A Trial Investigating the Safety and Effects of One or Tw... | NCT04949490 | Trialant
NCT04949490
Sponsor
BioNTech SE
Status
Completed
Last Update Posted
Sep 19, 2024Actual
Enrollment
137Actual
Phase
Phase 2
Conditions
COVID-19
SARS-CoV-2 Infection
Interventions
BNT162b2s01
BNT162b2
Countries
Germany
Protocol Section
Identification Module
NCT ID
NCT04949490
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
BNT162-14
Secondary IDs
ID
Type
Description
Link
2021-002387-50
EudraCT Number
Brief Title
A Trial Investigating the Safety and Effects of One or Two Additional Doses of Comirnaty or One Dose of BNT162b2s01 in BNT162-01 or BNT162-04 Trial Subjects
Official Title
A Phase II, Open-label, Rollover Trial to Evaluate the Safety and Immunogenicity of One or Two Boosting Doses of Comirnaty or One Dose of BNT162b2s01 in BNT162-01 Trial Subjects, or Two Boosting Doses of Comirnaty in BNT162-04 Trial Subjects
Acronym
Not provided
Organization
BioNTech SEINDUSTRY
Status Module
Record Verification Date
May 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 26, 2021Actual
Primary Completion Date
Apr 14, 2022Actual
Completion Date
Sep 16, 2022Actual
First Submitted Date
Jun 25, 2021
First Submission Date that Met QC Criteria
Jun 25, 2021
First Posted Date
Jul 2, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Sep 15, 2023
Results First Submitted that Met QC Criteria
May 2, 2024
Results First Posted Date
Sep 19, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 2, 2024
Last Update Posted Date
Sep 19, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
BioNTech SEINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Trial to evaluate the safety and immunogenicity of one or two boosting doses of Comirnaty or one dose of BNT162b2s01 (Variant of concern [VOC] strain B.1.351) in BNT162-01 trial participants, or two boosting doses of Comirnaty in BNT162-04 trial participants.
Trial participants from BNT162-01 who received two injections of 30 μg Comirnaty were randomized 2:1 to one booster injection (BNT162b2s01: Comirnaty). Trial participants in either the trial BNT162-01 or BNT162-04 who did not receive the full two vaccinations of 30 μg Comirnaty were offered two injections of 30 μg Comirnaty as per the conditional marketing authorization. All potential rollover volunteers must enroll in this trial within less than 18 months of their last injection of a BNT162 candidate vaccine in the parent BNT162-01 or BNT162-04 trials.
Detailed Description
Group A trial participants were randomized 2:1 to BNT162b2s01:Comirnaty. Group B trial participants were allocated to trial treatment without active randomization and selected participants were asked to participate in the detailed immunogenicity assessment based on their parent trial cohort.
Conditions Module
Conditions
COVID-19
SARS-CoV-2 Infection
Keywords
Infections, Respiratory
Virus Diseases
Infection Viral
Vaccine Adverse Reaction
RNA Virus Infections
Protection Against COVID-19 and Infections With SARS-CoV-2
Prevention of COVID-19 disease
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
137Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group A, BNT162b2s01 30 μg (1 dose)
Experimental
Trial participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) in the parent trial received one booster injection of BNT162b2s01 on Day 1. Day 1 (baseline in this trial) must have occurred ≥24 weeks after the last BNT162b2 (Comirnaty) injection in the parent BNT162-01 trial.
Biological: BNT162b2s01
Group A, BNT162b2 30 μg (1 dose)
Experimental
Trial participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) in the parent trial received one booster injection of BNT162b2 (Comirnaty) on Day 1. Day 1 (baseline in this trial) must have occurred ≥24 weeks after the last BNT162b2 (Comirnaty) injection in the parent BNT162-01 trial.
Biological: BNT162b2
Group B, BNT162b2 30 μg (2 doses)
Experimental
Trial participants in either the trial BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) in the respective parent trial were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21. Day 1 (baseline in this trial) must have occurred ≥12 weeks after receiving the last BNT162 candidate vaccine in the respective parent BNT162-01 or BNT162-04 trial.
Biological: BNT162b2
Group B transplant subjects, BNT162b2 30 μg (2 doses)
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BNT162b2s01
Biological
intramuscular (IM) injection
Group A, BNT162b2s01 30 μg (1 dose)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)
For treatment-emergent SAEs and AESIs (TESAEs, TEAESIs), the data refers to the interval "Dose 1 up to 28 days after Dose 1". For other SAEs and AESIs, the data refers to the interval "Dose 1 up to 26 weeks after Dose 1".
A TESAE/TEAESI is defined as any SAE/AESI with an onset after the first IMP dose or worsened after the first IMP dose (if the SAE/AESI was present before the first administration of IMP). SAEs/AESIs with an onset date more than 28 days after the last administration of IMP will be considered as TESAE/TEAESI only if assessed as related to IMP by the investigator.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
Up to 26 weeks after the first IMP injection
The Number and Percentage of Participants With Solicited Local Reactions at the Injection Site Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.
Local reactions (pain, tenderness, erythema/redness, induration/swelling) were graded using criteria based on the guidance given in US FDA Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials"; the guidance uses the Grades 1 (mild), 2 (moderate), 3 (severe), and 4 (potentially life-threatening). The reporting of local reactions was based on the participant's assessments via daily solicited reports in the participant diaries.
Participants of the Group B immunology subset are part of the Group B. The 'Total' arms include all participants from the respective Group A and Group B immunology subset arms presented.
Group A: From Day 1 to Day 8; For Group B (except transplant participants): From Day 1 to Day 8 for Dose 1, and from Day 22 to Day 29 for Dose 2. For Group B transplant participants: From Day 1 to Day 8 for Dose 1, and up to 7 days after Dose 2.
The Number and Percentage of Participants With Solicited Systemic Reactions Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.
Secondary Outcomes
Measure
Description
Time Frame
Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351
For Group A participants and Group B participants (except transplant subjects). Non-transplant participants of the Group B immunology subset are also part of the respective Group B arm and therefore occurring in more than one arm/group. The 'Total' arm for Group A include all participants from the Group A arms/groups.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Had given informed consent by signing the informed consent form (ICF) before initiation of any trial-specific procedures.
Were willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions (including those requested by the German and federal Governments, e.g., to follow good practices to reduce chances of spreading COVID 19), and other requirements of the trial.
Have received BNT162 vaccine candidates in the BNT162-01 or BNT162-04 trials.
Remained overall healthy (i.e., has not medically deteriorated significantly since participation in the parent trial, is not anticipated to die in the next 26 weeks, and is able to provide blood as specified by the trial without anticipated, deleterious medical consequences) in the clinical judgment of the investigator based on medical history and physical examination. Screening clinical laboratory tests are to assess the participants' "new baseline" unless required for eligibility. Note: in particular, caution should be used with a subject who has a history of cardiovascular disease, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy, or clinically significant arrhythmia.
Agreed not to enroll in another trial of an IMP, starting after Visit 0 and continuously until Visit 5 (Day 50).
Less than 18 months have passed since their last IMP injection in their parent trial.
If they received 30 μg Comirnaty twice in the BNT162-01 trial, Visit 1 in this trial is ≥24 weeks after their last IMP injection, unless the subject is a Cohort 13 transplant subject of the BNT162-01 trial.
If they received any other BNT162 vaccine candidate than Comirnaty in the BNT162-01 or BNT162-04 trial or are a Cohort 13 transplant subject, Visit 1 in this trial is ≥12 weeks after their last IMP injection.
Have not been diagnosed with SARS-CoV-2 infection in the 12 weeks prior to day 1 (baseline). Participants who screen-fail on this criterion may be rescreened.
Exclusion Criteria:
Have received any SARS-CoV-2 vaccine outside of the BNT162-01 or BNT162-04 trials.
Have had a known allergy, hypersensitivity, or intolerance to the planned IMP including any excipients of the IMP.
Have had a current febrile illness (body temperature ≥38.0°C) or other acute illness within 48 hours prior to day 1/IMP injection in this trial. Participants who screen-fail on this criterion may be rescreened.
Have received a live or live attenuated vaccine within 30 days prior to day 1/IMP injection, or any other vaccination within 14 days prior to day 1/IMP injection. Participants who screen-fail on this criterion may be rescreened.
Have had an ongoing AE assessed as related to any BNT162-01 or BNT162-04 trial vaccine.
Quandt J, Muik A, Salisch N, Lui BG, Lutz S, Kruger K, Wallisch AK, Adams-Quack P, Bacher M, Finlayson A, Ozhelvaci O, Vogler I, Grikscheit K, Hoehl S, Goetsch U, Ciesek S, Tureci O, Sahin U. Omicron BA.1 breakthrough infection drives cross-variant neutralization and memory B cell formation against conserved epitopes. Sci Immunol. 2022 Sep 16;7(75):eabq2427. doi: 10.1126/sciimmunol.abq2427. Epub 2022 Sep 16.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
All enrolled participants were allocated to treatment. Participants of the Group B immunology subset are also included in the respective Group B arms. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
Recruitment Details
This rollover study (BNT162-14) has enrolled BNT162-01 (NCT04380701) or BNT162-04 (NCT04537949) study participants meeting all inclusion/exclusion criteria defined in the study protocol.
The first participant was enrolled on 26 JUL 2021. The last visit of the last participant was on 16 SEP 2022.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Group A Comirnaty
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2 (Comirnaty) on Day 1.
BNT162b2: intramuscular (IM) injection
FG001
Group A BNT162b2s01
Periods
Title
Milestones
Reasons Not Completed
Group A and Group B
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jan 20, 2022
Sep 4, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Transplant trial participants from Cohort 13 of the trial BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty). Day 1 (baseline in this trial) must have occurred ≥12 weeks after receiving the last BNT162 candidate vaccine in the parent BNT162-01 trial.
Biological: BNT162b2
BNT162b2
Biological
IM injection
Group A, BNT162b2 30 μg (1 dose)
Group B transplant subjects, BNT162b2 30 μg (2 doses)
Group B, BNT162b2 30 μg (2 doses)
Comirnaty
Systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills and fever) were graded using criteria based on the guidance given in US FDA Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials"; the guidance uses the Grades 1 (mild), 2 (moderate), 3 (severe), and 4 (potentially life-threatening). The reporting of systemic reactions was based on the participant's assessments via daily solicited reports in the participant diaries.
Participants of the Group B immunology subset are part of the Group B. The 'Total' arms include all participants from the respective Group A and Group B immunology subset arms presented.
Group A: From Day 1 to Day 8; For Group B (except transplant participants): From Day 1 to Day 8 for Dose 1, and from Day 22 to Day 29 for Dose 2. For Group B transplant participants: From Day 1 to Day 8 for Dose 1, and up to 7 days after Dose 2.
The Number and Percentage of Participants With at Least One Unsolicited TEAE Occurring up to 28 Days After IMP Injection in Each Treatment Group for Group A and for a Selected Subset (Immunology Subset) of Group B Participants
A TEAE is defined as any AE with an onset after the first IMP injection or worsened after the first IMP injection (if the AE was present before the first administration of IMP). AEs with an onset date more than 28 days after the last administration of IMP will be considered as treatment-emergent only if assessed as related to IMP by the investigator.
Participants of the Group B immunology subset are part of the Group B. The 'Total' arms include all participants from the respective Group A and Group B immunology subset arms presented.
Group A: Up to 28 days after Dose 1. Group B: Up to 28 days after Dose 1 and up to 28 days after Dose 2.
Group A: At baseline (Day 1) and Day 8 and at Week 4 Day 29), Week 12 (Day 85), and Week 26 (Day 182). Group B: At baseline (Day 1) and Day 8 and at Week 3 (Day 22), Week 4 (Day 29), Week 7 (Day 50), Week 12 (Day 85), and Week 26 (Day 182).
Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351
For Group A participants and Group B participants (except transplant subjects). Non-transplant participants in the Group B immunology subset arm are also part of the respective Group B arm and therefore occurring in more than one arm/group. The 'Total' arm for Group A include all participants from the Group A arms/groups.
Group A: At baseline (Day 1) and Day 8 and at Week 4 Day 29), Week 12 (Day 85), and Week 26 (Day 182). Group B: At baseline (Day 1) and Day 8 and at Week 3 (Day 22), Week 4 (Day 29), Week 7 (Day 50), Week 12 (Day 85), and Week 26 (Day 182).
SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain
For Group A only. The geometric mean titer (GMT) ratio is calculated as the GMT of reference divided by the GMT of variant B.1.351.
The 'Total' arm for Group A include all participants from the two Group A arms/groups.
Up to 26 weeks after the first IMP injection (Dose 1)
Neutralizing Antibody Titers (Reference Strain) Derived From SARS-CoV-2
For Group B transplant subjects, assessed at baseline (Day 1 of Dose 1) and then Day 8, Weeks 4, 12, and 26 post Dose 1, and at Dose 2 (Day 1) and the Day 8, Weeks 4, 12, and 26 post Dose 2.
Because the 11 participants of the arm 'Group B Immunology Subset Transplant Participants' are the same 11 participants of the arm 'Group B Immunology Subset Transplant Participants', data is not presented for this arm to avoid duplication of data.
From baseline (Day 1 of Dose 1) up to 26 weeks after Dose 2
Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2
For Group B transplant subjects, assessed at baseline (Day 1 of Dose 1) and then Day 8, Weeks 4, 12, and 26 post Dose 1, and at Dose 2 (Day 1) and the Day 8, Weeks 4, 12, and 26 post Dose 2.
Because the 11 participants of the arm 'Group B Immunology Subset Transplant Participants' are the same 11 participants of the arm 'Group B Immunology Subset Transplant Participants', data is not presented for this arm to avoid duplication of data.
From baseline (Day 1 of Dose 1) up to 26 weeks after Dose 2
Frankfurt
60590
Germany
University Hospital Heidelberg, Clinical Pharmacology
Heidelberg
69117
Germany
CRS Clinical Research Services Mannheim GmbH
Mannheim
68167
Germany
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2s01 on Day 1.
BNT162b2s01: IM injection
FG002
Group B Non-transplant Participants
Study participants in either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
FG003
Group B Transplant Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
FG004
Group B Immunology Subset Non-transplant Participants
Study participants in either the study BNT162-01 (excluding transplant study participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
FG005
Group B Immunology Subset Transplant Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
FG00021 subjects
FG00144 subjects
FG00261 subjects
FG00311 subjects
FG0040 subjectsData of the Group B immunology subset participants is presented as separated period for full transparency.
FG0050 subjectsData of the Group B immunology subset participants is presented as separated period for full transparency.
COMPLETED
FG00021 subjects
FG00144 subjects
FG00260 subjects
FG0039 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG0040 subjects
FG0050 subjects
Type
Comment
Reasons
Non-study SARS-COV-2 vaccination
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG0040 subjects
FG0050 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Subset Group B Immunogenicity Evaluation
Type
Comment
Milestone Data
STARTED
FG0000 subjectsGroup A participants are not included in the Subset of Group B for Immunogenicity Evaluation.
FG0010 subjectsGroup A participants are not included in the Subset of Group B for Immunogenicity Evaluation.
FG0020 subjectsNot all Group B participants are included in the subset of Group B for immunogenicity evaluation. Data of the participants included in the immunology subset is presented in separate columns on the right.
FG0030 subjectsNot all Group B participants are included in the subset of Group B for immunogenicity evaluation. Data of the participants included in the immunology subset is presented in separate columns on the right.
FG00422 subjectsData of the Group B immunology subset participants is presented as separated period for full transparency.
FG00511 subjectsData of the Group B immunology subset participants is presented as separated period for full transparency.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Non-study SARS-COV-2 vaccination
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group A Comirnaty
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2 (Comirnaty) on Day 1.
BNT162b2: intramuscular (IM) injection
BG001
Group A BNT162b2s01
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2s01 on Day 1.
BNT162b2s01: IM injection
BG002
Group B Non-transplant Participants
Study participants in either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
BG003
Group B Transplant Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00021
BG00144
BG00261
BG00311
BG004137
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG00021
ParticipantsBG00144
ParticipantsBG00261
ParticipantsBG003
Age, Continuous
Per the planned analyses, totals were only calculated for participants in Group A and Group B, respectively.
Mean
Standard Deviation
years
Title
Denominators
Categories
Group A
ParticipantsBG00021
ParticipantsBG00144
ParticipantsBG002
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG00021
ParticipantsBG00144
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG00021
ParticipantsBG00144
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG00021
ParticipantsBG00144
ParticipantsBG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
Germany
ParticipantsBG00021
ParticipantsBG00144
ParticipantsBG002
Weight
Per the planned analyses, totals were only calculated for participants in Group A and Group B, respectively.
Mean
Standard Deviation
kg
Title
Denominators
Categories
Group A
ParticipantsBG00021
ParticipantsBG00144
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)
For treatment-emergent SAEs and AESIs (TESAEs, TEAESIs), the data refers to the interval "Dose 1 up to 28 days after Dose 1". For other SAEs and AESIs, the data refers to the interval "Dose 1 up to 26 weeks after Dose 1".
A TESAE/TEAESI is defined as any SAE/AESI with an onset after the first IMP dose or worsened after the first IMP dose (if the SAE/AESI was present before the first administration of IMP). SAEs/AESIs with an onset date more than 28 days after the last administration of IMP will be considered as TESAE/TEAESI only if assessed as related to IMP by the investigator.
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
Safety set, i.e., all participants who received at least one dose of IMP.
Posted
Count of Participants
Participants
Up to 26 weeks after the first IMP injection
ID
Title
Description
OG000
Group A Comirnaty
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2 (Comirnaty) on Day 1.
BNT162b2: intramuscular (IM) injection
OG001
Group A BNT162b2s01
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2s01 on Day 1.
BNT162b2s01: IM injection
OG002
Group A Total
All Group A study participants, i.e., study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty), received one booster injection of BNT162b2s01 or BNT162b2 on Day 1.
BNT162b2s01 and BNT162b2: IM injection
OG003
Group B Non-transplant Participants
Study participants in either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
OG004
Group B Transplant Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
OG005
Group B Total
All Group B study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
Units
Counts
Participants
OG00021
OG00144
OG00265
OG003
Title
Denominators
Categories
Any SAE
Title
Measurements
OG0000
OG0012
OG0022
OG003
Primary
The Number and Percentage of Participants With Solicited Local Reactions at the Injection Site Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.
Local reactions (pain, tenderness, erythema/redness, induration/swelling) were graded using criteria based on the guidance given in US FDA Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials"; the guidance uses the Grades 1 (mild), 2 (moderate), 3 (severe), and 4 (potentially life-threatening). The reporting of local reactions was based on the participant's assessments via daily solicited reports in the participant diaries.
Participants of the Group B immunology subset are part of the Group B. The 'Total' arms include all participants from the respective Group A and Group B immunology subset arms presented.
Safety set, i.e., all participants who received at least one dose of IMP.
Posted
Count of Participants
Participants
Group A: From Day 1 to Day 8; For Group B (except transplant participants): From Day 1 to Day 8 for Dose 1, and from Day 22 to Day 29 for Dose 2. For Group B transplant participants: From Day 1 to Day 8 for Dose 1, and up to 7 days after Dose 2.
ID
Title
Description
OG000
Group A Comirnaty
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2 (Comirnaty) on Day 1.
BNT162b2: intramuscular (IM) injection
OG001
Primary
The Number and Percentage of Participants With Solicited Systemic Reactions Recorded up to 7 Days After Each IMP Injection for Group A and for a Selected Subset (Immunology Subset) of Group B Participants.
Systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills and fever) were graded using criteria based on the guidance given in US FDA Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials"; the guidance uses the Grades 1 (mild), 2 (moderate), 3 (severe), and 4 (potentially life-threatening). The reporting of systemic reactions was based on the participant's assessments via daily solicited reports in the participant diaries.
Participants of the Group B immunology subset are part of the Group B. The 'Total' arms include all participants from the respective Group A and Group B immunology subset arms presented.
Safety set, i.e., all participants who received at least one dose of IMP.
Posted
Count of Participants
Participants
Group A: From Day 1 to Day 8; For Group B (except transplant participants): From Day 1 to Day 8 for Dose 1, and from Day 22 to Day 29 for Dose 2. For Group B transplant participants: From Day 1 to Day 8 for Dose 1, and up to 7 days after Dose 2.
ID
Title
Description
OG000
Group A Comirnaty
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2 (Comirnaty) on Day 1.
BNT162b2: intramuscular (IM) injection
OG001
Primary
The Number and Percentage of Participants With at Least One Unsolicited TEAE Occurring up to 28 Days After IMP Injection in Each Treatment Group for Group A and for a Selected Subset (Immunology Subset) of Group B Participants
A TEAE is defined as any AE with an onset after the first IMP injection or worsened after the first IMP injection (if the AE was present before the first administration of IMP). AEs with an onset date more than 28 days after the last administration of IMP will be considered as treatment-emergent only if assessed as related to IMP by the investigator.
Participants of the Group B immunology subset are part of the Group B. The 'Total' arms include all participants from the respective Group A and Group B immunology subset arms presented.
Safety set, i.e., all participants who received at least one dose of IMP.
Posted
Count of Participants
Participants
Group A: Up to 28 days after Dose 1. Group B: Up to 28 days after Dose 1 and up to 28 days after Dose 2.
ID
Title
Description
OG000
Group A Comirnaty
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2 (Comirnaty) on Day 1.
BNT162b2: intramuscular (IM) injection
OG001
Group A BNT162b2s01
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2s01 on Day 1.
BNT162b2s01: IM injection
Secondary
Neutralizing Antibody Titers From Reference Strain and SARS-CoV-2 Variant B.1.351
For Group A participants and Group B participants (except transplant subjects). Non-transplant participants of the Group B immunology subset are also part of the respective Group B arm and therefore occurring in more than one arm/group. The 'Total' arm for Group A include all participants from the Group A arms/groups.
Immunogenicity set, i.e., all participants who received at least one dose of IMP and have at least one post-baseline immunogenicity assessment.
Posted
Geometric Mean
95% Confidence Interval
Titer
Group A: At baseline (Day 1) and Day 8 and at Week 4 Day 29), Week 12 (Day 85), and Week 26 (Day 182). Group B: At baseline (Day 1) and Day 8 and at Week 3 (Day 22), Week 4 (Day 29), Week 7 (Day 50), Week 12 (Day 85), and Week 26 (Day 182).
ID
Title
Description
OG000
Group A Comirnaty
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2 (Comirnaty) on Day 1.
BNT162b2: intramuscular (IM) injection
OG001
Group A BNT162b2s01
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2s01 on Day 1.
BNT162b2s01: IM injection
Secondary
Antibody Titers (ELISA) to Recombinant S1 and RBD Protein Derived From Reference and SARS-CoV-2 Variant B.1.351
For Group A participants and Group B participants (except transplant subjects). Non-transplant participants in the Group B immunology subset arm are also part of the respective Group B arm and therefore occurring in more than one arm/group. The 'Total' arm for Group A include all participants from the Group A arms/groups.
Immunogenicity set, i.e., all participants who received at least one dose of IMP and have at least one post-baseline immunogenicity assessment.
Posted
Geometric Mean
95% Confidence Interval
Titer
Group A: At baseline (Day 1) and Day 8 and at Week 4 Day 29), Week 12 (Day 85), and Week 26 (Day 182). Group B: At baseline (Day 1) and Day 8 and at Week 3 (Day 22), Week 4 (Day 29), Week 7 (Day 50), Week 12 (Day 85), and Week 26 (Day 182).
ID
Title
Description
OG000
Group A Comirnaty
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2 (Comirnaty) on Day 1.
BNT162b2: intramuscular (IM) injection
OG001
Group A BNT162b2s01
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2s01 on Day 1.
BNT162b2s01: IM injection
Secondary
SARS-CoV-2 Functional Cross-neutralization (GMT Ratios) of Variant B.1.351 to Reference Strain
For Group A only. The geometric mean titer (GMT) ratio is calculated as the GMT of reference divided by the GMT of variant B.1.351.
The 'Total' arm for Group A include all participants from the two Group A arms/groups.
Immunogenicity set, i.e., all participants who received at least one dose of IMP and have at least one post-baseline immunogenicity assessment.
Posted
Number
GMT ratio
Up to 26 weeks after the first IMP injection (Dose 1)
ID
Title
Description
OG000
Group A Comirnaty
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2 (Comirnaty) on Day 1.
BNT162b2: intramuscular (IM) injection
OG001
Group A BNT162b2s01
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2s01 on Day 1.
BNT162b2s01: IM injection
OG002
Group A Total
All Group A study participants, i.e., study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty), received one booster injection of BNT162b2s01 or BNT162b2 on Day 1.
BNT162b2s01 and BNT162b2: IM injection
Secondary
Neutralizing Antibody Titers (Reference Strain) Derived From SARS-CoV-2
For Group B transplant subjects, assessed at baseline (Day 1 of Dose 1) and then Day 8, Weeks 4, 12, and 26 post Dose 1, and at Dose 2 (Day 1) and the Day 8, Weeks 4, 12, and 26 post Dose 2.
Because the 11 participants of the arm 'Group B Immunology Subset Transplant Participants' are the same 11 participants of the arm 'Group B Immunology Subset Transplant Participants', data is not presented for this arm to avoid duplication of data.
Immunogenicity set, i.e., all participants who received at least one dose of IMP and have at least one post-baseline immunogenicity assessment.
Posted
Geometric Mean
95% Confidence Interval
Titer
From baseline (Day 1 of Dose 1) up to 26 weeks after Dose 2
ID
Title
Description
OG000
Group B Transplant Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
Units
Counts
Participants
OG000
Secondary
Antibody Titers (ELISA) (Reference Strain) to Recombinant S1 and RBD Protein Derived From SARS-CoV-2
For Group B transplant subjects, assessed at baseline (Day 1 of Dose 1) and then Day 8, Weeks 4, 12, and 26 post Dose 1, and at Dose 2 (Day 1) and the Day 8, Weeks 4, 12, and 26 post Dose 2.
Because the 11 participants of the arm 'Group B Immunology Subset Transplant Participants' are the same 11 participants of the arm 'Group B Immunology Subset Transplant Participants', data is not presented for this arm to avoid duplication of data.
Immunogenicity set, i.e., all participants who received at least one dose of IMP and have at least one post-baseline immunogenicity assessment.
Posted
Geometric Mean
95% Confidence Interval
Titer
From baseline (Day 1 of Dose 1) up to 26 weeks after Dose 2
ID
Title
Description
OG000
Group B Transplant Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
Units
Counts
Participants
OG000
Time Frame
Local reactions/systemic events: within 7 days after each IMP dose; SAEs: from Day 1 (Dose 1) up to Day 182 after Dose 2 (approximately 26 weeks after Dose 2); Other AEs in participants with Dose 2 (Group B): All AEs from Day 1 up to Day 50 and in addition if assessed as IMP-related from Day 50 up to Day 182 after Dose 2; Other AEs in participants without Dose 2 (Group A): All AEs from Day 1 up to Day 29 and in addition if assessed as IMP-related from Day 29 up to Day 182.
Description
Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. The 'Total' arms include all participants from the respective Group A, Group B, and Group B immunology subset arms presented. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Group A Comirnaty
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2 (Comirnaty) on Day 1.
BNT162b2: intramuscular (IM) injection
0
21
0
21
3
21
EG001
Group A BNT162b2s01
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2s01 on Day 1.
BNT162b2s01: IM injection
0
44
2
44
7
44
EG002
Group A Total
All Group A study participants, i.e., study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty), received one booster injection of BNT162b2s01 or BNT162b2 on Day 1.
BNT162b2s01 and BNT162b2: IM injection
0
65
2
65
10
65
EG003
Group B Non-transplant Participants
Study participants in either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
0
61
1
61
4
61
EG004
Group B Transplant Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
0
11
4
11
7
11
EG005
Group B Total
All Group B study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
0
72
5
72
11
72
EG006
Group B Immunology Subset Non-transplant Participants
Study participants in either the study BNT162-01 (excluding transplant study participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
0
22
0
22
4
22
EG007
Group B Immunology Subset Transplant Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
0
11
4
11
7
11
EG008
Group B Immunology Subset Total
All Group B immunology subset study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
0
33
4
33
11
33
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Supraventricular tachycardia
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected44 at risk
EG0021 affected65 at risk
EG0030 affected61 at risk
EG0040 affected11 at risk
EG0050 affected72 at risk
EG0060 affected22 at risk
EG0070 affected11 at risk
EG0080 affected33 at risk
Chronic sinusitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected44 at risk
EG0020 affected65 at risk
EG003
Hepatitis E
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected44 at risk
EG0020 affected65 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected44 at risk
EG0020 affected65 at risk
EG003
Shunt blood flow excessive
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected44 at risk
EG0020 affected65 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected44 at risk
EG0020 affected65 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected44 at risk
EG0021 affected65 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected44 at risk
EG0020 affected65 at risk
EG0030 affected61 at risk
EG0041 affected11 at risk
EG0051 affected72 at risk
EG0060 affected22 at risk
EG0071 affected11 at risk
EG0081 affected33 at risk
Fatigue
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected21 at risk
EG0012 affected44 at risk
EG0022 affected65 at risk
EG003
Pyrexia
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected44 at risk
EG0020 affected65 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 affected21 at risk
EG0013 affected44 at risk
EG0024 affected65 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected44 at risk
EG0020 affected65 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0002 affected21 at risk
EG0011 affected44 at risk
EG0023 affected65 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected44 at risk
EG0020 affected65 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected44 at risk
EG0020 affected65 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected44 at risk
EG0020 affected65 at risk
EG003
Headache
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected44 at risk
EG0021 affected65 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Principal Investigators respectively trial sites shall not publish or refer to in writing or orally, in whole or in part, any data, information or materials generated from the study and the services, without the prior written consent of the sponsor.
Group B Immunology Subset Non-transplant Participants
Study participants in either the study BNT162-01 (excluding transplant study participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
OG007
Group B Immunology Subset Transplant Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
OG008
Group B Immunology Subset Total
All Group B immunology subset study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
61
OG00411
OG00572
OG00622
OG00711
OG00833
1
OG0044
OG0055
OG0060
OG0074
OG0084
Any related SAE
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
Any TESAE
Title
Measurements
OG0000
OG0011
OG0021
OG0030
OG0041
OG0051
OG0060
OG0070
OG0080
Any related TESAE
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
Any AESI
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
Any related AESI
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
Any TEAESI
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
Group A BNT162b2s01
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2s01 on Day 1.
BNT162b2s01: IM injection
OG002
Group A Total
All Group A study participants, i.e., study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty), received one booster injection of BNT162b2s01 or BNT162b2 on Day 1.
BNT162b2s01 and BNT162b2: IM injection
OG003
Group B Immunology Subset Non-transplant Participants
Study participants in either the study BNT162-01 (excluding transplant study participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
OG004
Group B Immunology Subset Transplant Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
OG005
Group B Immunology Subset Total
All Group B immunology subset study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
Units
Counts
Participants
OG00021
OG00144
OG00265
OG00322
OG00411
OG00533
Title
Denominators
Categories
Dose 1 up to 7 days after Dose 1: Number of participants with any local reaction
ParticipantsOG00021
ParticipantsOG00144
ParticipantsOG00265
ParticipantsOG00322
ParticipantsOG00411
ParticipantsOG00533
Title
Measurements
OG00020
OG00141
OG00261
OG003
Dose 1 up to 7 days after Dose 1: Number of participants with any grade >= 3 local reaction
ParticipantsOG00021
ParticipantsOG00144
ParticipantsOG00265
ParticipantsOG003
Dose 2 up to 7 days after Dose 2: Number of participants with any local reaction
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Dose 2 up to 7 days after Dose 2: Number of participants with any grade >= 3 local reaction
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Group A BNT162b2s01
Study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) received one booster injection of BNT162b2s01 on Day 1.
BNT162b2s01: IM injection
OG002
Group A Total
All Group A study participants, i.e., study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty), received one booster injection of BNT162b2s01 or BNT162b2 on Day 1.
BNT162b2s01 and BNT162b2: IM injection
OG003
Group B Immunology Subset Non-transplant Participants
Study participants in either the study BNT162-01 (excluding transplant study participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
OG004
Group B Immunology Subset Transplant Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
OG005
Group B Immunology Subset Total
All Group B immunology subset study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
Units
Counts
Participants
OG00021
OG00144
OG00265
OG00322
OG00411
OG00533
Title
Denominators
Categories
Dose 1 up to 7 days after Dose 1: Number of participants with any systemic reaction
ParticipantsOG00021
ParticipantsOG00144
ParticipantsOG00265
ParticipantsOG00322
ParticipantsOG00411
ParticipantsOG00533
Title
Measurements
OG00018
OG00133
OG00251
OG003
Dose 1 up to 7 days after Dose 1: Number of participants with any grade >= 3 systemic reaction
ParticipantsOG00021
ParticipantsOG00144
ParticipantsOG00265
ParticipantsOG003
Dose 2 up to 7 days after Dose 2: Number of participants with any systemic reaction
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Dose 2 up to 7 days after Dose 2: Number of participants with any grade >= 3 systemic reaction
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
OG002
Group A Total
All Group A study participants, i.e., study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty), received one booster injection of BNT162b2s01 or BNT162b2 on Day 1.
BNT162b2s01 and BNT162b2: IM injection
OG003
Group B Immunology Subset Non-transplant Participants
Study participants in either the study BNT162-01 (excluding transplant study participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
OG004
Group B Immunology Subset Transplant Participants
Transplant study participants from Cohort 13 of the study BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty).
BNT162b2: IM injection
OG005
Group B Immunology Subset Total
All Group B immunology subset study participants, i.e., transplant study participants from Cohort 13 of the study BNT162-01 who received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of 30 μg BNT162b2, and non-transplant study participants from either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 were offered two injections of 30 μg BNT162b2 as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
Units
Counts
Participants
OG00021
OG00144
OG00265
OG00322
OG00411
OG00533
Title
Denominators
Categories
Dose 1 up to 28 days after Dose 1: Number of participants with any TEAE
ParticipantsOG00021
ParticipantsOG00144
ParticipantsOG00265
ParticipantsOG00322
ParticipantsOG00411
ParticipantsOG00533
Title
Measurements
OG0008
OG00114
OG00222
OG003
Dose 1 up to 28 days after Dose 1: Number of participants with any grade >=3 TEAE
ParticipantsOG00021
ParticipantsOG00144
ParticipantsOG00265
ParticipantsOG003
Dose 2 up to 28 days after Dose 2; Number of participants with any TEAE
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Dose 2 up to 28 days after Dose 2; Number of participants with any grade >=3 TEAE
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
OG002
Group A Total
All Group A study participants, i.e., study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty), received one booster injection of BNT162b2s01 or BNT162b2 on Day 1.
BNT162b2s01 and BNT162b2: IM injection
OG003
Group B Non-transplant Participants
Study participants in either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
OG004
Group B Immunology Subset Non-transplant Participants
Study participants in either the study BNT162-01 (excluding transplant study participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
All Group A study participants, i.e., study participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty), received one booster injection of BNT162b2s01 or BNT162b2 on Day 1.
BNT162b2s01 and BNT162b2: IM injection
OG003
Group B Non-transplant Participants
Study participants in either the study BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.
BNT162b2: IM injection
OG004
Group B Immunology Subset Non-transplant Participants
Study participants in either the study BNT162-01 (excluding transplant study participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21.