A Study to Learn About New COVID-19 RNA Vaccine Candidate... | NCT05472038 | Trialant
NCT05472038
Sponsor
BioNTech SE
Status
Completed
Last Update Posted
Oct 1, 2025Actual
Enrollment
1,453Actual
Phase
Phase 2Phase 3
Conditions
SARS-CoV-2 Infection
COVID-19
Interventions
BNT162b5 Bivalent (WT/OMI BA.2)
BNT162b2 Bivalent (WT/OMI BA.1)
BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
BNT162b5 Bivalent (Original/OMI BA.4/BA.5)
BNT162b6 Bivalent (Original/OMI BA.4/BA.5)
BNT162b7 Bivalent (Original/OMI BA.4/BA.5)
BNT162b7 Monovalent (OMI BA.4/BA.5)
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT05472038
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C4591044
Secondary IDs
ID
Type
Description
Link
2022-002008-19
Registry Identifier
EudraCT
NCT05472038
Registry Identifier
ClinicalTrials.gov
Brief Title
A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals
Official Title
AN INTERVENTIONAL, RANDOMIZED, ACTIVE-CONTROLLED, PHASE 1/2/3 STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162b RNA-BASED VACCINE CANDIDATES IN COVID-19 VACCINE-EXPERIENCED HEALTHY INDIVIDUALS
Acronym
Not provided
Organization
BioNTech SEINDUSTRY
Status Module
Record Verification Date
Sep 2025
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, 2022Actual
Primary Completion Date
Mar 26, 2024Actual
Completion Date
Mar 26, 2024Actual
First Submitted Date
Jul 15, 2022
First Submission Date that Met QC Criteria
Jul 22, 2022
First Posted Date
Jul 25, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Mar 10, 2025
Results First Submitted that Met QC Criteria
Sep 10, 2025
Results First Posted Date
Oct 1, 2025Actual
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
Sep 10, 2025
Last Update Posted Date
Oct 1, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
BioNTech SEINDUSTRY
Collaborators
Name
Class
Pfizer
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
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
The purpose of this clinical trial is to learn about the safety, tolerability and immunogenicity of BNT162b RNA-based SARS-CoV-2 vaccine candidates in adults to prevent COVID-19.
For all cohorts (groups of participants), this study is seeking participants who are healthy (who may have preexisting disease if it is stable); All participants will receive a single dose of the study vaccine at the first study clinic and will return to the study clinic at least 4 more times. At each clinic visit, a blood sample will be taken. The study is about 6 months long for each participant. The vaccine candidates in this study are investigational but are very similar to BNT162b2 (Comirnaty), a COVID-19 RNA vaccine approved for use in the US and in many countries.
For Cohort 1, this study included participants who were:
18 through 55 years of age
have received 1 booster dose of a US-authorized COVID-19 vaccine, with the last dose being 90 or more days before Visit 1 of this study.
All participants in Cohort 1 will receive 1 of the 2 study vaccines at a 30 microgram dose: BNT162b5 Bivalent (WT/OMI BA.2) or BNT162b2 Bivalent (WT/OMI BA.1).
For Cohort 2, this study included participants who were:
12 years of age and older
have received 3 prior doses of 30 micrograms BNT162b2, with the last dose being 150 to 365 days before Visit 1 of this study.
Participants 12 through 17 years of age will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 micrograms.
Participants 18 years and older will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at either a 30 microgram or a 60 microgram dose.
For Cohort 3, this study included participants who were:
18 years of age and older
have received 3 prior doses of 30 micrograms BNT162b2, with the last dose being 150 to 365 days before Visit 1 of this study.
Participants will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 micrograms.
For Cohort 4, this study is seeking participants who are:
18 through 55 years of age
have received 3 or 4 prior doses of a US-authorized mRNA COVID-19 vaccine (and dose level), with the last dose being a US-authorized BA.4/BA.5-adapted bivalent vaccine and dose level at least 150 days before Visit 1 of this study.
All participants in Cohort 4 will receive 1 of the 5 study vaccines at a 30 microgram dose: BNT162b2 Bivalent (Original/ OMI BA.4/BA.5), BNT162b5 Bivalent (Original/OMI BA.4/BA.5), BNT162b6 Bivalent (Original/OMI BA.4/BA.5), BNT162b7 Bivalent (Original/OMI BA.4/BA.5) or BNT162b7 Monovalent (OMI BA.4/BA.5).
Detailed Description
Not provided
Conditions Module
Conditions
SARS-CoV-2 Infection
COVID-19
Keywords
SARS-CoV-2 infection
COVID-19
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 2Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,453Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1: BNT162b5 Bivalent (WT/OMI BA.2)
Experimental
Participants will receive 30 µg of BNT162b5 Bivalent (WT/OMI BA.2) at Visit 1.
Biological: BNT162b5 Bivalent (WT/OMI BA.2)
Cohort 1: BNT162b2 Bivalent (WT/OMI BA.1)
Experimental
Participants will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.1) at Visit 1.
Biological: BNT162b2 Bivalent (WT/OMI BA.1)
Cohort 2 -Group 1: 12-17 years; 30 µg
Experimental
Participants 12-17 years old will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.
Biological: BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
Cohort 2 - Group 2: 18-55 years; 30 µg
Experimental
Participants 18-55 years old will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.
Biological: BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
Cohort 2 - Group 3: 18-55 years; 60 µg
Experimental
Participants 18-55 years old will receive 60 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.
Biological: BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BNT162b5 Bivalent (WT/OMI BA.2)
Biological
BNT162b5 Wild Type and BNT162b5 OMICRON [B.1.1.529 sublineage BA.2]
Cohort 1: BNT162b5 Bivalent (WT/OMI BA.2)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Cohort 1: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Local reactions were recorded by participants in an electronic diary (e-diary). Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild: greater than (>) 2.0 to 5.0 centimeter (cm), moderate: >5.0 to 10.0 cm, severe: >10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity and grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Local reactions reported as adverse events (AEs) in the case report form within 7 days after the study vaccination were also reported.
From Day 1 to Day 7 after study vaccination
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Systemic events were recorded by participants in an e-diary. Fever was oral temperature greater than or equal to (>=) 38 degree Celsius (deg C) and categorized as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours (h), moderate: >2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator/medically qualified person. Systemic events reported as AEs in the CRF within 7 days after vaccination were also reported.
From Day 1 to Day 7 after study vaccination
Cohort 1: Percentage of Participants With Adverse Events (AEs) From Study Vaccination Through 1 Month After Study Vaccination
Secondary Outcomes
Measure
Description
Time Frame
GMR of the Reference-Strain- NTs of BNT162b2 [WT/OMI BA.4/BA.5] 30mcg Cohort 2 (Group 4)/ Cohort 3 (Group 2) Combined in C4591044 Compared to NT of BNT162b2 30mcg in C4591031 [NCT04955626] >55 Years of Age- 1 Month After Vaccination
Model based GMT of reference strain NTs induced by BNT162b2 Bivalent 30mcg groups of study C4591044 [NCT05472038] Cohort 2/3 combined and BNT162b2 30 mcg of study C4591031 [NCT04955626] Substudy E among participants >55 years of age presented as descriptive data. GMTs, 2-sided 95% CIs calculated by exponentiating LS means, corresponding CIs based on analysis of logarithmically transformed NT using linear regression model with terms of baseline NT (log scale), vaccine group. Assay results below LLOQ set to 0.5*LLOQ. Model based GMR: OMI BA.4/BA.5 NTs induced 1 month after BNT162b2 Bivalent vaccination in study C4591044 to 1 month after BNT162b2 vaccination in study C4591031 [NCT04955626] among participants >55 years of age reported in statistical section. Outcome measure was planned per protocol to be analyzed in participants from Cohort 2 (Group 4) + Cohort 3 (Group 2) and control arm of BNT162b2 experienced participants >55 years of age from study C4591031 [NCT04955626] Substudy E.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Age:
Cohort 1: 18 through 55 years of age.
Cohort 2: 12 years of age and older.
Cohort 3: 18 years of age and older.
Cohort 4: 18 through 55 years of age.
Willing and able to comply with all scheduled visits/contacts, study procedures and lifestyle considerations.
- Received of 1 booster dose of a US-authorized COVID-19 vaccine, with the dose being 90 or more days before first study visit. Documented receipt of all prior COVID-19 vaccines is required.
Cohorts 2 and 3:
- Received 3 prior doses of 30 micrograms BNT162b2, with last dose being 150 to 365 days before first study visit. Documented receipt of all prior COVID-19 vaccines is required.
Cohort 4:
- Received 3 or 4 prior doses of a US-authorized mRNA COVID-19 vaccine (and dose level), with the last dose being a US-authorized Omicron BA.4/BA.5-adapted vaccine and dose level at least 150 days before first study visit. Documented receipt of all prior COVID-19 vaccines is required.
Exclusion Criteria:
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines.
Known or suspected immunodeficiency.
Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
Women who are pregnant or breastfeeding.
Other medical or psychiatric condition, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Immunosuppressants/radiotherapy:
Cohorts 1 and 2: Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before study vaccination through end of study.
Cohorts 3 and 4: Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease), or radiotherapy, within 60 days before enrollment or planned receipt through conclusion of the study.
Blood/plasma products, immunoglobulin, or monoclonal antibodies:
Cohorts 1, 2, 3: Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study vaccination or planned receipt throughout the study.
Cohort 4: Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies used for treatment/prevention of COVID-19 or those considered immunosuppressive, from 60 days before study vaccination or planned receipt throughout the study.
Other study participation:
Cohorts 1 and 2: Participation in other studies involving a study intervention within 28 days before randomization. Anticipated participation in other studies within 28 days after receipt of study intervention in this study.
Cohorts 3 and 4: Participation in other studies involving receipt of a study intervention within 28 days before randomization. Anticipated participation in other studies involving a study intervention from randomization through the end of this study.
Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
Cohort 4 only: History of myocarditis or pericarditis
Gayed J, Bangad V, Xu X, Mensa F, Cutler M, Tureci O, Sahin U, Modjarrad K, Swanson KA, Anderson AS, Gurtman A, Kitchin N; C4591054 Study Group. Immunogenicity of the Monovalent Omicron XBB.1.5-Adapted BNT162b2 COVID-19 Vaccine against XBB.1.5, BA.2.86, and JN.1 Sublineages: A Phase 2/3 Trial. Vaccines (Basel). 2024 Jul 2;12(7):734. doi: 10.3390/vaccines12070734.
Study consisted of 4 cohorts. Cohort 1 and 4 had distinct participant groups and objectives, while cohorts are different, they are part of same study. Both arms (Cohort 2 Group 2 and Cohort 3 Group 1) and (Cohort 2 Group 4 and Cohort 3 Group 2) received the same treatment and are from the same age group. As mentioned in the Protocol Objective section, arms with the same treatment and age group will be combined to provide a more comprehensive summary, rather than being listed in separate columns.
Recruitment Details
The study consisted of 4 cohorts. Cohort 1 and 4 had distinct participant groups and objectives. Where appropriate, and as per planned analyses, data is summarized and combined for Cohort 2 (C2) and Cohort 3 (C3) 30 micrograms (mcg) groups (G) per age category to provide sufficient power for the immunogenicity hypotheses for each of the age groups.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/ OMI BA.2] 30 mcg)
Participants aged 18-55 years received BNT162b5 Bivalent (wild type [WT]/ omicron [OMI] BA.2) 30 micrograms (mcg) intramuscularly at Visit 1 (Day 1).
FG001
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/ OMI BA.1] 30 mcg)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
1
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
Jul 27, 2023
Mar 5, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Phase 1/2/3, randomized, active-controlled, parallel group study.
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Quadruple
Masking Description
Cohort 1 and Cohort 2 (18 years and older): Observer-blind Cohort 2 (12-17 years) and Cohort 3: Open-label Cohort 4: Observer-blind
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data.
From study vaccination on Day 1 through 1 month after study vaccination
Cohort 1: Percentage of Participants With Serious Adverse Events (SAEs) From Study Vaccination Through 6 Months After Study Vaccination
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE that resulted in death, was life-threatening, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event, medical event was judged by investigator; required inpatient hospitalization or prolongation of existing hospitalization.
From study vaccination on Day 1 through 6 months after study vaccination
Cohort 1: Geometric Mean Titer (GMT) of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain Neutralizing Titers (NTs) at Baseline- Participants Without Evidence of Infection
GMTs and the corresponding 2-sided confidence intervals (CIs) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). Assay results below the lower limit of quantification (LLOQ) were set to 0.5*LLOQ.
At baseline (before study vaccination)
Cohort 1: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain NTs at Baseline- Participants With or Without Evidence of Infection
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution).
At baseline (before study vaccination)
Cohort 1: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain NTs at 1 Month After Study Vaccination- Participants Without Evidence of Infection
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
1 month after the study vaccination
Cohort 1: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain NTs at 1 Month After Study Vaccination- Participants With or Without Evidence of Infection
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
1 month after the study vaccination
Cohort 1: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain- NTs From Before the Study Vaccination to 1 Month After the Study Vaccination- Participants Without Evidence of Infection
GMFR from before study vaccination to 1 month after study vaccination for each strain-specific neutralizing titer was reported in this endpoint. GMFRs and 2-sided 95% CIs were calculated by exponentiating mean logarithm of fold rises and corresponding CIs (based on student-t distribution). Assay results below lower limit of quantitation (LLOQ) were set to 0.5*LLOQ in analysis.
From before the study vaccination to 1 month after the study vaccination
Cohort 1: GMFR of SARS-CoV-2 Omicron Strain (BA.1 and BA2) and Reference Strain- NTs From Before the Study Vaccination to 1 Month After the Study Vaccination- Participants With or Without Evidence of Infection
GMFR from before study vaccination to 1 month after study vaccination for each strain-specific neutralizing titer was reported in this endpoint. GMFRs and 2-sided 95% CIs were calculated by exponentiating mean logarithm of fold rises and corresponding CIs (based on student-t distribution). Assay results below LLOQ were set to 0.5*LLOQ in analysis.
From before the study vaccination to 1 month after the study vaccination
Cohort 1: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain- NTs at 1 Month After Study Vaccination- Participants Without Evidence of Infection
Seroresponse was defined as achieving >= 4-fold rise in NTs from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination measure of >= 4*LLOQ was considered a seroresponse.
1 month after the study vaccination
Cohort 1: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain- NTs at 1 Month After Study Vaccination- Participants With or Without Evidence of Infection
Seroresponse was defined as achieving >= 4-fold rise in NTs from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination measure of >= 4*LLOQ was considered a seroresponse.
1 month after the study vaccination
Cohort 2: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Local reactions were recorded by participants in an e-diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild: > 2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm, severe: >10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity and grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Local reactions reported as AEs in the case report form within 7 days after the study vaccination were also reported.
From Day 1 to Day 7 after study vaccination
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Systemic events were recorded by participants in an e-diary. Fever was oral temperature >= 38 deg C and categorized as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24h, moderate: >2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator or medically qualified person. Systemic events reported as AEs in the CRF within 7 days after vaccination were also reported.
From Day 1 to Day 7 after study vaccination
Cohort 2: Percentage of Participants With AEs From Study Vaccination Through 1 Month After Study Vaccination
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data.
From study vaccination through 1 month after study vaccination
Cohort 2: Percentage of Participants With SAEs From Study Vaccination Through 6 Month After Study Vaccination
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE that resulted in death, was life-threatening, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization.
From study vaccination through 6 months after study vaccination
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Local reactions were recorded by participants in an e-diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild: >2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm, severe: >10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity and grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Local reactions reported as AEs in the case report form within 7 days after the study vaccination were also reported.
From Day 1 to Day 7 after study vaccination
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Systemic events were recorded by participants in an e-diary. Fever was oral temperature >= 38 deg C and categorized as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 h, moderate: >2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator/medically qualified person. Systemic events reported as AEs in the CRF within 7 days after vaccination were also reported.
From Day 1 to Day 7 after study vaccination
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants With AEs From Study Vaccination Through 1 Month After Study Vaccination
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data.
From study vaccination through 1 month after study vaccination
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants With SAEs From Study Vaccination Through 6 Month After Study Vaccination
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE that resulted in death, was life-threatening, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization.
From study vaccination through 6 months after study vaccination
GMR of Omicron (BA.4/BA.5)- NT of BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg Cohort 2 (Group 4)/ Cohort 3 (Group 2) Combined in C4591044 Compared to NT of BNT162b2 30 mcg in C4591031 [NCT04955626]- 1 Month After Vaccination Among Participants >55 Years
Model based GMT of OMI BA.4/BA.5 NTs induced by BNT162b2 Bivalent 30mcg groups of study C4591044 Cohort 2/3 combined and BNT162b2 30mcg of study C4591031 [NCT04955626] Substudy E among participants >55 years are reported as descriptive data. GMTs and 95% CIs were calculated by exponentiating least square (LS) means and corresponding CI based on analysis of logarithmically transformed NT using a linear regression model with terms of baseline NT (log scale) and vaccine group. Assay results below LLOQ were set to 0.5*LLOQ. Model based geometric mean ratio (GMR) are reported in statistical section: OMI BA.4/BA.5 NTs induced 1 month post BNT162b2 Bivalent vaccination in study C4591044 to 1 month post BNT162b2 vaccination in study C4591031 [NCT04955626] among participants >55 years. Outcome measure was planned per protocol to be analyzed in participants of Cohort 2 (Group 4) + Cohort 3 (Group 2) of C4591044 and BNT162b2 experienced participants of study C4591031 [NCT04955626] (control arm).
1 month after study vaccination
Difference in Percentage of Participants With Seroresponse to OMI BA.4/BA.5 for BNT162b2 Bivalent[WT/OMI BA.4/BA.5]30mcg Cohort2(Group4)/Cohort3(Group2)Combined in C4591044 and BNT162b2 30mcg in C4591031-1 Month After Vaccination in Participants >55 Years
Seroresponse: achieving >=4-fold rise in NTs from baseline (before study vaccination). If baseline measurement was below LLOQ, postvaccination measure of >= 4*LLOQ was considered seroresponse. Percentage of participants with seroresponse to OMI BA.4/BA.5 for BNT162b2 Bivalent 30 mcg in Study C4591044 [NCT05472038] Cohort 2/3 combined and BNT162b2 30 mcg in Study C4591031 [NCT04955626] Substudy E among participants >55 years of age are presented as descriptive data. Adjusted difference in seroresponse rate to OMI BA.4/BA.5 between BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30 mcg 1 month after vaccination in study C4591044 and 1 month after BNT162b2 vaccination in study C4591031 [NCT04955626] among participants >55 years of age is reported in statistical section. Outcome measure was planned per protocol to be analyzed in participants from Cohort 2 (Group 4) + Cohort 3 (Group 2) and control arm of BNT162b2 experienced participants >55 years of age from study C4591031 [NCT04955626] Substudy E.
1 month after study vaccination
GMR of Omicron (BA.4/BA.5)- NTs of BNT162b2 Bivalent[WT/OMI BA.4/BA.5]30mcg Cohort2 (Group2)/Cohort3 (Group1)Combined for 18-55 Years Compared to BNT162b2 30mcg Cohort2 (Group4)/Cohort3 (Group2)Combined for >55 Years- 1 Month After Vaccination in C4591044
Model based GMT of OMI BA.4/BA.5 NTs induced by BNT162b2 Bivalent 30 mcg groups of study C4591044 [NCT05472038] Cohort 2/3 combined in participants 18-55 years of age compared to participants >55 years of age are presented as descriptive data. GMTs and 2-sided 95% CIs were calculated by exponentiating LS means and corresponding CIs based on analysis of logarithmically transformed NT using a linear regression model with terms of baseline NT (log scale) and vaccine group. Assay results below LLOQ were set to 0.5*LLOQ. Model based GMR: OMI BA.4/BA.5 NTs induced 1 month after BNT162b2 Bivalent vaccination in study C4591044 among participants 18-55 years of age compared to participants >55 years of age is reported in statistical section. The outcome measure was planned per protocol to be analyzed in participants combined from Cohort 2 (Group 2) + Cohort 3 (Group 1) and Cohort 2 (Group 4) + Cohort 3 (Group 2).
1 month after study vaccination
Difference in Percentage of Participants With Seroresponse to OMI BA.4/BA.5 of BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30 mcg Cohort2 (Group2)/Cohort3 (Group1) 18-55 Years and Cohort2 (Group4)/Cohort3 (Group2) >55 Years- 1 Month After Vaccination in C4591044
Seroresponse was defined as achieving >= 4-fold rise in NTs from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination measure of >= 4*LLOQ was considered a seroresponse. Percentage of participants with seroresponse to OMI BA.4/BA.5 for BNT162b2 Bivalent 30 mcg in Study C4591044 [NCT05472038] Cohort 2/3 combined in participants 18-55 years of age compared to participants >55 years of age are presented as descriptive data. Adjusted difference in seroresponse rate to OMI BA.4/BA.5 between BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30 mcg 1 month after vaccination in study C4591044 in participants 18-55 years of age compared to participants >55 years of age is reported in statistical section. The outcome measure was planned per protocol to be analyzed in participants combined from Cohort 2 (Group 2) + Cohort 3 (Group 1) and Cohort 2 (Group 4) + Cohort 3 (Group 2).
1 month after study vaccination
Cohort 2: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.4/BA.5) and Reference Strain NTs at Baseline- Participants With or Without Evidence of Infection
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). This outcome measure was planned per protocol to be analyzed in participants from Cohort 2 and control arms of BNT162b2 Bivalent (WT/OMI BA.1) experienced participants from study C4591031 [NCT04955626] Substudy E.
At baseline (before study vaccination)
Cohort 2: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.4/BA.5) and Reference Strain NTs at 1 Month- Participants With or Without Evidence of Infection
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). This outcome measure was planned per protocol to be analyzed in participants from Cohort 2 and control arms of BNT162b2 experienced participants from study C4591031 [NCT04955626] Substudy E.
1 month after the study vaccination
Cohort 2: GMFR of SARS-CoV-2 Omicron Strain (BA.1 and BA.4/BA.5) and Reference Strain- NTs From Before the Study Vaccination to 1 Month After the Study Vaccination- Participants With or Without Evidence of Infection
GMFR from before the study vaccination to 1 month after the study vaccination for each strain-specific neutralizing titer was reported in this outcome measure. GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student-t distribution). Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. This outcome measure was planned per protocol to be analyzed in participants from Cohort 2 and control arms of BNT162b2 experienced participants from study C4591031 [NCT04955626] Substudy E.
From before the study vaccination to 1 month after the study vaccination
Cohort 2: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.1 and BA.4/BA.5) and Reference Strain- NTs at 1 Month After Study Vaccination- Participants With or Without Evidence of Infection
Seroresponse was defined as achieving >= 4-fold rise in NTs from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination measure of >= 4*LLOQ was considered a seroresponse. Percentage of participants with seroresponse to OMI BA.4/BA.5 for BNT162b2 Bivalent 30 and 60 mcg in Study C4591044 [NCT05472038] Cohort 2 and BNT162b2 30 mcg in Study C4591031 [NCT04955626] Substudy E are presented as descriptive data. This outcome measure was planned per protocol to be analyzed in participants from Cohort 2 and control arms of BNT162b2 experienced participants 18-55 years of age and >55 years of age from study C4591031 [NCT04955626] Substudy E.
1 month after the study vaccination
Cohort 4: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Local reactions were recorded by participants in an e-diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild: >2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm, severe: >10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity and grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Local reactions reported as AEs in the case report form within 7 days after the study vaccination were also reported.
From Day 1 to Day 7 after study vaccination
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Systemic events were recorded by participants in an e-diary. Fever was oral temperature >= 38 deg C and categorized as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24h, moderate: >2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator or medically qualified person. Systemic events reported as AEs in the CRF within 7 days after vaccination were also reported.
From Day 1 to Day 7 after study vaccination
Cohort 4: Percentage of Participants With AEs From Study Vaccination Through 1 Month After Study Vaccination
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data.
From study vaccination through 1 month after study vaccination
Cohort 4: Percentage of Participants With SAEs From Study Vaccination Through 6 Months After Study Vaccination
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE that resulted in death, was life-threatening, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization.
From study vaccination through 6 months after study vaccination
Cohort 4: GMT of SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain NTs at Baseline- Participants With or Without Evidence of Infection
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution).
At baseline (before study vaccination)
Cohort 4: GMT of SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain NTs at 1 Month After Study Vaccination- Participants With or Without Evidence of Infection
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution).
1 month after the study vaccination
Cohort 4: GMFR of SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain- NTs From Before the Study Vaccination to 1 Month After the Study Vaccination- Participants With or Without Evidence of Infection
GMFR from before study vaccination to 1 month after study vaccination for each strain-specific neutralizing titer was reported in this endpoint. GMFRs and 2-sided 95% CIs were calculated by exponentiating mean logarithm of fold rises and corresponding CIs (based on student-t distribution). Assay results below LLOQ were set to 0.5*LLOQ in analysis.
From before the study vaccination to 1 month after study vaccination
Cohort 4: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain- NTs at 1 Month After Study Vaccination- Participants With or Without Evidence of Infection
Seroresponse was defined as achieving >= 4-fold rise in NTs from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination measure of >= 4*LLOQ was considered a seroresponse.
1 month after study vaccination
1 month after study vaccination
Cohort 2 (Group 2) + Cohort 3 (Group 1) Combined and Cohort 2 (Group 4) + Cohort 3 (Group 2) Combined: GMT of Omicron BA.4/BA.5 and Reference Strain NT at Baseline and 1 Month After the Study Vaccination
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). This outcome measure was planned per protocol to be analyzed in participants from Cohort 2 (Group 2) + Cohort 3 (Group 1), Cohort 2 (Group 4) + Cohort 3 (Group 2) and control arm of BNT162b2 experienced participants >55 years of age from study C4591031 [NCT04955626] Substudy E.
At baseline and 1 month after study vaccination
Cohort 2 (Group 2) + Cohort 3 (Group 1) Combined and Cohort 2 (Group 4) + Cohort 3 (Group 2) Combined: GMFR of SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain- NTs From Before the Study Vaccination to 1 Month After the Study Vaccination
GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. GMFR from before the study vaccination to 1 month after study vaccination for Omicron BA.4/BA.5 and reference strain neutralizing titer was reported in this outcome measure. This outcome measure was planned per protocol to be analyzed in participants from Cohort 2 (Group 2) + Cohort 3 (Group 1), Cohort 2 (Group 4) + Cohort 3 (Group 2) and control arm of BNT162b2 experienced participants >55 years of age from study C4591031 [NCT04955626] Substudy E.
From before the study vaccination to 1 month after study vaccination
Cohort 2 (Group 2) + Cohort 3 (Group 1) Combined and Cohort 2 (Group 4) + Cohort 3 (Group 2) Combined: Percentages of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain- NTs at 1 Month After the Study Vaccination
Seroresponse was defined as achieving >= 4-fold rise in NTs from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination measure of >= 4*LLOQ was considered a seroresponse. Percentage of participants with seroresponse to OMI BA.4/BA.5 for BNT162b2 Bivalent 30 mcg in Study C4591044 [NCT05472038] Cohort 2/3 combined and BNT162b2 30 mcg in Study C4591031 [NCT04955626] Substudy E among participants >55 years of age are presented as descriptive data. This outcome measure was planned per protocol to be analyzed in participants from Cohort 2 (Group 2) + Cohort 3 (Group 1), Cohort 2 (Group 4) + Cohort 3 (Group 2) and control arm of BNT162b2 experienced participants >55 years of age from study C4591031 [NCT04955626] Substudy E.
1 month after the study vaccination
San Diego
California
92123
United States
Bayview Research Group, LLC
Valley Village
California
91607
United States
Diablo Clinical Research, Inc.
Walnut Creek
California
94598
United States
Clinical Research Consulting
Milford
Connecticut
06460
United States
Research Centers of America ( Hollywood )
Hollywood
Florida
33024
United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville
Florida
32256
United States
Acevedo Clinical Research Associates
Miami
Florida
33142
United States
Clinical Research Atlanta
Stockbridge
Georgia
30281
United States
East-West Medical Research Institute
Honolulu
Hawaii
96814
United States
Kentucky Pediatric/ Adult Research
Bardstown
Kentucky
40004
United States
Clinical Research Professionals
Chesterfield
Missouri
63005
United States
Sundance Clinical Research
St Louis
Missouri
63141
United States
Velocity Clinical Research, Omaha
Omaha
Nebraska
68134
United States
South Jersey Infectious Disease
Somers Point
New Jersey
08244
United States
Rochester Clinical Research, LLC
Rochester
New York
14609
United States
Accellacare - Charlotte
Charlotte
North Carolina
28211
United States
PharmQuest Life Sciences, LLC
Greensboro
North Carolina
27408
United States
Accellacare - Wilmington
Wilmington
North Carolina
28401
United States
Senders Pediatrics
Cleveland
Ohio
44121
United States
Centricity Research Columbus Ohio Multispecialty
Columbus
Ohio
43213
United States
Kaiser Permanente Northwest Center for Health Research
Portland
Oregon
97227
United States
Clinical Neuroscience Solutions Inc.
Memphis
Tennessee
38119
United States
Benchmark Research
Austin
Texas
78705
United States
Tekton Research, LLC.
Austin
Texas
78745
United States
DM Clinical Research - Bellaire
Houston
Texas
77081
United States
IMA Clinical Research San Antonio
San Antonio
Texas
78229
United States
DM Clinical Research - MDC
Tomball
Texas
77375
United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City
Utah
84109
United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City
Utah
84121
United States
Virginia Research Center
Midlothian
Virginia
23114
United States
Derived
Gayed J, Diya O, Lowry FS, Xu X, Bangad V, Mensa F, Zou J, Xie X, Hu Y, Lu C, Cutler M, Belanger T, Cooper D, Koury K, Anderson AS, Tureci O, Sahin U, Swanson KA, Modjarrad K, Gurtman A, Kitchin N; C4591054 Study Group. Safety and Immunogenicity of the Monovalent Omicron XBB.1.5-Adapted BNT162b2 COVID-19 Vaccine in Individuals >/=12 Years Old: A Phase 2/3 Trial. Vaccines (Basel). 2024 Jan 24;12(2):118. doi: 10.3390/vaccines12020118.
Usdan L, Patel S, Rodriguez H, Xu X, Lee DY, Finn D, Wyper H, Lowry FS, Mensa FJ, Lu C, Cooper D, Koury K, Anderson AS, Tureci O, Sahin U, Swanson KA, Gruber WC, Kitchin N; C4591044 Study Group. A Bivalent Omicron-BA.4/BA.5-Adapted BNT162b2 Booster in >/=12-Year-Olds. Clin Infect Dis. 2024 May 15;78(5):1194-1203. doi: 10.1093/cid/ciad718.
Participants aged 18-55 years received BNT162b2 Bivalent (WT/ OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
FG002
Cohort 2 (Group 1): 12-17 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 12-17 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
FG003
Cohort 2 (Group 2) + Cohort 3 (Group 1): 18-55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
FG004
Cohort 2 (Group 3): 18-55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 60 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
FG005
Cohort 2 (Group 4) + Cohort 3 (Group 2): >55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg)
Participants aged more than (>) 55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
FG006
Cohort 2 (Group 5): >55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 60 mcg)
Participants aged >55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
FG007
Cohort 4: 18-55 Years (BNT162b2 Bivalent [Original/ OMI BA.4 /BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
FG008
Cohort 4: 18-55 Years (BNT162b5 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b5 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
FG009
Cohort 4: 18-55 Years (BNT162b6 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b6 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
FG010
Cohort 4: 18-55 Years (BNT162b7 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b7 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
Participants aged 18-55 years received BNT162b7 Monovalent (OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
FG000104 subjects
FG001102 subjects
FG002108 subjects
FG003314 subjects
FG004110 subjects
FG005306 subjects
FG006102 subjects
FG00762 subjects
FG00862 subjects
FG00960 subjects
FG01060 subjects
FG01163 subjects
COMPLETED
FG000102 subjects
FG00196 subjects
FG002103 subjects
FG003298 subjects
FG004106 subjects
FG005300 subjects
FG006101 subjects
FG00759 subjects
FG00857 subjects
FG00958 subjects
FG01055 subjects
FG01159 subjects
NOT COMPLETED
FG0002 subjects
FG0016 subjects
FG0025 subjects
FG00316 subjects
FG0044 subjects
FG0056 subjects
FG0061 subjects
FG0073 subjects
FG0085 subjects
FG0092 subjects
FG0105 subjects
FG0114 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0013 subjects
FG0023 subjects
FG0039 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0013 subjects
FG0021 subjects
FG0036 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Not vaccinated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Study consisted of 4 cohorts. Cohort 1 and 4 had distinct participant groups and objectives, while cohorts are different, they are part of same study. Both arms (Cohort 2 Group 2 and Cohort 3 Group 1) and (Cohort 2 Group 4 and Cohort 3 Group 2) received the same treatment and are from the same age group. As mentioned in the Protocol Objective section, arms with the same treatment and age group will be combined to provide a more comprehensive summary, rather than being listed in separate columns.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/ OMI BA.2] 30 mcg)
Participants aged 18-55 years received BNT162b5 Bivalent (WT/ OMI BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
BG001
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/ OMI BA.1] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/ OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
BG002
Cohort 2 (Group 1): 12-17 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 12-17 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
BG003
Cohort 2 (Group 2) + Cohort 3 (Group 1): 18-55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
BG004
Cohort 2 (Group 3): 18-55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 60 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
BG005
Cohort 2 (Group 4) + Cohort 3 (Group 2): >55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg)
Participants aged > 55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
BG006
Cohort 2 (Group 5): >55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 60 mcg)
Participants aged >55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
BG007
Cohort 4: 18-55 Years (BNT162b2 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
BG008
Cohort 4: 18-55 Years (BNT162b5 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b5 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
BG009
Cohort 4: 18-55 Years (BNT162b6 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b6 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
BG010
Cohort 4: 18-55 Years (BNT162b7 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b7 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
Participants aged 18-55 years received BNT162b7 Monovalent (OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000104
BG001102
BG002108
BG003314
BG004110
BG005306
BG006102
BG00762
BG00862
BG00960
BG01060
BG01163
BG0121453
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Adolescents (12-17 years)
BG0000
BG0010
BG002108
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00052
BG00158
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00018
BG00123
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
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
Cohort 1: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Local reactions were recorded by participants in an electronic diary (e-diary). Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild: greater than (>) 2.0 to 5.0 centimeter (cm), moderate: >5.0 to 10.0 cm, severe: >10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity and grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Local reactions reported as adverse events (AEs) in the case report form within 7 days after the study vaccination were also reported.
Safety population included all participants who received the study intervention and where appropriate informed consent was obtained.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 to Day 7 after study vaccination
ID
Title
Description
OG000
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI] BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
OG001
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
Units
Counts
Participants
OG000104
OG001102
Title
Denominators
Categories
Redness: Any
Title
Measurements
OG0005.8(2.1 to 12.1)
OG0015.9(2.2 to 12.4)
Redness: Mild
Title
Measurements
OG000
Primary
Cohort 1: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Systemic events were recorded by participants in an e-diary. Fever was oral temperature greater than or equal to (>=) 38 degree Celsius (deg C) and categorized as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours (h), moderate: >2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator/medically qualified person. Systemic events reported as AEs in the CRF within 7 days after vaccination were also reported.
Safety population included all participants who received the study intervention and where appropriate informed consent was obtained.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 to Day 7 after study vaccination
ID
Title
Description
OG000
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
OG001
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
Primary
Cohort 1: Percentage of Participants With Adverse Events (AEs) From Study Vaccination Through 1 Month After Study Vaccination
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data.
Safety population included all participants who received the study intervention and where appropriate informed consent was obtained.
Posted
Number
95% Confidence Interval
Percentage of participants
From study vaccination on Day 1 through 1 month after study vaccination
ID
Title
Description
OG000
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
OG001
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
Units
Counts
Participants
Primary
Cohort 1: Percentage of Participants With Serious Adverse Events (SAEs) From Study Vaccination Through 6 Months After Study Vaccination
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE that resulted in death, was life-threatening, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event, medical event was judged by investigator; required inpatient hospitalization or prolongation of existing hospitalization.
Safety population included all participants who received the study intervention and where appropriate informed consent was obtained.
Posted
Number
95% Confidence Interval
Percentage of participants
From study vaccination on Day 1 through 6 months after study vaccination
ID
Title
Description
OG000
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
OG001
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1)
Primary
Cohort 1: Geometric Mean Titer (GMT) of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain Neutralizing Titers (NTs) at Baseline- Participants Without Evidence of Infection
GMTs and the corresponding 2-sided confidence intervals (CIs) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). Assay results below the lower limit of quantification (LLOQ) were set to 0.5*LLOQ.
Evaluable immunogenicity population (EIP): randomized participants who received intervention to which they were randomized, 1 valid, determinate immunogenicity result from blood sample collected 28-42 days post vaccination, no important protocol deviations. Analysis performed in participants without evidence of infection up to 1 month post vaccination. Overall Number of Participants Analyzed= participants evaluable for outcome measure; Number Analyzed= participants evaluable for specified rows.
Posted
Geometric Mean
95% Confidence Interval
Titer
At baseline (before study vaccination)
ID
Title
Description
OG000
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
OG001
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
Primary
Cohort 1: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain NTs at Baseline- Participants With or Without Evidence of Infection
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution).
EIP: all eligible randomized/assigned participants who received study intervention to which they were randomized/assigned, had at least 1 valid, determinate immunogenicity result from blood sample collected within 28-42 days after study vaccination, had no other important protocol deviations as determined by clinician. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination. ''Number Analyzed'' =participants evaluable for specified rows.
Posted
Geometric Mean
95% Confidence Interval
Titer
At baseline (before study vaccination)
ID
Title
Description
OG000
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
OG001
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
Primary
Cohort 1: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain NTs at 1 Month After Study Vaccination- Participants Without Evidence of Infection
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
EIP: randomized participants who received intervention to which they were randomized, 1 valid, determinate immunogenicity result from blood sample collected 28-42 days post vaccination, no important protocol deviations. Analysis performed in participants without evidence of infection up to 1 month post vaccination. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure; ''Number Analyzed'' signifies participants evaluable for specified rows.
Posted
Geometric Mean
95% Confidence Interval
Titer
1 month after the study vaccination
ID
Title
Description
OG000
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
OG001
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
Primary
Cohort 1: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain NTs at 1 Month After Study Vaccination- Participants With or Without Evidence of Infection
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
EIP: all eligible randomized/assigned participants who received study intervention to which they were randomized/assigned, had at least 1 valid, determinate immunogenicity result from blood sample collected within 28-42 days after study vaccination, had no other important protocol deviations as determined by clinician. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination. ''Number Analyzed'' = participants evaluable for specified rows.
Posted
Geometric Mean
95% Confidence Interval
Titer
1 month after the study vaccination
ID
Title
Description
OG000
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
OG001
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
Primary
Cohort 1: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain- NTs From Before the Study Vaccination to 1 Month After the Study Vaccination- Participants Without Evidence of Infection
GMFR from before study vaccination to 1 month after study vaccination for each strain-specific neutralizing titer was reported in this endpoint. GMFRs and 2-sided 95% CIs were calculated by exponentiating mean logarithm of fold rises and corresponding CIs (based on student-t distribution). Assay results below lower limit of quantitation (LLOQ) were set to 0.5*LLOQ in analysis.
EIP: randomized participants who received intervention to which they were randomized, 1 valid, determinate immunogenicity result from blood sample collected 28-42 days post vaccination, no important protocol deviations. Analysis performed in participants without evidence of infection up to 1 month post vaccination. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure; ''Number Analyzed'' signifies participants evaluable for specified rows.
Posted
Geometric Mean
96% Confidence Interval
Fold rise
From before the study vaccination to 1 month after the study vaccination
ID
Title
Description
OG000
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
OG001
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
Primary
Cohort 1: GMFR of SARS-CoV-2 Omicron Strain (BA.1 and BA2) and Reference Strain- NTs From Before the Study Vaccination to 1 Month After the Study Vaccination- Participants With or Without Evidence of Infection
GMFR from before study vaccination to 1 month after study vaccination for each strain-specific neutralizing titer was reported in this endpoint. GMFRs and 2-sided 95% CIs were calculated by exponentiating mean logarithm of fold rises and corresponding CIs (based on student-t distribution). Assay results below LLOQ were set to 0.5*LLOQ in analysis.
EIP: all eligible randomized/assigned participants who received study intervention to which they were randomized/assigned, had at least 1 valid, determinate immunogenicity result from blood sample collected within 28-42 days after study vaccination, had no other important protocol deviations as determined by clinician. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination. ''Number Analyzed''= participants evaluable for specified rows.
Posted
Geometric Mean
95% Confidence Interval
Fold rise
From before the study vaccination to 1 month after the study vaccination
ID
Title
Description
OG000
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
OG001
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
Primary
Cohort 1: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain- NTs at 1 Month After Study Vaccination- Participants Without Evidence of Infection
Seroresponse was defined as achieving >= 4-fold rise in NTs from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination measure of >= 4*LLOQ was considered a seroresponse.
EIP: randomized participants who received intervention to which they were randomized, 1 valid, determinate immunogenicity result from blood sample collected 28-42 days post vaccination, no important protocol deviations. Analysis performed in participants without evidence of infection up to 1 month post vaccination. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure; ''Number Analyzed'' signifies participants evaluable for specified rows.
Posted
Number
95% Confidence Interval
Percentage of participants
1 month after the study vaccination
ID
Title
Description
OG000
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
OG001
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
Primary
Cohort 1: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.1 and BA.2) and Reference Strain- NTs at 1 Month After Study Vaccination- Participants With or Without Evidence of Infection
Seroresponse was defined as achieving >= 4-fold rise in NTs from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination measure of >= 4*LLOQ was considered a seroresponse.
EIP: all eligible randomized/assigned participants who received study intervention to which they were randomized/assigned, had at least 1 valid, determinate immunogenicity result from blood sample collected within 28-42 days after study vaccination, had no other important protocol deviations as determined by clinician. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination. ''Number Analyzed'' = participants evaluable for specified rows.
Posted
Number
95% Confidence Interval
Percentage of participants
1 month after the study vaccination
ID
Title
Description
OG000
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/OMI BA.2] 30 mcg)
Participants aged 18-55 years received BNT162b5 Bivalent (WT/OMI BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
OG001
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
Primary
Cohort 2: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Local reactions were recorded by participants in an e-diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild: > 2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm, severe: >10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity and grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Local reactions reported as AEs in the case report form within 7 days after the study vaccination were also reported.
Safety population included all participants who received the study intervention and where appropriate informed consent was obtained. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable for the specified rows.
Participants aged 12-17 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
OG001
Primary
Cohort 2: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Systemic events were recorded by participants in an e-diary. Fever was oral temperature >= 38 deg C and categorized as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24h, moderate: >2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator or medically qualified person. Systemic events reported as AEs in the CRF within 7 days after vaccination were also reported.
Safety population included all participants who received the study intervention and where appropriate informed consent was obtained. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Participants aged 12-17 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
Primary
Cohort 2: Percentage of Participants With AEs From Study Vaccination Through 1 Month After Study Vaccination
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data.
Safety population included all participants who received the study intervention and where appropriate informed consent was obtained.
Posted
Number
95% Confidence Interval
Percentage of participants
From study vaccination through 1 month after study vaccination
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
Primary
Cohort 2: Percentage of Participants With SAEs From Study Vaccination Through 6 Month After Study Vaccination
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE that resulted in death, was life-threatening, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization.
Safety population included all participants who received the study intervention and where appropriate informed consent was obtained.
Posted
Number
95% Confidence Interval
Percentage of participants
From study vaccination through 6 months after study vaccination
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Local reactions were recorded by participants in an e-diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild: >2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm, severe: >10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity and grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Local reactions reported as AEs in the case report form within 7 days after the study vaccination were also reported.
Safety population included all participants who received the study intervention and where appropriate informed consent was obtained. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable for the specified rows. The outcome measure was planned per protocol to be analyzed in participants combined from Cohort 2 (Group 2) + Cohort 3 (Group 1) and Cohort 2 (Group 4) + Cohort 3 (Group 2).
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
Primary
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Systemic events were recorded by participants in an e-diary. Fever was oral temperature >= 38 deg C and categorized as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 h, moderate: >2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator/medically qualified person. Systemic events reported as AEs in the CRF within 7 days after vaccination were also reported.
Safety population included all participants who received the study intervention and where appropriate informed consent was obtained. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows. The outcome measure was planned per protocol to be analyzed in participants combined from Cohort 2 (Group 2) + Cohort 3 (Group 1) and Cohort 2 (Group 4) + Cohort 3 (Group 2).
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants With AEs From Study Vaccination Through 1 Month After Study Vaccination
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data.
Safety population included all participants who received the study intervention and where appropriate informed consent was obtained. The outcome measure was planned per protocol to be analyzed in participants combined from Cohort 2 (Group 2) + Cohort 3 (Group 1) and Cohort 2 (Group 4) + Cohort 3 (Group 2).
Posted
Number
95% Confidence Interval
Percentage of participants
From study vaccination through 1 month after study vaccination
Participants aged >55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
Primary
Cohort 2 (Group 2 and 4) + Cohort 3 (Group 1 and Group 2): Percentage of Participants With SAEs From Study Vaccination Through 6 Month After Study Vaccination
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE that resulted in death, was life-threatening, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization.
Safety population included all participants who received the study intervention and where appropriate informed consent was obtained. The outcome measure was planned per protocol to be analyzed in participants combined from Cohort 2 (Group 2) + Cohort 3 (Group 1) and Cohort 2 (Group 4) + Cohort 3 (Group 2).
Posted
Number
95% Confidence Interval
Percentage of participants
From study vaccination through 6 months after study vaccination
Participants aged >55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
Primary
GMR of Omicron (BA.4/BA.5)- NT of BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg Cohort 2 (Group 4)/ Cohort 3 (Group 2) Combined in C4591044 Compared to NT of BNT162b2 30 mcg in C4591031 [NCT04955626]- 1 Month After Vaccination Among Participants >55 Years
Model based GMT of OMI BA.4/BA.5 NTs induced by BNT162b2 Bivalent 30mcg groups of study C4591044 Cohort 2/3 combined and BNT162b2 30mcg of study C4591031 [NCT04955626] Substudy E among participants >55 years are reported as descriptive data. GMTs and 95% CIs were calculated by exponentiating least square (LS) means and corresponding CI based on analysis of logarithmically transformed NT using a linear regression model with terms of baseline NT (log scale) and vaccine group. Assay results below LLOQ were set to 0.5*LLOQ. Model based geometric mean ratio (GMR) are reported in statistical section: OMI BA.4/BA.5 NTs induced 1 month post BNT162b2 Bivalent vaccination in study C4591044 to 1 month post BNT162b2 vaccination in study C4591031 [NCT04955626] among participants >55 years. Outcome measure was planned per protocol to be analyzed in participants of Cohort 2 (Group 4) + Cohort 3 (Group 2) of C4591044 and BNT162b2 experienced participants of study C4591031 [NCT04955626] (control arm).
EIP: all assigned/ randomized participants who received study intervention to which they were randomized/assigned, had at least 1 valid, determinate immunogenicity result from blood sample collected within 28-42 days post vaccination and had no other important protocol deviations. Analysis was performed in participants with or without evidence of infection up to 1 month post vaccination. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
Titer
1 month after study vaccination
ID
Title
Description
OG000
Primary
Difference in Percentage of Participants With Seroresponse to OMI BA.4/BA.5 for BNT162b2 Bivalent[WT/OMI BA.4/BA.5]30mcg Cohort2(Group4)/Cohort3(Group2)Combined in C4591044 and BNT162b2 30mcg in C4591031-1 Month After Vaccination in Participants >55 Years
Seroresponse: achieving >=4-fold rise in NTs from baseline (before study vaccination). If baseline measurement was below LLOQ, postvaccination measure of >= 4*LLOQ was considered seroresponse. Percentage of participants with seroresponse to OMI BA.4/BA.5 for BNT162b2 Bivalent 30 mcg in Study C4591044 [NCT05472038] Cohort 2/3 combined and BNT162b2 30 mcg in Study C4591031 [NCT04955626] Substudy E among participants >55 years of age are presented as descriptive data. Adjusted difference in seroresponse rate to OMI BA.4/BA.5 between BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30 mcg 1 month after vaccination in study C4591044 and 1 month after BNT162b2 vaccination in study C4591031 [NCT04955626] among participants >55 years of age is reported in statistical section. Outcome measure was planned per protocol to be analyzed in participants from Cohort 2 (Group 4) + Cohort 3 (Group 2) and control arm of BNT162b2 experienced participants >55 years of age from study C4591031 [NCT04955626] Substudy E.
EIP: all eligible, randomized participants who received study intervention to which they were randomized, had at least 1 valid and determinate immunogenicity result from blood sample collected within 28-42 days post study vaccination and had no other important protocol deviations. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
1 month after study vaccination
ID
Title
Description
Primary
GMR of Omicron (BA.4/BA.5)- NTs of BNT162b2 Bivalent[WT/OMI BA.4/BA.5]30mcg Cohort2 (Group2)/Cohort3 (Group1)Combined for 18-55 Years Compared to BNT162b2 30mcg Cohort2 (Group4)/Cohort3 (Group2)Combined for >55 Years- 1 Month After Vaccination in C4591044
Model based GMT of OMI BA.4/BA.5 NTs induced by BNT162b2 Bivalent 30 mcg groups of study C4591044 [NCT05472038] Cohort 2/3 combined in participants 18-55 years of age compared to participants >55 years of age are presented as descriptive data. GMTs and 2-sided 95% CIs were calculated by exponentiating LS means and corresponding CIs based on analysis of logarithmically transformed NT using a linear regression model with terms of baseline NT (log scale) and vaccine group. Assay results below LLOQ were set to 0.5*LLOQ. Model based GMR: OMI BA.4/BA.5 NTs induced 1 month after BNT162b2 Bivalent vaccination in study C4591044 among participants 18-55 years of age compared to participants >55 years of age is reported in statistical section. The outcome measure was planned per protocol to be analyzed in participants combined from Cohort 2 (Group 2) + Cohort 3 (Group 1) and Cohort 2 (Group 4) + Cohort 3 (Group 2).
EIP: all eligible, randomized participants who received study intervention to which they were randomized, had at least 1 valid and determinate immunogenicity result from blood sample collected within 28-42 days post study vaccination and had no other important protocol deviations. Analysis was performed in participants with or without prior evidence of infection up to 1 month post vaccination. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Difference in Percentage of Participants With Seroresponse to OMI BA.4/BA.5 of BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30 mcg Cohort2 (Group2)/Cohort3 (Group1) 18-55 Years and Cohort2 (Group4)/Cohort3 (Group2) >55 Years- 1 Month After Vaccination in C4591044
Seroresponse was defined as achieving >= 4-fold rise in NTs from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination measure of >= 4*LLOQ was considered a seroresponse. Percentage of participants with seroresponse to OMI BA.4/BA.5 for BNT162b2 Bivalent 30 mcg in Study C4591044 [NCT05472038] Cohort 2/3 combined in participants 18-55 years of age compared to participants >55 years of age are presented as descriptive data. Adjusted difference in seroresponse rate to OMI BA.4/BA.5 between BNT162b2 Bivalent [WT/OMI BA.4/BA.5] 30 mcg 1 month after vaccination in study C4591044 in participants 18-55 years of age compared to participants >55 years of age is reported in statistical section. The outcome measure was planned per protocol to be analyzed in participants combined from Cohort 2 (Group 2) + Cohort 3 (Group 1) and Cohort 2 (Group 4) + Cohort 3 (Group 2).
EIP: all eligible, randomized participants who received study intervention to which they were randomized, had at least 1 valid and determinate immunogenicity result from blood sample collected within 28-42 days post study vaccination and had no important protocol deviations. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Cohort 2: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.4/BA.5) and Reference Strain NTs at Baseline- Participants With or Without Evidence of Infection
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). This outcome measure was planned per protocol to be analyzed in participants from Cohort 2 and control arms of BNT162b2 Bivalent (WT/OMI BA.1) experienced participants from study C4591031 [NCT04955626] Substudy E.
EIP: eligible, randomized participants received study intervention to which they were randomized, 1 valid, determinate immunogenicity result from blood sample collected within 28-42 days post study vaccination, no important protocol deviations. Analysis performed in participants with or without evidence of infection up to 1 month post study vaccination. Overall Number of Participants Analyzed= participants evaluable for outcome measure; Number Analyzed= participants evaluable for specified rows.
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
Primary
Cohort 2: GMT of SARS-CoV-2 Omicron Strain (BA.1 and BA.4/BA.5) and Reference Strain NTs at 1 Month- Participants With or Without Evidence of Infection
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). This outcome measure was planned per protocol to be analyzed in participants from Cohort 2 and control arms of BNT162b2 experienced participants from study C4591031 [NCT04955626] Substudy E.
EIP: eligible, randomized participants received study intervention to which they were randomized, 1 valid, determinate immunogenicity result from blood sample collected within 28-42 days post study vaccination, no important protocol deviations. Analysis performed in participants with or without evidence of infection up to 1 month post study vaccination. Here, ''Number Analyzed'' signifies participants evaluable for specified rows.
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
Primary
Cohort 2: GMFR of SARS-CoV-2 Omicron Strain (BA.1 and BA.4/BA.5) and Reference Strain- NTs From Before the Study Vaccination to 1 Month After the Study Vaccination- Participants With or Without Evidence of Infection
GMFR from before the study vaccination to 1 month after the study vaccination for each strain-specific neutralizing titer was reported in this outcome measure. GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student-t distribution). Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. This outcome measure was planned per protocol to be analyzed in participants from Cohort 2 and control arms of BNT162b2 experienced participants from study C4591031 [NCT04955626] Substudy E.
EIP: eligible, randomized participants received study intervention to which they were randomized, 1 valid, determinate immunogenicity result from blood sample collected within 28-42 days post study vaccination, no important protocol deviations. Analysis performed in participants with or without evidence of infection up to 1 month post study vaccination. Overall Number of Participants Analyzed= participants evaluable for outcome measure; Number Analyzed= participants evaluable for specified rows.
Posted
Geometric Mean
95% Confidence Interval
Fold rise
From before the study vaccination to 1 month after the study vaccination
Participants aged 12-17 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
Primary
Cohort 2: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.1 and BA.4/BA.5) and Reference Strain- NTs at 1 Month After Study Vaccination- Participants With or Without Evidence of Infection
Seroresponse was defined as achieving >= 4-fold rise in NTs from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination measure of >= 4*LLOQ was considered a seroresponse. Percentage of participants with seroresponse to OMI BA.4/BA.5 for BNT162b2 Bivalent 30 and 60 mcg in Study C4591044 [NCT05472038] Cohort 2 and BNT162b2 30 mcg in Study C4591031 [NCT04955626] Substudy E are presented as descriptive data. This outcome measure was planned per protocol to be analyzed in participants from Cohort 2 and control arms of BNT162b2 experienced participants 18-55 years of age and >55 years of age from study C4591031 [NCT04955626] Substudy E.
EIP: eligible, randomized participants received study intervention to which they were randomized, 1 valid, determinate immunogenicity result from blood sample collected within 28-42 days post study vaccination, no important protocol deviations. Analysis performed in participants with or without evidence of infection up to 1 month post study vaccination. Overall Number of Participants Analyzed= participants evaluable for outcome measure; Number Analyzed= participants evaluable for specified rows.
Participants aged 12-17 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
Secondary
GMR of the Reference-Strain- NTs of BNT162b2 [WT/OMI BA.4/BA.5] 30mcg Cohort 2 (Group 4)/ Cohort 3 (Group 2) Combined in C4591044 Compared to NT of BNT162b2 30mcg in C4591031 [NCT04955626] >55 Years of Age- 1 Month After Vaccination
Model based GMT of reference strain NTs induced by BNT162b2 Bivalent 30mcg groups of study C4591044 [NCT05472038] Cohort 2/3 combined and BNT162b2 30 mcg of study C4591031 [NCT04955626] Substudy E among participants >55 years of age presented as descriptive data. GMTs, 2-sided 95% CIs calculated by exponentiating LS means, corresponding CIs based on analysis of logarithmically transformed NT using linear regression model with terms of baseline NT (log scale), vaccine group. Assay results below LLOQ set to 0.5*LLOQ. Model based GMR: OMI BA.4/BA.5 NTs induced 1 month after BNT162b2 Bivalent vaccination in study C4591044 to 1 month after BNT162b2 vaccination in study C4591031 [NCT04955626] among participants >55 years of age reported in statistical section. Outcome measure was planned per protocol to be analyzed in participants from Cohort 2 (Group 4) + Cohort 3 (Group 2) and control arm of BNT162b2 experienced participants >55 years of age from study C4591031 [NCT04955626] Substudy E.
EIP included all assigned/ randomized participants who received study intervention to which they were randomized/assigned, had at least 1 valid and determinate immunogenicity result from blood sample collected within 28-42 days post the vaccination and had no other important protocol deviations. Analysis in participants with or without prior evidence of infection up to 1 month post vaccination. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
Titer
1 month after study vaccination
ID
Title
Description
OG000
Secondary
Cohort 2 (Group 2) + Cohort 3 (Group 1) Combined and Cohort 2 (Group 4) + Cohort 3 (Group 2) Combined: GMT of Omicron BA.4/BA.5 and Reference Strain NT at Baseline and 1 Month After the Study Vaccination
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). This outcome measure was planned per protocol to be analyzed in participants from Cohort 2 (Group 2) + Cohort 3 (Group 1), Cohort 2 (Group 4) + Cohort 3 (Group 2) and control arm of BNT162b2 experienced participants >55 years of age from study C4591031 [NCT04955626] Substudy E.
EIP included all assigned/ randomized participants who received study intervention to which they were randomized/assigned, had at least 1 valid and determinate immunogenicity result from blood sample collected within 28-42 days post the vaccination and had no other important protocol deviations. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination. Here, ''Number Analyzed'' signifies participants evaluable for specified rows.
Cohort 2 (Group 2) + Cohort 3 (Group 1) Combined and Cohort 2 (Group 4) + Cohort 3 (Group 2) Combined: GMFR of SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain- NTs From Before the Study Vaccination to 1 Month After the Study Vaccination
GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. GMFR from before the study vaccination to 1 month after study vaccination for Omicron BA.4/BA.5 and reference strain neutralizing titer was reported in this outcome measure. This outcome measure was planned per protocol to be analyzed in participants from Cohort 2 (Group 2) + Cohort 3 (Group 1), Cohort 2 (Group 4) + Cohort 3 (Group 2) and control arm of BNT162b2 experienced participants >55 years of age from study C4591031 [NCT04955626] Substudy E.
EIP included all assigned/ randomized participants who received study intervention to which they were randomized/assigned, had at least 1 valid and determinate immunogenicity result from blood sample collected within 28-42 days post the vaccination and had no other important protocol deviations. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination. Here, ''Number Analyzed'' signifies participants evaluable for specified rows.
Posted
Geometric Mean
95% Confidence Interval
Fold rise
From before the study vaccination to 1 month after study vaccination
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
Secondary
Cohort 2 (Group 2) + Cohort 3 (Group 1) Combined and Cohort 2 (Group 4) + Cohort 3 (Group 2) Combined: Percentages of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain- NTs at 1 Month After the Study Vaccination
Seroresponse was defined as achieving >= 4-fold rise in NTs from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination measure of >= 4*LLOQ was considered a seroresponse. Percentage of participants with seroresponse to OMI BA.4/BA.5 for BNT162b2 Bivalent 30 mcg in Study C4591044 [NCT05472038] Cohort 2/3 combined and BNT162b2 30 mcg in Study C4591031 [NCT04955626] Substudy E among participants >55 years of age are presented as descriptive data. This outcome measure was planned per protocol to be analyzed in participants from Cohort 2 (Group 2) + Cohort 3 (Group 1), Cohort 2 (Group 4) + Cohort 3 (Group 2) and control arm of BNT162b2 experienced participants >55 years of age from study C4591031 [NCT04955626] Substudy E.
EIP was analyzed. Analysis was performed in EIP with or without evidence of infection up to 1 month post study vaccination. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable for specified rows.
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
Primary
Cohort 4: Percentage of Participants Reporting Local Reactions Within 7 Days After Study Vaccination
Local reactions were recorded by participants in an e-diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild: >2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm, severe: >10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity and grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Local reactions reported as AEs in the case report form within 7 days after the study vaccination were also reported.
Safety population included all participants who received the study intervention and where appropriate informed consent was obtained. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 to Day 7 after study vaccination
ID
Title
Description
OG000
Cohort 4: 18-55 Years (BNT162b2 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
OG001
Cohort 4: 18-55 Years (BNT162b5 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Primary
Cohort 4: Percentage of Participants Reporting Systemic Events Within 7 Days After Study Vaccination
Systemic events were recorded by participants in an e-diary. Fever was oral temperature >= 38 deg C and categorized as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24h, moderate: >2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator or medically qualified person. Systemic events reported as AEs in the CRF within 7 days after vaccination were also reported.
Safety population included all participants who received the study intervention and where appropriate informed consent was obtained. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 to Day 7 after study vaccination
ID
Title
Description
OG000
Cohort 4: 18-55 Years (BNT162b2 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
Primary
Cohort 4: Percentage of Participants With AEs From Study Vaccination Through 1 Month After Study Vaccination
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data.
Safety population included all participants who received the study intervention and where appropriate informed consent was obtained.
Posted
Number
95% Confidence Interval
Percentage of participants
From study vaccination through 1 month after study vaccination
ID
Title
Description
OG000
Cohort 4: 18-55 Years (BNT162b2 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
OG001
Cohort 4: 18-55 Years (BNT162b5 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b5 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
OG002
Cohort 4: 18-55 Years (BNT162b6 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b6 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
Primary
Cohort 4: Percentage of Participants With SAEs From Study Vaccination Through 6 Months After Study Vaccination
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE that resulted in death, was life-threatening, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization.
Safety population included all participants who received the study intervention and where appropriate informed consent was obtained.
Posted
Number
95% Confidence Interval
Percentage of participants
From study vaccination through 6 months after study vaccination
ID
Title
Description
OG000
Cohort 4: 18-55 Years (BNT162b2 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
OG001
Cohort 4: 18-55 Years (BNT162b5 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b5 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
OG002
Cohort 4: 18-55 Years (BNT162b6 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Primary
Cohort 4: GMT of SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain NTs at Baseline- Participants With or Without Evidence of Infection
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution).
EIP included all assigned/ randomized participants who received study intervention to which they were randomized/assigned, had at least 1 valid and determinate immunogenicity result from blood sample collected within 28-42 days post the vaccination and had no other important protocol deviations. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination.
Posted
Geometric Mean
95% Confidence Interval
Titer
At baseline (before study vaccination)
ID
Title
Description
OG000
Cohort 4: 18-55 Years (BNT162b2 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
OG001
Cohort 4: 18-55 Years (BNT162b5 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b5 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
OG002
Cohort 4: 18-55 Years (BNT162b6 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Primary
Cohort 4: GMT of SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain NTs at 1 Month After Study Vaccination- Participants With or Without Evidence of Infection
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution).
EIP included all assigned/ randomized participants who received study intervention to which they were randomized/assigned, had at least 1 valid and determinate immunogenicity result from blood sample collected within 28-42 days post the vaccination and had no other important protocol deviations. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination.
Posted
Geometric Mean
95% Confidence Interval
Titer
1 month after the study vaccination
ID
Title
Description
OG000
Cohort 4: 18-55 Years (BNT162b2 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
OG001
Cohort 4: 18-55 Years (BNT162b5 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b5 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
OG002
Cohort 4: 18-55 Years (BNT162b6 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Primary
Cohort 4: GMFR of SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain- NTs From Before the Study Vaccination to 1 Month After the Study Vaccination- Participants With or Without Evidence of Infection
GMFR from before study vaccination to 1 month after study vaccination for each strain-specific neutralizing titer was reported in this endpoint. GMFRs and 2-sided 95% CIs were calculated by exponentiating mean logarithm of fold rises and corresponding CIs (based on student-t distribution). Assay results below LLOQ were set to 0.5*LLOQ in analysis.
EIP included all assigned/ randomized participants who received study intervention to which they were randomized/assigned, had at least 1 valid and determinate immunogenicity result from blood sample collected within 28-42 days post the vaccination and had no other important protocol deviations. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination.
Posted
Geometric Mean
95% Confidence Interval
Fold rise
From before the study vaccination to 1 month after study vaccination
ID
Title
Description
OG000
Cohort 4: 18-55 Years (BNT162b2 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
OG001
Cohort 4: 18-55 Years (BNT162b5 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b5 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
Primary
Cohort 4: Percentage of Participants With Seroresponse to SARS-CoV-2 Omicron Strain (BA.4/BA.5) and Reference Strain- NTs at 1 Month After Study Vaccination- Participants With or Without Evidence of Infection
Seroresponse was defined as achieving >= 4-fold rise in NTs from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination measure of >= 4*LLOQ was considered a seroresponse.
EIP included all assigned/ randomized participants who received study intervention to which they were randomized/assigned, had at least 1 valid and determinate immunogenicity result from blood sample collected within 28-42 days post the vaccination and had no other important protocol deviations. Analysis was performed in participants with or without evidence of infection up to 1 month post study vaccination.
Posted
Number
95% Confidence Interval
Percentage of participants
1 month after study vaccination
ID
Title
Description
OG000
Cohort 4: 18-55 Years (BNT162b2 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
OG001
Cohort 4: 18-55 Years (BNT162b5 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b5 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
Time Frame
Local reactions and systemic events: From Day 1 to Day 7 after study vaccination; AE: From study vaccination on Day 1 through 1 month after study vaccination, SAE and Death: From study vaccination on Day 1 through 6 months after study vaccination
Description
Same event may appear as non-SAE and SAE, what is presented are distinct. Event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. Safety population: all participants who received study intervention and where appropriate informed consent was obtained. Per analysis planned, data is summarized & combined for Cohort 2/ Cohort 3 30 mcg groups per age category. MedDRA for Cohort1/Cohort 4: v27.0; for Cohort 2/Cohort 3: v26.0.
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
Cohort 1: 18-55 Years (BNT162b5 Bivalent [WT/ OMI BA.2] 30 mcg)
Participants aged 18-55 years received BNT162b5 Bivalent (WT/ OMI BA.2) 30 mcg intramuscularly at Visit 1 (Day 1).
0
104
1
104
97
104
EG001
Cohort 1: 18-55 Years (BNT162b2 Bivalent [WT/ OMI BA.1] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/ OMI BA.1) 30 mcg intramuscularly at Visit 1 (Day 1).
0
102
2
102
91
102
EG002
Cohort 2 (Group 1): 12-17 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 12-17 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
0
107
1
107
96
107
EG003
Cohort 2 (Group 2) + Cohort 3 (Group 1): 18-55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
0
313
2
313
269
313
EG004
Cohort 2 (Group 3): 18-55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 60 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
0
110
1
110
106
110
EG005
Cohort 2 (Group 4) + Cohort 3 (Group 2): >55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 30 mcg)
Participants aged > 55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
1
306
10
306
210
306
EG006
Cohort 2 (Group 5): >55 Years (BNT162b2 Bivalent [WT/ OMI BA.4/ BA.5] 60 mcg)
Participants aged >55 years received BNT162b2 Bivalent (WT/ OMI BA.4/ BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
0
102
0
102
82
102
EG007
Cohort 4: 18-55 Years (BNT162b2 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b2 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
0
62
1
62
55
62
EG008
Cohort 4: 18-55 Years (BNT162b5 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b5 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
0
62
0
62
56
62
EG009
Cohort 4: 18-55 Years (BNT162b6 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b6 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
0
60
0
60
52
60
EG010
Cohort 4: 18-55 Years (BNT162b7 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b7 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
Participants aged 18-55 years received BNT162b7 Monovalent (OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
0
63
0
63
56
63
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute kidney injury
Renal and urinary disorders
26.0
Non-systematic Assessment
EG0001 events1 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG0030 events0 affected313 at risk
EG0040 events0 affected110 at risk
EG0050 events0 affected306 at risk
EG0060 events0 affected102 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected62 at risk
EG0090 events0 affected60 at risk
EG0100 events0 affected60 at risk
EG0110 events0 affected63 at risk
Adenocarcinoma pancreas
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Alcohol poisoning
Injury, poisoning and procedural complications
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0021 events1 affected107 at risk
EG003
Arrhythmia
Cardiac disorders
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Biliary colic
Hepatobiliary disorders
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0011 events1 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Diverticulitis
Infections and infestations
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Enterocolitis infectious
Infections and infestations
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Gastroenteritis
Infections and infestations
26.0
Non-systematic Assessment
EG0001 events1 affected104 at risk
EG0010 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Hypotension
Vascular disorders
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Left ventricular failure
Cardiac disorders
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Normocytic anaemia
Blood and lymphatic system disorders
26.0
Non-systematic Assessment
EG0001 events1 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0011 events1 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Post procedural infection
Infections and infestations
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0011 events1 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Suicidal ideation
Psychiatric disorders
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0021 events1 affected107 at risk
EG003
Syncope
Nervous system disorders
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Testicular germ cell cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Arthralgia (JOINT PAIN)
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG00019 events19 affected104 at risk
EG00118 events18 affected102 at risk
EG00213 events13 affected107 at risk
EG00346 events46 affected313 at risk
EG004
Back pain
Musculoskeletal and connective tissue disorders
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Bell's palsy
Nervous system disorders
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Blood pressure increased
Investigations
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
COVID-19
Infections and infestations
26.0
Non-systematic Assessment
EG0003 events3 affected104 at risk
EG0014 events4 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Chills (CHILLS)
General disorders
26.0
Systematic Assessment
EG00022 events22 affected104 at risk
EG00120 events20 affected102 at risk
EG00225 events25 affected107 at risk
EG003
Diarrhoea
Gastrointestinal disorders
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Diarrhoea (DIARRHEA)
Gastrointestinal disorders
26.0
Systematic Assessment
EG00015 events15 affected104 at risk
EG00120 events20 affected102 at risk
EG0027 events7 affected107 at risk
EG003
Ear pain
Ear and labyrinth disorders
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Fatigue
General disorders
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0023 events3 affected107 at risk
EG003
Fatigue (FATIGUE)
General disorders
26.0
Systematic Assessment
EG00076 events76 affected104 at risk
EG00164 events64 affected102 at risk
EG00272 events72 affected107 at risk
EG003
Headache
Nervous system disorders
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Headache (HEADACHE)
Nervous system disorders
26.0
Systematic Assessment
EG00055 events55 affected104 at risk
EG00147 events47 affected102 at risk
EG00254 events54 affected107 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Injection site erythema (REDNESS)
General disorders
26.0
Systematic Assessment
EG0006 events6 affected104 at risk
EG0016 events6 affected102 at risk
EG0026 events6 affected107 at risk
EG003
Injection site pain
General disorders
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0022 events2 affected107 at risk
EG003
Injection site pain (PAIN)
General disorders
26.0
Systematic Assessment
EG00086 events86 affected104 at risk
EG00183 events83 affected102 at risk
EG00275 events75 affected107 at risk
EG003
Injection site swelling (SWELLING)
General disorders
26.0
Systematic Assessment
EG00011 events11 affected104 at risk
EG00111 events11 affected102 at risk
EG0028 events8 affected107 at risk
EG003
Joint abscess
Infections and infestations
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0022 events2 affected107 at risk
EG003
Myalgia (MUSCLE PAIN)
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG00037 events37 affected104 at risk
EG00139 events39 affected102 at risk
EG00228 events28 affected107 at risk
EG003
Otitis media
Infections and infestations
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Pyrexia (FEVER)
General disorders
26.0
Systematic Assessment
EG0002 events2 affected104 at risk
EG0016 events6 affected102 at risk
EG00210 events10 affected107 at risk
EG003
Sinusitis
Infections and infestations
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0022 events2 affected107 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Upper respiratory tract infection
Infections and infestations
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Urinary tract infection
Infections and infestations
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Vomiting
Gastrointestinal disorders
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Vomiting (VOMITING)
Gastrointestinal disorders
26.0
Systematic Assessment
EG0001 events1 affected104 at risk
EG0012 events2 affected102 at risk
EG0023 events3 affected107 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
26.0
Non-systematic Assessment
EG0000 events0 affected104 at risk
EG0010 events0 affected102 at risk
EG0020 events0 affected107 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
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Participants aged >55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
OG001
BNT162b2 30 mcg: C4591031 Substudy E
BNT162b2 experienced participants >55 years of age in study C4591031 [NCT04955626] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 [NCT05472038] study.
Units
Counts
Participants
OG000282
OG001273
Title
Denominators
Categories
Title
Measurements
OG0003373.4(3000.3 to 3793.0)
OG0011160.7(1030.3 to 1307.7)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Model-Based GMR
2.91
2-Sided
95
2.45
3.44
Superiority
Superiority based on GMR was declared if the lower limit of the 2-sided 95% CI for the GMR was greater than 1.
Participants aged >55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
OG001
BNT162b2 30 mcg: C4591031 Sub Study E
BNT162b2 experienced participants >55 years of age in study C4591031 [NCT04955626] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 study.
Units
Counts
Participants
OG000282
OG001273
Title
Denominators
Categories
Title
Measurements
OG00066.7(60.8 to 72.1)
OG00146.5(40.5 to 52.6)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Adjusted Difference in Percentages
26.77
2-Sided
95
19.59
33.95
Adjusted difference and 2-Sided CI based on the Miettinen and Nurminen method stratified by baseline NT category (< median,>= median) for difference in proportions. The median of baseline NT was calculated based on pooled data in 2 comparator groups.
Non-Inferiority
Noninferiority based on seroresponse was declared if the lower limit of the 2-sided 95% CI for the difference in percentages of participants with seroresponse is >-5%.
Participants aged 18 to 55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
Participants aged >55 years of age, received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
Units
Counts
Participants
OG000294
OG001282
Title
Denominators
Categories
Title
Measurements
OG0004254.2(3779.6 to 4788.4)
OG0014344.4(3850.2 to 4902.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Model-Based GMR
0.98
2-Sided
95
0.83
1.16
GMR and 2-sided 95% CIs were calculated by exponentiating the difference of LS means and corresponding CIs based on the regression model included terms for baseline neutralizing titer and comparison group.
Non-Inferiority
Noninferiority based on the GMR was declared if the lower limit of the 2-sided 95% CI for the GMR is greater than 0.67 (1.5-fold criterion) and the point estimate of the GMR was >=0.8.
Participants aged 18-55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
Participants aged >55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
Units
Counts
Participants
OG000294
OG001282
Title
Denominators
Categories
Title
Measurements
OG00061.2(55.4 to 66.8)
OG00166.7(60.8 to 72.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Adjusted Difference in Percentages
-3.03
2-Sided
95
-9.68
3.63
2-Sided CI based on Miettinen and Nurminen method stratified by baseline NT category(< median,>= median)for difference in percentage(seroresponse rate).Median of baseline neutralizing titers was calculated based on pooled data in 2 comparator groups.
Non-Inferiority
Noninferiority based on seroresponse was declared if the lower limit of the 2-sided 95% CI for the difference in percentages of participants with seroresponse is >-10%.
Participants aged >55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
OG005
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 [NCT04955626] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 [NCT05472038] study.
OG006
18-55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 [NCT04955626] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 [NCT05472038] study.
OG007
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants >55 years of age in study C4591031 [NCT04955626] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 [NCT05472038] study.
OG008
>55 Years (BNT162b2 Bivalent [WT/OMI BA.1] 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants >55 years of age in study C4591031 [NCT04955626] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 [NCT05472038] study.
Participants aged >55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
OG005
18-55 Years (BNT162b2 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 [NCT04955626] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 [NCT05472038] study.
OG006
18-55 Years (BNT162b2 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 [NCT04955626] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 [NCT05472038] study.
OG007
>55 Years (BNT162b2 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants >55 years of age in study C4591031 [NCT04955626] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 [NCT05472038] study.
OG008
>55 Years (BNT162b2 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants >55 years of age in study C4591031 [NCT04955626] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 [NCT05472038] study.
Participants aged >55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
OG005
18-55 Years (BNT162b2 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 [NCT04955626] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 [NCT05472038] study.
OG006
18-55 Years (BNT162b2 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 [NCT04955626] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 [NCT05472038] study.
OG007
>55 Years (BNT162b2 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants >55 years of age in study C4591031 [NCT04955626] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 [NCT05472038] study.
OG008
>55 Years (BNT162b2 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants >55 years of age in study C4591031 [NCT04955626] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 [NCT05472038] study.
Participants aged >55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 60 mcg intramuscularly at Visit 1 (Day 1).
OG005
18-55 Years (BNT162b2 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 [NCT04955626] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 [NCT05472038] study.
OG006
18-55 Years (BNT162b2 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants 18-55 years of age in study C4591031 [NCT04955626] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 [NCT05472038] study.
OG007
>55 Years (BNT162b2 30 mcg): C4591031 Substudy E
BNT162b2 experienced participants >55 years of age in study C4591031 [NCT04955626] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 [NCT05472038] study.
OG008
>55 Years (BNT162b2 60 mcg): C4591031 Substudy E
BNT162b2 experienced participants >55 years of age in study C4591031 [NCT04955626] received one dose (60 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 [NCT05472038] study.
Participants aged >55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
OG001
BNT162b2 30 mcg: C4591031 Substudy E
BNT162b2 experienced participants >55 years of age in study C4591031 [NCT04955626] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 [NCT05472038] study.
Units
Counts
Participants
OG000284
OG001287
Title
Denominators
Categories
Title
Measurements
OG00015361.6(14082.9 to 16756.5)
OG00111117.2(10196.4 to 12121.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Model-Based GMR
1.38
2-Sided
95
1.22
1.56
GMR and 2-sided 95% CIs were calculated by exponentiating the difference of LS means and corresponding CIs based on the regression model included terms for baseline neutralizing titer and comparison group.
Non-Inferiority
Noninferiority based on the GMR was declared if the lower limit of the 2-sided 95% CI for the GMR is greater than 0.67 (1.5-fold criterion) and the point estimate of the GMR was >=0.8.
Participants aged >55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
OG002
BNT162b2 30 mcg: C4591031 Substudy E
BNT162b2 experienced participants >55 years of age in study C4591031 [NCT04955626] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 [NCT05472038] study.
Participants aged >55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
OG002
BNT162b2 30 mcg: C4591031 Substudy E
BNT162b2 experienced participants >55 years of age in study C4591031 [NCT04955626] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 [NCT05472038] study.
Participants aged >55 years received BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
OG002
BNT162b2 30 mcg: C4591031 Substudy E
BNT162b2 experienced participants >55 years of age in study C4591031 [NCT04955626] received one dose (30 mcg) of BNT162b2 intramuscularly. As planned this group served as immunogenicity control arm and participants are not included in enrollment number of current C4591044 [NCT05472038] study.
Units
Counts
Participants
OG000295
OG001284
OG002287
Title
Denominators
Categories
Omicron BA.4/BA.5
ParticipantsOG000294
ParticipantsOG001282
ParticipantsOG002273
Title
Measurements
OG00061.2(55.4 to 66.8)
OG00166.7(60.8 to 72.1)
OG00246.5(40.5 to 52.6)
Reference strain
ParticipantsOG000295
ParticipantsOG001284
ParticipantsOG002287
Title
Measurements
OG000
Participants aged 18-55 years received BNT162b5 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
OG002
Cohort 4: 18-55 Years (BNT162b6 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b6 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).
OG003
Cohort 4: 18-55 Years (BNT162b7 Bivalent [Original/ OMI BA.4/ BA.5] 30 mcg)
Participants aged 18-55 years received BNT162b7 Bivalent (Original/ OMI BA.4/ BA.5) 30 mcg intramuscularly at Visit 1 (Day 1).