A Study to Learn About New COVD-19 RNA Vaccine Candidates... | NCT05997290 | Trialant
NCT05997290
Sponsor
BioNTech SE
Status
Completed
Last Update Posted
Apr 28, 2026Actual
Enrollment
1,051Actual
Phase
Phase 2Phase 3
Conditions
SARS-CoV-2 Infection
COVID-19
Interventions
BNT162b2 (Omi XBB.1.5)
BNT162b2 (Omi JN.1)
BNT162b2 (Omi KP.2)
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT05997290
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C4591054
Secondary IDs
ID
Type
Description
Link
2024-000361-24
Registry Identifier
EudraCT
NCT05997290
Registry Identifier
ClinicalTrials.gov
Brief Title
A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals
Official Title
A PHASE 2/3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162b2 RNA-BASED VACCINE CANDIDATES FOR SARS-CoV-2 NEW VARIANTS IN HEALTHY INDIVIDUALS
Acronym
Not provided
Organization
BioNTech SEINDUSTRY
Status Module
Record Verification Date
Apr 2026
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
Aug 10, 2023Actual
Primary Completion Date
Mar 13, 2025Actual
Completion Date
Mar 13, 2025Actual
First Submitted Date
Aug 10, 2023
First Submission Date that Met QC Criteria
Aug 10, 2023
First Posted Date
Aug 18, 2023Actual
Results Waived
Not provided
Results First Submitted Date
Mar 9, 2026
Results First Submitted that Met QC Criteria
Apr 7, 2026
Results First Posted Date
Apr 28, 2026Actual
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
Apr 7, 2026
Last Update Posted Date
Apr 28, 2026Actual
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 protocol is to learn about the safety, tolerability, and immunogenicity of new BNT162b2 RNA-based vaccine candidates targeting new variants of SARS-CoV-2 in healthy people.
Substudy A:
This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose,
in people who are 12 years of age and older,
who previously received at least 3 doses of a US-authorized mRNA COVID-19 vaccine, with the most recent dose being an Omicron BA.4/BA.5-adapted bivalent vaccine received at least 150 days before the study vaccination (Visit 1).
The study is about 6 months long for each participant.
Participants will have at least 5 visits to the clinic.
At each clinic visit a blood sample will be taken.
At least 1 nasal swab will taken.
Substudy B:
This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose,
in people who are 12 years of age and older,
who are COVID-19 vaccine-naïve
who have had any positive SARS-CoV-2 test result >28 days before study vaccine administration.
The study is about 6 months long for each participant.
Participants will have at least 5 visits to the clinic.
At each clinic visit a blood sample will be taken.
At least 1 nasal swab will taken.
Substudy C:
This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi JN.1) and BNT162b2 (Omi KP.2) given as a single 30 µg dose to:
Cohort 1: people who are 18 years of age and older, who will receive BNT162b2 (Omi JN.1), and,
Cohort 2: people who are 12 years of age and older, who will receive BNT162b2 (Omi JN.1), and,
Cohort 3: people who are 18 years of age and older who will receive BNT162b2 (Omi KP.2).
Participants may have never received a COVID-19 vaccine or, may have previously received COVID-19 vaccine(s), with the most recent dose received at least 150 days before the study vaccination (Visit 1).
The study is about 6 months long for each participant.
Participants will have at least 6 visits (Cohorts 1 and 3) or at least 5 visits (Cohort 2) to the clinic.
At each clinic visit a blood sample will be taken.
At least 1 nasal swab will taken.
Detailed Description
Not provided
Conditions Module
Conditions
SARS-CoV-2 Infection
COVID-19
Keywords
COVID-19
Coronavirus
Vaccine
SARS-CoV-2
RNA Vaccine
Vaccine-naïve
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
1,051Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
SSA: Group 1
Experimental
Participants 12 years of age and older, COVID-19 vaccine-experienced will receive 30 µg of BNT162b2 (Omi XBB.1.5) at Visit 1.
Biological: BNT162b2 (Omi XBB.1.5)
SSB: Group 2
Experimental
Participants 12 years of age and older who were previously exposed to SARS-CoV-2 and are COVID-19 vaccine-naïve will receive 30 μg of BNT162b2 (Omi XBB.1.5) at Visit 1
Biological: BNT162b2 (Omi XBB.1.5)
SSC: Group 3
Experimental
Cohort 1 - Participants 18 years of age and older will receive 30 µg of BNT162b2 (Omi JN.1) at Visit 1.
Biological: BNT162b2 (Omi JN.1)
SSC: Group 4
Experimental
Cohort 2 - Participants 12 years of age and older will receive 30 µg of BNT162b2 (Omi JN.1) at Visit 1.
Biological: BNT162b2 (Omi JN.1)
SSC - Group 5
Experimental
Cohort 3 - Participants 18 years of age and older who will receive 30 µg of BNT162b2 (Omi KP.2) at Visit 1.
Biological: BNT162b2 (Omi KP.2)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BNT162b2 (Omi XBB.1.5)
Biological
BNT162b2 monovalent (Omicron XBB.1.5)
SSA: Group 1
SSB: Group 2
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSA
Local reactions: pain at injection site, redness and swelling were recorded by participants in an electronic diary (e-diary) or as adverse events (AEs) in the case report form (CRF). Redness and swelling were recorded in measuring device units (mdu) (range: 1 to 21), 1 mdu =0.5 centimeter (cm) and were graded as mild (greater than [>] 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] and necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room [ER] visit or hospitalization for severe pain at injection site). Grade 4 local reactions were classified by investigator or medically qualified person.
Day 1 to Day 7 after vaccination
Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSA
Systemic events were recorded by participants in an e-diary or as AEs in the CRF. Fever: defined as oral temperature more than or equal to (>=38) degree Celsius (C) and categorized as >= 38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Fatigue, headache, chills, new or worsened muscle pain and joint pain were graded as: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild: 1-2 times in 24 hours (h), moderate: >2 times in 24h, severe: required intravenous (IV) hydration. Diarrhea was graded as: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h. Grade 4 for all events except fever: ER visit/hospitalization. Grade 4 systemic events were classified by investigator or medically qualified person.
Day 1 to Day 7 after vaccination
Percentage of Participants With Adverse Events (AEs) From Vaccination Through 1 Month After Vaccination: SSA
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with use of study intervention, whether or not considered related to study intervention. A serious AE (SAE) was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event. AEs included both SAEs and all non-SAEs. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
SSA
Inclusion Criteria:
Received at least 3 prior doses of a US-authorized mRNA COVID-19 vaccine, with the most recent dose being a US-authorized Omicron BA.4/BA.5-adapted bivalent vaccine received at least 150 days before Visit 1 (Day 1).
Willing and able to comply with all scheduled visits/contacts, study procedures and lifestyle considerations.
Capable of giving, or parent(s)/legal guardian capable of giving, signed informed consent.
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.
Immunocompromised with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
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.
Any 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.
History of myocarditis or pericarditis.
Receipt of 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.
Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, used for the treatment or prevention of COVID-19 or those that are considered immunosuppressive, from 60 days before study vaccination or planned receipt throughout the study.
Participation in other studies involving receipt of other study intervention within 28 days before enrollment. Anticipated participation in other studies involving other study intervention from enrollment 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.
SSB
Inclusion Criteria:
COVID-19 vaccine-naïve.
Any positive SARS-CoV-2 test result >28 days before study intervention administration.
Willing and able to comply with all scheduled visits/contacts, study procedures and lifestyle considerations.
Capable of giving or parent(s)/legal guardian capable of giving, signed informed consent.
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.
Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
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.
Any medical or psychiatric condition, including recent (within the past year) or active suicidal ideation/behavior, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
History of myocarditis or pericarditis.
Receipt of 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.
Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies used for the treatment or prevention of COVID-19 or those that are considered immunosuppressive, from 60 days before study intervention administration or planned receipt throughout the study.
Participation in other studies involving receipt of other study intervention within 28 days before enrollment. Anticipated participation in other studies involving other study intervention from enrollment 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.
Willing and able to comply with all scheduled visits/contacts, study procedures and lifestyle considerations.
Capable of giving, or parent(s)/legal guardian capable of giving, signed informed consent.
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.
Immunocompromised with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
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.
Any 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.
History of myocarditis or pericarditis.
Receipt of 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.
Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, used for the treatment or prevention of COVID-19 or those that are considered immunosuppressive, from 60 days before study vaccination or planned receipt throughout the study.
Receipt of a COVID-19 vaccine less than 150 days before study intervention administration Visit 1 (Day 1).
Participation in other studies involving receipt of other study intervention within 28 days before enrollment. Anticipated participation in other studies involving other study intervention from enrollment 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.
Diya O, Gayed J, Lowry FS, Ma H, Bangad V, Mensa F, Zou J, Xie X, Hu Y, Cutler M, Belanger T, Cooper D, Xu X, Mogg R, Tureci O, Sahin U, Swanson KA, Modjarrad K, Anderson AS, Gurtman A, Kitchin N. Safety and Immunogenicity of Monovalent Omicron KP.2-Adapted BNT162b2 COVID-19 Vaccine in Adults: Single-Arm Substudy from a Phase 2/3 Trial. Infect Dis Ther. 2025 Aug;14(8):1973-1987. doi: 10.1007/s40121-025-01185-4. Epub 2025 Jul 1.
SSA: A total of 417 participants were assigned, out of which 412 were vaccinated. SSB: A total of 311 participants were assigned and vaccinated. SSC: A total of 321 participants were assigned, out of which 318 were vaccinated. As per study objectives, arms for SSC cohort 1 and 2 have been combined.
Recruitment Details
In this study there were 3 sub-studies: sub-study A (SSA), sub-study B (SSB), and sub-study C (SSC).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
SSA - Group 1: 12-17 Years
Participants aged 12 to 17 years who received at least 3 prior doses of US-authorized messenger RNA (mRNA) coronavirus disease 2019 (COVID-19) vaccine with the most recent dose being the Omicron (Omi) BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 microgram (mcg) via intramuscular (IM) route on Day 1 of this study.
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
Aug 7, 2024
Feb 25, 2026
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
MeSH Terms
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Phase 2/3, controlled study
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Open-label
Who Masked
Not provided
BNT162b2 (Omi JN.1)
Biological
BNT162b2 monovalent (Omicron JN.1)
SSC: Group 3
SSC: Group 4
BNT162b2 (Omi KP.2)
Biological
BNT162b2 monovalent (Omicron KP.2)
SSC - Group 5
From vaccination on Day 1 up to 1 month after vaccination
Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSA
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event.
From vaccination on Day 1 up to 6 months after vaccination
Geometric Mean Titers (GMT) of SARS-CoV-2 Omi XBB.1.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group From Study C4591044
GMTs and 2-sided 95 percentage (%) confidence interval (CIs) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ.
At 1 month after vaccination
GMT of SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group From Study C4591044
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
At 1 month after vaccination
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Omi XBB.1.5-Neutralizing Titers From Before Study Vaccination to 1 Month After Vaccination: SSA and Historical Control of Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group From Study C4591044
GMFRs were defined as geometric mean ratios of the results after vaccination to the results before vaccination. GMFR and 2-sided 95% CI 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.
From before vaccination on Day 1 up to 1 month after vaccination
GMFR of SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group From Study C4591044
GMFRs were defined as geometric mean ratios of the results after vaccination to the results before vaccination. GMFR and 2-sided 95% CI 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.
From before vaccination on Day 1 up to 1 month after vaccination
Percentage of Participants With Seroresponse to SARS-CoV-2 Omi XBB.1.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group From Study C4591044
Seroresponse was defined as achieving >= 4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination assay result of >= 4* LLOQ was considered a seroresponse.
At 1 month after vaccination
Percentage of Participants With Seroresponse to SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group From Study C4591044
Seroresponse was defined as achieving >= 4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination assay result of >= 4* LLOQ was considered a seroresponse.
At 1 month after vaccination
Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSB
Local reactions: pain at injection site, redness and swelling were recorded by participants in an e-diary or as AEs in the CRF. Redness and swelling were recorded in mdu (range:1 to 21), 1 mdu= 0.5 cm and were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] and necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 local reactions were classified by investigator or medically qualified person.
Day 1 to Day 7 after vaccination
Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSB
Systemic events were recorded by participants in an e-diary or as AEs in the CRF. Fever: defined as oral temperature >=38 degree C and categorized as >= 38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Fatigue, headache, chills, new or worsened muscle pain and joint pain were graded as: mild (didn't interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild: 1-2 times in 24h, moderate: >2 times in 24h, severe: required IV hydration. Diarrhea were graded as: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h. Grade 4 for all events except fever: ER visit/hospitalization. Grade 4 systemic events were classified by investigator or medically qualified person.
Day 1 to Day 7 after vaccination
Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSB
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with use of study intervention, whether or not considered related to study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event. AEs included both SAEs and all non-SAEs. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
From vaccination on Day 1 up to 1 month after vaccination
Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSB
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event.
From vaccination on Day 1 up to 6 months after vaccination
Geometric Mean Ratio (GMR) of the SARS-CoV-2 XBB.1.5-Neutralizing Titers 1 Month After BNT162b2 (Omi XBB.1.5) COVID-19 Vaccine-Naive Participants in SSB Versus Vaccine-Experienced Participants in SSA
GMTs / GMRs and 2-sided 95% CIs were calculated by exponentiating the least square (LS) means / difference of LS means and the corresponding CIs based on analysis of log-transformed assay results using a linear regression model with baseline assay results (log scale), age and vaccine group as covariates. Assay results below the LLOQ were set to 0.5*LLOQ. GMT was reported in descriptive section and GMR was reported in statistical analysis section
At 1 month after vaccination
Percentage of Participants and Difference in Percentage of Participants With Seroresponse to the XBB.1.5 Strain 1 Month After BNT162b2 (Omi XBB.1.5) COVID-19 Vaccine Naive Participants in SSB Versus Vaccine-Experienced Participants in SSA
Seroresponse was defined as achieving >=4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination assay result of >= 4* LLOQ was considered a seroresponse. Percentage of participants with seroresponse were reported in descriptive section and difference in percentage of participants with seroresponse in SSB: All Age Groups (Vaccine Naive)- SSA: All Age Groups (Vaccine Experienced Control) were reported in statistical analysis section.
At 1 month after vaccination
Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSC Cohort 2; SSC Cohort 1 and 2 Combined
Local reactions: pain at injection site, redness and swelling were recorded by participants in an e-diary or as AEs in the CRF. Redness and swelling were recorded in mdu (range:1 to 21), 1 mdu= 0.5 cm and were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] and necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 local reactions were classified by investigator or medically qualified person.
Day 1 to Day 7 after vaccination
Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSC Cohort 2; SSC Cohort 1 and 2 Combined
Systemic events were recorded by participants in an e-diary or as AEs in the CRF. Fever: defined as oral temperature >=38 degree C and categorized as >= 38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Fatigue, headache, chills, new or worsened muscle pain and joint pain were graded as: mild (didn't interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild: 1-2 times in 24h, moderate: >2 times in 24h, severe: required IV hydration. Diarrhea were graded as: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h. Grade 4 for all events except fever: ER visit/hospitalization. Grade 4 systemic events were classified by investigator or medically qualified person.
Day 1 to Day 7 after vaccination
Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSC Cohort 2; SSC Cohort 1 and 2 Combined
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with use of study intervention, whether or not considered related to study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event. AEs included both SAEs and all non-SAEs. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
From vaccination on Day 1 up to 1 month after vaccination
Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSC Cohort 2; SSC Cohort 1 and 2 Combined
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event.
From vaccination on Day 1 up to 6 months after vaccination
Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSC Cohort 3
Local reactions: pain at injection site, redness and swelling were recorded by participants in an e-diary or as AEs in the CRF. Redness and swelling were recorded in mdu (range:1 to 21), 1 mdu= 0.5 cm and were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] and necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 local reactions were classified by investigator or medically qualified person.
Day 1 to Day 7 after vaccination
Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSC Cohort 3
Systemic events were recorded by participants in an e-diary or as AEs in the CRF. Fever: defined as oral temperature >=38 deg C and categorized as >= 38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and joint pain: mild (didn't interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild: 1-2 times in 24h, moderate: >2 times in 24h, severe: required IV hydration. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h. Grade 4 for all events except fever: ER visit/hospitalization. Grade 4 events were classified by investigator or medically qualified person.
Day 1 to Day 7 after vaccination
Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSC Cohort 3
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with use of study intervention, whether or not considered related to study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event. AEs included both SAEs and all non-SAEs. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
From vaccination on Day 1 up to 1 month after vaccination
Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSC Cohort 3
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event.
From vaccination on Day 1 up to 6 months after vaccination
GMTs of SARS-CoV-2 Omi JN.1 and XBB.1.5 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohorts 1 + 2 Combined and Historical Control Group From SSA
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
At 1 month after vaccination
GMFR of SARS-CoV-2 Omi JN.1 and XBB.1.5 Variant-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination in SSC Cohorts 1 + 2 Combined and Historical Control Group From SSA
GMFRs were defined as geometric mean ratios of the results after vaccination to the results before 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.
From before Vaccination to 1 month after Vaccination
Percentage of Participants With Seroresponse to SARS-CoV-2 OMI JN.1 and XBB.1.5 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohorts 1 + 2 Combined and Historical Control Group From SSA
Seroresponse was defined as achieving a >=4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, a postvaccination assay result >=4 *LLOQ is considered a seroresponse.
At 1 month after vaccination
GMTs of SARS-CoV-2 Omi KP.2 and Omi JN.1 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohort 3 and SSC Cohorts 1 + 2 Combined as Control
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
At 1 month after vaccination
GMFR of SARS-CoV-2 Omi KP.2 and Omi JN.1 Variant-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination in SSC Cohort 3 and Cohorts 1 + 2 Combined as Control
GMFRs were defined as geometric mean ratios of the results after vaccination to the results before 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.
From before vaccination on Day 1 up to 1 month after vaccination
Percentage of Participants With Seroresponse to SARS-CoV-2 Omi KP.2 and Omi JN.1 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohort 3 and Cohorts 1 + 2 Combined as Control
Seroresponse was defined as achieving a >=4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, a postvaccination assay result >=4 *LLOQ is considered a seroresponse.
At 1 month after vaccination
Huntsville
Alabama
35801
United States
Alliance for Multispecialty Research, LLC
Mobile
Alabama
36608
United States
Epic Medical Research - Surprise
Surprise
Arizona
85378
United States
Alliance for Multispecialty Research, LLC
Tempe
Arizona
85281
United States
West Coast Research
Dublin
California
94568
United States
California Research Foundation
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
Indago Research & Health Center, Inc
Hialeah
Florida
33012
United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City
Utah
84121
United States
Alliance for Multispecialty Research, LLC
Norfolk
Virginia
23502
United States
Derived
Diya O, Gayed J, Lowry FS, Ma H, Bangad V, Mensa F, Zou J, Xie X, Hu Y, Cutler M, Belanger T, Cooper D, Xu X, Koury K, Tureci O, Sahin U, Swanson KA, Modjarrad K, Anderson AS, Gurtman A, Kitchin N. A phase 2/3 trial to investigate the safety and immunogenicity of monovalent Omicron JN.1-adapted BNT162b2 COVID-19 vaccine in adults >/=18 years old. Vaccine. 2025 Apr 11;52:126869. doi: 10.1016/j.vaccine.2025.126869. Epub 2025 Feb 24.
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.
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.
FG001
SSA - Group 2: 18-55 Years
Participants aged 18 to 55 years who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
FG002
SSA - Group 3: >55 Years
Participants aged >55 years who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
FG003
SSB - Group 1: 12-17 Years
Participants aged 12 to 17 years who were previously exposed to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and were COVID-19 vaccine naive were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
FG004
SSB - Group 2: 18-55 Years
Participants aged 18 to 55 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine naive were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
FG005
SSB - Group 3: >55 Years
Participants aged >55 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine naive were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
FG006
SSC - Cohort 2: 12-17 Years
Participants aged 12 to 17 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
FG007
SSC - Cohort 1 and Cohort 2 Combined: 18-55 Years
Participants aged 18 to 55 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
FG008
SSC - Cohort 1 and Cohort 2 Combined: >55 Years
Participants aged >55 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
FG009
SSC - Cohort 3: 18-55 Years
Participants aged 18 to 55 years were assigned to receive a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.
FG010
SSC - Cohort 3: >55 Years
Participants aged >55 years were assigned to receive a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.
FG00030 subjects
FG001177 subjectsParticipants who were assigned to vaccine.
FG002210 subjectsParticipants who were assigned to vaccine.
FG0039 subjects
FG004253 subjects
FG00549 subjects
FG00618 subjects
FG00795 subjectsParticipants who were assigned to vaccine.
FG008106 subjects
FG00951 subjects
FG01051 subjects
Safety Population
Safety population: all participants who received the study intervention.
FG00030 subjects
FG001174 subjects
FG002208 subjects
FG0039 subjects
FG004253 subjects
FG00549 subjects
FG00618 subjects
FG00792 subjects
FG008106 subjects
FG00951 subjects
FG01051 subjects
Evaluable Immunogenicity Population
Evaluable immunogenicity population (EIP): all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician.
FG00027 subjects
FG001167 subjects
FG002188 subjects
FG0039 subjects
FG004243 subjects
FG00547 subjects
FG00618 subjects
FG00791 subjects
FG008103 subjects
FG00950 subjects
FG01050 subjects
COMPLETED
FG00029 subjects
FG001172 subjects
FG002203 subjects
FG0039 subjects
FG004225 subjects
FG00544 subjects
FG00618 subjects
FG00787 subjects
FG008100 subjects
FG00948 subjects
FG01049 subjects
NOT COMPLETED
FG0001 subjects
FG0015 subjects
FG0027 subjects
FG0030 subjects
FG00428 subjects
FG0055 subjects
FG0060 subjects
FG0078 subjects
FG0086 subjects
FG0093 subjects
FG0102 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG0046 subjects
FG0051 subjects
FG0060 subjects
FG0072 subjects
FG0081 subjects
FG0091 subjects
FG0100 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Assigned but not vaccinated
FG0000 subjects
FG0013 subjects
FG0022 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Baseline analysis population was evaluated on safety population which included all participants who received the study intervention.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
SSA - Group 1: 12-17 Years
Participants aged 12 to 17 years who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study
BG001
SSA - Group 2: 18-55 Years
Participants aged 18 to 55 years who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
BG002
SSA - Group 3: >55 Years
Participants aged >55 years who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
BG003
SSB - Group 1: 12-17 Years
Participants aged 12 to 17 years who were previously exposed to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and were COVID-19 vaccine naive were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
BG004
SSB - Group 2: 18-55 Years
Participants aged 18 to 55 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine naive were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
BG005
SSB - Group 3: >55 Years
Participants aged >55 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine naive were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
BG006
SSC - Cohort 2: 12-17 Years
Participants aged 12 to 17 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
BG007
SSC - Cohort 1 and Cohort 2 Combined: 18-55 Years
Participants aged 18 to 55 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
BG008
SSC - Cohort 1 and Cohort 2 Combined: >55 Years
Participants aged >55 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
BG009
SSC - Cohort 3: 18-55 Years
Participants aged 18 to 55 years were assigned to receive a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.
BG010
SSC - Cohort 3: >55 Years
Participants aged >55 years were assigned to receive a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.
BG011
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00030
BG001174
BG002208
BG0039
BG004253
BG00549
BG00618
BG00792
BG008106
BG00951
BG01051
BG0111041
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
Age
Title
Measurements
12-17 Years
BG00030
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00019
BG001100
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0006
BG00135
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
Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSA
Local reactions: pain at injection site, redness and swelling were recorded by participants in an electronic diary (e-diary) or as adverse events (AEs) in the case report form (CRF). Redness and swelling were recorded in measuring device units (mdu) (range: 1 to 21), 1 mdu =0.5 centimeter (cm) and were graded as mild (greater than [>] 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] and necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (emergency room [ER] visit or hospitalization for severe pain at injection site). Grade 4 local reactions were classified by investigator or medically qualified person.
Safety population included all participants who received the study intervention. Here, "Overall Number of Participants Analyzed" signifies number of participants reporting at least 1 response in the e-diary.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after vaccination
ID
Title
Description
OG000
SSA - Group 1: 12-17 Years
Participants aged 12 to 17 years who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study
OG001
SSA - Group 2: 18-55 Years
Participants aged 18 to 55 years who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
OG002
SSA - Group 3: >55 Years
Participants aged >55 years who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omicron BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
OG003
SSA - All Age Groups
Participants with any age >=12 years of SSA who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
Units
Counts
Participants
OG00030
OG001174
OG002206
OG003
Title
Denominators
Categories
Redness: Any
Title
Measurements
OG00010.0(2.1 to 26.5)
OG0014.0(1.6 to 8.1)
OG0025.8(3.0 to 10.0)
OG003
Primary
Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSA
Systemic events were recorded by participants in an e-diary or as AEs in the CRF. Fever: defined as oral temperature more than or equal to (>=38) degree Celsius (C) and categorized as >= 38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Fatigue, headache, chills, new or worsened muscle pain and joint pain were graded as: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild: 1-2 times in 24 hours (h), moderate: >2 times in 24h, severe: required intravenous (IV) hydration. Diarrhea was graded as: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h. Grade 4 for all events except fever: ER visit/hospitalization. Grade 4 systemic events were classified by investigator or medically qualified person.
Safety population included all participants who received the study intervention. Here, "Overall Number of Participants Analyzed" signifies number of participants reporting at least 1 response in the e-diary.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after vaccination
ID
Title
Description
OG000
SSA - Group 1: 12-17 Years
Participants aged 12 to 17 years who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study
Primary
Percentage of Participants With Adverse Events (AEs) From Vaccination Through 1 Month After Vaccination: SSA
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with use of study intervention, whether or not considered related to study intervention. A serious AE (SAE) was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event. AEs included both SAEs and all non-SAEs. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Safety population included all participants who received the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From vaccination on Day 1 up to 1 month after vaccination
ID
Title
Description
OG000
SSA - Group 1: 12-17 Years
Participants aged 12 to 17 years who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study
OG001
SSA - Group 2: 18-55 Years
Primary
Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSA
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event.
Safety population included all participants who received the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From vaccination on Day 1 up to 6 months after vaccination
ID
Title
Description
OG000
SSA - Group 1: 12-17 Years
Participants aged 12 to 17 years who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study
OG001
SSA - Group 2: 18-55 Years
Participants aged 18 to 55 years who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
Primary
Geometric Mean Titers (GMT) of SARS-CoV-2 Omi XBB.1.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group From Study C4591044
GMTs and 2-sided 95 percentage (%) confidence interval (CIs) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ.
For C4591054: EIP was analyzed. Here, "Overall Number of Participants Analyzed" = participants with valid and determinate assay results in EIP. For C4591044: Historical data from Cohort 2/ 3 matched to the relevant evaluation time point was used as control for this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
Titer
At 1 month after vaccination
ID
Title
Description
OG000
SSA - Group 1: 12-17 Years
Participants aged 12 to 17 years who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study
OG001
SSA - Group 2: 18-55 Years
Participants aged 18 to 55 years who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
Primary
GMT of SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group From Study C4591044
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
For C4591054: EIP was analyzed. Here, "Overall Number of Participants Analyzed" = participants with valid and determinate assay results in EIP. For C4591044: Historical data from Cohort 2/ 3 matched to the relevant evaluation time point was used as control for this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
Titer
At 1 month after vaccination
ID
Title
Description
OG000
SSA - Group 1: 12-17 Years
Participants aged 12 to 17 years who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study
OG001
SSA - Group 2: 18-55 Years
Participants aged 18 to 55 years who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
Primary
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Omi XBB.1.5-Neutralizing Titers From Before Study Vaccination to 1 Month After Vaccination: SSA and Historical Control of Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group From Study C4591044
GMFRs were defined as geometric mean ratios of the results after vaccination to the results before vaccination. GMFR and 2-sided 95% CI 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.
For C4591054: EIP was analyzed. Here, "Overall Number of Participants Analyzed" = participants with valid and determinate assay results in EIP. For C4591044: Historical data from Cohort 2/ 3 matched to the relevant evaluation time point was used as control for this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
Fold rise
From before vaccination on Day 1 up to 1 month after vaccination
ID
Title
Description
OG000
SSA - Group 1: 12-17 Years
Participants aged 12 to 17 years who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study
OG001
SSA - Group 2: 18-55 Years
Participants aged 18 to 55 years who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
Primary
GMFR of SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group From Study C4591044
GMFRs were defined as geometric mean ratios of the results after vaccination to the results before vaccination. GMFR and 2-sided 95% CI 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.
For C4591054: EIP was analyzed. Here, "Overall Number of Participants Analyzed" = participants with valid and determinate assay results in EIP. For C4591044: Historical data from Cohort 2/ 3 matched to the relevant evaluation time point was used as control for this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
Fold rise
From before vaccination on Day 1 up to 1 month after vaccination
ID
Title
Description
OG000
SSA - Group 1: 12-17 Years
Participants aged 12 to 17 years who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study
OG001
SSA - Group 2: 18-55 Years
Participants aged 18 to 55 years who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
Primary
Percentage of Participants With Seroresponse to SARS-CoV-2 Omi XBB.1.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group From Study C4591044
Seroresponse was defined as achieving >= 4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination assay result of >= 4* LLOQ was considered a seroresponse.
For C4591054: EIP was analyzed. Here, "Overall Number of Participants Analyzed" = participants with valid and determinate assay results in EIP. For C4591044: Historical data from Cohort 2/ 3 matched to the relevant evaluation time point was used as control for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
At 1 month after vaccination
ID
Title
Description
OG000
SSA - Group 1: 12-17 Years
Participants aged 12 to 17 years who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study
OG001
SSA - Group 2: 18-55 Years
Participants aged 18 to 55 years who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
Primary
Percentage of Participants With Seroresponse to SARS-CoV-2 Omi BA.4/BA.5-Neutralizing Titers at 1 Month After Vaccination: SSA and Historical Control of the Bivalent BNT162b2 (WT/Omi BA.4/BA.5) Group From Study C4591044
Seroresponse was defined as achieving >= 4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination assay result of >= 4* LLOQ was considered a seroresponse.
For C4591054: EIP was analyzed. Here, "Overall Number of Participants Analyzed" = participants with valid and determinate assay results in EIP. For C4591044: Historical data from Cohort 2/ 3 matched to the relevant evaluation time point was used as control for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
At 1 month after vaccination
ID
Title
Description
OG000
SSA - Group 1: 12-17 Years
Participants aged 12 to 17 years who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study
OG001
SSA - Group 2: 18-55 Years
Participants aged 18 to 55 years who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
Primary
Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSB
Local reactions: pain at injection site, redness and swelling were recorded by participants in an e-diary or as AEs in the CRF. Redness and swelling were recorded in mdu (range:1 to 21), 1 mdu= 0.5 cm and were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] and necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 local reactions were classified by investigator or medically qualified person.
Safety population included all participants who received the study intervention. Here, "Overall Number of Participants Analyzed" signifies number of participants reporting at least 1 response in the e-diary.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after vaccination
ID
Title
Description
OG000
SSB - Group 1: 12-17 Years
Participants aged 12 to 17 years who were previously exposed to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and were COVID-19 vaccine naive were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
OG001
SSB - Group 2: 18-55 Years
Participants aged 18 to 55 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine naive were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
Primary
Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSB
Systemic events were recorded by participants in an e-diary or as AEs in the CRF. Fever: defined as oral temperature >=38 degree C and categorized as >= 38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Fatigue, headache, chills, new or worsened muscle pain and joint pain were graded as: mild (didn't interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild: 1-2 times in 24h, moderate: >2 times in 24h, severe: required IV hydration. Diarrhea were graded as: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h. Grade 4 for all events except fever: ER visit/hospitalization. Grade 4 systemic events were classified by investigator or medically qualified person.
Safety population included all participants who received the study intervention. Here, "Overall Number of Participants Analyzed" signifies number of participants reporting at least 1 response in the e-diary.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after vaccination
ID
Title
Description
OG000
SSB - Group 1: 12-17 Years
Participants aged 12 to 17 years who were previously exposed to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and were COVID-19 vaccine naive were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
OG001
SSB - Group 2: 18-55 Years
Primary
Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSB
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with use of study intervention, whether or not considered related to study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event. AEs included both SAEs and all non-SAEs. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Safety population included all participants who received the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From vaccination on Day 1 up to 1 month after vaccination
ID
Title
Description
OG000
SSB - Group 1: 12-17 Years
Participants aged 12 to 17 years who were previously exposed to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and were COVID-19 vaccine naive were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
OG001
SSB - Group 2: 18-55 Years
Participants aged 18 to 55 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine naive were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
Primary
Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSB
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event.
Safety population included all participants who received the study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From vaccination on Day 1 up to 6 months after vaccination
ID
Title
Description
OG000
SSB - Group 1: 12-17 Years
Participants aged 12 to 17 years who were previously exposed to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and were COVID-19 vaccine naive were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
OG001
SSB - Group 2: 18-55 Years
Participants aged 18 to 55 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine naive were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
Primary
Geometric Mean Ratio (GMR) of the SARS-CoV-2 XBB.1.5-Neutralizing Titers 1 Month After BNT162b2 (Omi XBB.1.5) COVID-19 Vaccine-Naive Participants in SSB Versus Vaccine-Experienced Participants in SSA
GMTs / GMRs and 2-sided 95% CIs were calculated by exponentiating the least square (LS) means / difference of LS means and the corresponding CIs based on analysis of log-transformed assay results using a linear regression model with baseline assay results (log scale), age and vaccine group as covariates. Assay results below the LLOQ were set to 0.5*LLOQ. GMT was reported in descriptive section and GMR was reported in statistical analysis section
EIP included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. Here, "Overall Number of Participants Analyzed" signifies participants with valid and determinate assay results in EIP.
Posted
Geometric Mean
95% Confidence Interval
Titer
At 1 month after vaccination
ID
Title
Description
OG000
SSB: All Age Groups (Vaccine Naive)
Participants aged >=12 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine-naïve were randomized to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 in SSB.
OG001
SSA: All Age Groups (Vaccine Experienced Control)
Primary
Percentage of Participants and Difference in Percentage of Participants With Seroresponse to the XBB.1.5 Strain 1 Month After BNT162b2 (Omi XBB.1.5) COVID-19 Vaccine Naive Participants in SSB Versus Vaccine-Experienced Participants in SSA
Seroresponse was defined as achieving >=4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination assay result of >= 4* LLOQ was considered a seroresponse. Percentage of participants with seroresponse were reported in descriptive section and difference in percentage of participants with seroresponse in SSB: All Age Groups (Vaccine Naive)- SSA: All Age Groups (Vaccine Experienced Control) were reported in statistical analysis section.
EIP included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. Here, "Overall Number of Participants Analyzed" signifies participants with valid and determinate assay results in EIP.
Posted
Number
95% Confidence Interval
Percentage of participants
At 1 month after vaccination
ID
Title
Description
OG000
SSB: All Age Groups (Vaccine Naive)
Participants aged >=12 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine-naïve were randomized to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 in SSB.
OG001
Primary
Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSC Cohort 2; SSC Cohort 1 and 2 Combined
Local reactions: pain at injection site, redness and swelling were recorded by participants in an e-diary or as AEs in the CRF. Redness and swelling were recorded in mdu (range:1 to 21), 1 mdu= 0.5 cm and were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] and necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 local reactions were classified by investigator or medically qualified person.
Safety population included all participants who received study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after vaccination
ID
Title
Description
OG000
SSC - Cohort 2: 12-17 Years
Participants aged 12 to 17 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
OG001
SSC - Cohort 1 and Cohort 2 Combined: 18-55 Years
Participants aged 18 to 55 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
Primary
Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSC Cohort 2; SSC Cohort 1 and 2 Combined
Systemic events were recorded by participants in an e-diary or as AEs in the CRF. Fever: defined as oral temperature >=38 degree C and categorized as >= 38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Fatigue, headache, chills, new or worsened muscle pain and joint pain were graded as: mild (didn't interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild: 1-2 times in 24h, moderate: >2 times in 24h, severe: required IV hydration. Diarrhea were graded as: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h. Grade 4 for all events except fever: ER visit/hospitalization. Grade 4 systemic events were classified by investigator or medically qualified person.
Safety population included all participants who received study intervention. Here "Number Analyzed" signifies participants evaluable at specific events.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after vaccination
ID
Title
Description
OG000
SSC - Cohort 2: 12-17 Years
Participants aged 12 to 17 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
OG001
SSC - Cohort 1 and Cohort 2 Combined: 18-55 Years
Primary
Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSC Cohort 2; SSC Cohort 1 and 2 Combined
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with use of study intervention, whether or not considered related to study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event. AEs included both SAEs and all non-SAEs. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Safety population included all participants who received study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From vaccination on Day 1 up to 1 month after vaccination
ID
Title
Description
OG000
SSC - Cohort 2: 12-17 Years
Participants aged 12 to 17 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
OG001
SSC - Cohort 1 and Cohort 2 Combined: 18-55 Years
Participants aged 18 to 55 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
Primary
Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSC Cohort 2; SSC Cohort 1 and 2 Combined
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event.
Safety population included all participants who received study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From vaccination on Day 1 up to 6 months after vaccination
ID
Title
Description
OG000
SSC - Cohort 2: 12-17 Years
Participants aged 12 to 17 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
OG001
SSC - Cohort 1 and Cohort 2 Combined: 18-55 Years
Participants aged 18 to 55 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
OG002
Primary
Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSC Cohort 3
Local reactions: pain at injection site, redness and swelling were recorded by participants in an e-diary or as AEs in the CRF. Redness and swelling were recorded in mdu (range:1 to 21), 1 mdu= 0.5 cm and were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] and necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 local reactions were classified by investigator or medically qualified person.
Safety population included all participants who received study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after vaccination
ID
Title
Description
OG000
SSC - Cohort 3: 18-55 Years
Participants aged 18 to 55 years were assigned to receive a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.
OG001
SSC - Cohort 3: >55 Years
Participants aged >55 years were assigned to receive a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.
OG002
Primary
Percentage of Participants With Systemic Events Within 7 Days After Vaccination: SSC Cohort 3
Systemic events were recorded by participants in an e-diary or as AEs in the CRF. Fever: defined as oral temperature >=38 deg C and categorized as >= 38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and joint pain: mild (didn't interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild: 1-2 times in 24h, moderate: >2 times in 24h, severe: required IV hydration. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h, severe: 6 or more loose stools in 24h. Grade 4 for all events except fever: ER visit/hospitalization. Grade 4 events were classified by investigator or medically qualified person.
Safety population included all participants who received study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 to Day 7 after vaccination
ID
Title
Description
OG000
SSC - Cohort 3: 18-55 Years
Participants aged 18 to 55 years were assigned to receive a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.
OG001
SSC - Cohort 3: >55 Years
Participants aged >55 years were assigned to receive a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.
Primary
Percentage of Participants With AEs From Vaccination Through 1 Month After Vaccination: SSC Cohort 3
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with use of study intervention, whether or not considered related to study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event. AEs included both SAEs and all non-SAEs. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Safety population included all participants who received study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From vaccination on Day 1 up to 1 month after vaccination
ID
Title
Description
OG000
SSC - Cohort 3: 18-55 Years
Participants aged 18 to 55 years were assigned to receive a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.
OG001
SSC - Cohort 3: >55 Years
Participants aged >55 years were assigned to receive a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.
Primary
Percentage of Participants With SAEs From Vaccination Through 6 Months After the Study Vaccination: SSC Cohort 3
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect, any other event pre-specified in protocol of the study; or considered as an important medical event.
Safety population included all participants who received study intervention.
Posted
Number
95% Confidence Interval
Percentage of participants
From vaccination on Day 1 up to 6 months after vaccination
ID
Title
Description
OG000
SSC - Cohort 3: 18-55 Years
Participants aged 18 to 55 years were assigned to receive a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.
OG001
SSC - Cohort 3: >55 Years
Participants aged >55 years were assigned to receive a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.
OG002
SSC- Cohort 3 Combined: All Age Groups
Primary
GMTs of SARS-CoV-2 Omi JN.1 and XBB.1.5 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohorts 1 + 2 Combined and Historical Control Group From SSA
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
EIP included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. Here, "Number Analyzed" signifies participants evaluable for specific variant.
Posted
Geometric Mean
95% Confidence Interval
Titers
At 1 month after vaccination
ID
Title
Description
OG000
SSC - Cohort 2: 12-17 Years
Participants aged 12 to 17 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
OG001
SSC - Cohort 1 and Cohort 2 Combined: 18-55 Years
Participants aged 18 to 55 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
OG002
SSC - Cohort 1 and Cohort 2 Combined: >55 Years
Primary
GMFR of SARS-CoV-2 Omi JN.1 and XBB.1.5 Variant-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination in SSC Cohorts 1 + 2 Combined and Historical Control Group From SSA
GMFRs were defined as geometric mean ratios of the results after vaccination to the results before 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.
EIP included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician.Here, "Number Analyzed" signifies participants evaluable for specific variant.
Posted
Geometric Mean
95% Confidence Interval
Fold rise
From before Vaccination to 1 month after Vaccination
ID
Title
Description
OG000
SSC - Cohort 2: 12-17 Years
Participants aged 12 to 17 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
OG001
SSC - Cohort 1 and Cohort 2 Combined: 18-55 Years
Participants aged 18 to 55 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
Primary
Percentage of Participants With Seroresponse to SARS-CoV-2 OMI JN.1 and XBB.1.5 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohorts 1 + 2 Combined and Historical Control Group From SSA
Seroresponse was defined as achieving a >=4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, a postvaccination assay result >=4 *LLOQ is considered a seroresponse.
EIP included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. Here, "Number Analyzed" signifies participants evaluable for specific variant
Posted
Number
95% Confidence Interval
Percentage of participants
At 1 month after vaccination
ID
Title
Description
OG000
SSC - Cohort 2: 12-17 Years
Participants aged 12 to 17 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
OG001
SSC - Cohort 1 and Cohort 2 Combined: 18-55 Years
Participants aged 18 to 55 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
OG002
Primary
GMTs of SARS-CoV-2 Omi KP.2 and Omi JN.1 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohort 3 and SSC Cohorts 1 + 2 Combined as Control
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
EIP included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. SSC combined cohorts 1 and 2 acted as control for this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
Titer
At 1 month after vaccination
ID
Title
Description
OG000
SSC - Cohort 3: 18-55 Years
Participants aged 18 to 55 years were assigned to receive a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.
OG001
SSC - Cohort 3: >55 Years
Participants aged >55 years were assigned to receive a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.
OG002
SSC- Cohort 3 Combined: All Age Groups
Primary
GMFR of SARS-CoV-2 Omi KP.2 and Omi JN.1 Variant-Neutralizing Titers From Before Vaccination to 1 Month After Vaccination in SSC Cohort 3 and Cohorts 1 + 2 Combined as Control
GMFRs were defined as geometric mean ratios of the results after vaccination to the results before 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.
EIP included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. Here, 'Number Analyzed' signifies number of participants evaluable for the specific variants. SSC combined cohorts 1 and 2 acted as control for this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
Fold rise
From before vaccination on Day 1 up to 1 month after vaccination
ID
Title
Description
OG000
SSC - Cohort 3: 18-55 Years
Participants aged 18 to 55 years were assigned to receive a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.
OG001
SSC - Cohort 3: >55 Years
Participants aged >55 years were assigned to receive a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.
Primary
Percentage of Participants With Seroresponse to SARS-CoV-2 Omi KP.2 and Omi JN.1 Variant-Neutralizing Titers at 1 Month After Vaccination in SSC Cohort 3 and Cohorts 1 + 2 Combined as Control
Seroresponse was defined as achieving a >=4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, a postvaccination assay result >=4 *LLOQ is considered a seroresponse.
EIP included all eligible assigned participants who received the study intervention to which they were assigned, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 28 to 42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. Here, "Number Analyzed" signifies participants evaluable for specific variant
Posted
Number
95% Confidence Interval
Percentage of participants
At 1 month after vaccination
ID
Title
Description
OG000
SSC - Cohort 3: 18-55 Years
Participants aged 18 to 55 years were assigned to receive a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.
OG001
SSC - Cohort 3: >55 Years
Participants aged >55 years were assigned to receive a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.
OG002
SSC- Cohort 3 Combined: All Age Groups
Time Frame
Local reactions and systemic events by systematic assessment: Day 1 to Day 7 after vaccination; Non-systematic assessment: SAEs and all-cause mortality = from Day 1 of vaccination up to 6 months after vaccination and Non-SAEs = from Day 1 of vaccination up to 1 month after vaccination
Description
Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population included all participants who received the study intervention.
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
SSA - Group 1: 12-17 Years
Participants aged 12 to 17 years who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study
0
30
1
30
27
30
EG001
SSA - Group 2: 18-55 Years
Participants aged 18 to 55 years who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
0
174
0
174
154
174
EG002
SSA - Group 3: >55 Years
Participants aged >55 years who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omicron BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
1
208
4
208
134
208
EG003
SSB - Group 1: 12-17 Years
Participants aged 12 to 17 years who were previously exposed to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and were COVID-19 vaccine naive were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
0
9
0
9
4
9
EG004
SSB - Group 2: 18-55 Years
Participants aged 18 to 55 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine naive were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
0
253
2
253
166
253
EG005
SSB - Group 3: >55 Years
Participants aged >55 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine naive were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
0
49
1
49
25
49
EG006
SSC - Cohort 2: 12-17 Years
Participants aged 12 to 17 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
0
18
0
18
16
18
EG007
SSC - Cohort 1 and Cohort 2 Combined: 18-55 Years
Participants aged 18 to 55 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
0
92
1
92
77
92
EG008
SSC - Cohort 1 and Cohort 2 Combined: >55 Years
Participants aged >55 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
1
106
3
106
66
106
EG009
SSC - Cohort 3: 18-55 Years
Participants aged 18 to 55 years were assigned to receive a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.
0
51
0
51
43
51
EG010
SSC - Cohort 3: >55 Years
Participants aged >55 years were assigned to receive a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.
0
51
1
51
35
51
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cardiac arrest
Cardiac disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0021 affected208 at risk
EG0030 affected9 at risk
EG004
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0021 affected208 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0021 affected208 at risk
EG003
Paroxysmal nocturnal haemoglobinuria
Renal and urinary disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0021 affected208 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0021 affected208 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0001 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Invasive lobular breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0021 affected208 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Viral infection
Infections and infestations
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0012 affected174 at risk
EG0020 affected208 at risk
EG0030 affected9 at risk
EG004
Headache (HEADACHE)
Nervous system disorders
MedDRA 27.1
Systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG00011 affected30 at risk
EG00176 affected174 at risk
EG00254 affected208 at risk
EG003
Restless arm syndrome
Nervous system disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0001 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0013 affected174 at risk
EG0020 affected208 at risk
EG003
Diarrhoea (DIARRHEA)
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG00121 affected174 at risk
EG00218 affected208 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0012 affected174 at risk
EG0020 affected208 at risk
EG003
Vomiting (VOMITING)
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0014 affected174 at risk
EG0020 affected208 at risk
EG003
Arthralgia (JOINT PAIN)
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0005 affected30 at risk
EG00125 affected174 at risk
EG00216 affected208 at risk
EG003
Myalgia (MUSCLE PAIN)
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0007 affected30 at risk
EG00138 affected174 at risk
EG00225 affected208 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0001 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Sialoadenitis
Infections and infestations
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0001 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Chills (CHILLS)
General disorders
MedDRA 27.1
Systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0006 affected30 at risk
EG00116 affected174 at risk
EG00219 affected208 at risk
EG003
Fatigue
General disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0012 affected174 at risk
EG0022 affected208 at risk
EG003
Fatigue (FATIGUE)
General disorders
MedDRA 27.1
Systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG00017 affected30 at risk
EG00199 affected174 at risk
EG00273 affected208 at risk
EG003
Injection site erythema (REDNESS)
General disorders
MedDRA 27.1
Systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0003 affected30 at risk
EG0017 affected174 at risk
EG00212 affected208 at risk
EG003
Injection site pain
General disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0024 affected208 at risk
EG003
Injection site pain (PAIN)
General disorders
MedDRA 27.1
Systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG00024 affected30 at risk
EG001132 affected174 at risk
EG002107 affected208 at risk
EG003
Injection site pruritus
General disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0001 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Injection site swelling (SWELLING)
General disorders
MedDRA 27.1
Systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0005 affected30 at risk
EG00113 affected174 at risk
EG00212 affected208 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0012 affected174 at risk
EG0021 affected208 at risk
EG003
Pyrexia (FEVER)
General disorders
MedDRA 27.1
Systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0005 affected30 at risk
EG0017 affected174 at risk
EG0028 affected208 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0001 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Heavy menstrual bleeding
Reproductive system and breast disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0001 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Depression
Psychiatric disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0001 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Axillary pain
General disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Pyrexia
General disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Ear disorder
Ear and labyrinth disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Ear infection
Infections and infestations
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 at risk
EG003
Breast tenderness
Reproductive system and breast disorders
MedDRA 27.1
Non-systematic Assessment
MedDRA version 26.1 was used for SSA and SSB Cohorts. MedDRA v27.1 was used for SSC Cohort.
EG0000 affected30 at risk
EG0010 affected174 at risk
EG0020 affected208 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
Sponsor (or its agents) 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 18 to 55 years who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
OG002
SSA - Group 3: >55 Years
Participants aged >55 years who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omicron BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
OG003
SSA - All Age Groups
Participants with any age >=12 years of SSA who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
Units
Counts
Participants
OG00030
OG001174
OG002206
OG003410
Title
Denominators
Categories
Fever: Any
Title
Measurements
OG00016.7(5.6 to 34.7)
OG0014.0(1.6 to 8.1)
OG0023.9(1.7 to 7.5)
OG0034.9(3.0 to 7.4)
Fever: >=38.0 degree C to 38.4 degree C
Title
Measurements
OG00010.0(2.1 to 26.5)
OG0013.4(1.3 to 7.4)
OG0022.4(0.8 to 5.6)
OG003
Fever: >38.4 degree C to 38.9 degree C
Title
Measurements
OG0003.3(0.1 to 17.2)
OG0010.6(0.0 to 3.2)
OG0021.0(0.1 to 3.5)
OG003
Fever: >38.9 degree C to 40.0 degree C
Title
Measurements
OG0003.3(0.1 to 17.2)
OG0010(0.0 to 2.1)
OG0020.5(0.0 to 2.7)
OG003
Fever: >40.0 degree C
Title
Measurements
OG0000(0.0 to 11.6)
OG0010(0.0 to 2.1)
OG0020(0.0 to 1.8)
OG003
Fatigue: Any
Title
Measurements
OG00056.7(37.4 to 74.5)
OG00156.9(49.2 to 64.4)
OG00235.4(28.9 to 42.4)
OG003
Fatigue: Mild
Title
Measurements
OG00030.0(14.7 to 49.4)
OG00131.6(24.8 to 39.1)
OG00218.4(13.4 to 24.4)
OG003
Fatigue: Moderate
Title
Measurements
OG00026.7(12.3 to 45.9)
OG00124.1(18.0 to 31.2)
OG00217.0(12.1 to 22.8)
OG003
Fatigue: Severe
Title
Measurements
OG0000(0.0 to 11.6)
OG0011.1(0.1 to 4.1)
OG0020(0.0 to 1.8)
OG003
Fatigue: Grade 4
Title
Measurements
OG0000(0.0 to 11.6)
OG0010(0.0 to 2.1)
OG0020(0.0 to 1.8)
OG003
Headache: Any
Title
Measurements
OG00036.7(19.9 to 56.1)
OG00143.7(36.2 to 51.4)
OG00226.2(20.3 to 32.8)
OG003
Headache: Mild
Title
Measurements
OG00030.0(14.7 to 49.4)
OG00131.0(24.3 to 38.5)
OG00220.4(15.1 to 26.5)
OG003
Headache: Moderate
Title
Measurements
OG0006.7(0.8 to 22.1)
OG00112.6(8.1 to 18.5)
OG0025.8(3.0 to 10.0)
OG003
Headache: Severe
Title
Measurements
OG0000(0.0 to 11.6)
OG0010(0.0 to 2.1)
OG0020(0.0 to 1.8)
OG003
Headache: Grade 4
Title
Measurements
OG0000(0.0 to 11.6)
OG0010(0.0 to 2.1)
OG0020(0.0 to 1.8)
OG003
Chills: Any
Title
Measurements
OG00020.0(7.7 to 38.6)
OG0019.2(5.3 to 14.5)
OG0029.2(5.6 to 14.0)
OG003
Chills: Mild
Title
Measurements
OG00010.0(2.1 to 26.5)
OG0016.9(3.6 to 11.7)
OG0026.3(3.4 to 10.5)
OG003
Chills: Moderate
Title
Measurements
OG00010.0(2.1 to 26.5)
OG0012.3(0.6 to 5.8)
OG0022.9(1.1 to 6.2)
OG003
Chills: Severe
Title
Measurements
OG0000(0.0 to 11.6)
OG0010(0.0 to 2.1)
OG0020(0.0 to 1.8)
OG003
Chills: Grade 4
Title
Measurements
OG0000(0.0 to 11.6)
OG0010(0.0 to 2.1)
OG0020(0.0 to 1.8)
OG003
Vomiting: Any
Title
Measurements
OG0000(0.0 to 11.6)
OG0012.3(0.6 to 5.8)
OG0020(0.0 to 1.8)
OG003
Vomiting: Mild
Title
Measurements
OG0000(0.0 to 11.6)
OG0012.3(0.6 to 5.8)
OG0020(0.0 to 1.8)
OG003
Vomiting: Moderate
Title
Measurements
OG0000(0.0 to 11.6)
OG0010(0.0 to 2.1)
OG0020(0.0 to 1.8)
OG003
Vomiting: Severe
Title
Measurements
OG0000(0.0 to 11.6)
OG0010(0.0 to 2.1)
OG0020(0.0 to 1.8)
OG003
Vomiting: Grade 4
Title
Measurements
OG0000(0.0 to 11.6)
OG0010(0.0 to 2.1)
OG0020(0.0 to 1.8)
OG003
Diarrhea: Any
Title
Measurements
OG0000(0.0 to 11.6)
OG00113.2(8.6 to 19.2)
OG0028.7(5.3 to 13.5)
OG003
Diarrhea: Mild
Title
Measurements
OG0000(0.0 to 11.6)
OG00111.5(7.2 to 17.2)
OG0027.3(4.1 to 11.7)
OG003
Diarrhea: Moderate
Title
Measurements
OG0000(0.0 to 11.6)
OG0011.1(0.1 to 4.1)
OG0021.5(0.3 to 4.2)
OG003
Diarrhea: Severe
Title
Measurements
OG0000(0.0 to 11.6)
OG0010.6(0.0 to 3.2)
OG0020(0.0 to 1.8)
OG003
Diarrhea: Grade 4
Title
Measurements
OG0000(0.0 to 11.6)
OG0010(0.0 to 2.1)
OG0020(0.0 to 1.8)
OG003
New or worsened muscle pain: Any
Title
Measurements
OG00023.3(9.9 to 42.3)
OG00121.8(15.9 to 28.7)
OG00212.1(8.0 to 17.4)
OG003
New or worsened muscle pain: Mild
Title
Measurements
OG0003.3(0.1 to 17.2)
OG00112.1(7.6 to 17.9)
OG0025.3(2.7 to 9.4)
OG003
New or worsened muscle pain: Moderate
Title
Measurements
OG00020.0(7.7 to 38.6)
OG0019.8(5.8 to 15.2)
OG0026.8(3.8 to 11.1)
OG003
New or worsened muscle pain: Severe
Title
Measurements
OG0000(0.0 to 11.6)
OG0010(0.0 to 2.1)
OG0020(0.0 to 1.8)
OG003
New or worsened muscle pain: Grade 4
Title
Measurements
OG0000(0.0 to 11.6)
OG0010(0.0 to 2.1)
OG0020(0.0 to 1.8)
OG003
New or worsened joint pain: Any
Title
Measurements
OG00016.7(5.6 to 34.7)
OG00114.4(9.5 to 20.5)
OG0027.8(4.5 to 12.3)
OG003
New or worsened joint pain: Mild
Title
Measurements
OG0006.7(0.8 to 22.1)
OG0018.6(4.9 to 13.8)
OG0025.3(2.7 to 9.4)
OG003
New or worsened joint pain: Moderate
Title
Measurements
OG00010.0(2.1 to 26.5)
OG0015.7(2.8 to 10.3)
OG0022.4(0.8 to 5.6)
OG003
New or worsened joint pain: Severe
Title
Measurements
OG0000(0.0 to 11.6)
OG0010(0.0 to 2.1)
OG0020(0.0 to 1.8)
OG003
New or worsened joint pain: Grade 4
Title
Measurements
OG0000(0.0 to 11.6)
OG0010(0.0 to 2.1)
OG0020(0.0 to 1.8)
OG003
Participants aged 18 to 55 years who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
OG002
SSA - Group 3: >55 Years
Participants aged >55 years who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omicron BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
OG003
SSA - All Age Groups
Participants with any age >=12 years of SSA who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
Units
Counts
Participants
OG00030
OG001174
OG002208
OG003412
Title
Denominators
Categories
Title
Measurements
OG00016.7(5.6 to 34.7)
OG0017.5(4.0 to 12.4)
OG0028.2(4.8 to 12.8)
OG0038.5(6.0 to 11.6)
OG002
SSA - Group 3: >55 Years
Participants aged >55 years who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omicron BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
OG003
SSA - All Age Groups
Participants with any age >=12 years of SSA who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
Units
Counts
Participants
OG00030
OG001174
OG002208
OG003412
Title
Denominators
Categories
Title
Measurements
OG0003.3(0.1 to 17.2)
OG0010(0.0 to 2.1)
OG0021.9(0.5 to 4.9)
OG0031.2(0.4 to 2.8)
OG002
SSA - Group 3: >55 Years
Participants aged >55 years who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omicron BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
OG003
Cohort 2/ 3 From C4591044 - Historical Control: 12-17 Years
Participants aged 12 to 17 years from Cohort 2/ 3 the C4591044 (NCT05472038) who received BNT162b2 (WT/Omi BA.4/BA.5) 30 mcg as fourth dose were included in this reporting group. Participants included in this arm were not enrolled in the study, only their relevant historical data was used as a reference. This arm served as a control arm for this outcome measure
OG004
Cohort 2/ 3 From C4591044 - Historical Control: 18-55 Years
Participants aged 18 to 55 years from Cohort 2/ 3 of study C4591044 (NCT05472038) who received BNT162b2 (WT/Omi BA.4/BA.5) 30 mcg as fourth dose were included in this reporting group. Participants included in this arm were not enrolled in the study, only their relevant historical data was used as a reference. This arm served as a control arm for this outcome measure.
OG005
Cohort 2/ 3 From C4591044 - Historical Control: >55 Years
Participants aged >55 years from Cohort 2/ 3 the C4591044 (NCT05472038) who received BNT162b2 (WT/ Omi BA.4/BA.5) 30 mcg as fourth dose were included in this reporting group. Participants included in this arm were not enrolled in the study, only their relevant historical data was used as a reference. This arm served as a control arm for this outcome measure
OG006
SSA- All Age Groups
Participants with any age >=12 years of SSA who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
OG007
SSA - Historical Control: All Age Groups
Participants from SSA of the current study C4591054 (NCT05997290) with any age >=12 years who received BNT162b2 (Omi XBB.1.5) 30 mcg. This arm served as control for this outcome measure.
Units
Counts
Participants
OG00027
OG001166
OG002185
OG00315
OG00485
OG005100
OG006378
OG007200
Title
Denominators
Categories
Title
Measurements
OG0003632.1(2043.8 to 6454.7)
OG0012503.6(2003.0 to 3129.3)
OG0022606.8(2065.5 to 3289.9)
OG003837.1(459.5 to 1524.9)
OG004615.5(459.0 to 825.2)
OG005560.4(430.0 to 730.2)
OG0062622.3(2246.6 to 3060.9)
OG007601.0(499.5 to 723.1)
OG002
SSA - Group 3: >55 Years
Participants aged >55 years who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omicron BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
OG003
Cohort 2/ 3 From C4591044 - Historical Control: 12-17 Years
Participants aged 12 to 17 years from Cohort 2/ 3 the C4591044 (NCT05472038) who received BNT162b2 (WT/Omi BA.4/BA.5) 30 mcg as fourth dose were included in this reporting group. Participants included in this arm were not enrolled in the study, only their relevant historical data was used as a reference. This arm served as a control arm for this outcome measure
OG004
Cohort 2/ 3 From C4591044 - Historical Control: 18-55 Years
Participants aged 18 to 55 years from Cohort 2/ 3 of study C4591044 (NCT05472038) who received BNT162b2 (WT/Omi BA.4/BA.5) 30 mcg as fourth dose were included in this reporting group. Participants included in this arm were not enrolled in the study, only their relevant historical data was used as a reference. This arm served as a control arm for this outcome measure.
OG005
Cohort 2/ 3 From C4591044 - Historical Control: >55 Years
Participants aged >55 years from Cohort 2/ 3 the C4591044 (NCT05472038) who received BNT162b2 (WT/ Omi BA.4/BA.5) 30 mcg as fourth dose were included in this reporting group. Participants included in this arm were not enrolled in the study, only their relevant historical data was used as a reference. This arm served as a control arm for this outcome measure
OG006
SSA- All Age Groups
Participants with any age >=12 years of SSA who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
OG007
SSA - Historical Control: All Age Groups
Participants from SSA of the current study C4591054 (NCT05997290) with any age >=12 years who received BNT162b2 (Omi XBB.1.5) 30 mcg. This arm served as control for this outcome measure.
Units
Counts
Participants
OG00026
OG001167
OG002187
OG00315
OG00485
OG005100
OG006380
OG007200
Title
Denominators
Categories
Title
Measurements
OG0007903.6(4961.5 to 12590.4)
OG0014831.8(4044.5 to 5772.3)
OG0025046.1(4123.3 to 6175.3)
OG0036376.3(3568.4 to 11393.8)
OG0043868.2(2974.8 to 5029.9)
OG0054122.7(3261.2 to 5211.6)
OG0065105.1(4483.4 to 5813.0)
OG0074146.0(3512.6 to 4893.5)
OG002
SSA - Group 3: >55 Years
Participants aged >55 years who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omicron BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
OG003
Cohort 2/ 3 From C4591044 - Historical Control: 12-17 Years
Participants aged 12 to 17 years from Cohort 2/ 3 the C4591044 (NCT05472038) who received BNT162b2 (WT/Omi BA.4/BA.5) 30 mcg as fourth dose were included in this reporting group. Participants included in this arm were not enrolled in the study, only their relevant historical data was used as a reference. This arm served as a control arm for this outcome measure
OG004
Cohort 2/ 3 From C4591044 - Historical Control: 18-55 Years
Participants aged 18 to 55 years from Cohort 2/ 3 of study C4591044 (NCT05472038) who received BNT162b2 (WT/Omi BA.4/BA.5) 30 mcg as fourth dose were included in this reporting group. Participants included in this arm were not enrolled in the study, only their relevant historical data was used as a reference. This arm served as a control arm for this outcome measure.
OG005
Cohort 2/ 3 From C4591044 - Historical Control: >55 Years
Participants aged >55 years from Cohort 2/ 3 the C4591044 (NCT05472038) who received BNT162b2 (WT/ Omi BA.4/BA.5) 30 mcg as fourth dose were included in this reporting group. Participants included in this arm were not enrolled in the study, only their relevant historical data was used as a reference. This arm served as a control arm for this outcome measure
OG006
SSA- All Age Groups
Participants with any age >=12 years of SSA who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
OG007
SSA - Historical Control: All Age Groups
Participants from SSA of the current study C4591054 (NCT05997290) with any age >=12 years who received BNT162b2 (Omi XBB.1.5) 30 mcg. This arm served as control for this outcome measure.
Units
Counts
Participants
OG00027
OG001165
OG002184
OG00315
OG00482
OG005100
OG006376
OG007197
Title
Denominators
Categories
Title
Measurements
OG00011.8(6.3 to 22.2)
OG00110.7(8.7 to 13.1)
OG00213.5(10.7 to 17.1)
OG0037.1(3.9 to 12.8)
OG0046.1(4.5 to 8.3)
OG0055.2(4.1 to 6.5)
OG00612.1(10.4 to 14.0)
OG0075.7(4.8 to 6.8)
OG002
SSA - Group 3: >55 Years
Participants aged >55 years who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omicron BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
OG003
Cohort 2/ 3 From C4591044 - Historical Control: 12-17 Years
Participants aged 12 to 17 years from Cohort 2/ 3 the C4591044 (NCT05472038) who received BNT162b2 (WT/Omi BA.4/BA.5) 30 mcg as fourth dose were included in this reporting group. Participants included in this arm were not enrolled in the study, only their relevant historical data was used as a reference. This arm served as a control arm for this outcome measure
OG004
Cohort 2/ 3 From C4591044 - Historical Control: 18-55 Years
Participants aged 18 to 55 years from Cohort 2/ 3 of study C4591044 (NCT05472038) who received BNT162b2 (WT/Omi BA.4/BA.5) 30 mcg as fourth dose were included in this reporting group. Participants included in this arm were not enrolled in the study, only their relevant historical data was used as a reference. This arm served as a control arm for this outcome measure.
OG005
Cohort 2/ 3 From C4591044 - Historical Control: >55 Years
Participants aged >55 years from Cohort 2/ 3 the C4591044 (NCT05472038) who received BNT162b2 (WT/ Omi BA.4/BA.5) 30 mcg as fourth dose were included in this reporting group. Participants included in this arm were not enrolled in the study, only their relevant historical data was used as a reference. This arm served as a control arm for this outcome measure
OG006
SSA- All Age Groups
Participants with any age >=12 years of SSA who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
OG007
SSA - Historical Control: All Age Groups
Participants from SSA of the current study C4591054 (NCT05997290) with any age >=12 years who received BNT162b2 (Omi XBB.1.5) 30 mcg. This arm served as control for this outcome measure.
Units
Counts
Participants
OG00026
OG001167
OG002186
OG00315
OG00485
OG005100
OG006379
OG007200
Title
Denominators
Categories
Title
Measurements
OG0003.5(2.2 to 5.8)
OG0014.3(3.7 to 5.0)
OG0025.1(4.3 to 6.2)
OG0035.7(3.4 to 9.4)
OG0046.2(4.6 to 8.4)
OG0057.4(5.7 to 9.6)
OG0064.6(4.1 to 5.2)
OG0076.8(5.6 to 8.1)
OG002
SSA - Group 3: >55 Years
Participants aged >55 years who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omicron BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
OG003
Cohort 2/ 3 From C4591044 - Historical Control: 12-17 Years
Participants aged 12 to 17 years from Cohort 2/ 3 the C4591044 (NCT05472038) who received BNT162b2 (WT/Omi BA.4/BA.5) 30 mcg as fourth dose were included in this reporting group. Participants included in this arm were not enrolled in the study, only their relevant historical data was used as a reference. This arm served as a control arm for this outcome measure
OG004
Cohort 2/ 3 From C4591044 - Historical Control: 18-55 Years
Participants aged 18 to 55 years from Cohort 2/ 3 of study C4591044 (NCT05472038) who received BNT162b2 (WT/Omi BA.4/BA.5) 30 mcg as fourth dose were included in this reporting group. Participants included in this arm were not enrolled in the study, only their relevant historical data was used as a reference. This arm served as a control arm for this outcome measure.
OG005
Cohort 2/ 3 From C4591044 - Historical Control: >55 Years
Participants aged >55 years from Cohort 2/ 3 the C4591044 (NCT05472038) who received BNT162b2 (WT/ Omi BA.4/BA.5) 30 mcg as fourth dose were included in this reporting group. Participants included in this arm were not enrolled in the study, only their relevant historical data was used as a reference. This arm served as a control arm for this outcome measure
OG006
SSA- All Age Groups
Participants with any age >=12 years of SSA who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
OG007
SSA - Historical Control: All Age Groups
Participants from SSA of the current study C4591054 (NCT05997290) with any age >=12 years who received BNT162b2 (Omi XBB.1.5) 30 mcg. This arm served as control for this outcome measure.
Units
Counts
Participants
OG00027
OG001165
OG002184
OG00315
OG00482
OG005100
OG006376
OG007197
Title
Denominators
Categories
Title
Measurements
OG00074.1(53.7 to 88.9)
OG00176.4(69.1 to 82.6)
OG00271.7(64.6 to 78.1)
OG00366.7(38.4 to 88.2)
OG00452.4(41.1 to 63.6)
OG00551.0(40.8 to 61.1)
OG00673.9(69.2 to 78.3)
OG00752.8(45.6 to 59.9)
OG002
SSA - Group 3: >55 Years
Participants aged >55 years who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omicron BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
OG003
Cohort 2/ 3 From C4591044 - Historical Control: 12-17 Years
Participants aged 12 to 17 years from Cohort 2/ 3 the C4591044 (NCT05472038) who received BNT162b2 (WT/Omi BA.4/BA.5) 30 mcg as fourth dose were included in this reporting group. Participants included in this arm were not enrolled in the study, only their relevant historical data was used as a reference. This arm served as a control arm for this outcome measure
OG004
Cohort 2/ 3 From C4591044 - Historical Control: 18-55 Years
Participants aged 18 to 55 years from Cohort 2/ 3 of study C4591044 (NCT05472038) who received BNT162b2 (WT/Omi BA.4/BA.5) 30 mcg as fourth dose were included in this reporting group. Participants included in this arm were not enrolled in the study, only their relevant historical data was used as a reference. This arm served as a control arm for this outcome measure.
OG005
Cohort 2/ 3 From C4591044 - Historical Control: >55 Years
Participants aged >55 years from Cohort 2/ 3 the C4591044 (NCT05472038) who received BNT162b2 (WT/ Omi BA.4/BA.5) 30 mcg as fourth dose were included in this reporting group. Participants included in this arm were not enrolled in the study, only their relevant historical data was used as a reference. This arm served as a control arm for this outcome measure
OG006
SSA- All Age Groups
Participants with any age >=12 years of SSA who received at least 3 prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
OG007
SSA - Historical Control: All Age Groups
Participants from SSA of the current study C4591054 (NCT05997290) with any age >=12 years who received BNT162b2 (Omi XBB.1.5) 30 mcg. This arm served as control for this outcome measure.
Units
Counts
Participants
OG00026
OG001167
OG002186
OG00315
OG00485
OG005100
OG006379
OG007200
Title
Denominators
Categories
Title
Measurements
OG00046.2(26.6 to 66.6)
OG00143.7(36.1 to 51.6)
OG00252.7(45.3 to 60.0)
OG00373.3(44.9 to 92.2)
OG00458.8(47.6 to 69.4)
OG00565.0(54.8 to 74.3)
OG00648.3(43.2 to 53.4)
OG00763.0(55.9 to 69.7)
OG002
SSB - Group 3: >55 Years
Participants aged >55 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine naive were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
OG003
SSB - All Age Groups
Participants with any age >=12 who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine naive were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 in this study.
Units
Counts
Participants
OG0009
OG001250
OG00249
OG003308
Title
Denominators
Categories
Redness: Any
Title
Measurements
OG0000(0.0 to 33.6)
OG0018.8(5.6 to 13.0)
OG0022.0(0.1 to 10.9)
OG0037.5(4.8 to 11.0)
Redness: Mild
Title
Measurements
OG0000(0.0 to 33.6)
OG0015.6(3.1 to 9.2)
OG0022.0(0.1 to 10.9)
OG003
Redness: Moderate
Title
Measurements
OG0000(0.0 to 33.6)
OG0012.8(1.1 to 5.7)
OG0020(0.0 to 7.3)
OG003
Redness: Severe
Title
Measurements
OG0000(0.0 to 33.6)
OG0010.4(0.0 to 2.2)
OG0020(0.0 to 7.3)
OG003
Redness: Grade 4
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 1.5)
OG0020(0.0 to 7.3)
OG003
Swelling: Any
Title
Measurements
OG00011.1(0.3 to 48.2)
OG00112.0(8.2 to 16.7)
OG00210.2(3.4 to 22.2)
OG003
Swelling: Mild
Title
Measurements
OG00011.1(0.3 to 48.2)
OG0016.8(4.0 to 10.7)
OG0028.2(2.3 to 19.6)
OG003
Swelling: Moderate
Title
Measurements
OG0000(0.0 to 33.6)
OG0015.2(2.8 to 8.7)
OG0022.0(0.1 to 10.9)
OG003
Swelling: Severe
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 1.5)
OG0020(0.0 to 7.3)
OG003
Swelling: Grade 4
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 1.5)
OG0020(0.0 to 7.3)
OG003
Pain at the injection site: Any
Title
Measurements
OG00044.4(13.7 to 78.8)
OG00158.0(51.6 to 64.2)
OG00236.7(23.4 to 51.7)
OG003
Pain at the injection site: Mild
Title
Measurements
OG00044.4(13.7 to 78.8)
OG00136.4(30.4 to 42.7)
OG00232.7(19.9 to 47.5)
OG003
Pain at the injection site: Moderate
Title
Measurements
OG0000(0.0 to 33.6)
OG00121.2(16.3 to 26.8)
OG0024.1(0.5 to 14.0)
OG003
Pain at the injection site: Severe
Title
Measurements
OG0000(0.0 to 33.6)
OG0010.4(0.0 to 2.2)
OG0020(0.0 to 7.3)
OG003
Pain at the injection site: Grade 4
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 1.5)
OG0020(0.0 to 7.3)
OG003
Participants aged 18 to 55 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine naive were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
OG002
SSB - Group 3: >55 Years
Participants aged >55 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine naive were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
OG003
SSB - All Age Groups
Participants with any age >=12 who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine naive were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 in this study.
Units
Counts
Participants
OG0009
OG001250
OG00249
OG003308
Title
Denominators
Categories
Fever: Any
Title
Measurements
OG00011.1(0.3 to 48.2)
OG0012.4(0.9 to 5.2)
OG0026.1(1.3 to 16.9)
OG0033.2(1.6 to 5.9)
Fever: >=38.0 degree C to 38.4 degree C
Title
Measurements
OG0000(0.0 to 33.6)
OG0010.8(0.1 to 2.9)
OG0024.1(0.5 to 14.0)
OG003
Fever: >38.4 degree C to 38.9 degree C
Title
Measurements
OG00011.1(0.3 to 48.2)
OG0011.2(0.2 to 3.5)
OG0020(0.0 to 7.3)
OG003
Fever: >38.9 degree C to 40.0 degree C
Title
Measurements
OG0000(0.0 to 33.6)
OG0010.4(0.0 to 2.2)
OG0022.0(0.1 to 10.9)
OG003
Fever: >40.0 degree C
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 1.5)
OG0020(0.0 to 7.3)
OG003
Fatigue: Any
Title
Measurements
OG00011.1(0.3 to 48.2)
OG00134.8(28.9 to 41.1)
OG00224.5(13.3 to 38.9)
OG003
Fatigue: Mild
Title
Measurements
OG0000(0.0 to 33.6)
OG00113.6(9.6 to 18.5)
OG0028.2(2.3 to 19.6)
OG003
Fatigue: Moderate
Title
Measurements
OG00011.1(0.3 to 48.2)
OG00121.2(16.3 to 26.8)
OG00216.3(7.3 to 29.7)
OG003
Fatigue: Severe
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 1.5)
OG0020(0.0 to 7.3)
OG003
Fatigue: Grade 4
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 1.5)
OG0020(0.0 to 7.3)
OG003
Headache: Any
Title
Measurements
OG00011.1(0.3 to 48.2)
OG00130.8(25.1 to 36.9)
OG00216.3(7.3 to 29.7)
OG003
Headache: Mild
Title
Measurements
OG00011.1(0.3 to 48.2)
OG00112.0(8.2 to 16.7)
OG00212.2(4.6 to 24.8)
OG003
Headache: Moderate
Title
Measurements
OG0000(0.0 to 33.6)
OG00118.0(13.4 to 23.3)
OG0024.1(0.5 to 14.0)
OG003
Headache: Severe
Title
Measurements
OG0000(0.0 to 33.6)
OG0010.8(0.1 to 2.9)
OG0020(0.0 to 7.3)
OG003
Headache: Grade 4
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 1.5)
OG0020(0.0 to 7.3)
OG003
Chills: Any
Title
Measurements
OG00011.1(0.3 to 48.2)
OG00112.0(8.2 to 16.7)
OG00210.2(3.4 to 22.2)
OG003
Chills: Mild
Title
Measurements
OG00011.1(0.3 to 48.2)
OG0017.2(4.3 to 11.1)
OG0024.1(0.5 to 14.0)
OG003
Chills: Moderate
Title
Measurements
OG0000(0.0 to 33.6)
OG0014.8(2.5 to 8.2)
OG0026.1(1.3 to 16.9)
OG003
Chills: Severe
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 1.5)
OG0020(0.0 to 7.3)
OG003
Chills: Grade 4
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 1.5)
OG0020(0.0 to 7.3)
OG003
Vomiting: Any
Title
Measurements
OG0000(0.0 to 33.6)
OG0014.8(2.5 to 8.2)
OG0022.0(0.1 to 10.9)
OG003
Vomiting: Mild
Title
Measurements
OG0000(0.0 to 33.6)
OG0012.4(0.9 to 5.2)
OG0022.0(0.1 to 10.9)
OG003
Vomiting: Moderate
Title
Measurements
OG0000(0.0 to 33.6)
OG0012.4(0.9 to 5.2)
OG0020(0.0 to 7.3)
OG003
Vomiting: Severe
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 1.5)
OG0020(0.0 to 7.3)
OG003
Vomiting: Grade 4
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 1.5)
OG0020(0.0 to 7.3)
OG003
Diarrhea: Any
Title
Measurements
OG00011.1(0.3 to 48.2)
OG00116.8(12.4 to 22.0)
OG0028.2(2.3 to 19.6)
OG003
Diarrhea: Mild
Title
Measurements
OG00011.1(0.3 to 48.2)
OG00110.0(6.6 to 14.4)
OG0026.1(1.3 to 16.9)
OG003
Diarrhea: Moderate
Title
Measurements
OG0000(0.0 to 33.6)
OG0016.4(3.7 to 10.2)
OG0022.0(0.1 to 10.9)
OG003
Diarrhea: Severe
Title
Measurements
OG0000(0.0 to 33.6)
OG0010.4(0.0 to 2.2)
OG0020(0.0 to 7.3)
OG003
Diarrhea: Grade 4
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 1.5)
OG0020(0.0 to 7.3)
OG003
New or worsened muscle pain: Any
Title
Measurements
OG00011.1(0.3 to 48.2)
OG00118.0(13.4 to 23.3)
OG00218.4(8.8 to 32.0)
OG003
New or worsened muscle pain: Mild
Title
Measurements
OG00011.1(0.3 to 48.2)
OG0018.0(5.0 to 12.1)
OG00210.2(3.4 to 22.2)
OG003
New or worsened muscle pain: Moderate
Title
Measurements
OG0000(0.0 to 33.6)
OG00110.0(6.6 to 14.4)
OG0028.2(2.3 to 19.6)
OG003
New or worsened muscle pain: Severe
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 1.5)
OG0020(0.0 to 7.3)
OG003
New or worsened muscle pain: Grade 4
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 1.5)
OG0020(0.0 to 7.3)
OG003
New or worsened joint pain: Any
Title
Measurements
OG00011.1(0.3 to 48.2)
OG00112.8(8.9 to 17.6)
OG00212.2(4.6 to 24.8)
OG003
New or worsened joint pain: Mild
Title
Measurements
OG00011.1(0.3 to 48.2)
OG0016.4(3.7 to 10.2)
OG0026.1(1.3 to 16.9)
OG003
New or worsened joint pain: Moderate
Title
Measurements
OG0000(0.0 to 33.6)
OG0016.4(3.7 to 10.2)
OG0026.1(1.3 to 16.9)
OG003
New or worsened joint pain: Severe
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 1.5)
OG0020(0.0 to 7.3)
OG003
New or worsened joint pain: Grade 4
Title
Measurements
OG0000(0.0 to 33.6)
OG0010(0.0 to 1.5)
OG0020(0.0 to 7.3)
OG003
OG002
SSB - Group 3: >55 Years
Participants aged >55 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine naive were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
OG003
SSB - All Age Groups
Participants with any age >=12 who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine naive were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 in this study.
Units
Counts
Participants
OG0009
OG001253
OG00249
OG003311
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 33.6)
OG0012.4(0.9 to 5.1)
OG0022.0(0.1 to 10.9)
OG0032.3(0.9 to 4.6)
OG002
SSB - Group 3: >55 Years
Participants aged >55 years who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine naive were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study.
OG003
SSB - All Age Groups
Participants with any age >=12 who were previously exposed to SARS-CoV-2 and were COVID-19 vaccine naive were assigned to receive a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 in this study.
Units
Counts
Participants
OG0009
OG001253
OG00249
OG003311
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 33.6)
OG0010.8(0.1 to 2.8)
OG0022.0(0.1 to 10.9)
OG0031.0(0.2 to 2.8)
Participants from SSA with any age >=12 years who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study. This arm served as control arm for this outcome measure.
Units
Counts
Participants
OG000298
OG001295
Title
Denominators
Categories
Title
Measurements
OG0004951.6(4222.8 to 5806.2)
OG0012566.5(2186.8 to 3012.1)
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
GMRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the difference in LS means (Substudy B - Substudy A) and the corresponding CIs based on analysis of log-transformed assay results using a linear regression model with baseline assay results (log scale), age and vaccine group as covariates.
GMR
1.93
2-Sided
95
1.52
2.44
Non-Inferiority
Noninferiority of GMR was met if the lower limit of the 95% CI was greater than 0.67.
SSA: All Age Groups (Vaccine Experienced Control)
Participants from SSA with any age >=12 years who received at least three prior doses of US-authorized mRNA COVID-19 vaccine with the most recent dose being the Omi BA.4/BA.5 received at least 150 days prior to the study vaccination were included. Participants received a single dose of BNT162b2 (Omi XBB.1.5) 30 mcg via IM route on Day 1 of this study. This arm served as control arm for this outcome measure.
Units
Counts
Participants
OG000298
OG001295
Title
Denominators
Categories
Title
Measurements
OG00084.9(80.3 to 88.8)
OG00173.9(68.5 to 78.8)
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
Difference in percentage of participants
7.31
2-Sided
95
1.34
13.28
2-Sided CI, based on the Miettinen and Nurminen method stratified by baseline neutralizing titer category (< median, >= median) and age group (< median, >= median).
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 was greater than -10%.
OG002
SSC - Cohort 1 and Cohort 2 Combined: >55 Years
Participants aged >55 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
OG003
SSC- Cohort 1 and Cohort 2 Combined: All Age Groups
Participants from Cohorts 1 and 2 of SSC with any age >=18 years group who received a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
Units
Counts
Participants
OG00018
OG00192
OG002106
OG003216
Title
Denominators
Categories
Redness: any
Title
Measurements
OG00011.1(1.4 to 34.7)
OG0018.7(3.8 to 16.4)
OG0029.4(4.6 to 16.7)
OG0039.3(5.7 to 13.9)
Redness: mild
Title
Measurements
OG0005.6(0.1 to 27.3)
OG0011.1(0.0 to 5.9)
OG0026.6(2.7 to 13.1)
OG003
Redness: moderate
Title
Measurements
OG0005.6(0.1 to 27.3)
OG0016.5(2.4 to 13.7)
OG0022.8(0.6 to 8.0)
OG003
Redness: severe
Title
Measurements
OG0000(0.0 to 18.5)
OG0011.1(0.0 to 5.9)
OG0020(0.0 to 3.4)
OG003
Redness: grade 4
Title
Measurements
OG0000(0.0 to 18.5)
OG0010(0.0 to 3.9)
OG0020(0.0 to 3.4)
OG003
Swelling: any
Title
Measurements
OG0000(0.0 to 18.5)
OG00113.0(6.9 to 21.7)
OG00211.3(6.0 to 18.9)
OG003
Swelling: mild
Title
Measurements
OG0000(0.0 to 18.5)
OG0018.7(3.8 to 16.4)
OG0024.7(1.5 to 10.7)
OG003
Swelling: moderate
Title
Measurements
OG0000(0.0 to 18.5)
OG0014.3(1.2 to 10.8)
OG0026.6(2.7 to 13.1)
OG003
Swelling: severe
Title
Measurements
OG0000(0.0 to 18.5)
OG0010(0.0 to 3.9)
OG0020(0.0 to 3.4)
OG003
Swelling: grade 4
Title
Measurements
OG0000(0.0 to 18.5)
OG0010(0.0 to 3.9)
OG0020(0.0 to 3.4)
OG003
Pain at the injection site: any
Title
Measurements
OG00088.9(65.3 to 98.6)
OG00172.8(62.6 to 81.6)
OG00249.1(39.2 to 59.0)
OG003
Pain at the injection site: mild
Title
Measurements
OG00055.6(30.8 to 78.5)
OG00158.7(47.9 to 68.9)
OG00242.5(32.9 to 52.4)
OG003
Pain at the injection site: moderate
Title
Measurements
OG00027.8(9.7 to 53.5)
OG00112.0(6.1 to 20.4)
OG0025.7(2.1 to 11.9)
OG003
Pain at the injection site: severe
Title
Measurements
OG0005.6(0.1 to 27.3)
OG0012.2(0.3 to 7.6)
OG0020.9(0.0 to 5.1)
OG003
Pain at the injection site: grade 4
Title
Measurements
OG0000(0.0 to 18.5)
OG0010(0.0 to 3.9)
OG0020(0.0 to 3.4)
OG003
Participants aged 18 to 55 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
OG002
SSC - Cohort 1 and Cohort 2 Combined: >55 Years
Participants aged >55 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
OG003
SSC- Cohort 1 and Cohort 2 Combined: All Age Groups
Participants from Cohorts 1 and 2 of SSC with any age >=18 years group who received a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
Units
Counts
Participants
OG00018
OG00192
OG002106
OG003216
Title
Denominators
Categories
Fever: any
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002104
ParticipantsOG003214
Title
Measurements
OG00011.1(1.4 to 34.7)
OG0014.3(1.2 to 10.8)
OG0021.9(0.2 to 6.8)
OG003
Fever: >=38.0 degree C to 38.4 degree C
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002104
ParticipantsOG003214
Fever: >38.4 degree C to 38.9 degree C
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002104
ParticipantsOG003214
Fever: >38.9 degree C to 40.0 degree C
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002104
ParticipantsOG003214
Fever: >40.0 degree C
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002104
ParticipantsOG003214
Fatigue: any
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
Fatigue: mild
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
Fatigue: moderate
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
Fatigue: severe
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
Fatigue: grade 4
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
Headache: any
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
Headache: mild
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
Headache: moderate
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
Headache: severe
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
Headache: grade 4
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
Chills: any
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
Chills: mild
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
Chills: moderate
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
Chills: severe
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
Chills: grade 4
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
Vomiting: any
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
Vomiting: mild
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
Vomiting: moderate
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
Vomiting: severe
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
Vomiting: grade 4
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
Diarrhoea: any
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
Diarrhoea: mild
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
Diarrhoea: moderate
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
Diarrhoea: severe
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
Diarrhoea: grade 4
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
New or worsened muscle pain: any
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
New or worsened muscle pain: mild
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
New or worsened muscle pain: moderate
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
New or worsened muscle pain: severe
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
New or worsened muscle pain: grade 4
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
New or worsened joint pain: any
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
New or worsened joint pain: mild
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
New or worsened joint pain: moderate
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
New or worsened joint pain: severe
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
New or worsened joint pain: grade 4
ParticipantsOG00018
ParticipantsOG00192
ParticipantsOG002106
ParticipantsOG003216
OG002
SSC - Cohort 1 and Cohort 2 Combined: >55 Years
Participants aged >55 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
OG003
SSC- Cohort 1 and Cohort 2 Combined: All Age Groups
Participants from Cohorts 1 and 2 of SSC with any age >=18 years group who received a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
Units
Counts
Participants
OG00018
OG00192
OG002106
OG003216
Title
Denominators
Categories
Title
Measurements
OG0005.6(0.1 to 27.3)
OG0013.3(0.7 to 9.2)
OG0028.5(4.0 to 15.5)
OG0036.0(3.2 to 10.1)
SSC - Cohort 1 and Cohort 2 Combined: >55 Years
Participants aged >55 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
OG003
SSC- Cohort 1 and Cohort 2 Combined: All Age Groups
Participants from Cohorts 1 and 2 of SSC with any age >=18 years group who received a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
Units
Counts
Participants
OG00018
OG00192
OG002106
OG003216
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 18.5)
OG0011.1(0.0 to 5.9)
OG0022.8(0.6 to 8.0)
OG0031.9(0.5 to 4.7)
SSC- Cohort 3 Combined: All Age Groups
Participants of Cohort 3 from SSC of any age >=18 years who received a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.
Units
Counts
Participants
OG00051
OG00151
OG002102
Title
Denominators
Categories
Redness: any
Title
Measurements
OG0005.9(1.2 to 16.2)
OG0012.0(0.0 to 10.4)
OG0023.9(1.1 to 9.7)
Redness: mild
Title
Measurements
OG0002.0(0.0 to 10.4)
OG0012.0(0.0 to 10.4)
OG0022.0(0.2 to 6.9)
Redness: moderate
Title
Measurements
OG0003.9(0.5 to 13.5)
OG0010(0.0 to 7.0)
OG0022.0(0.2 to 6.9)
Redness: severe
Title
Measurements
OG0000(0.0 to 7.0)
OG0010(0.0 to 7.0)
OG0020(0.0 to 3.6)
Redness: grade 4
Title
Measurements
OG0000(0.0 to 7.0)
OG0010(0.0 to 7.0)
OG0020(0.0 to 3.6)
Swelling: any
Title
Measurements
OG0009.8(3.3 to 21.4)
OG0013.9(0.5 to 13.5)
OG0026.9(2.8 to 13.6)
Swelling: mild
Title
Measurements
OG0003.9(0.5 to 13.5)
OG0013.9(0.5 to 13.5)
OG0023.9(1.1 to 9.7)
Swelling: moderate
Title
Measurements
OG0005.9(1.2 to 16.2)
OG0010(0.0 to 7.0)
OG0022.9(0.6 to 8.4)
Swelling: severe
Title
Measurements
OG0000(0.0 to 7.0)
OG0010(0.0 to 7.0)
OG0020(0.0 to 3.6)
Swelling: grade 4
Title
Measurements
OG0000(0.0 to 7.0)
OG0010(0.0 to 7.0)
OG0020(0.0 to 3.6)
Pain at the injection site: any
Title
Measurements
OG00072.5(58.3 to 84.1)
OG00145.1(31.1 to 59.7)
OG00258.8(48.6 to 68.5)
Pain at the injection site: mild
Title
Measurements
OG00060.8(46.1 to 74.2)
OG00139.2(25.8 to 53.9)
OG00250.0(39.9 to 60.1)
Pain at the injection site: moderate
Title
Measurements
OG00011.8(4.4 to 23.9)
OG0015.9(1.2 to 16.2)
OG0028.8(4.1 to 16.1)
Pain at the injection site: severe
Title
Measurements
OG0000(0.0 to 7.0)
OG0010(0.0 to 7.0)
OG0020(0.0 to 3.6)
Pain at the injection site: grade 4
Title
Measurements
OG0000(0.0 to 7.0)
OG0010(0.0 to 7.0)
OG0020(0.0 to 3.6)
OG002
SSC- Cohort 3 Combined: All Age Groups
Participants of Cohort 3 from SSC of any age >=18 years who received a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.
Units
Counts
Participants
OG00051
OG00151
OG002102
Title
Denominators
Categories
Fever: any
Title
Measurements
OG0003.9(0.5 to 13.5)
OG0013.9(0.5 to 13.5)
OG0023.9(1.1 to 9.7)
Fever: >=38.0 degree C to 38.4 degree C
Title
Measurements
OG0003.9(0.5 to 13.5)
OG0012.0(0.0 to 10.4)
OG0022.9(0.6 to 8.4)
Fever: >38.4 degree C to 38.9 degree C
Title
Measurements
OG0000(0.0 to 7.0)
OG0012.0(0.0 to 10.4)
OG0021.0(0.0 to 5.3)
Fever: >38.9 degree C to 40.0 degree C
Title
Measurements
OG0000(0.0 to 7.0)
OG0010(0.0 to 7.0)
OG0020(0.0 to 3.6)
Fever: >40.0 degree C
Title
Measurements
OG0000(0.0 to 7.0)
OG0010(0.0 to 7.0)
OG0020(0.0 to 3.6)
Fatigue: any
Title
Measurements
OG00058.8(44.2 to 72.4)
OG00133.3(20.8 to 47.9)
OG00246.1(36.2 to 56.2)
Fatigue: mild
Title
Measurements
OG00033.3(20.8 to 47.9)
OG00119.6(9.8 to 33.1)
OG00226.5(18.2 to 36.1)
Fatigue: moderate
Title
Measurements
OG00025.5(14.3 to 39.6)
OG00113.7(5.7 to 26.3)
OG00219.6(12.4 to 28.6)
Fatigue: severe
Title
Measurements
OG0000(0.0 to 7.0)
OG0010(0.0 to 7.0)
OG0020(0.0 to 3.6)
Fatigue: grade 4
Title
Measurements
OG0000(0.0 to 7.0)
OG0010(0.0 to 7.0)
OG0020(0.0 to 3.6)
Headache: any
Title
Measurements
OG00039.2(25.8 to 53.9)
OG00117.6(8.4 to 30.9)
OG00228.4(19.9 to 38.2)
Headache: mild
Title
Measurements
OG00027.5(15.9 to 41.7)
OG00111.8(4.4 to 23.9)
OG00219.6(12.4 to 28.6)
Headache: moderate
Title
Measurements
OG00011.8(4.4 to 23.9)
OG0015.9(1.2 to 16.2)
OG0028.8(4.1 to 16.1)
Headache: severe
Title
Measurements
OG0000(0.0 to 7.0)
OG0010(0.0 to 7.0)
OG0020(0.0 to 3.6)
Headache: grade 4
Title
Measurements
OG0000(0.0 to 7.0)
OG0010(0.0 to 7.0)
OG0020(0.0 to 3.6)
Chills: any
Title
Measurements
OG0007.8(2.2 to 18.9)
OG0019.8(3.3 to 21.4)
OG0028.8(4.1 to 16.1)
Chills: mild
Title
Measurements
OG0003.9(0.5 to 13.5)
OG0019.8(3.3 to 21.4)
OG0026.9(2.8 to 13.6)
Chills: moderate
Title
Measurements
OG0003.9(0.5 to 13.5)
OG0010(0.0 to 7.0)
OG0022.0(0.2 to 6.9)
Chills: severe
Title
Measurements
OG0000(0.0 to 7.0)
OG0010(0.0 to 7.0)
OG0020(0.0 to 3.6)
Chills: grade 4
Title
Measurements
OG0000(0.0 to 7.0)
OG0010(0.0 to 7.0)
OG0020(0.0 to 3.6)
Vomiting: any
Title
Measurements
OG0002.0(0.0 to 10.4)
OG0013.9(0.5 to 13.5)
OG0022.9(0.6 to 8.4)
Vomiting: mild
Title
Measurements
OG0002.0(0.0 to 10.4)
OG0012.0(0.0 to 10.4)
OG0022.0(0.2 to 6.9)
Vomiting: moderate
Title
Measurements
OG0000(0.0 to 7.0)
OG0012.0(0.0 to 10.4)
OG0021.0(0.0 to 5.3)
Vomiting: severe
Title
Measurements
OG0000(0.0 to 7.0)
OG0010(0.0 to 7.0)
OG0020(0.0 to 3.6)
Vomiting: grade 4
Title
Measurements
OG0000(0.0 to 7.0)
OG0010(0.0 to 7.0)
OG0020(0.0 to 3.6)
Diarrhea: any
Title
Measurements
OG00011.8(4.4 to 23.9)
OG0017.8(2.2 to 18.9)
OG0029.8(4.8 to 17.3)
Diarrhea: mild
Title
Measurements
OG0007.8(2.2 to 18.9)
OG0017.8(2.2 to 18.9)
OG0027.8(3.4 to 14.9)
Diarrhea: moderate
Title
Measurements
OG0003.9(0.5 to 13.5)
OG0010(0.0 to 7.0)
OG0022.0(0.2 to 6.9)
Diarrhea: severe
Title
Measurements
OG0000(0.0 to 7.0)
OG0010(0.0 to 7.0)
OG0020(0.0 to 3.6)
Diarrhea: grade 4
Title
Measurements
OG0000(0.0 to 7.0)
OG0010(0.0 to 7.0)
OG0020(0.0 to 3.6)
New or worsened muscle pain: any
Title
Measurements
OG00033.3(20.8 to 47.9)
OG0019.8(3.3 to 21.4)
OG00221.6(14.0 to 30.8)
New or worsened muscle pain: mild
Title
Measurements
OG00017.6(8.4 to 30.9)
OG0017.8(2.2 to 18.9)
OG00212.7(7.0 to 20.8)
New or worsened muscle pain: moderate
Title
Measurements
OG00015.7(7.0 to 28.6)
OG0012.0(0.0 to 10.4)
OG0028.8(4.1 to 16.1)
New or worsened muscle pain: severe
Title
Measurements
OG0000(0.0 to 7.0)
OG0010(0.0 to 7.0)
OG0020(0.0 to 3.6)
New or worsened muscle pain: grade 4
Title
Measurements
OG0000(0.0 to 7.0)
OG0010(0.0 to 7.0)
OG0020(0.0 to 3.6)
New or worsened joint pain: any
Title
Measurements
OG00013.7(5.7 to 26.3)
OG0013.9(0.5 to 13.5)
OG0028.8(4.1 to 16.1)
New or worsened joint pain: mild
Title
Measurements
OG00011.8(4.4 to 23.9)
OG0012.0(0.0 to 10.4)
OG0026.9(2.8 to 13.6)
New or worsened joint pain: moderate
Title
Measurements
OG0002.0(0.0 to 10.4)
OG0012.0(0.0 to 10.4)
OG0022.0(0.2 to 6.9)
New or worsened joint pain: severe
Title
Measurements
OG0000(0.0 to 7.0)
OG0010(0.0 to 7.0)
OG0020(0.0 to 3.6)
New or worsened joint pain: grade 4
Title
Measurements
OG0000(0.0 to 7.0)
OG0010(0.0 to 7.0)
OG0020(0.0 to 3.6)
OG002
SSC- Cohort 3 Combined: All Age Groups
Participants of Cohort 3 from SSC of any age >=18 years who received a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.
Units
Counts
Participants
OG00051
OG00151
OG002102
Title
Denominators
Categories
Title
Measurements
OG00013.7(5.7 to 26.3)
OG0015.9(1.2 to 16.2)
OG0029.8(4.8 to 17.3)
Participants of Cohort 3 from SSC of any age >=18 years who received a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.
Units
Counts
Participants
OG00051
OG00151
OG002102
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 7.0)
OG0012.0(0.0 to 10.4)
OG0021.0(0.0 to 5.3)
Participants aged >55 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
OG003
SSC- Cohort 1 and Cohort 2 Combined: All Age Groups
Participants from Cohorts 1 and 2 of SSC with any age >=18 years group who received a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
OG004
SSA - Historical Control: 12-17 Years
Participants from SSA of the current study C4591054 (NCT05997290) aged 12 to 17 years were assigned to receive BNT162b2 (Omi XBB.1.5) 30 mcg. This arm served as control for this outcome measure.
OG005
SSA - Historical Control: 18-55 Years
Participants from SSA of the current study C4591054 (NCT05997290) aged 18 to 55 years were assigned to receive BNT162b2 (Omi XBB.1.5) 30 mcg. This arm served as control for this outcome measure.
OG006
SSA - Historical Control: >55 Years
Participants from SSA of the current study C4591054 (NCT05997290) aged greater than 55 years were assigned to receive BNT162b2 (Omi XBB.1.5) 30 mcg. This arm served as control for this outcome measure.
OG007
SSA - Historical Control: All Age Groups
Participants from SSA of the current study C4591054 (NCT05997290) with any age >=12 years who received BNT162b2 (Omi XBB.1.5) 30 mcg. This arm served as control for this outcome measure.
Units
Counts
Participants
OG00018
OG00191
OG002103
OG003212
OG00417
OG00585
OG00698
OG007200
Title
Denominators
Categories
Omicron JN.1
ParticipantsOG00018
ParticipantsOG00191
ParticipantsOG002103
ParticipantsOG003212
ParticipantsOG00417
ParticipantsOG00584
ParticipantsOG00698
ParticipantsOG007199
Title
Measurements
OG0003920.4(2296.3 to 6693.2)
OG0011895.8(1456.8 to 2467.0)
OG0022275.2(1771.0 to 2923.1)
OG003
Omicron XBB.1.5
ParticipantsOG00018
ParticipantsOG00191
ParticipantsOG002103
ParticipantsOG003212
OG002
SSC - Cohort 1 and Cohort 2 Combined: >55 Years
Participants aged >55 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
OG003
SSC- Cohort 1 and Cohort 2 Combined: All Age Groups
Participants from Cohorts 1 and 2 of SSC with any age >=18 years group who received a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
OG004
SSA - Historical Control: 12-17 Years
Participants from SSA of the current study C4591054 (NCT05997290) aged 12 to 17 years were assigned to receive BNT162b2 (Omi XBB.1.5) 30 mcg. This arm served as control for this outcome measure.
OG005
SSA - Historical Control: 18-55 Years
Participants from SSA of the current study C4591054 (NCT05997290) aged 18 to 55 years were assigned to receive BNT162b2 (Omi XBB.1.5) 30 mcg. This arm served as control for this outcome measure.
OG006
SSA - Historical Control: >55 Years
Participants from SSA of the current study C4591054 (NCT05997290) aged greater than 55 years were assigned to receive BNT162b2 (Omi XBB.1.5) 30 mcg. This arm served as control for this outcome measure.
OG007
SSA - Historical Control: All Age Groups
Participants from SSA of the current study C4591054 (NCT05997290) with any age >=12 years who received BNT162b2 (Omi XBB.1.5) 30 mcg. This arm served as control for this outcome measure.
Units
Counts
Participants
OG00018
OG00191
OG002103
OG003212
OG00417
OG00585
OG00698
OG007200
Title
Denominators
Categories
Omicron JN.1
ParticipantsOG00017
ParticipantsOG00191
ParticipantsOG002103
ParticipantsOG003211
ParticipantsOG00417
ParticipantsOG00583
ParticipantsOG00697
ParticipantsOG007197
Title
Measurements
OG00015.5(5.8 to 41.5)
OG00111.2(8.3 to 15.0)
OG00211.4(8.4 to 15.4)
OG003
Omicron XBB.1.5
ParticipantsOG00018
ParticipantsOG00191
ParticipantsOG002103
ParticipantsOG003212
SSC - Cohort 1 and Cohort 2 Combined: >55 Years
Participants aged >55 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
OG003
SSC- Cohort 1 and Cohort 2 Combined: All Age Groups
Participants from Cohorts 1 and 2 of SSC with any age >=18 years group who received a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
OG004
SSA - Historical Control: 12-17 Years
Participants from SSA of the current study C4591054 (NCT05997290) aged 12 to 17 years were assigned to receive BNT162b2 (Omi XBB.1.5) 30 mcg. This arm served as control for this outcome measure.
OG005
SSA - Historical Control: 18-55 Years
Participants from SSA of the current study C4591054 (NCT05997290) aged 18 to 55 years were assigned to receive BNT162b2 (Omi XBB.1.5) 30 mcg. This arm served as control for this outcome measure.
OG006
SSA - Historical Control: >55 Years
Participants from SSA of the current study C4591054 (NCT05997290) aged greater than 55 years were assigned to receive BNT162b2 (Omi XBB.1.5) 30 mcg. This arm served as control for this outcome measure.
OG007
SSA - Historical Control: All Age Groups
Participants from SSA of the current study C4591054 (NCT05997290) with any age >=12 years who received BNT162b2 (Omi XBB.1.5) 30 mcg. This arm served as control for this outcome measure.
Units
Counts
Participants
OG00018
OG00191
OG002103
OG003212
OG00417
OG00585
OG00698
OG007200
Title
Denominators
Categories
Omicron JN.1
ParticipantsOG00017
ParticipantsOG00191
ParticipantsOG002103
ParticipantsOG003211
ParticipantsOG00417
ParticipantsOG00583
ParticipantsOG00697
ParticipantsOG007197
Title
Measurements
OG00070.6(44.0 to 89.7)
OG00173.6(63.3 to 82.3)
OG00268.0(58.0 to 76.8)
OG003
Omicron XBB.1.5
ParticipantsOG00018
ParticipantsOG00191
ParticipantsOG002103
ParticipantsOG003212
Participants of Cohort 3 from SSC of any age >=18 years who received a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.
OG003
SSC - Cohort 1 and Cohort 2 Combined: 18-55 Years
Participants aged 18 to 55 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
OG004
SSC - Cohort 1 and Cohort 2 Combined: >55 Years
Participants aged >55 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
OG005
SSC- Cohort 1 and Cohort 2 Combined: All Age Groups
Participants from Cohorts 1 and 2 of SSC with any age >=18 years group who received a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
Units
Counts
Participants
OG00050
OG00150
OG002100
OG00391
OG004103
OG005194
Title
Denominators
Categories
Omicron KP.2
Title
Measurements
OG0002037.8(1326.3 to 3130.9)
OG0012498.8(1590.4 to 3926.0)
OG0022256.5(1660.2 to 3067.0)
OG003890.4(648.6 to 1222.2)
OG004858.5(641.5 to 1148.8)
OG005873.3(706.1 to 1080.2)
Omicron JN.1
Title
Measurements
OG0003738.8(2566.9 to 5445.6)
OG0014990.5(3309.3 to 7525.7)
OG0024319.5(3280.7 to 5687.2)
OG003
OG002
SSC- Cohort 3 Combined: All Age Groups
Participants of Cohort 3 from SSC of any age >=18 years who received a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.
OG003
SSC - Cohort 1 and Cohort 2 Combined: 18-55 Years
Participants aged 18 to 55 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
OG004
SSC - Cohort 1 and Cohort 2 Combined: >55 Years
Participants aged >55 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
OG005
SSC- Cohort 1 and Cohort 2 Combined: All Age Groups
Participants from Cohorts 1 and 2 of SSC with any age >=18 years group who received a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
Units
Counts
Participants
OG00050
OG00150
OG002100
OG00391
OG004103
OG005194
Title
Denominators
Categories
Omicron KP.2
ParticipantsOG00049
ParticipantsOG00150
ParticipantsOG00299
ParticipantsOG00391
ParticipantsOG004103
ParticipantsOG005194
Title
Measurements
OG0008.9(6.3 to 12.5)
OG00113.4(8.1 to 22.1)
OG00211.0(8.1 to 14.8)
OG003
Omicron JN.1
ParticipantsOG00050
ParticipantsOG00150
ParticipantsOG002100
ParticipantsOG00391
Participants of Cohort 3 from SSC of any age >=18 years who received a single dose of BNT162b2 (Omi KP.2) 30 mcg via IM route on Day 1 of this study.
OG003
SSC - Cohort 1 and Cohort 2 Combined: 18-55 Years
Participants aged 18 to 55 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
OG004
SSC - Cohort 1 and Cohort 2 Combined: >55 Years
Participants aged >55 years were assigned to receive a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.
OG005
SSC- Cohort 1 and Cohort 2 Combined: All Age Groups
Participants from Cohorts 1 and 2 of SSC with any age >=18 years group who received a single dose of BNT162b2 (Omi JN.1) 30 mcg via IM route on Day 1 of this study.