Document text
Clinical Study Data Reviewer’s
Guide
sBLA Analysis for Participants, 12-15 Years of
Age
BioNTech SE and PFIZER INC.
Study C4591001
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This document is confidential Page 2 of 60 Clinical Data Reviewer’s Guide Revision history
Version Summary of Major Change(s) and Impact Version Date
1.0 First approved version of Clinical Data Reviewer’s Guide 06-Dec-2021
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Clinical Study Data Reviewer’s Guide
Contents
Table of Contents
1. Introduction ................................ ................................ ................................ ......................... 5
1.1 Purpose ................................ ................................ ................................ ........................ 5
1.2 Acronyms ................................ ................................ ................................ ..................... 5
1.3 Study Data Standards and Dictionary Inventory ................................ ................................ ... 5
2. Protocol Description ................................ ................................ ................................ .............. 6
2.1 Protoc ol Number and Title................................ ................................ ............................... 6
2.2 Protocol Design ................................ ................................ ................................ ............. 8
2.2.1 Phase 1 ................................ ................................ ................................ .................. 9
2.2.2 Phase 2/3 ................................ ................................ ................................ ............. 10
2.3 Trial Design Datasets ................................ ................................ ................................ .... 12
2.3.1 TA - Trial Arms ................................ ................................ ................................ .... 12
2.3.2 TE - Trial Elements ................................ ................................ ............................... 13
2.3.3 TI - Trial Inclusion/Exclusion Criteria ................................ ................................ ...... 13
2.3.4 TS - Trial Summary ................................ ................................ ............................... 13
2.3.5 TV - Trial Visits ................................ ................................ ................................ ... 13
3. Subject Data Description ................................ ................................ ................................ ...... 16
3.1 Overview ................................ ................................ ................................ .................... 16
3.2 Traceability Flow Diagram ................................ ................................ ............................ 16
3.3 Annotated CRFs ................................ ................................ ................................ .......... 16
3.4 SDTM Subject Domains ................................ ................................ ................................ 18
3.4.1 AE - Adverse Events ................................ ................................ ............................. 19
3.4.2 CE - Clinical Events ................................ ................................ .............................. 20
3.4.3 CM - Concomitant Medications ................................ ................................ ............... 21
3.4.4 CO - Comments ................................ ................................ ................................ .... 22
3.4.5 DI - Device Identifiers ................................ ................................ ........................... 22
3.4.6 DM - Demographics ................................ ................................ .............................. 22
3.4.7 DS - Disposition ................................ ................................ ................................ ... 22
3.4.8 DV - Protocol Deviations ................................ ................................ ....................... 23
3.4.9 EC - Exposure as Collected ................................ ................................ ..................... 23
3.4.10 EX - Exposure ................................ ................................ ................................ ...... 23
3.4.11 FACE - Findings About Events or Interventions ................................ ......................... 23
3.4.12 FAHO - Findings About Events or Interventions ................................ ........................ 24
3.4.13 HO - Healthcare Encounters ................................ ................................ .................... 24
3.4.14 IE - Inclusion/Exclusion Criteria Not Met ................................ ................................ . 24
3.4.15 IS - Immunogenicity Specimen Assessment ................................ ............................... 25
3.4.16 LB - Laboratory Test Results ................................ ................................ .................. 25
3.4.17 MB - Microbiology Specimen ................................ ................................ ..................... 25
3.4.18 MH - Medical History ................................ ................................ ................................ 25
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3.4.20 SE - Subject Elements ................................ ................................ ................................ 25
3.4.21 SV - Subject Visits ................................ ................................ ................................ .... 26
3.4.22 VS - Vital Signs ................................ ................................ ................................ ........ 26
4 Data Conformance Summary ................................ ................................ ................................ .... 27
4.1 Conformance Inputs ................................ ................................ ................................ ........... 27
4.2 Issues Summary ................................ ................................ ................................ ................ 27
4.3 Additional Conformance Details ................................ ................................ .......................... 47
Appendix I: Inclusion/Exclusion Criteria ................................ ................................ ....................... 48
Appendix II: Data Cutoff Algorithm in Standard Domains ...............................................................57
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1. Introduction
1.1 Purpose
This document provides context for tabulation datasets and terminology that benefit from additional
explanation beyond the Data Definitions document (define.xml). In addition, this document provides
a summary of SDTM conformance findings.
1.2 Acronyms
Acronym Translation
GMR
Geometric Mean Ratio
modRNA
Nucleoside -Modified Messenger Ribonucleic Acid
NAAT
Nucleic Acid Amplification Test
SARS -CoV-2
Severe Acute Respiratory Syndrome Coronavirus 2
SoA
Schedule of Activities
VE
Vaccine Efficacy
WOCBP
Woman/Women of Childbearing Potential
1.3 Study Data Standards and Dictionary Inventory
Standard or Dictionary Versions Used
SDTM •SDTM v1.4
•SDTM -IG v3.2
Controlled Terminology CDISC SDTM Controlled Terminology, 2020 -03-27
Data Definitions Define -XML v2.0
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Standard or Dictionary Versions Used
Medications Dictionary WHODD GLOBAL B3Mar2 1, SNOMED 2020 -09-01, UNII
2020 -08-18, MED -RT 2020 -09-08
Medical Events Dictionary MedDRA v24.0
2. Protocol Description
2.1 Protocol Number and Title
Protocol Number: C4591001
Protocol Short Title: A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity, and
Efficacy of RNA Vaccine Candidates Against COVID -19 in Healthy Individuals.
Note: Protocol Amendment’s 13, 14 and beyond mentioned elsewhere in the submission
documentation are out of scope for this submission and have not been included in this cSDRG.
Protocol Versions:
Amendment 12: 2021 -01-14
• Because of a formatting error in protocol amendment 11, exclusion criterion 4 was
inadvertently added to exclusion criterion 3 and the subsequent criteria renumbered. This
amendment corrects that error.
Amendment 11: 2021-01-04
• Added a potential intensive surveillance period for nasal swabbing, for assessment via
NAAT:
o Corresponding SoA and procedures added
Amendment 10: 2020 -12-01
• Added the possibility of administering BNT162b2 to participants who originally received
placebo, following any local or national recommendations.
• Added the possibility of administering BNT162b2 to participants who originally received
placebo, following completion of the active safety surveillance period.
Amendment 9: 2020 -10-29
• To better align with the natural history of SARS -CoV-2 infection, added Phase 2/3
secondary efficacy objectives, estimands, and endpoints to include COVID -19 cases that
occur from 14 days after the second dose; also modified the existing secondary efficacy
objectives, estimands, and endpoints to include COVID -19 cases that occur from 14 days, as
well as 7 days, after the second dose;
o Made corresponding changes to the study design, study assessments and procedures,
and statistical analysis sections.
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• Clarified that interim analyses will be conducted after accrual of at least 62, 92, and 120
cases.
• Included any participants 16 through 17 years of age enrolled under this amendment in the
reactogenicity subset.
• Clarified that serology data after a postbaseline positive SARS -CoV-2 test result will not be
included in the analysis based on the evaluable immunogenicity populations.
Amendment 8: 2020 -10-15
• Clarified that for participants who are not in the reactogenicity subset, local reactions and
systemic events following vaccination should be detected and reported as AEs.
• Clarified that premenarchal females are not WOCBP.
Amendment 7: 2020 -10-06
• Reduced the lower age range to include adolescents 12 to 15 years of age and added
corresponding objectives.
• Added that 2 periods of potential COVID -19 symptoms within 4 days will be considered as a
single illness.
Amendment 6: 2020 -09-08
• Removed exclusion criterion 2 (ie, known infection with HIV, HCV, or HBV) for Phase 3
and added criteria for HIV-positive participants.
• Decreased the lower age limit and removed the upper age limit for inclusion in Phase 2/3 in
order to evaluate BNT162b2 30 μg in older adolescents and those over 85 years of age;
updated the title and other references to adults to align with this change.
• Clarified that inclusion criterion 4 (ie, participants at higher risk for acquiring COVID -19) is
applicable for Phase 2/3 only, and provided some examples
Amendment 5: 2020 -07-24
• Clarified that a single vaccine candidate, administered as 2 doses 21 days apart, will be
studied in Phase 2/3.
• Stated that the vaccine candidate selected for Phase 2/3 evaluation is BNT162b2 at a dose of
30 μg.
• Renamed Stage 1 to Phase 1, removed Stage 2, and renamed Stage 3 to Phase 2/3.
• Clarified which stopping rules apply to which phase of the study.
• Moved the immunogenicity objectives in Phase 2/3 to become exploratory.
• Modified exclusion criterion 5, so that participants with a previous clinical or
microbiological diagnosis of COVID -19 are excluded from all phases of the study.
Amendment 4: 2020 -06-30
• BNT162b3 candidate has been added to the protocol.
• Further nonclinical data are available to support the study of the BNT162b3 candidate in
humans, and the candidate has been added to the protocol.
• The 6-month safety follow -up telephone contact has been changed to an in-person visit for
Stage 3 participants, to allow collection of an immunogenicity blood sample.
Amendment 3: 2020 -06-10
• 20-μg dose level is formally included for BNT162b1 and BNT162b2.
• In order to increase flexibility enrolling participants, an extended screening window
(increased from 14 to 28 days) for sentinel participants in Stage 1 has been added. This is
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considered acceptable since eligible participants are expected to be either healthy or have stable
medical conditions.
Amendment 2: 2020 -05-27
• Added a 50-μg dose level for vaccine candidates based on the modRNA platform (ie,
BNT162b1, BNT162b2, and BNT162b3).
Amendment 1: 2020 -05-13
• Decreased the dose levels for BNT162a1 and BNT162c2
• Modified exclusion criteria and prohibited inhaled/nebulized corticosteroids for sentinel
participants in Stage 1.
Original Protocol 2020 -04-15
2.2 Protocol Design
The study consists of 2 parts. Phase 1: to identify preferred vaccine candidate(s) and dose level(s); Phase
2/3: an expanded cohort and efficacy part. These parts, and the progression between them, are detailed in
the schema.
Phase 1 For each vaccine candidate (4:1 randomization active:placebo)
Age: 18 -55 y Age: 65 -85 y
Low -dose -level 2-dose group (n=15)
IRC (safety) IRC (safety Low -dose -level 2-dose group (n=15)
after Dose 1)
Mid-dose -level 2-dose group (n=15)
IRC (safety) IRC (safety Mid-dose -level 2-dose group (n=15)
after Dose 1)
High -dose -level 2-dose group (n=15)
IRC (safety High -dose -level 2-dose group (n=15)
after Dose 1)
IRC choice of group(s) for Phase 2/3
(safety & immunogenicity after Doses 1 and 2)
Phase 2/3 Single vaccine candidate (1:1 randomization active:placebo)
Safety and immunogenicity
analysis of Phase 2 data
(first 360 participants) by
unblinded team (these
participants will also be
included in Phase 3
analyses) Age: ≥12
(Stratified 12-15, 16-55, or >55)
BNT162b2 30 µg or placebo 2 doses
(n~21,999 per group, total n~43.998)
Abbreviation: IRC = internal review committee.
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The study will evaluate the safety, tolerability, and immunogenicity of 2 different SARS -CoV-2 RNA
vaccine candidates against COVID -19 and the efficacy of 1 candidate:
• As a 2-dose (separated by 21 days) schedule;
• At various different dose levels in Phase 1;
• In 3 age groups: (Phase 1: 18 to 55 years of age, 65 to 85 years of age; Phase 2/3: ≥ 12 years
of age [stratified as 12-15, 16-55, or >55 years of age]).
Dependent upon safety and/or immunogenicity data generated during the course of this study, or
the BioNTech study conducted in Germany (BNT162 -01), it is possible that groups in Phase 1
may be started at the next highest dose, groups may not be started, groups may be terminated
early, and/or groups may be added with dose levels below the lowest stated dose or intermediate
between the lowest and highest stated doses.
The study is observer -blinded, as the physical appearance of the investigational vaccine
candidates and the placebo may differ. The participant, investigator, study coordinator, and other
site staff will be blinded. At the study site, only the dispenser(s)/administrator(s) are unblinded.
To facilitate rapid review of data in real time, sponsor staff will be unblinded to vaccine
allocation for the participants in Phase 1.
2.2.1 Phase 1
Each group (vaccine candidate/dose level/age group) will comprise 15 participants;
12 participants will be randomized to receive active vaccine and 3 to receive placebo.
For each vaccine candidate/dose level/age group, the following apply:
• Additional safety assessments (see protocol, Section 8.2)
• Controlled enrollment (required only for the first candidate and/or dose level studied):
• No more than 5 participants (4 active, 1 placebo) can be vaccinated on the first day
• The first 5 participants must be observed by blinded site staff for at least 4 hours after
vaccination for any acute reactions
• Vaccination of the remaining participants will commence no sooner than 24 hours after
the fifth participant received his or her vaccination
• Application of stopping rules
• IRC review of safety data to determine escalation to the next dose level in the 18- to 55-year
age cohort:
• Escalation between dose levels will be based on IRC review of at least 7-day post–Dose
1 safety data in this study and/or the BioNTech study conducted in Germany (BNT162 -
01)
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• Note that, since both candidates are based upon the same RNA platform, dose escalation
for the second candidate studied may be based upon the safety profile of the first
candidate studied being deemed acceptable at the same, or a higher, dose level by the
IRC
Groups of participants 65 to 85 years of age will not be started until safety data for the RNA
platform have been deemed acceptable at the same, or a higher, dose level in the 18- to 55-year
age cohort by the IRC.
In this phase, 13 groups will be studied, corresponding to a total of 195 participants.
The IRC will select 1 vaccine candidate that, in Phase 1, has an established dose level per age
group based on induction of a post–Dose 2 immune response, including neutralizing antibodies,
which is expected to be associated with protection against COVID -19, for progression into Phase
2/3.
Participants who originally received placebo and become eligible for receipt of BNT162b2 or
another COVID -19 vaccine according to local or national recommendations (detailed separately,
and available in the electronic study reference portal) will have the opportunity to receive
BNT162b2 as part of the study. The investigator will ensure the participant meets at least 1 of the
recommendation criteria. Any Phase 1 placebo recipient who has not already been offered the
opportunity to receive BNT162b2 will be given this opportunity at the approximate time
participants in Phase 2/3 reach Visit 4. Any participant who originally received placebo but then
goes on to receive BNT162b2 will move to a new visit schedule (Protocol Section 1.3.3).
2.2.2 Phase 2/3
On the basis of safety and/or immunogenicity data generated during the course of this study,
and/or the BioNTech study conducted in Germany (BNT162 -01), 1 vaccine candidate was
selected to proceed into Phase 2/3. Participants in this phase will be ≥12 years of age, stratified as
follows: 12 to 15 years, 16 to 55 years, or >55 years. The 12- to 15-year stratum will comprise up
to approximately 2000 participants enrolled at selected investigational sites. It is intended that a
minimum of 40% of participants will be in the >55-year stratum. Commencement of each age
stratum will be based upon satisfactory post–Dose 2 safety and immunogenicity data from the 18 -
to 55-year and 65- to 85-year age groups in Phase 1, respectively. The vaccine candidate selected
for Phase 2/3 evaluation is BNT162b2 at a dose of 30 μg.
Phase 2/3 is event -driven. Under the assumption of a true VE rate of ≥60%, after the second dose
of investigational product, a target of 164 primary -endpoint cases of confirmed COVID -19 due to
SARS -CoV-2 occurring at least 7 days following the second dose of the primary series of the
candidate vaccine will be sufficient to provide 90% power to conclude true VE >30% with high
probability. The total number of participants enrolled in Phase 2/3 may vary depending on the
incidence of COVID -19 at the time of the enrollment, the true underlying VE, and a potential
early stop for efficacy or futility.
Assuming a COVID -19 attack rate of 1.3% per year in the placebo group, accrual of 164 first
primary -endpoint cases within 6 months, an estimated 20% non-evaluable rate, and 1:1
randomization, the BNT162b2 vaccine candidate selected for Phase 2/3 is expected to comprise
approximately 21,999 vaccine recipients. This is the number of participants initially targeted for
Phase 2/3 and may be adjusted based on advice from DMC analyses of case accumulation and the
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percentage of participants who are seropositive at baseline. Dependent upon the evolution of the
pandemic, it is possible that the COVID -19 attack rate may be much highe r, in which case accrual
would be expected to be more rapid, enabling the study’s primary endpoint to be evaluated much
sooner.
The first 360 participants enrolled (180 to active vaccine and 180 to placebo, stratified equally
between 18 to 55 years and >55 to 85 years) will comprise the “Phase 2” portion. Safety data
through 7 days after Dose 2 and immunogenicity data through 1 month after Dose 2 from these
360 participants will be analyzed by the unblinded statistical team, reviewed by the DMC, and
submitted to appropriate regulatory authorities for review. Enrollment may continue during this
period and these participants would be included in the efficacy evaluation in the “Phase 3”
portion of the study.
In Phase 3, up to approximately 2000 participants, enrolled at selected sites, are anticipated to be
12 to 15 years of age. Noninferiority of immune response to prophylactic BNT162b2 in
participants 12 to 15 years of age to response in participants 16 to 25 years of age will be assessed
based on the GMR of SARS -CoV-2 neutralizing titers using a 1.5-fold margin. A sample size of
225 evaluable participants (or 280 vaccine recipients) per age group will provide a power of
90.8% to declare the noninferiority in terms of GMR (lower limit of 95% CI for GMR >0.67). A
random sample of 280 participants from each of the 2 age groups (12 to 15 years and 16 to 25
years) will be selected as an immunogenicity subset for the noninferiority assessment.
The initial BNT162b2 was manufactured using “Process 1”; however, “Process 2” was developed
to support an increased scale of manufacture. In the study, each lot of “Process 2”-manufactured
BNT162b2 will be administered to approximately 250 participants 16 to 55 years of age. The
safety and immunogenicity of prophylactic BNT162b2 in individuals 16 to 55 years of age
vaccinated with “Process 1” and each lot of “Process 2” study intervention will be described. A
random sample of 250 participants from those vaccinated with study intervention produced by
manufacturing “Process 1” will be selected for this descriptive analysis.
Participants are expected to participate for up to a maximum of approximately 26 months. The
duration of study follow -up may be shorter among participants enrolled in Phase 1 dosing arms
that are not evaluated in Phase 2/3.
Participants ≥ 16 years of age who originally received placebo and become eligible for receipt of
BNT162b2 or another COVID -19 vaccine according to local or national recomme ndations
(detailed separately, and available in the electronic study reference portal) will have the
opportunity to receive BNT162b2 as part of the study. The investigator will ensure the participant
meets at least 1 of the recommendation criteria.
Any Phase 2/3 placebo recipient ≥16 years of age who has not already been offered the
opportunity to receive BNT162b2 will be given this opportunity from 6 months after Vaccination
2 (at the time of the originally planned Visit 4).
Any participant who originally received placebo but then goes on to receive BNT162b2 will
move to a new visit schedule (Protocol Section 1.3.3).
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An intensive period of surveillance to evaluate the efficacy of BNT162b2 against asymptomatic
SARS -CoV-2 infection may be conducted at selected sites among Phase 2/3 participants following
approval of protocol amendment 11. After an initial in-person visit where a blood sample
will be collected and a nasal (midturbinate) swab obtained, nasal (midturbinate) swabs
will be obtained from consented participants every 2 weeks until Visit 4, or a sufficient number of
cases of SARS -CoV-2 infection have accrued to evaluate this objective, whichever is sooner, per
the SoA. The swabs will be tested at a central laboratory using NAAT to detect SARS -CoV-2.
Participants who originally received placebo and become eligible for receipt of BNT162b2
according to local or national recommendations and then receive BNT162b2 as part of the study
will not participate in surveillance for asymptomatic SARS -CoV-2 infection; if they become
eligible during the surveillance period, the swabbing every 2 weeks will cease.
2.3 Trial Design Datasets
Are Trial Design datasets included in the submission? - Yes
Dataset Dataset Label
TA Trial Arms
TE Trial Elements
TI Trial Inclusion/Exclusion Criteria
TS Trial Summary
TV Trial Visits
2.3.1 TA - Trial Arms
For Phase 1, subjects were randomly assigned to receive either BNT162b1, BNT162b2, or placebo.
For Phase 2/3, subjects were randomly assigned to receive either BNT162b2 or placebo.
The detailed information for ARM and ARMCD was shown in the table below.
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ARM ARMCD
BNT162b1 Phase 1 (10 mcg) B1_10
BNT162b1 Phase 1 (100/10 mcg) B1_100
BNT162b1 Phase 1 (20 mcg) B1_20
BNT162b1 Phase 1 (30 mcg) B1_30
BNT162b2 Phase 1 (10 mcg) B2_10
BNT162b2 Phase 1 (20 mcg) B2_20
BNT162b2 Phase 1 (30 mcg) B2_30
BNT162b2 Phase 2/3 (30 mcg) B2_P23_30
Placebo PLACEBO
2.3.2 TE - Trial Elements
There were ten trial elements in this study for Phase 1 including one screening element and eight
vaccination elements: BNT162b1 (10 mcg), BNT162b1 (20 mcg), BNT162b1 (30 mcg), BNT162b1
(100 mcg), BNT162b2 (10 mcg), BNT162b2 (20 mcg), BNT162b2 (30 mcg), and Placebo. There was
also one follow -up element.
There were 4 trial elements in this study for Phase 2/3 including one screening element and 2
vaccination elements: BNT162b2 (30 mcg) and Placebo. There was also one follow -up element.
For Placebo subject from Phase 1 that qualified to receive BNT162b2 (30 mcg), additional elements
were included: Screening Open Label & Follow -up Open Label.
2.3.3 TI - Trial Inclusion/Exclusion Criteria
See Appendix I: Inclusion/Exclusion Criteria for the complete text of each inclusion or exclusion
criteria.
2.3.4 TS - Trial Summary
The Trial Summary (TS) dataset details a summary of the trial in a structured format. Each record in
the Trial Summary dataset contains the value of a parameter, a characteristic of the trial. Trial
Summary was used to record basic information about the study such as trial phase, protocol title, and
trial objectives, as well as information about the planned and actual trial characteristics.
In accordance with the FDA business rule, the values for PARAMCD equal to AGEMIN,
PLANSUB, and NARMS has been combined into one record. The minimum age for Phase 1 is 18
years while Phase 2/3 is 12. The planned number of arms for Phase 1 is 7 while Phase 2/3 is 2.
2.3.5 TV - Trial Visits
The trial visits dataset describes the planned visits of the trial and consists of 19 visits for Phase 1 and
11 visits for Phase 2/3. Each visit and visit description are shown in the table below.
Visits V4_WEEK3_VAX2_S_R; V5_WEEK1_POSTVAX2_S_R; V6_WEEK2_POSTVAX2_S_R;
V6_WEEK2_POSTVAX2_S_R; are for subjects who received 100mcg during vaccination 1 for
Phase 1. Dose of 100 mcg was deemed too high and the dosing/visit was stopped for approximately 4
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months. After 4 months, the subject returned and received 10 mcg at vaccination 2 and completed the
rest of the visits.
Visits in the chart below with the suffix of “_S” and “_L” , excluding COVID visits, are related to
Phase 1 and Phase 2/3 respectively.
VISITNUM VISIT VISITDY Description
1 COVID_A COVID -19 illness onset
200 COVID_A1 After the visit of COVID -19 illness onset
2 COVID_B COVID -19 illness onset
201 COVID_B1 After the visit of COVID -19 illness onset
3 COVID_C COVID -19 illness onset
202 COVID_C1 After the visit of COVID -19 illness onset
4 COVID_D COVID -19 illness onset
203 COVID_D1 After the visit of COVID -19 illness onset
5 COVID_E COVID -19 illness onset
204 COVID_E1 After the visit of COVID -19 illness onset
6 COVID_F COVID -19 illness onset
205 COVID_F1 After the visit of COVID -19 illness onset
7 COVID_G COVID -19 illness onset
206 COVID_G1 After the visit of COVID -19 illness onset
8 COVID_H COVID -19 illness onset
207 COVID_H1 After the visit of COVID -19 illness onset
9 COVID_I COVID -19 illness onset
208 COVID_I1 After the visit of COVID -19 illness onset
10 COVID_J COVID -19 illness onset
209 COVID_J1 After the visit of COVID -19 illness onset
11 COVID_K COVID -19 illness onset
210 COVID_K1 After the visit of COVID -19 illness onset
12 COVID_L COVID -19 illness onset
211 COVID_L1 After the visit of COVID -19 illness onset
13 COVID_M COVID -19 illness onset
212 COVID_M1 After the visit of COVID -19 illness onset
14 COVID_N COVID -19 illness onset
213 COVID_N1 After the visit of COVID -19 illness onset
15 COVID_O COVID -19 illness onset
214 COVID_O1 After the visit of COVID -19 illness onset
16 COVID_P COVID -19 illness onset
215 COVID_P1 After the visit of COVID -19 illness onset
17 COVID_Q COVID -19 illness onset
216 COVID_Q1 After the visit of COVID -19 illness onset
18 COVID_R COVID -19 illness onset
217 COVID_R1 After the visit of COVID -19 illness onset
19 COVID_S COVID -19 illness onset
218 COVID_S1 After the visit of COVID -19 illness onset
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VISITNUM VISIT VISITDY Description
20 COVID_T COVID -19 illness onset
219 COVID_T1 After the visit of COVID -19 illness onset
60776 End of Treatment Start of end of treatment visit
60777 Follow -Up First day of follow -up visit
60772 POT_COVID_CONVA 28 to 35 days after potential COVID -19 illness visit
60771 POT_COVID_ILL Optimally within 3 days after potential
COVID -19 illness onset
51231792 REVAX_CONTACT Start of contact
60747 SCR Informed consent
20210 SSWAB_WEEK10 Surveillance swab sample collection at week 10
20212 SSWAB_WEEK12 Surveillance swab sample collection at week 12
20214 SSWAB_WEEK14 Surveillance swab sample collection at week 14
20216 SSWAB_WEEK16 Surveillance swab sample collection at week 16
20218 SSWAB_WEEK18 Surveillance swab sample collection at week 18
20202 SSWAB_WEEK2 Surveillance swab sample collection at week 2
20220 SSWAB_WEEK20 Surveillance swab sample collection at week 20
20222 SSWAB_WEEK22 Surveillance swab sample collection at week 22
20224 SSWAB_WEEK24 Surveillance swab sample collection at week 13
20226 SSWAB_WEEK26 Surveillance swab sample collection at week 14
20228 SSWAB_WEEK28 Surveillance swab sample collection at week 15
20204 SSWAB_WEEK4 Surveillance swab sample collection at week 4
20206 SSWAB_WEEK6 Surveillance swab sample collection at week 6
20208 SSWAB_WEEK8 Surveillance swab sample collection at week 8
60765 V1_DAY1_VAX1_L 1 Day 1
60748 V1_DAY1_VAX1_S 1 Day 1
60757 V10_MONTH24_S 749 714 to 742 days after visit 4
51231793 V101_VAX3 Open label vaccination 1
51231794 V102_VAX4 Open label vaccination 2
51231795 V103_MONTH1 28 to 35 Days after visit 102
51231796 V104_MONTH6 175 to 189 days after visit 102
51231797 V105_MONTH18 532 to 560 days after visit 102
60749 V2_DAY2_POSTVAX1_S 2 1 to 3 days after visit 1
60766 V2_VAX2_L 21 19 to 23 days after visit 1 or 56 to 70 days after visit
56985855 V201_SURVEIL_CONSENT Infection Surveillance Consent
60767 V3_MONTH1_POSTVAX2_L 51 28 to 35 days after visit 2
60750 V3_WEEK1_POSTVAX1_S 7 6 to 8 days after visit 1
60768 V4_MONTH6_L 173 154 to 168 days after visit 2
60751 V4_WEEK3_VAX2_S 21 19 to 23 days after visit 1
1165454 V4_WEEK3_VAX2_S_R NA
60769 V5_MONTH12_L 371 350 to 378 days after visit 2
60752 V5_WEEK1_POSTVAX2_S 28 6 to 8 days after visit 4
1165455 V5_WEEK1_POSTVAX2_S_R 6 to 8 days after visit 4_R
60770 V6_MONTH24_L 733 714 to 742 days after visit 2
60753 V6_WEEK2_POSTVAX2_S 35 12 to 16 days after visit 4
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VISITNUM VISIT VISITDY Description
1165456 V6_WEEK2_POSTVAX2_S_R 12 to 16 days after visit 4_R
60754 V7_MONTH1_S 52 28 to 35 days after visit 4
1165457 V7_MONTH1_S_R 28 to 35 days after visit 4_R
60755 V8_MONTH6_S 182 154 to 168 days after visit 4
60756 V9_MONTH12_S 385 350 to 378 days after visit 4
3. Subject Data Description
3.1 Overview
Are the submitted data taken from an ongoing study? Yes
For analysis, a data cutoff of 02Sept2021 was applied on the SDTM data.
Furthermore, any data related to the booster portion of the Phase 1 subjects
was also programmatically excluded from SDTM data. Details about the
cutoff algorithm applied to the SDTM data can be found in Appendix II.
Were the SDTM datasets used as sources for the analysis datasets? Yes
Do the submission datasets include screen failures? No
Were any domains planned, but not submitted because no data were collected? No
Are the submitted data a subset of collected data? No
Is adjudication data present? No
3.2 Traceability Flow Diagram
3.3 Annotated CRFs
Collected fields and pages that have not been tabulated have been annotated as "Not Submitted".
Pfizer collects certain data elements to facilitate operational processes including data cleaning and
dynamically creating additional forms in the electronic data capture system . All fields and pages that
have been annotated as "Not Submitted" meet this criterion and are described below.
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Explanation of data fields [Not Submitted]
aCRF page
Number(s) Data Collection Field Explanation of why [NOT SUBMITTED]
24, 91, 93 1. Lowest Level Term,
2. Lowest Level Term Code,
3. High Level Term,
4. High Level Term Code,
5. High Level Group Term,
6. High Level Group Term Code,
7. Primary System Organ Class
8. Primary System Organ Class Code
Not needed for analysis
14
Cohort Selection Not needed for analysis. The whole page is
annotated as NOT SUBMITTED.
35
Inform Enrollment Not needed for analysis. The whole page is
annotated as NOT SUBMITTED.
36
HIV Status Not needed for analysis. The whole page is
annotated as NOT SUBMITTED.
63
Casebook Signature Form Not needed for analysis. The whole page is
annotated as NOT SUBMITTED.
84
Further Vaccination Confirmation Not needed for analysis. The whole page is
annotated as NOT SUBMITTED.
89
Inform Screening Not needed for analysis. The whole page is
annotated as NOT SUBMITTED.
95, 96, 97
Stratification Not needed for analysis. The whole page is
annotated as NOT SUBMITTED.
98
Subject Status Not needed for analysis. The whole page is
annotated as NOT SUBMITTED.
105
Unplanned assessments Not needed for analysis. The whole page is
annotated as NOT SUBMITTED.
12, 15, 16, 24,
40, 41, 42, 70,
72, 76, 77, 82,
83, 91, 93, 106,
108, 110
Comparison Term
Not needed for analysis.
15, 16, 76, 110 Concomitant Medications Pre-
specified
Not needed for analysis.
33
COVID -19 Surveillance Visit
Not needed for analysis.
18, 19, 20, 21 1. Follow -Up Contact Category
2. Was contact made?
3. If No, why?
4. Comments
Not needed for analysis.
30, 31, 32, 33,
34
Erroneous Visit
Not needed for analysis.
105
Contact Outcome
Not needed for analysis.
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40 1. Category of Clinical Event
2. Was a diagnosis obtained for
Potential COVID -19 Illness? (NO)
Not needed for analysis.
41, 42
Was a diagnosis obtained? (NO)
Not needed for analysis.
64, 65
Lab Sub-Panel
Not needed for analysis.
87, 90, 100
Sample Collected?
Not needed for analysis.
75, 87, 88, 90,
100
Sample ID
Not needed for analysis.
81
CISR Category
Not needed for analysis.
91, 93
Event Pre-specified
Not needed for analysis.
102 1. Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?
2. Were injection site reactions
present on the last day the Subject
Diary was completed?
Not needed for analysis.
108
Container Number
Not needed for analysis.
3.4 SDTM Subject Domains
Dataset - Dataset Label Efficacy Safety Other SUPP -- Related Using
RELREC
AE - Adverse Events X X DS, CE
CE - Clinical Events X X AE, FACE,
VS
CM - Concomitant
Medications X X
CO - Comments X
DI - Device Identifiers X MB, LB
DM - Demographics X X
DS - Disposition X X AE
DV - Protocol Deviations X X
EC - Exposure as Collected X X
EX - Exposure X X
FACE - Findings About
Events or Interventions X X CE
FAHO - Findings About
Events or Interventions X HO
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Dataset - Dataset Label Efficacy Safety Other SUPP -- Related Using
RELREC
HO - Healthcare Encounters X X FAHO
IE - Inclusion/Exclusion
Criteria Not Met X X
IS - Immunogenicity
Specimen Assessment X X
LB - Laboratory Test Results X X DI
MB - Microbiology Specimen X X DI
MH - Medical History X X
MO - Morphology X X
SE - Subject Elements X
SV - Subject Visits X
VS - Vital Signs X X CE
3.4.1 AE - Adverse Events
Adverse events dataset consists of one record per adverse event per subject.
The entry of a “Y” for the serious adverse event variable, AESER, indicates the AE meets the criteria
as serious per investigator report and the definition in the CRF guidance.
Adverse events, medication errors, newly diagnosed chronic medical conditions and reactogenicity
are included in the AE dataset and distinguished by AECAT. To implement the CDISC Vaccines
TAUG flat model, records of reactogenicity are added to AE domain from CE with AECAT=
“REACTOGENICITY”, when the duration of reactogenicity events go beyond the planned
observation period. AECAT = ”MEDICATION ERROR ” represents AE as a result of a study
medication error collected in SUPPAE.
A relationship has been defined in RELREC between the disposition event where DSDECOD=
ADVERSE EVENT or DEATH and the adverse event leading to discontinuation. The observations
are related by AESEQ and DSSEQ. A relationship has also been defined between the adverse events
and clinical event summary records and are related by AELNKGRP and CELNKGRP.
QNAM Description
AECMGIV Concomitant Medication Given
AEMEFL Medication Error Associated With
AE
AEMERES Is AE a Result of a Medication
Error
AENDGIV Was a Non-Drug Treatment given
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QNAM Description
AERELTXT Event Due to Other Specify
AESUBJDC Discontinued because of this AE
DICTVER Dictionary Name and Version
LSTCGDTC Date/Time of Last change
3.4.2 CE - Clinical Events
Clinical Events dataset consists of one record per event per subject.
Clinical Events implements Vaccines TAUG flat model for reactogenicity records, where it
summarizes each symptom event per vaccination per subject. CECAT = “REACTOGENICITY”.
The corresponding daily assessments from the e-diary are in FACE.
Unplanned assessments occurring during the diary period will be utilized along with the e-diary data
in creating the summary records in CE, even if the assessment was not required per protocol (no
symptom reported or symptom was reported but not severe). The worst reported severity will be
mapped for each symptom in the summary record and stop date will reflect the latest symptom date
from the e-diary or unplanned assessment, or from Symptom Resolved Dates form if continued past
the diary period.
Reactogenicity exclusions are as follows:
• If subject is not part of reactogenicity subset but has unplanned reactogenicity assessments
(unplanned temp or unplanned assessment of local reaction/systemic event), or has
unplanned assessments without any diary data, then these unplanned assessments were
dropped from FACE/VS and summary CE records were not generated.
• If an unplanned assessment exists with an assessment date (CEDTC) falling after the stop
date recorded on the Symptom Resolved Dates CRF, these records were dropped from FACE
for that visit. Only data up through the stop date from Symptom Resolved Dates in the CRF
were used to create the CE records.
• If a subject has diary data and their symptom did not occur during the diary period but was
on the unplanned assessment after diary period, then the unplanned assessment was dropped
(symptom must begin during diary period to be part of reactogenicity).
• If there were unplanned assessments after the diary period and the Symptom Resolved Dates
form was present but did not have a stop date or 'ongoing' recorded for that symptom, then
the unplanned assessments were dropped.
Potential COVID -19 illness from the ILLNESS DETAILS - POTENTIAL COVID -19
ILLNESS CRF is included with CECAT = “EFFICACY”. The investigator’s diagnosis is in
CETERM. Subjects who progress to severe disease, as defined in the protocol, will have data entered
on the ILLNESS DETAILS - SEVERE COVID -19 ILLNESS CRF which is reported in the CE
domain with CECAT = ‘SEVERE COVID -19 ILLNESS’ and CESCAT (Subcategory) denoting
whether there was significant acute renal, hepatic, or neurologic dysfunction.
As agreed with CBER, CE includes event records for “COVID -19 like illness” and “COVID -19
confirmed” in the CE domain for subjects who were assigned to a vaccination arm (DM.ARM is not
“SCREEN FAILURE” or “NOT ASSIGNED”) as follows:
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• The “COVID -19 confirmed” events are based on the “Clinical disease endpoint case flag”
(CDECASE) in SUPPDM.
• “COVID -19 like illness” is flagged “Y” when a subject has at least one pre-specified
symptom. Please note that a subject may have more than one occurrence of “COVID -19 like
illness” if symptoms presented during different illness visits, but only has one record for
“COVID -19 confirmed” that has a visit associated when the case was assessed to be positive.
• When there is confirmed COVID -19, the assessment of each pre-specified symptom
corresponding to that symptomatic period (i.e., corresponding COVID Illness visit) will
additionally be included in the CE domain, with CESCAT = “SIGNS AND SYMPTOMS OF
DISEASE” .
• As start and stop dates were not collected for each symptom individually, CESTDTC and
CEENDTC was not populated for each symptom but the date first symptom started and date
last symptom resolved was mapped to CESTDTC and CEENDTC in the “COVID -19 like
illness” and “COVID -19 confirmed” records.
• The individual symptoms have VISIT and collection date (CEDTC) populated from the
relevant COVID Illness visit.
• Toxicity grade for a COVID -19 like illness is collected in the ILLNESS DETAILS -
POTENTIAL COVID -19 ILLNESS CRF so CETOXGR is populated instead of CESEV in
the “COVID -19 like illness” and “COVID -19 confirmed” records. It is not collected for each
symptom individually.
• For COVID illness, CRF will collect toxicity grade as 0 for asymptomatic subjects. If an
illness visit is performed for asymptomatic participant, toxicity grade will be reported as "0"
while the participant is asymptomatic. If participant later experiences symptoms, the
appropriate toxicity grade will be updated.
A relationship has been defined in RELREC been defined between the adverse events and clinical
event summary records and are related by AELNKGRP and CELNKGRP. A relationship has also
been defined between clinical event summary records and findings about records. The observations
are related by CELNKGRP and FALNKGRP. A relationship has also been defined between clinical
event summary records and temperature vital signs records using CELNKGRP and VSLNKGRP.
QNAM Description
CEDRVFL Derived Flag
CEEVAL Evaluator
DICTVER Dictionary Name and Version
ONGNXVIS Reported Ongoing at Next Visit
RCENDTC Reported Clinical Event End Date
QNAM = “CEDRVFL” is used to indicate that an entire record is derived.
3.4.3 CM - Concomitant Medications
Concomitant Medications dataset consists of one record per recorded medication occurrence or
constant -dosing interval per subject.
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QNAM Description
CMCODE Standardized Medication Code
DICTVER Dictionary Name and Version
3.4.4 CO - Comments
Comments dataset consists of one record per comment per subject.
3.4.5 DI - Device Identifiers
Device identifiers dataset consists of one record per device identifier per device.
A relationship has been defined in RELREC between the device identifier records and the
corresponding laboratory and microbiology records. The observations are related by SPDEVID.
3.4.6 DM - Demographics
Demographics dataset consists of one record per subject.
Specify Other Race and Ethnicity have been submitted in SUPPDM.
QNAM Description
CDECASE Clinical disease endpoint case flag
RACE1 Race1
RACE2 Race2
RACIALD Racial Designation
REACTOFL Reactogenicity Population Flag
As agreed with CBER, CDECASE qualifier in SUPPDM is populated for each subject from
the ADaM primary endpoint case flag for the first primary efficacy endpoint, as defined in the
protocol. This flag is derived based on ADSL and ADC19EF ADaM datasets.
3.4.7 DS - Disposition
Disposition dataset consists of one record per disposition status or protocol milestone
per subject.
If Participants terminated early, the appropriate reason for discontinuation as per protocol
are recorded in the End of Treatment (EOT) and Follow -up (FUP) visit Disposition
pages.
DSPHASE in SUPPDS corresponds to the pages and can be used to link the records
with multiple disposition per EPOCH.
A relationship has been defined in RELREC between the disposition event where
DSDECOD= ADVERSE EVENT or DEATH and the adverse event leading to
discontinuation. The observations are related by AESEQ and DSSEQ.
QNAM Description
DSPHASE Disposition Phase
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3.4.8 DV - Protocol Deviations
Protocol Deviations dataset consists of one record per protocol deviation per subject
QNAM Description
ACTSITE Actual Site of Deviation Occurrence
CAPE Confirmed Analysis Population Exclusion
DESGTOR Visit Designator
DVTERM1 Protocol Deviation Term 1
SOURCE Source of the data
3.4.9 EC - Exposure as Collected
Exposure as collected dataset consists of one record per protocol -specified study treatment,
collected -dosing interval, per subject, per mood.
QNAM Description
ECCD Standardized Medication Code
ECDECOD Standardized Medication Name
ECOBSV Observed Post Dose For Specified Time
ECOBSVD Details Of Subject Observation
ECOBSVT Timeframe Subject Was Observed
ECTDV Temporary Delay of Vaccination
FDDTC Date of First Delay
3.4.10 EX - Exposure
Exposure dataset consists of one record per constant dosing interval per subject.
• Participants ≥ 16 years of age who originally received placebo and became eligible for receipt of
BNT162b2 or another COVID -19 vaccine will have additional vaccination records.
• For subjects with temporary delay of vaccination without treatment information and vaccination
date, data will not be used or retained in SDTM.
QNAM Description
EXCD Standardized Medication Code
EXDECOD Standardized Medication Name
EXOBSV Observed Post Dose For Specified Time
EXOBSVD Details Of Subject Observation
EXOBSVT Timeframe Subject Was Observed
EXTDV Temporary Delay of Vaccination
FDDTC Date of First Delay
3.4.11 FACE - Findings About Events or Interventions
Findings About dataset consists of one record per finding per object per time point per time point
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reference per visit per subject.
FACE implements flat model for reactogenicity records, including e-diary and unplanned
assessments of reactogenicity findings. Unplanned assessments are under FACAT =
“REACTOGENICITY - UNPLANNED ASSESSMENT ” while diary data has FACAT =
“REACTOGENICITY”. FASTAT = “NOT DONE” records are generated for any missed diary
days and are flagged with FADRVFL = “Y”.
Subjects not part of reactogenicity subset should not have any e-diary data, unplanned assessments or
Symptom Resolved Dates form completed.
a. Programming does not generate any ‘NOT DONE’ records for these subjects. Any e-
diary and Symptom Resolved Dates CRF data that was completed is dropped if subject is
not part of reactogenicity subset.
b. Unplanned assessments without an e-diary will be dropped from reactogenicity datasets
and would be counted only as an adverse event or COVID -19 symptom in the relevant
domain.
Signs and symptoms of COVID -19 are included with FACAT = “EFFICACY”.
A relationship has been defined in RELREC between clinical event summary records and findings
about records. The observations are related by CELNKGRP and FALNKGRP.
QNAM Description
CLTYP Collection Type
FALANG Language Version of Instrument
3.4.12 FAHO - Findings About Events or Interventions
Findings About dataset consists of one record per finding per object per time point per time point
reference per visit per subject.
A relationship has been defined in RELREC been defined between healthcare encounter events and
the corresponding findings about event records. The observations are related by HOLNKID and
FALNKID.
3.4.13 HO - Healthcare Encounters
Healthcare Encounters dataset consists of one record per healthcare encounter per subject.
A relationship has been defined in RELREC been defined between healthcare encounter events and
the corresponding findings about event records. The observations are related by HOLNKID and
FALNKID.
QNAM Description
HCUHSP Hospitalized due to COVID -19 illness?
HCUICU Been in ICU due to COVID -19 illness?
HCUIDIS Disease Name
3.4.14 IE - Inclusion/Exclusion Criteria Not Met
Inclusion/Exclusion Criteria Not Met dataset consists of one record per inclusion/exclusion criterion
not met per subject.
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3.4.15 IS - Immunogenicity Specimen Assessment
Immunogenicity Specimen Assessment dataset consists of one record per test per visit per subject.
QNAM Description
ETRKDOR Data Origin
3.4.16 LB - Laboratory Test Results
Laboratory Test Results dataset consists of one record per analyte per planned time point number per
time point reference per visit per subject.
A relationship has been defined in RELREC between the device identifier records and the
corresponding laboratory records. The observations are related by SPDEVID.
QNAM Description
LBSTTYPE Standardized Unit
LBUNEVFL Not Evaluable Flag
3.4.1 7 MB - Microbiology Specimen
Microbiology Specimen dataset consists of one record per microbiology specimen finding per time
point per visit per subject.
SARS -CoV-2 test results from local labs will have MBCAT = “CONFIRMATION OF
INFECTION” (as collected in the CRF) and central labs have MBCAT = “VIROLOGY”.
A relationship has been defined in RELREC between the device identifier records and the
corresponding microbiology records. The observations are related by SPDEVID.
QNAM Description
ETRKDOR Data Origin
TRADEOTH Other Trade Name
3.4.1 8 MH - Medical History
Medical History dataset consists of one record per medical history event per subject.
QNAM Description
DICTVER Dictionary Name and Version
3.4.19 MO - Morphology
Morphology dataset consists of one record per Morphology finding per location per time point per
visit per subject.
3.4.2 0 SE - Subject Elements
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Subject Elements dataset consists of one record per actual element per subject.
3.4.2 1 SV - Subject Visits
Subject Visits dataset consists of one record per actual visit per subject.
3.4.2 2 VS - Vital Signs
Vital Signs dataset consists of one record per vital sign measurement per time point per visit per
subject.
To implement the CDISC Vaccines TAUG flat model, temperature records from e-diary are
mapped to VS domain with VSCAT = “REACTOGENICITY” . Any unplanned temperature
assessments by the investigator post vaccination are included with VSCAT =
“REACTOGENICITY - UNPLANNED TEMPERATURE ”. VSSTAT = “NOT DONE” records
are generated for any missed diary days and are flagged with VSDRVFL = “Y”.
Non-reactogenicity vital signs have VSCAT = “GENERAL VITAL SIGNS”.
A relationship has also been defined between clinical event summary records and temperature vital
signs records using CELNKGRP and VSLNKGRP.
QNAM Description
CLTYP Collection Type
VSCOLSRT Collected Summary Result Type
CLTYP in SUPPVS will be “DIARY CARD” for assessments by the subject in the e-diary or
“CRF” if recorded by the investigator.
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4.1 Conformance Inputs
Was a validator used to evaluate conformance? Yes
If yes, specify the version(s) of the validation rules: Pinnacle 21 Enterprise version 4.1.4
Validation Engine version 1907.2
Were sponsor -defined validation rules used to evaluate conformance? No
Were the SDTM datasets evaluated in relation to define.xml? Yes
Was define.xml evaluated? Yes
Provide any additional compliance evaluation information:
4.2 Issues Summary
Check
ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning AE 736
(47.24%) New terms were added to extensible codelist EPOCH
(C99079) as per the study protocol:
•VACCINATION
•REPEAT SCREENING 1
•OPEN LABEL FOLLOW -UP
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning CE 10424
(19.11%) New term was added to extensible codelist EPOCH
(C99079) as per the study protocol needs:
•VACCINATION
•REPEAT SCREENING 1
•OPEN LABEL FOLLOW -UP
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning CM 114
(63.33%) New term was added to extensible codelist EPOCH
(C99079) for the study protocol needs:
•VACCINATION
•REPEAT SCREENING 1
•OPEN LABEL FOLLOW -UP
CT2002 RACE value not found in 'Race'
extensible codelist Warning DM 53 (2.34%) New terms were added to extensible codelist RACE
(C74457) as per the study protocol needs:
•MULTIPLE
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning DS 3272
(20.55%) New term was added to extensible codelist EPOCH
(C99079) as per the study protocol needs:
•VACCINATION
•REPEAT SCREENING 1
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning DV 1918
(57.55%) New terms were added to extensible codelist EPOCH
(C99079) as per the study protocol:
•VACCINATION
•REPEAT SCREENING 1
•OPEN LABEL FOLLOW -UP
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning EC 4507
(69.22%) New term was added to extensible codelist EPOCH
(C99079) as per the study protocol needs:
•VACCINATION
•REPEAT SCREENING 1
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning EX 4507
(69.22%) New term was added to extensible codelist EPOCH
(C99079) as per the study protocol needs:
•VACCINATION
•REPEAT SCREENING 1
CT2002 EXDOSU value not found in 'Unit'
extensible codelist Warning EX 6511
(100.00%) New terms were added to extensible codelist Unit
(C71620) as per the study protocol needs:
•mcg
CT2002 FAORRESU value not found in
'Unit' extensible codelist Warning FA 1390
(0.37%) New terms were added to extensible codelist Unit
(C71620) as per the study protocol needs:
•CALIPER UNIT
•VISITS/CONTACTS
CT2002 FASTRESU value not found in 'Unit'
extensible codelist Warning FA 295 (<
0.1%) New term was added to ext ensible codelist Unit
(C71620) as per the study protocol needs:
•VISITS/CONTACTS
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning FA 369458
(98.18%) New term was added to extensible codelist EPOCH
(C99079) as per the study protocol needs:
•VACCINATION
•REPEAT SCREENING 1
•OPEN LABEL FOLLOW -UP
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning HO 3096
(60.48%) New term was added to extensible codelist EPOCH
(C99079) for the study protocol needs:
•VACCINATION
•REPEAT SCREENING 1
•OPEN LABEL FOLLOW -UP
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning IS 1238
(16.11%) New terms were added to extensible codelist EPOCH
(C99079) as per the study protocol:
•VACCINATION
•REPEAT SCREENING 1
CT2002 ISORRESU value not found in 'Unit'
extensible codelist Warning IS 7685
(100.00%) New terms were added to extensible codelist Unit
(C71620) as per the study protocol needs:
•NA
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning LB 1337
(35.77%) New term was added to extensible codelist EPOCH
(C99079) as per the study protocol needs:
•VACCINATION
•REPEAT SCREENING 1
•OPEN LABEL FOLLOW -UP
CT2002 LBORRESU value not found in
'Unit' extensible codelist Warning LB 287
(7.68%) New terms were added to extensible codelist Unit
(C71620) as per the study protocol needs:
•10^3/uL
•10^6/cu mm
•/uL
CT2002 MBSPEC value not found in
'Specimen Type' extensible codelist Warning MB 19181
(98.30%) New terms were added to extensible codelist
Specimen Type (C78734) for the study protocol
needs:
•NASAL_SWAB
•NASAL_SWAB_SELF
•RESPIRATORY SECRETIONS
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning MB 6338
(32.48%) New term was added to extensible codelist EPOCH
(C99079) as per the study protocol needs:
•VACCINATION
•REPEAT SCREENING 1
•OPEN LABEL FOLLOW -UP
CT2002 MBMETHOD value not found in
'Method' extensible codelist Warning MB 18148
(93.01%) New terms were added to extensible codelist
METHOD (C854 92) as per the study protocol:
•NEXT GENERATION SEQUENCING
•REVERSE TRANSCRIPTASE PCR
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning MO 2 (66.67%) New term was added to extensible codelist EPOCH
(C99079) for the study protocol needs:
•REPEAT SCREENING 1
•OPEN LABEL FOLLOW -UP
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning SE 4207
(43.22%) New term was added to extensible codelist EPOCH
(C99079) for the study protocol needs:
•VACCINATION
•REPEAT SCREENING 1
•OPEN LABEL FOLLOW -UP
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning SV 12475
(48.33%) New term was added to extensible codelist EPOCH
(C99079) as per the study protocol needs:
•VACCINATION
•REPEAT SCREENING 1
•OPEN LABEL FOLLOW -UP
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning TA 12
(38.71%) New term was added to extensible codelist EPOCH
(C99079) as per the study protocol needs:
•VACCINATION
•OPEN LABEL FOLLOW -UP
•REPEAT SCREENING 1
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning VS 42888
(99.79%) New term was added to extensible codelist EPOCH
(C99079) as per the study protocol needs:
•VACCINATION
•REPEAT SCREENING 1
CT2005 DSDECOD value not found in
'Completion/Reason for Non -
Completion' extensible codelist when
DSCAT == 'DISPOSITION EVENT' Warning DS 14 (0.21%) New term was added to extensible codelist NCOMPLT
(C66727) for the study protocol needs:
•NO LONGER MEETS ELIGIBILITY CRITERIA
CT2005 TSVAL v alue not found in 'Trial
Phase Response' extensible codelist
when TSPARMCD == 'TPHASE' Warning TS 1
(100.00%) New term was added to extensible codelist TPHASE
(C66737) for the study protocol needs:
•PHASE I/II/III TRIAL
CT2005 TSVAL value not found in 'Trial
Blinding Schema Response'
extensible codelist when
TSPARMCD == 'TBLIND' Warning TS 1
(100.00%) New term was added to extensible codelist TBLIND
(C66735) for the study protocol needs:
•OBSERVER BLIND
SD0002 NULL value in SPDEVID variable
marked as Re quired Error DI 2 (2.27%) This rule fired for 2 records in DI domain where
SPDEVID was null. At the time of data extraction
study is still ongoing and complete SPDEVID data was
not obtained at the time of the snapshot.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD0005 Duplicate value for LBSEQ variable Error LB 614
(81.65%) This is a false positive by P21 and is part of a known
issue for SD0005 -- rule logic is flagging falsely (per
P21 support).
LBSEQ values are unique for each record within LB
domain and within each Unique Subject Identi fier
(USUBJID), Sponsor Defined ID (LBSPID) variables
value.
SD0005 Duplicate value for MBSEQ variable Error MB 306
(91.62%) This is a false positive by P21. It is not an issue with
MBSEQ but is an issue with not having a unique
record for USUBJID and MBS PID -- rule logic is
flagging falsely (per P21 support). MBSEQ values are
unique for each record within MB domain and within
each Unique Subject Identifier (USUBJID), Sponsor
Defined Identifier (MBSPID) variables value.
SD0006 No baseline flag record in LB for
subject Warning DM 1296
(57.32%) Per protocol safety lab data is not collected for Phase
2/3. Lab data could be collected for COVID illness
visits, which are during study conduct and will not be
used to set the baseline flag.
SD0006 No baseline flag record in MB for
subject Warning DM 1 (< 0.1%) For this 1 subjects microbiology data is not collected.
SD0007 Inconsistent value for Standard Units Error LB 26 (4.02%) This check fired for several lab tests with
inconsistencies in standard units.
As a standard course of action, laboratory unit
inconsistencies are reviewed by the clinical team. At
the time of data extraction, study is still ongoing and
the check may not have been completed at the time
of this data snapshot.
SD0016 Missing value for FASTRESC, when
FADRVFL='Y' Warning FA 43600
(97.71%) As per CBER guidance, the records were derived for
missed diary days and FADRVFL flag is used to
indicate that data was not collected.
SD0016 Missing value for VSSTRE SC, when
VSDRVFL='Y' Warning VS 4360
(100.00%) As per CBER guidance, the records were derived for
missed diary days and VSDRVFL flag is used to
indicate that data was not collected.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD0021 Missing End Time -Point value Warning CE 169
(0.31%) Start and End dates are missing as they are not
collected so the reference timepoint values will be
missing as well.
SD0021 Missing End Time -Point value Warning CM 178
(98.89%) No End Date/Time captured in CONCOMITANT
MEDICATIONS - BASELINE (CONMED BSL) and
CONCOMI TANT MEDICATIONS - NON STUDY
VACCINATIONS (CONMED VAX).
SD0021 Missing End Time -Point value Warning HO 295
(5.76%) For 295 records Start and End dates are missing as
they are not collected on the HEALTHCARE
UTILIZATION ASSESSMENT CRF
SD0022 Missing Start Time -Point value Warning CE 169
(0.31%) CESTDTC is missing for CECAT='REACTOGENICITY' or
'EFFICACY' where CEOCCUR='N' and is as per the
CBER/OVRR flat model implementation. For CECAT =
"EFFICACY" where CEOCCUR='N' , CESTDTC is not
collected o n the CRF "Illness Details" page.
SD0022 Missing Start Time -Point value Warning HO 295
(5.76%) For 295 records Start and End dates are missing as
they are not collected on the HEALTHCARE
UTILIZATION ASSESSMENT CRF
SD0027 Missing value for VSORRES, when
VSORRESU is provided Warning VS 1 (< 0.1%) Incorrect information entered at site, the values will
remain missing per site confirmation.
SD0030 Missing value for VSSTRESC, when
VSSTRESU is provided Warning VS 1 (< 0.1%) Incorrect information entered at site in VSORRES,
since VSSTRESC is derived from VSORRES and since
VSORRES is missing for this subject, the values will
remain missing for this submission.
SD0041 Value for CEOCCUR is populated
for unsolicited Intervention or Event Error CE 4648
(97.79%) At the request of CBER, records with CETERM=COVID -
19 like illness and COVID -19 have been added for all
subjects, with CEOCCUR = Y or N. These are
considered derived records rather than spontaneous.
(References: IND 19736.92).
SD0057 SDTM Expected variable
ISSTRESN not found Warning IS 1
(100.00%) ISORRES has values as “POS” and “NEG”, no
numerical values present to be mapped into
ISSTRESN.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD0057 SDTM Expected variable
ISSTRESU not found Warning IS 1
(100.00%) Units for test values were "NA" in the lab file and
were not mapped into the IS domain.
SD0065 USUBJID/VISIT/VISITNUM values
do not match SV domain data Warning CE 2 (0.17%) For subject 10131872: covid -19 symptoms starting
date is not going to s how up in SV. He only came for
assessment on 8SEP and as it was beyond cutoff date
of 2SEP its not going to show up in SV. He has 30AUG
in CE, as that was the symptom starting date and not
the visit date.
For subject 11421346: the data filled late by the s ite,
will rem ain as is.
Explanation as per study team's email: Mon 25 -10-
2021 15:21
SD0065 USUBJID/VISIT/VISITNUM values
do not match SV domain data Warning MB 1 (< 0.1%) For subject 11421346: the data filled late by the site,
will rem ain as is.
Explanation as per study team's email: Mon 25 -10-
2021 15:21
SD0072 Invalid RDOMAIN Error RELREC 297
(49.17%) As per SDTM IG 3.2 section 4.1.1.7 Splitting Domains:
"In RELREC, if a dataset level relationship is defined
for a split Findings About domain, th en RDOMAIN
may contain the four -character dataset name".
P21 doesn't recognize FACE or FAHO as valid
RDOMAINS.
SD0080 AE start date is after the latest
Disposition date Error AE 34 (2.18%) At the time of data extraction, study is still ongoing
and disposition status is collected at the completion
or discontinuation of each stage of the study
therefore may not have occurred at the time of this
data snapshot.
SD0082 Exposure end date is after the latest
Disposition date Warning EX 59 (0.91%) At the time of data extraction, study is still ongoing
and disposition status is collected at the completion
or discontinuation of each stage of the study
therefore may not have occurred at the time of this
data snapshot.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1023 VISIT/VISITNUM values do not
match TV domain data Warning MB 3 (< 0.1%) These records having VISIT=COVID_AR1, COVID_BR1
are illness visits and considered unplanned and not
included in the TV domain.
SD1082 Variable length is too long for actual
data Error CE 1 (2.94%) According to FDA technical conformance guide
section 3.3.3: The allotted length for each column
containing character (text) data should be set to the
maximum length of the variable used across all
datasets in the study except for suppqual datasets.
This is a Pinnacle 21 false positive issue since it only
checks the length of the variable within the data set.
SD1082 Variable length is too long for actual
data Error CO 4 (40.00%) According to FDA technical conformance guide
section 3.3.3: The allotted length for each column
containing character (text) data should be set to the
maximum length of the variable used across all
datasets in the study except for suppqual datasets.
This is a Pinnacle 21 false positive issue since it only
checks the length of the vari able within the data set.
SD1082 Variable length is too long for actual
data Error DM 1 (4.00%) According to FDA technical conformance guide
section 3.3.3: The allotted length for each column
containing character (text) data should be set to the
maximum length of the variable used across all
datasets in the study except for suppqual datasets.
This is a Pinnacle 21 false positive issue since it only
checks the length of the variable within the data set.
SD1082 Variable length is too long for actual
data Error EC 1 (5.00%) According to FDA technical conformance guide
section 3.3.3: The allotted length for each column
containing character (text) data should be set to the
maximum length of the variable used across all
datasets in the study except for suppqual datasets.
This is a Pinnacle 21 false positive issue since it only
checks the length of the varia ble within the data set.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1082 Variable length is too long for actual
data Error EX 1 (5.26%) According to FDA technical conformance guide
section 3.3.3: The allotted length for each column
containing character (text) data should be set to the
maximum le ngth of the variable used across all
datasets in the study except for suppqual datasets.
This is a Pinnacle 21 false positive issue since it only
checks the length of the variable within the data set.
SD1082 Variable length is too long for actual
data Error FA 1 (3.13%) According to FDA technical conformance guide
section 3.3.3: The allotted length for each column
containing character (text) data should be set to the
maximum length of the variable used across all
datasets in the study except for suppqua l datasets.
This is a Pinnacle 21 false positive issue since it only
checks the length of the variable within the data set.
SD1082 Variable length is too long for actual
data Error HO 1 (5.56%) According to FDA technical conformance guide
section 3.3.3: T he allotted length for each column
containing character (text) data should be set to the
maximum length of the variable used across all
datasets in the study except for suppqual datasets.
This is a Pinnacle 21 false positive issue since it only
checks the length of the variable within the data set.
SD1082 Variable length is too long for actual
data Error IE 2 (16.67%) According to FDA technical conformance guide
section 3.3.3: The allotted length for each column
containing character (text) data should be set to the
maximum length of the variable used across all
datasets in the study except for suppqual datasets.
This is a Pinnacle 21 false positive issue since it only
checks the length of the variable within the data set.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1082 Variable length is too long for actual
data Error IS 1 (5.56%) According to FDA technical conformance guide
section 3.3.3: The allotted length for each column
containing character (text) data should be set to the
maximum length of the variable used across all
datasets in the study except for suppqual datasets.
Pinnacle 21 provides false positive information since
it only checks the length of the variable within the
data set.
SD1082 Variable length is too long for actual
data Error LB 2 (7.69%) According to FDA technical conformance guide
section 3.3.3: The allotted length for each column
containing character (text) data should be set to the
maxim um length of the variable used across all
datasets in the study except for suppqual datasets.
This is a Pinnacle 21 false positive issue since it only
checks the length of the variable within the data set.
SD1082 Variable length is too long for actual
data Error MB 2 (8.33%) According to FDA technical conformance guide
section 3.3.3: The allotted length for each column
containing character (text) data should be set to the
maximum length of the variable used across all
datasets in the study except for suppqual datasets.
This is a Pinnacle 21 false positive issue since it only
checks the length of the variable within the data set.
SD1082 Variable length is too long for actual
data Error MH 2 (10.53%) According to FDA technical conformance guide
section 3.3.3: The allotted length for each column
containing character (text) data should be set to the
maximum length of the variable used across all
datasets in the study except for suppqual datasets.
Pinnacle 21 provides false positive information since
it only checks the length of the variable within the
data set.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1082 Variable length is too long for actual
data Error MO 1 (6.67%) According to FDA technical conformance guide
section 3.3.3: The allotted length for each column
containing character (text) data should be set to the
maximum length of the variable used across all
datasets in the study except for suppqual datasets.
Pinnacl e 21 provides false positive information since
it only checks the length of the variable within the
data set.
SD1082 Variable length is too long for actual
data Error SV 1 (12.50%) According to FDA technical conformance guide
section 3.3.3: The allotted l ength for each column
containing character (text) data should be set to the
maximum length of the variable used across all
datasets in the study except for suppqual datasets.
Pinnacle 21 provides false positive information since
it only checks the length o f the variable within the
data set.
SD1082 Variable length is too long for actual
data Error VS 1 (3.33%) According to FDA technical conformance guide
section 3.3.3: The allotted length for each column
containing character (text) data should be set to the
maximum length of the variable used across all
datasets in the study except for suppqual datasets.
Pinnacl e 21 provides false positive information since
it only checks the length of the variable within the
data set.
SD1097 No Treatment Emergent info for
Adverse Event Warning AE 1558
(100.00%) In Vaccine studies Treatment Emergent flag is not
required per comm unication from CBER/OVRR.
SD1117 Duplicate records Warning FA 1 (< 0.1%) The FAOBJ which appears to be duplicate for records,
which are not pre -specified for collection on the CRF,
however the verbatim term is unique for these
records and are coded to sam e preferred term.
SD1124 Missing value for FAREASND,
when FASTAT is 'NOT DONE' Warning FA 11 (<
0.1%) Reason for NOT DONE for variable FAREASND is not
collected on the CRF.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1124 Missing value for LBREASND,
when LBSTAT is 'NOT DONE' Warning LB 263
(100.00%) Reason for NOT DONE for variable LBREASND is not
collected on the CRF.
SD1124 Missing value for VSREASND,
when VSSTAT is 'NOT DONE' Warning VS 9 (0.21%) Reason for NOT DONE for variable VSREASND is not
collected on the CRF
SD1143 No Details info for AESMIE
Adverse Event in SUPPAE domain Warning AE 5
(100.00%) The CRF is not designed with a free text "other
specify" field to capture the description of Other
Medically Important Serious Adverse Events. The
description details are the AET ERM/AEDECOD and
therefore AESOSP is not mapped to SUPPAE.
SD1201 Duplicate records in CE domain Warning CE 17473
(32.04%) CETPTREF is different for all specified CETERMs either
VACCINATION 1, VACCINATION 2 . Therefore, these
records are not true duplicate s.
SD1201 Duplicate records in DS domain Warning DS 16 (0.10%) Duplicate dates are expected in DS domain.
SD1201 Duplicate records in DV domain Warning DV 322
(9.66%) DVSPID values are unique for these records.
Therefore, these are not true duplicates.
SD1202 AESTDTC date is after RFPENDTC Error AE 6 (0.43%) At the time of data extraction, study is still ongoing
and RFPENDTC is derived as the maximum of date of
disposition, Subject Visits, date of death. Therefore
for ongoing subjects may not yet include completion
date of the current study phase where individual
dates from that phase may already be reported.
SD1202 CMSTDTC date is after RFPENDTC Error CM 4 (2.50%) At the time of data extraction, study is still ongoing
and RFP ENDTC is derived as the maximum of date of
disposition, Subject Visits, date of death. Therefore
for ongoing subjects may not yet include completion
date of the current study phase where individual
dates from that phase may already be reported.
SD1202 DVS TDTC date is after RFPENDTC Error DV 16 (0.53%) At the time of data extraction, study is still ongoing
and RFPENDTC is derived as the maximum of date of
disposition, Subject Visits, date of death. Therefore
for ongoing subjects may not yet include completion
date of the current study phase where individual
dates from that phase may already be reported.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1203 CODTC date is after RFPENDTC Error CO 1 (< 0.1%) At the time of data extraction, study is still ongoing
and RFPENDTC is derived as the maximum of date of
disposition, Subject Visits, date of death. Therefore
for ongoing subjects may not yet include completion
date of the current study phase where individual
dates from that phase may already be reported.
SD1203 ISDTC date is after RFPENDT C Error IS 1 (< 0.1%) At the time of data extraction, study is still ongoing
and RFPENDTC is derived as the maximum of date of
disposition, Subject Visits, date of death. Therefore
for ongoing subjects may not yet include completion
date of the current stu dy phase where individual
dates from that phase may already be reported.
SD1203 LBDTC date is after RFPENDTC Error LB 17 (0.54%) At the time of data extraction, study is still ongoing
and RFPENDTC is derived as the maximum of date of
disposition, Subject Visits, date of death. Therefore
for ongoing subjects may not yet include completion
date of the current study phase where individual
dates from that phase may already be reported.
SD1203 MBDTC date is after RFPENDTC Error MB 54 (0.31 %) At the time of data extraction, study is still ongoing
and RFPENDTC is derived as the maximum of date of
disposition, Subject Visits, date of death. Therefore
for ongoing subjects may not yet include completion
date of the current study phase where indi vidual
dates from that phase may already be reported.
SD1204 AEENDTC date is after RFPENDTC Error AE 3 (0.23%) At the time of data extraction, study is still ongoing
and RFPENDTC is derived as the maximum of date of
disposition, Subject Visits, date of death. Therefore
for ongoing subjects may not yet include completion
date of the current study phase where individual
dates from that phase may already be reported.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1204 CEENDTC date is after RFPENDTC Error CE 105
(1.07%) At the time of data extraction, study is still ongoing
and RFPENDTC is derived as the maximum of date of
disposition, Subject Visits, date of death. Therefore
for ongoing subjects may not yet include completion
date of the current study phase where individual
dates from that phase may a lready be reported.
SD1204 CMENDTC date is after
RFPENDTC Error CM 1
(100.00%) At the time of data extraction, study is still ongoing
and RFPENDTC is derived as the maximum of date of
disposition, Subject Visits, date of death. Therefore
for ongoing subje cts may not yet include completion
date of the current study phase where individual
dates from that phase may already be reported.
SD1234 Missing TYPE Parameter for Device Error DI 44
(100.00%) Device Type Parameter information is not available
for the Medical Device used in the study.
SD1258 RFSTDTC is populated for subject
who did not receive treatment Warning DM 4
(100.00%) There were subjects that were randomized but not
treated. Therefore, RFSTDTC was populated for those
records when ACTARM was 'No t Treated'. the actual
dosing start date RFXSTDTC is not populated
SD1274 HOTERM equals 'OTHER' Warning HO 812
(15.86%) OTHER is a collected term used in the HEALTH CARE
UTILIZATION crf form.
SD1282 ECTPTREF variable is present when
ECELTM, ECTPTNUM, and
ECTPT are missing Error EC 1
(100.00%) Based on CDISC TAUG, ECTPTREF can be populated
for Vaccine studies; ECELTM, ECTPTNUM, and ECTPT
are not necessary.
SD1282 EXTPTREF variable is present when
EXELTM, EXTPTNUM, and
EXTPT are missing Error EX 1
(100.00%) Based on CDISC TAUG, EXTPTREF can be populated
for Vaccine studies; EXELTM, EXTPTNUM, and EXTPT
are not necessary.
SD1299 No timing variables are present in
dataset Warning DI 1
(100.00%) In the SDTMIG -3.2 the DI domain does not list any
timing variables, moreover since Device Identifiers
are study level data rather than subject level data,
timing variables are not expected.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1319 DVSTDTC is before RFICDTC Error DV 11 (0.33%) These 11 records are flagged due to various protocol
deviation s occu rred before the Informed Consent
was signed or Consent date was collected/entered
into the system. Data is being reported as collected.
SD1331 DSSTDTC is after DSDTC Error DS 3 (< 0.1%) Data is reported as collected. This rule fired 3 subject
ID's, because of temporary delay in vaccination:
•C4591001 1009 10091301
•C4591001 1147 11471261
•C4591001 1147 11471262
SD1339 Missing EPOCH value, when a start
or observation date is provided Warning CE 385
(3.45%) For events domains --STDTC is used to der ive EPOCH.
Since CESTDTC is missing for these records, EPOCH is
not derived.
SD1339 Missing EPOCH value, when a start
or observation date is provided Warning HO 1 (< 0.1%) For HO domain --DTC is used to derive EPOCH. Since
HODTC is missing for these records, EPOCH is not
derived.
SD1354 ARMCD value not present in DM Error TA 22
(70.97%) Current TA ARMCD has the randomized codes based
on the protocol, including the 12 - 15 age group
randomization codes in Phase 2/3. Only the
randomization code for sub ject in 12 - 15 age group -
phase 2/3 are included in DM.ARMCD while the rest
(B1_10, B1_100, B1_20, B1_30, B2_10, B2_20,
B2_30) are not applicable in this submission.
SD1375 RFENDTC is populated for subject
who did not receive treatment Warning DM 4
(100.00%) There were subjects that were randomized but not
treated. Therefore, RFENDTC was populated for
those records when ACTARM was 'Not Treated'. the
actual dosing end date RFXENDTC is not populated
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1379 ETCD value not present in SE Error TE 6 (50.0 0%) Current TE ETCD has all the trial elements based on
the protocol. The trial elements below are not in
scope for Booster submission.
•VAXB1_10
•VAXB1_20
•VAXB1_30
•VAXB1100
•VAXB2_10
•VAXB2_20
SD2236 ACTARMCD does not equal
ARMCD Warning DM 4 (0.18%) There were subjects that were randomized but not
treated. Therefore, ARMCD (planned) has a different
value than ACTARMCD (actual), since these were not
treated the ACTARMCD has values = "NOTTRT".
SD2237 ACTARM does not equal ARM Warning DM 4 (0.18%) There were subjects that were randomized but not
treated. Therefore, ARM (planned) has a different
value than ACTARM (actual), since these were not
treated the ACTARM has values = "Not Treated".
SD2239 Inconsistent value for FATPT Error FA 611
(0.16%) Values a re populated correctly as per Vaccine TAUG.
P21 rule is expecting same TPT/TPTNUM used across
subject/DTC. Since DTC differs, P21 check fired,
however there is an inherent assumption in the rule
that for different times on same date, the timepoint
should b e different (e.g. 1 HR and 3 HRS timepoints
cannot have same date/time values), which does not
apply here.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD2239 Inconsistent value for VSTPT Error VS 717
(1.67%) Values are populated correctly as per Vaccine TAUG.
P21 rule is expecting same TPT/TPTNUM used across
subject/DTC. Since DTC differs, P21 check fired,
however there is an inherent assumption in the rule
that for different times on same date, the timepoint
should be different (e.g. 1 HR and 3 HRS timepoints
cannot have same date/time values), which does not
apply here.
SD2243 Invalid TSVCDREF value for
PCLAS Error TS 1
(100.00%) Due to the novel nature of the treatment, PCLAS is
not available in NDF -RT. TSVAL is set to "Vaccines,
Nucleic Acid" from CSP dictionary, CUI number
"C0600412 " is used in TSVALCD, and "CSP" is used in
TSVCDREF.
SD2260 Invalid TSVAL value for TRT Error TS 2
(100.00%) Due to the novel nature of the treatment, there is no
standard name for BNT162b1/BNT162b2 from FDA
substance registration system.
SD2261 Invalid TSVALCD value for TRT Error TS 2
(100.00%) There is no corresponding code for
BNT162b1/BNT162b2 from UNII
SD2263 Invalid TSVAL value for PCLAS Error TS 1
(100.00%) Due to the novel nature of the treatment, NDF -RT
TSVAL is set to "Vaccines, Nucleic Acid" from CSP
dictionary. And CUI number "C0600412" is used in
TSVALCD.
SD2264 Invalid TSVALCD value for PCLAS Error TS 1
(100.00%) Due to the novel nature of the treatment, PCLAS is
not available in NDF -RT. TSVAL is set to "Vaccines,
Nucleic Acid" from CSP dictionary. And CUI number
"C0600412" is used in TSVALCD.
SD2265 TSVAL/TSVALCD value mismatch
for PCLAS Error TS 1
(100.00%) Due to the novel nature of the treatment,
TSPARMCD=PCLAS is not available in NDF -RT. TSVAL
is set to "Vaccines, Nucleic A cid" from CSP dictionary.
And CUI number "C0600412" is used in TSVALCD.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
TS0006 No Baseline (ALT) test results for
Subject Error DM 2261
(100.00%) Per protocol safety lab data is not collected for Phase
2/3. Lab data could be collected for COVID illness
visits, which would be during study conduct and will
not be used to set the baseline flag.
TS0007 No Baseline (ALP) test results for
Subject Error DM 2261
(100.00%) Per protocol safety lab data is not collected for Phase
2/3. Lab data could be col lected for COVID illness
visits, which would be during study conduct and will
not be used to set the baseline flag.
TS0008 No Baseline (AST) test results for
Subject Error DM 2261
(100.00%) Per protocol safety lab data is not collected for Phase
2/3. Lab data could be collected for COVID illness
visits, which would be during study conduct and will
not be used to set the baseline flag.
TS0009 No Baseline (BILI) test results for
Subject Error DM 2261
(100.00%) Per protocol safety lab data is not collected for Phase
2/3. Lab data could be collected for COVID illness
visits, which would be during study conduct and will
not be used to set the baseline flag.
TS0012 Analysis Required variable AESEV
not found Error AE 1
(100.00%) AESEV not collected in the CRF for the study.
AETOXGR (Toxicity Grade) variable used for severity.
TS0039 No (ALT) test results Error DM 2230
(98.63%) Per protocol (ALT test results) are not collected for
Phase 2/3. Though it could be collected for COVID
illness visits.
TS0040 No (ALP) test results Error DM 2230
(98.63%) Per protocol (ALP test results) are not collected for
Phase 2/3. Though it could be collected for COVID
illness visits.
TS0041 No (AST) test results Error DM 2230
(98.63%) Per protocol (AST test results) are not collected for
Phase 2/3. Though it could be collected for COVID
illness visits.
TS0042 No (BILI) test results Error DM 2230
(98.63%) Per protocol (BILI test results) are not collected for
Phase 2/3. Though it could be collected for COVID
illness visits.
TS0047 No (SYSBP) test results for subject Error DM 2241
(99.12%) Per protocol blood pressure is not collected for Phase
2/3, though it could be collected for COVID illness
visits.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
TS0048 No (DIABP) test results for subject Error DM 2241
(99.12%) Per protocol blood pressure is not collected for Phase
2/3, though it could be collected for COVID illness
visits.
TS0049 No (HR) or (PULSE) test results for
subject Error DM 2241
(99.12%) Per protocol HR/PULSE test results are not collected
for Phase 2/3, though it could be collected for COVID
illness visits.
TS0050 Missing PC dataset Warning GLOBAL 1
(100.00%) Not applicable for this submission.
TS0051 Missing PP dataset Warning GLOBAL 1
(100.00%) Not applicable for this submission.
TS0053 Neither AESEV or AETOXGR is
populated Error AE 480
(30.81%) Reactogenicity events that are present after the diary
period were added to AE domain and severity or
toxicity grades were not captured after end of diary
period.
TS0057 LBSTRESN is populated but
LBSTNRHI is not populated Warning LB 1 (0.16%) Based on site confirmation, some reference ranges
were not available and will be missing in this
submission.
DD0050 Domain/SASDatasetName mismatch
for split dataset Error DEFINE 1
(100.00%) Per SDTM IG v3.2, sponsors may choose to split a
domain of topically related information into
physically separate datasets. Currently our internal
approach is to split FA by topic hence we have
dataset w ith names FACE, SUPPFACE, FAHO.
4.3 Additional C onformance Details
There are no additional details to be documented.
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Protocol/
Amendment
Version Category IETESTCD Full Text of Criterion
1.0, 2.0, 5.0 INCLUSION IN01A00 Male or female participants between the ages of 18 and 55 years, inclusive, 65
and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization
(dependent upon study stage)
6.0 INCLUSION IN01A05 Male or female participants between the ages of 18 and 55 years, inclusive, 65
and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization
(dependent upon study phase)
7.0 INCLUSION IN01A06 Male or female participants between the ages of 18 and 55 years, inclusive, and
65 and 85 years, inclusive (Phase 1), or >= 16 years (Phase 2/3), at
randomization
8.0 INCLUSION IN01A07 Male or female participants between the ages of 18 and 55 years, inclusive, and
65 and 85 years, inclusive (Phase 1), or >=12 years (Phase 2/3), at
randomization. Note that participants <18 years of age cannot be enrolled in the
EU
1.0, 2.0, 5.0,
6.0, 7.0, 8.0 INCLUSION IN02A00 Participants who are willing and able to comply with all scheduled visits,
vaccination plan, laboratory tests, lifestyle considerations, and other study
procedures
1.0, 2.0, 5.0 INCLUSION IN03A00 Healthy participants who are determined by medical history, physical
examination, and clinical judgment of the investigator to be eligible for inclusion
in the study. Note: Healthy participants with preexisting stable disease, defined
as disease not requiring significant change in therapy or hospitalization for
worsening disease during the 6 weeks before enrollment, can be included
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Version Category IETESTCD Full Text of Criterion
6.0 INCLUSION IN03A05 Healthy participants who are determined by medical history, physical
examination (if required), and clinical judgment of the investigator to be eligible
for inclusion in the study. Note: Healthy participants with preexisting stable
disease, defined as disease not requiring significant change in therapy or
hospitalization for worsening disease during the 6 weeks before enrollment, can
be included
7.0, 8.0 INCLUSION IN03A06 Healthy participants who are determined by medical history, physical
examination (if required), and clinical judgment of the investigator to be eligible
for inclusion in the study.
Note: Healthy participants with preexisting stable disease, defined as disease not
requiring significant change in therapy or hospitalization for worsening disease
during the 6 weeks before enrollment, can be included. Specific criteria for Phase
3 participants with known stable infection with human immunodeficiency virus
(HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) can be found in
Section 10.8
1.0, 2.0, 5.0,
6.0, 7.0 INCLUSION IN04A00 Capable of giving personal signed informed consent as described in Appendix 1,
which includes compliance with the requirements and restrictions listed in the
ICD and in this protocol
8.0 INCLUSION IN04A07 Capable of giving personal signed informed consent/have parent(s)/legal
guardian capable of giving signed informed consent as described in Appendix 1,
which includes compliance with the requirements and restrictions listed in the
ICD and in this protocol
6.0 INCLUSION IN05A05 Participants who, in the judgment of the investigator, are at risk for acquiring
COVID -19
7.0, 8.0 INCLUSION IN05A06 Phase 2/3 only: Participants who, in the judgment of the investigator, are at
higher risk for acquiring COVID -19 (including, but not limited to, use of mass
transportation, relevant demographics, front line essential workers and others)
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Version Category IETESTCD Full Text of Criterion
1.0, 2.0, 5.0,
6.0, 7.0, 8.0 EXCLUSION EX01A00 Other medical or psychiatric condition including recent (within the past year) or
active suicidal ideation/behavior or laboratory abnormality that may increase the
risk of study participation or, in the investigator's judgment, make the participant
inappropriate for the study
1.0, 2.0, 5.0, 6.0 EXCLUSION EX02A00 Known infection with human immunodeficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV)
7.0, 8.0 EXCLUSION EX02A06 Phase 1 & 2 only: Known infection with human immunodeficiency virus (HIV),
hepatitis C virus (HCV), or hepatitis B virus (HBV)
1.0, 2.0, 5.0, 6.0,
7.0, 8.0 EXCLUSION EX03A00 History of severe adverse reaction associated with a vaccine and/or severe
allergic reaction (eg, anaphylaxis) to any component of the study intervention(s)
1.0, 2.0, 5.0,
6.0, 7.0, 8.0 EXCLUSION EX04A00 Receipt of medications intended to prevent COVID 19
1.0, 2.0, 5.0 EXCLUSION EX05A00 Stages 1 and 2 only: Previous clinical or microbiological diagnosis of COVID -
19
6.0, 7.0 EXCLUSION EX05A05 Previous clinical or microbiological diagnosis of COVID -19
8.0 EXCLUSION EX05A07 Previous clinical (based on COVID -19 symptoms/signs alone, if a SARS -CoV-2
NAAT result was not available) or microbiological (based on COVID -19
symptoms/signs and a positive SARS -CoV-2 NAAT result) diagnosis of
COVID -19
1.0 EXCLUSION EX06A00 Sentinel participants in Stage 1 only: Individuals at high risk for severe COVID -
19, including those with any of the following risk factors: Hypertension, Diabetes
mellitus, Chronic pulmonary disease, Asthma, Current vaping or smoking,
History of chronic smoking within the prior year, BMI >30 kg/m2, Anticipating
the need for immunosuppressive treatment within the next 6 months
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2.0, 5.0 EXCLUSION EX06A01 Sentinel participants in Stage 1 only: Individuals at high risk for severe COVID -
19, including those with any of the following risk factors: Hypertension, Diabetes
mellitus, Chronic pulmonary disease, Asthma, Current vaping or smoking,
History of chronic smoking within the prior year, Chronic liver disease, Stage 3
or worse chronic kidney disease (glomerular filtration rate <60 mL/min/1.73 m2),
Resident in a long-term facility, BMI >30 kg/m2, Anticipating the need for
immunosuppressive treatment within the next 6 months
6.0, 7.0, 8.0 EXCLUSION EX06A05 Phase 1 only: Individuals at high risk for severe COVID -19,including those with
any of the following risk factors: Hypertension, Diabetes mellitus, Chronic
pulmonary disease, Asthma, Current vaping or smoking, History of chronic
smoking within the prior year, Chronic liver disease, Stage 3 or wors e chronic
kidney disease (glomerular filtration rate <60 mL/min/1.73 m2), Resident in a
long-term facility, BMI >30 kg/m2, Anticipating the need for
immunosuppressive treatment within the next 6 months
1.0, 2.0, 5.0 EXCLUSION EX07A00 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)
6.0, 7.0, 8.0 EXCLUSION EX07A05 Phase 1 only: Individuals currently working in occupations with high risk of
exposure to SARS -CoV-2 (eg, healthcare worker, emergency response
personnel)
1.0, 2.0, 5.0,
6.0, 7.0, 8.0 EXCLUSION EX08A00 Immunocompromised individuals with known or suspected immunodeficiency,
as determined by history and/or laboratory/physical examination.
1.0, 2.0 EXCLUSION EX09A00 Individuals with a history of autoimmune disease or an active autoimmune
disease requiring therapeutic intervention including but not limited to: systemic
or cutaneous lupus erythematosus, autoimmune arthritis/rheumatoid arthritis,
Guillain -Barre syndrome, multiple sclerosis, Sjogren's syndrome, idiopathic
thrombocytopenia purpura, glomerulonephritis, autoimmune thyroiditis, giant
cell arteritis (temporal arteritis), psoriasis, and insulin -dependent diabetes
mellitus (type 1)
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Version Category IETESTCD Full Text of Criterion
5.0 EXCLUSION EX09A04 Sentinel participants in Stage 1 only: Individuals with a history of autoimmune
disease or an active autoimmune disease requiring therapeutic intervention,
including but not limited to: systemic or cutaneous lupus erythematosus,
autoimmune arthritis/rheumatoid arthritis, Guillain -Barre syndrome, multiple
sclerosis, Sjogren's syndrome, idiopathic thrombocytopenia purpura,
glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal
arteritis), psoriasis, and insulin -dependent diabetes mellitus (type 1)
6.0, 7.0, 8.0 EXCLUSION EX09A05 Phase 1 only: Individuals with a history of autoimmune disease or an active
autoimmune disease requiring therapeutic intervention, including but not limited
to: systemic or cutaneous lupus erythematosus, autoimmune arthritis/rheumatoid
arthritis, Guillain -Barre syndrome, multiple sclerosis, Sjogren's syndrome,
idiopathic thrombocytopenia purpura, glomerulonephritis, autoimmune
thyroiditis, giant cell arteritis (temporal arteritis), psoriasis, and insulin -
dependent diabetes mellitus (type 1)
1.0, 2.0, 5.0,
6.0, 7.0, 8.0 EXCLUSION EX10A00 Bleeding diathesis or condition associated with prolonged bleeding that would, in
the opinion of the investigator, contraindicate intramuscular injection
1.0, 2.0, 5.0,
6.0, 7.0, 8.0 EXCLUSION EX11A00 Women who are pregnant or breastfeeding
1.0, 2.0, 5.0,
6.0, 7.0, 8.0 EXCLUSION EX12A00 Previous vaccination with any coronavirus vaccine
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1.0 EXCLUSION EX13A00 Individuals who receive treatment with immunosuppressive therapy, including
cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune
disease, or planned receipt throughout the study. If systemic corticosteroids have
been administered short term (<14 days) for treatment of an acute illness,
participants should not be enrolled into the study until corticosteroid therapy has
been discontinued for at least 28 days before study intervention administration.
Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes)
corticosteroids are permitted
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Version Category IETESTCD Full Text of Criterion
2.0 EXCLUSION EX13A01 Individuals who receive treatment with immunosuppressive therapy, including
cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune
disease, or planned receipt throughout the study. If systemic corticosteroids have
been administered short term (<14 days) for treatment of an acute illness,
participants should not be enrolled into the study until corticosteroid therapy has
been discontinued for at least 28 days before study intervention administration.
Inhaled/nebulized (except for sentinel subjects in Stage 1 – see exclusion 14),
intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted
1.0 EXCLUSION EX14A00 Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administration or planned receipt throughout the study
1.0 EXCLUSION EX15A00 Participation in other studies involving study intervention within 28 days prior to
study entry and/or during study participation
1.0 EXCLUSION EX16A00 Previous participation in other studies involving study intervention containing
lipid nanoparticles
1.0 EXCLUSION EX17A00 Sentinel participants in Stage 1 only: Positive serological test for SARS -CoV-2
IgM and/or IgG antibodies at the screening visit
6.0 EXCLUSION EX17A05 Phase 1 only: Positive serological test for SARS -CoV-2 IgM and/or IgG
antibodies at the screening visit
1.0 EXCLUSION EX18A00 Sentinel participants in Stage 1 only: Any screening hematology and/or blood
chemistry laboratory value that meets the definition of a >=Grade 1 abnormality.
Note: With the exception of bilirubin, participants with any stable Grade 1
abnormalities (according to the toxicity grading scale) may be considered eligible
at the discretion of the investigator. (Note: A "stable" Grade 1 laboratory
abnormality is defined as a report of Grade 1 on an initial blood sample that
remains <=Grade 1 upon repeat testing on a second sample from the same
participant)
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Version Category IETESTCD Full Text of Criterion
6.0 EXCLUSION EX18A05 Phase 1 only: Any screening hematology and/or blood chemistry laboratory value
that meets the definition of a >= Grade 1 abnormality Note: With the exception of
bilirubin, participants with any stable Grade 1 abnormalities (according to the
toxicity grading scale) may be considered eligible at the discretion of the
investigator. (Note: A "stable" Grade 1 laboratory abnormality is defined as a
report of Grade 1 on an initial blood sample that remains <= Grade 1 upon repeat
testing on a second sample from the same participant.)
1.0 EXCLUSION EX19A00 Sentinel participants in Stage 1 only: Positive test for HIV, hepatitis B surface
antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or hepatitis C virus
antibodies (HCV Abs) at the screening visit
6.0 EXCLUSION EX19A05 Phase 1 only: Positive test for HIV, hepatitis B surface antigen (HBsAg),
hepatitis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs)
at the screening visit
1.0 EXCLUSION EX20A00 Sentinel participants in Stage 1 only: SARS -CoV-2 NAAT -positive nasal swab
within 24 hours before receipt of study intervention
6.0 EXCLUSION EX20A05 Phase 1 only: SARS -CoV-2 NAAT -positive nasal swab within 24 hours before
receipt of study intervention
1.0 EXCLUSION EX21A00 Investigator site staff or Pfizer employees directly involved in the conduct of the
study, site staff otherwise supervised by the investigator, and their respective
family members
7.0 EXCLUSION EX21A06 Investigator site staff or Pfizer/BioNTech employees directly involved in the
conduct of the study, site staff otherwise supervised by the investigator, and their
respective family members
2.0 EXCLUSION EX22A01 Sentinel participants in Stage 1 only: Regular receipt of inhaled/nebulized
corticosteroids.
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6.0 EXCLUSION EX22A05 Phase 1 only: Regular receipt of inhaled/nebulized corticosteroids
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This document is confidential Page 57 of 60 Appendix II: Data Cutoff Algorithm in Standard Domains
Records are included in SDTM datasets as specified below with &cutoff equal to 02 September 2021
SDTM Domain Cutoff Description
AE
Apply util_partial_datetime_imputation.sas to AESTDTC and
AEENDTC to derive ASTDT AND AENDT respectively.
%util_partial_datetime_imputation(
_isodate =AESTDTC/AEENDTC
,_impdate = ASTDT/AENDT
,_impdateflag = %str(ASTDTF/AENDTF)
,_imputation_rule_date = %str(START/STOP));
All records with ASTDT <= &cutoff are included.
In addition,
If .<ASTDT <= &cutoff and AEENDT > cutoff date, then
- AEENDTC and AEENDY is set to missing
- AEENRTPT = ‘ONGOING’
- AEENTPT = ‘Last Subject Encounter’
- AEOUT = ‘NOT RECOVERED/NOT RESOLVED’
- AESDTH = ‘N’
end;
else if AESTDTC = ‘ ‘ and AEENDTC ne ‘ ‘and AENDT <= &cutoff
then the record is included.
If AESTDTC and AEENDTC are both missing, then the record is
included.
DROP ASTDT and AENDT
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This document is confidential Page 58 of 60 SDTM Domain Cutoff Description
DM Include all records with DMDTC <= &cutoff
If RFPENDTC > &cutoff then RFPENDT C = ‘ ‘
If RFSTDTC > &cutoff then do;
If randomization date > &cutoff then do;
RFSTDTC =' '; RFENDTC=' '; RFXSTDTC=' '; RFXENDTC=' ';
arm='NOT ASSIGNED'; armcd='NOTASSGN';
end;
else if randomization date <= &cutoff then do;
set RFSTDTC = randomization date;
RFENDTC=randomization date; RFXSTDTC=' ';
RFXENDTC=' ';
end;
Else if RFSTDTC <= &cutoff then do;
If RFENDTC > &cutoff then set RFENDTC=&cutoff;
RFXENDTC=&cutoff;
If DTHDTC > &cutoff then do;
set DTHDTC = ‘ ‘;
set DTHFL = ‘ ‘;
end;
EC Include all records with ECSTDTC <= &cutoff
If ECENDTC > &cutoff then do; ECENDTC = &cutoff; ECENDY =
ECENDTC – RFSTDTC +1; end;
EX Include all records with EXSTDTC <= &cutoff
If EXENDTC > &cutoff then do; EXENDTC = &cutoff; EXENDY =
EXENDTC – RFSTDTC +1; end;
CE/DV/FACE/FAHO/HO/IE/IS/LB/MB/MO/SV/VS/SE Include all records with ( CEDTC/ DVSTDTC/ (Datepart) FADTC
/HODTC/ IEDTC/ ISDTC/ (datepart) LBDTC/ MBDTC/ MODTC/
SVSTDTC/ VSDTC/ SESTDTC) <=
&cutoff
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This document is confidential Page 59 of 60 SDTM Domain Cutoff Description
DS/MH Include all records with DSDTC <= &cutoff and ( DSSTDTC/
MHSTDTC) <= &cutoff
CM
Apply util_partial_datetime_imputation.sas to CMSTDTC and
CMENDTC to derive ASTDT AND AENDT respectively.
%util_partial_datetime_imputation(
_isodate =CMSTDTC/CMENDTC
,_impdate = ASTDT/AENDT
,_impdateflag = %str(ASTDTF/AENDTF)
,_imputation_rule_date = %str(START/STOP));
All records with ASTDT <= &cutoff are included.
In addition,
If .<ASTDT <= &cutoff and AENDT > cutoff date, then
- CMENDTC is set to missing
- CMENRTPT = ‘ONGOING’
- CMENTPT = ‘Last Subject Encounter’
-
end;
else if CMSTDTC = ‘ ‘ and CMENDTC ne ‘ ‘ and CMENDTC<= &cutoff
then the record is included.
If CMSTDTC and CMENDTC are both missing then the record is
included.
DROP ASTDT and AENDT
CO If RDOMAIN = ‘IS’ then retain all obs where CODTC<= cutoff, else for
all other values of RDOMAIN, match with USUBJID /SEQ.
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Study C4591001 Clinical Study Data Reviewer’s Guide
This document is confidential Page 60 of 60 SDTM Domain Cutoff Description
RELREC Include all records If USUBJID = ‘ ’. for each domain in RDOMAIN,
match with USUBJID /SEQ if index(idvar,’SEQ’)>0; else match with
USUBJID/LNKID if index(idvar,’LNKID’)>0.
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