your diary
for the next 4 day(s).
Screen 46
[Computed] will display “Please continue to fill
out your diary for the next {1} day(s).”
Where {1} = a number of days
Example: Please continue to fill out your diary
for the next 4 day(s).
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Page 154
FDA-CBER-2022-5812-0228837
A-1426-0086 / App Subject Facing Screen Report 26-OCT-2020
C4591001-Post-12-July-2020 English (USA) enUS Version 4
Page 37 of 57 4 Form: COVID-19 Illness Diary
Screen 1
Message 1
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Page 155
FDA-CBER-2022-5812-0228838
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Page 38 of 57
Message 2
Message 3
Screen 2
Message 1
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Page 156
FDA-CBER-2022-5812-0228839
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C4591001-Post-12-July-2020 English (USA) enUS Version 4
Page 39 of 57
Message 2
090177e198823706\A pproved\A pproved On: 04-Nov-2021 12:49 (GMT )
Page 157
FDA-CBER-2022-5812-0228840
A-1426-0086 / App Subject Facing Screen Report 26-OCT-2020
C4591001-Post-12-July-2020 English (USA) enUS Version 4
Page 40 of 57 5 Form: Patient main menu
Screen 1
Message 1
Screen 2
Message 1
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FDA-CBER-2022-5812-0228841
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Page 41 of 57
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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FDA-CBER-2022-5812-0228842
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Page 42 of 57
Second [Computed] text below Hello, will either
display: “You have completed today's
Vaccination Diary.”, “You have completed
today's Vaccination Diary. Please remember to
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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FDA-CBER-2022-5812-0228843
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Page 43 of 57
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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FDA-CBER-2022-5812-0228844
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Page 44 of 57
Screen 5
Message 2
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Page 162
FDA-CBER-2022-5812-0228845
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C4591001-Post-12-July-2020 English (USA) enUS Version 4
Page 45 of 57
Message 3
Message 5
090177e198823706\A pproved\A pproved On: 04-Nov-2021 12:49 (GMT )
Page 163
FDA-CBER-2022-5812-0228846
A-1426-0086 / App Subject Facing Screen Report 26-OCT-2020
C4591001-Post-12-July-2020 English (USA) enUS Version 4
Page 46 of 57
Message 9
090177e198823706\A pproved\A pproved On: 04-Nov-2021 12:49 (GMT )
Page 164
FDA-CBER-2022-5812-0228847
A-1426-0086 / App Subject Facing Screen Report 26-OCT-2020
C4591001-Post-12-July-2020 English (USA) enUS Version 4
Page 47 of 57 6 Form: Subject training diary
Screen 1
Message 1
090177e198823706\A pproved\A pproved On: 04-Nov-2021 12:49 (GMT )
Page 165
FDA-CBER-2022-5812-0228848
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C4591001-Post-12-July-2020 English (USA) enUS Version 4
Page 48 of 57
Screen 2
Screen 3
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Page 166
FDA-CBER-2022-5812-0228849
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C4591001-Post-12-July-2020 English (USA) enUS Version 4
Page 49 of 57
Screen 4
[Computed] will display ‘Your reminder time is
{1}.’, where {1} will be the selected diary
reminder time.
Screen 5
090177e198823706\A pproved\A pproved On: 04-Nov-2021 12:49 (GMT )
Page 167
FDA-CBER-2022-5812-0228850
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C4591001-Post-12-July-2020 English (USA) enUS Version 4
Page 50 of 57
Screen 6
Screen 7
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Page 168
FDA-CBER-2022-5812-0228851
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C4591001-Post-12-July-2020 English (USA) enUS Version 4
Page 51 of 57
Screen 8
Screen 9
090177e198823706\A pproved\A pproved On: 04-Nov-2021 12:49 (GMT )
Page 169
FDA-CBER-2022-5812-0228852
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C4591001-Post-12-July-2020 English (USA) enUS Version 4
Page 52 of 57
Message 1
Screen 10
090177e198823706\A pproved\A pproved On: 04-Nov-2021 12:49 (GMT )
Page 170
FDA-CBER-2022-5812-0228853
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C4591001-Post-12-July-2020 English (USA) enUS Version 4
Page 53 of 57
Screen 11
Screen 12
090177e198823706\A pproved\A pproved On: 04-Nov-2021 12:49 (GMT )
Page 171
FDA-CBER-2022-5812-0228854
A-1426-0086 / App Subject Facing Screen Report 26-OCT-2020
C4591001-Post-12-July-2020 English (USA) enUS Version 4
Page 54 of 57 7 Form: Settings
Screen 1
Popup input 1
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Page 172
FDA-CBER-2022-5812-0228855
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C4591001-Post-12-July-2020 English (USA) enUS Version 4
Page 55 of 57 8 Form: Security question
Screen 1
[Computed] will show one of the following:
‘Your oldest sibling’s birth year (YY)’
‘Your mother’s birth year (YY)’
‘Last two digits of your childhood phone number’
‘Day of the month of your father’s birthday’
‘Day of the month of your mother’s birthday’
‘Childhood home door number (2 digits only)’
‘How old were you when you passed your driving
test?’
‘The year you got married (YY)’
Message 1
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Page 173
FDA-CBER-2022-5812-0228856
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Page 56 of 57
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
090177e198823706\A pproved\A pproved On: 04-Nov-2021 12:49 (GMT )
Page 174
FDA-CBER-2022-5812-0228857
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C4591001-Post-12-July-2020 English (USA) enUS Version 4
Page 57 of 57
Popup input 1
Message 1
090177e198823706\A pproved\A pproved On: 04-Nov-2021 12:49 (GMT )
Page 175
FDA-CBER-2022-5812-0228858
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090177e198823706\A pproved\A pproved On: 04-Nov-2021 12:49 (GMT )
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FDA-CBER-2022-5812-0228859