A Study to Evaluate the Safety, Tolerability, and Immunog... | NCT05596734 | Trialant
NCT05596734
Sponsor
BioNTech SE
Status
Completed
Last Update Posted
Jul 23, 2025Actual
Enrollment
1,019Actual
Phase
Phase 2
Conditions
Influenza, Human
COVID-19
Interventions
bivalent BNT162b2 (original/Omi BA.4/BA.5)
qIRV (22/23)
QIV
bIRV
tIRV
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT05596734
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C5261001
Secondary IDs
ID
Type
Description
Link
NCT05596734
Registry Identifier
ClinicalTrials.gov
Brief Title
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza
Official Title
A PHASE 1/2 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF COMBINED MODIFIED RNA VACCINE CANDIDATES AGAINST COVID-19 AND INFLUENZA IN HEALTHY INDIVIDUALS
Acronym
Not provided
Organization
BioNTech SEINDUSTRY
Status Module
Record Verification Date
Jul 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 28, 2022Actual
Primary Completion Date
Dec 28, 2023Actual
Completion Date
Dec 28, 2023Actual
First Submitted Date
Oct 26, 2022
First Submission Date that Met QC Criteria
Oct 26, 2022
First Posted Date
Oct 27, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Dec 19, 2024
Results First Submitted that Met QC Criteria
Jul 2, 2025
Results First Posted Date
Jul 23, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 2, 2025
Last Update Posted Date
Jul 23, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
BioNTech SEINDUSTRY
Collaborators
Name
Class
Pfizer
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
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
Substudy A: This is a Phase 1 randomized, open-label study to describe the safety and immunogenicity of up to 3 dose- level combinations of modRNA quadrivalent influenza vaccine (qIRV (22/23)) and bivalent BNT162b2 (original/Omi BA.4/BA.5). Participants will receive either:
qIRV (22/23)/bivalent BNT162b2 (original/Omi BA.4/BA.5), at 1 of the 3 dose-level combinations
qIRV (22/23) at dose level 1,
qIRV (22/23) at dose level 2, or
bivalent BNT162b2 (original/Omi BA.4/BA.5) at dose level 1 administered concurrently in the opposite arm to commercially licensed quadrivalent influenza vaccine (QIV).
Substudy B: This Phase 1/2 study will describe the safety, tolerability, and immunogenicity of quadrivalent influenza vaccine (qIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5), trivalent influenza vaccine (tIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5), and bivalent influenza vaccine (bIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5) when given concurrently with licensed quadrivalent influenza vaccine (QIV).
SSA: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18-64 Years)
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 centimeter (cm). Redness and swelling were graded as mild (Grade 1): greater than (>) 2.0 cm to 5.0 cm; moderate (Grade 2): >5.0 cm to 10.0 cm; severe (Grade 3): >10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Percentage of participants with any local reactions were reported in this outcome measure.
SSA: From Day 1 to Day 7 after Vaccination
SSA: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (>=65 Years)
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild (Grade 1): >2.0 cm to 5.0 cm; moderate (Grade 2): >5.0 cm to 10.0 cm; severe (Grade 3): >10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis. Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Percentage of participants with any local reactions were reported in this outcome measure.
SSA: From Day 1 to Day 7 after Vaccination
SSA: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18-64 Years)
Secondary Outcomes
Measure
Description
Time Frame
SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations 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. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
SSA: Inclusion Criteria:
Male or female participants 18 years of age and older
Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures.
Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
Capable of giving signed informed consent as described in the protocol.
For participants 18 through 64 years of age: participants who have received 3 prior doses of 30 µg BNT162b2, with the last dose being 150 to 365 days before Visit 1 (Day 1).
For participants 65 years of age and older: participants who have received 4 or 5 prior doses of a modRNA SARS-CoV-2 vaccine, with the last dose being a bivalent vaccine, 120 days to 365 days before Visit 1 (Day 1).
For Participants 65 years of age and older: receipt of licensed influenza vaccination for the 2022-2023 northern hemisphere season 120 days or more before study intervention administration.
SSA: Exclusion Criteria:
History of severe adverse reaction associated with any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
Immunocompromised individuals with known or suspected immunodeficiency.
Bleeding diathesis or condition associated with prolonged bleeding.
Women who are pregnant or breastfeeding.
Allergy to egg proteins (egg or egg products) or chicken proteins.
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before enrollment through conclusion of the study.
Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or planned receipt throughout the study.
For participants 18 through 64 years of age: vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration.
Participation in other studies involving a study intervention within 28 days before randomization. Anticipated participation in other studies within 28 days after receipt of study intervention in this study.
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.
Participation in strenuous or endurance exercise through Visit 3 of the study.
Prior history of heart disease.
Any abnormal screening troponin I laboratory value.
Screening 12-lead ECG that, as judged by the investigator, is consistent with probable or possible myocarditis or pericarditis, or demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
SSB: Inclusion Criteria
Male or female participants 18 years of age and older
Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures.
Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
Capable of giving signed informed consent as described in the protocol.
Participants who have received at least 3 prior US-authorized mRNA COVID-19 vaccines, with the last dose being an updated (bivalent) vaccine given at least 150 days before Day 1.
SSB: Exclusion Criteria
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 severe adverse reaction associated with any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
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
Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before enrollment through conclusion of the study.
Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or planned receipt throughout the study.
Vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration, or ongoing receipt of chronic antiviral therapy with activity against influenza
Participation in other studies involving administration of a study intervention within 28 days prior to, and/or during, participation in 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.
Initial enrollment only: Participation in strenuous or endurance exercise through Visit 3 (initial enrollment phase).
Initial enrollment only: Prior history of heart disease of concern
Initial enrollment only: Screening 12-lead ECG that, as judged by the investigator, is consistent with probable or possible myocarditis or pericarditis, or demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
North Alabama Research Center
Athens
Alabama
35611
United States
The Heart Center
References Module
Citations
Not provided
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
There were 2 sub studies: Sub study A and Sub study B. A total of 1019 participants were enrolled, out of which 1009 participants were vaccinated (sub study A: 377 and sub study B: 632).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
FG001
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
Periods
Title
Milestones
Reasons Not Completed
Substudy A
Type
Comment
Milestone Data
STARTED
(as vaccinated)
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
Feb 9, 2024
Dec 18, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Substudy A: Open-label unblinded.
Substudy B: Participants are blinded to their assigned study intervention.
Who Masked
Not provided
Biological: qIRV (22/23)
SSA: bivalent BNT162b2 (dose level 1) + QIV
Experimental
BNT162b2 administered intramuscularly into the deltoid muscle of the right arm, QIV administered intramuscularly into the deltoid muscle of the left arm
BNT162b2 administered intramuscularly into the deltoid muscle of the right arm, QIV administered intramuscularly into the deltoid muscle of the left arm
BNT162b2 administered intramuscularly into the deltoid muscle of the right arm, QIV administered intramuscularly into the deltoid muscle of the left arm
Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain. Events were recorded by participants in an electronic diary. Fever defined as oral temperature >=38.0 deg C and categorized as>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Vomiting graded as: G1: 1-2 times in 24 h; G2: >2 times in 24h; G3: required IV hydration. Diarrhea graded as: G1: 2-3 loose stools in 24h; G2: 4-5 loose stools in 24h; G3: 6 or more loose stools in 24h.Headache, fatigue, chills, new/worsened muscle pain and new/worsened joint pain: G1: didn't interfere with activity; G2: some interference with activity; G3: prevented daily routine activity. For all systemic events except fever, Grade 4=emergency room visit or hospitalization. Grade 4 events were classified by the investigator. Percentage of participants with any systemic events were reported in this outcome measure.
SSA: From Day 1 to Day 7 after Vaccination
SSA: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (>=65 Years)
Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain. Events were recorded by participants in an electronic diary. Fever defined as oral temperature >=38.0 deg C and categorized as>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Vomiting graded as: G1: 1-2 times in 24 h; G2: >2 times in 24h; G3: required IV hydration. Diarrhea graded as: G1: 2-3 loose stools in 24h; G2: 4-5 loose stools in 24h; G3: 6 or more loose stools in 24h.Headache, fatigue, chills, new/worsened muscle pain and new/worsened joint pain: G1: didn't interfere with activity; G2: some interference with activity; G3: prevented daily routine activity. For all systemic events except fever, Grade 4=emergency room visit or hospitalization. Grade 4 events were classified by the investigator. Percentage of participants with any systemic events were reported in this outcome measure.
SSA: From Day 1 to Day 7 after Vaccination
SSA: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination (18-64 Years)
An adverse event (AE) was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
SSA: From Vaccination on Day 1 through 4 Weeks after Vaccination
SSA: Percentage of Participants Reporting Adverse Events From Vaccination Through 4 Weeks After Vaccination (>=65 Years)
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
SSA: From Vaccination on Day 1 through 4 Weeks after Vaccination
SSA: Percentage of Participants Reporting Serious Adverse Events (SAEs) From Vaccination Through 6 Months After Vaccination (18-64 Years)
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event.
SSA: From Vaccination on Day 1 through 6 Months after Vaccination
SSA: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination (>=65 Years)
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event.
SSA: From Vaccination on Day 1 through 6 Months after Vaccination
SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (18-64 Years)
An abnormal troponin 1 result was defined as any troponin 1 level >=0.30 nanogram per milliliter.
SSA: 2 Days after Vaccination
SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (>=65 Years)
An abnormal troponin 1 result was defined as any troponin 1 level >=0.30 nanogram per milliliter.
SSA: 2 Days after Vaccination
SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (18-64 Years)
An abnormal troponin 1 result was defined as any troponin 1 level >=0.30 nanogram per milliliter.
SSA: 1 Week After Vaccination
SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (>=65 Years)
An abnormal troponin 1 result was defined as any troponin 1 level >=0.30 nanogram per milliliter.
SSA: 1 Week After Vaccination
SSA: Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination (18-64 Years)
An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: sustained atrial or ventricular arrhythmias, second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.
SSA: 2 Days after Vaccination
SSA: Percentage of Participants With New ECG Abnormalities at 2 Days After Vaccination (>=65 Years)
An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: sustained atrial or ventricular arrhythmias, second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.
SSA: 2 Days after Vaccination
SSA: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (18-64 Years)
An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: sustained atrial or ventricular arrhythmias, second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.
SSA: 1 Week after Vaccination
SSA: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (>=65 Years)
An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: sustained atrial or ventricular arrhythmias, second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.
SSA: 1 Week after Vaccination
SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (18- 64 Years)
An abnormal troponin 1 result was defined as any troponin 1 level >=0.30 nanogram per milliliter.
SSB: 2 Days after Vaccination
SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (18- 64 Years)
An abnormal troponin 1 result was defined as any troponin 1 level >=0.30 nanogram per milliliter.
SSB: 1 Week after Vaccination
SSB: Percentage of Participants With New ECG Abnormalities at 2 Days After Vaccination (18- 64 Years)
An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: sustained atrial or ventricular arrhythmias, second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.
SSB: 2 Days after Vaccination
SSB: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (18- 64 Years)
An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: sustained atrial or ventricular arrhythmias, second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.
SSB: 1 Week after Vaccination
SSB: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18- 64 Years)
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild (Grade 1): >2.0 cm to 5.0 cm; moderate (Grade 2): >5.0 cm to 10.0 cm; severe (Grade 3): >10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis. Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Percentage of participants with any local reactions were reported in this outcome measure.
SSB: From Day 1 to Day 7 after Vaccination
SSB: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18- 64 Years)
Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain. Events were recorded by participants in an electronic diary. Fever defined as oral temperature >=38.0 deg C and categorized as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Vomiting graded as: G1: 1-2 times in 24 h; G2: >2 times in 24h; G3: required IV hydration. Diarrhea graded as: G1: 2-3 loose stools in 24h; G2: 4-5 loose stools in 24h; G3: 6 or more loose stools in 24h. Headache, fatigue, chills, new/worsened muscle pain and new/worsened joint pain: G1: didn't interfere with activity; G2: some interference with activity; G3: prevented daily routine activity. For all systemic events except fever, Grade 4=emergency room visit or hospitalization. Grade 4 events were classified by the investigator. Percentage of participants with any systemic events were reported in this outcome measure.
SSB: From Day 1 to Day 7 after Vaccination
SSB: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination (18- 64 Years)
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
SSB: From Vaccination on Day 1 through 4 Weeks after Vaccination
SSB: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination (18- 64 Years)
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event.
SSB: From Vaccination on Day 1 through 6 Months after Vaccination
SSA: Before Vaccination and 4 Weeks after Vaccination
SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years)
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.
SSA: Before Vaccination and 4 Weeks after Vaccination
SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years)
GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. When pre-vaccination assay results were lower than the LLOQ and the post-vaccination results were greater than or equal to the LLOQ, the pre-vaccination assay results were set to LLOQ for the GMFR calculation. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.
SSA: Before Vaccination to 4 Weeks after Vaccination
SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years)
GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. When pre-vaccination assay results were lower than the LLOQ and the post-vaccination results were greater than or equal to the LLOQ, the pre-vaccination assay results were set to LLOQ for the GMFR calculation. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.
SSA: Before Vaccination to 4 Weeks after Vaccination
SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years)
Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.
SSA: 4 Weeks after Vaccination
SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years)
Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.
SSA: 4 Weeks after Vaccination
SSA: Percentage of Participants With Strain Specific HAI Titers Greater Than or Equal to (>=) 1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
Percentage of participants with HAI titer >=1:40 for each strain before vaccination and 4 weeks after vaccination is presented in this outcome measure. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.
SSA: Before Vaccination and at 4 Weeks after Vaccination
SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years)
Percentage of participants with HAI titer >=1:40 for each strain before vaccination and 4 weeks after vaccination is presented in this outcome measure. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.
SSA: Before Vaccination and at 4 Weeks After Vaccination
SSA: Percentage of Participants Achieving HAI Seroconversion for All Strains at 4 Weeks After Vaccination (18- 64 Years)
Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported combined for all strains (A/Wisconsin, A/Darwin, B/Austria and B/Phuket).
SSA: 4 Weeks after Vaccination
SSA: Percentage of Participants Achieving HAI Seroconversion for All Strains at 4 Weeks After Vaccination (>=65 Years)
Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported combined for all strains (A/Wisconsin, A/Darwin, B/Austria and B/Phuket).
SSA: 4 Weeks after Vaccination
SSA: Percentage of Participants With HAI Titers >= 1.40 for All Strain at 4 Weeks After Vaccination (18- 64 Years)
Percentage of participants achieving HAI titers >= 1:40 for each strain at 4 weeks after last vaccination is reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method. Data is reported combined for all strains (A/Wisconsin, A/Darwin, B/Austria and B/Phuket).
SSA: 4 Weeks after Vaccination
SSA: Percentage of Participants With HAI Titers >= 1.40 for All Strain at 4 Weeks After Vaccination (>=65 Years)
Percentage of participants achieving HAI titers >= 1:40 for each strain at 4 weeks after last vaccination is reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method. Data is reported combined for all strains (A/Wisconsin, A/Darwin, B/Austria and B/Phuket).
SSA: 4 Weeks after Vaccination
SSA: GMTs of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
GMT of SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2 reference strain (BNT162b2 Original [ancestral strain: Wuhan-Hu-1; USA-WA1/2020]) neutralizing titers before study vaccination and at 4 week after vaccination were reported in this outcome measure. GMT and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
SSA: Before Vaccination and 4 Weeks after Vaccination
SSA: GMTs of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination and at 4 Weeks After Vaccination (>=65 Years)
GMT of SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2 reference strain (BNT162b2 Original [ancestral strain: Wuhan-Hu-1; USA-WA1/2020]) neutralizing titers before study vaccination and at 4 week after vaccination was reported in this outcome measure. GMT and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
SSA: Before Vaccination and 4 Weeks after Vaccination
SSA: GMFR of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination to 4 Weeks After Vaccination (18- 64 Years)
GMFR of SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2 reference strain (BNT162b2 Original [ancestral strain: Wuhan-Hu-1; USA-WA1/2020]) neutralizing titers before study vaccination to 4 week after vaccination was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rise and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
SSA: Before Vaccination to 4 Weeks after Vaccination
SSA: GMFR of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination to 4 Weeks After Vaccination (>=65 Years)
GMFR of SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2 reference strain (BNT162b2 Original [ancestral strain: Wuhan-Hu-1; USA-WA1/2020]) neutralizing titers before study vaccination to 4 week after vaccination was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rise and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
SSA: Before Vaccination to 4 Weeks after Vaccination
SSA: Percentage of Participants With Seroresponse Based on SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers at 4 Weeks After Vaccination (18- 64 Years)
Seroresponse was defined as achieving >= 4-fold rise from baseline (before study vaccination). If the baseline measurement was below the LLOQ, the postvaccination assay result of >= 4*LLOQ was considered a seroresponse. Exact 2-sided 95% CI, based on the Clopper and Pearson method. Percentage of participants achieving seroresponse Based on SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2-Reference-Strain (ancestral strain (Wuhan-Hu-1; USA-WA1/2020) neutralizing titers at 4 weeks after study vaccination was reported in this outcome measure.
SSA: 4 Weeks after Vaccination
SSA: Percentage of Participants With Seroresponse Based on SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers at 4 Weeks After Vaccination (>=65 Years)
Seroresponse was defined as achieving >= 4-fold rise from baseline (before study vaccination). If the baseline measurement was below the LLOQ, the postvaccination assay result of >= 4*LLOQ was considered a seroresponse. Exact 2-sided 95% CI, based on the Clopper and Pearson method. Percentage of participants achieving seroresponse Based on SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2-Reference-Strain (ancestral strain (Wuhan-Hu-1; USA-WA1/2020) neutralizing titers at 4 weeks after study vaccination was reported in this outcome measure.
SSA:4 Weeks after Vaccination
SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria, A/Cambodia and B/Phuket.
SSB: Before Vaccination and 4 Weeks after Vaccination
SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years)
GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. When pre-vaccination assay results were lower than the LLOQ and the post-vaccination results were greater than or equal to the LLOQ, the pre-vaccination assay results were set to LLOQ for the GMFR calculation. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria, A/Cambodia and B/Phuket.
SSB: Before Vaccination to 4 Weeks after Vaccination
SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years)
Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria,
SSB: 4 Weeks after Vaccination
SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
Percentage of participants with HAI titer >=1:40 for each strain before vaccination and 4 weeks after vaccination is presented in this outcome measure. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria, A/Cambodia and B/Phuket.
SSB: Before Vaccination and at 4 Weeks after Vaccination
SSB: GMTs of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
GMT of SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2 reference strain (BNT162b2 Original [ancestral strain: Wuhan-Hu-1; USA-WA1/2020]) neutralizing titers before study vaccination and at 4 week after vaccination was reported in this outcome measure. GMT and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
SSB: Before Vaccination and at 4 Weeks after Vaccination
SSB: GMFR of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years)
GMFR of SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2 reference strain (BNT162b2 Original [ancestral strain: Wuhan-Hu-1; USA-WA1/2020]) neutralizing titers before study vaccination to 4 week after vaccination was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rise and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
SSB: 4 Weeks after Vaccination
SSB: Percentage of Participants With Seroresponse Based on SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers at 4 Weeks After Vaccination (18- 64 Years)
Seroresponse was defined as achieving >= 4-fold rise from baseline (before study vaccination). If the baseline measurement was below the LLOQ, the postvaccination assay result of >= 4*LLOQ was considered a seroresponse. Exact 2-sided 95% CI, based on the Clopper and Pearson method. Percentage of participants achieving seroresponse Based on SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2-Reference-Strain (ancestral strain (Wuhan-Hu-1; USA-WA1/2020) neutralizing titers at 4 weeks after study vaccination was reported in this outcome measure.
SSB: 4 Weeks after Vaccination
Athens
Alabama
35611
United States
HOPE Research Institute
Phoenix
Arizona
85018
United States
The Pain Center of Arizona
Phoenix
Arizona
85018
United States
Orange County Research Center
Lake Forest
California
92630
United States
Orange County Heart Institute
Orange
California
92868
United States
California Research Foundation
San Diego
California
92123
United States
Orange County Research Center
Tustin
California
92780
United States
Proactive Clinical Research,LLC
Fort Lauderdale
Florida
33308
United States
Finlay Medical Research
Greenacres City
Florida
33467
United States
Indago Research & Health Center, Inc
Hialeah
Florida
33012
United States
Research Centers of America ( Hollywood )
Hollywood
Florida
33024
United States
Angels Clinical Research Institute
Miami
Florida
33122
United States
Miami Clinical Research
Miami
Florida
33155
United States
Gerardo Polanco, MD
Miami
Florida
33156
United States
Research Institute of South Florida
Miami
Florida
33173
United States
Entrust Clinical Research
Miami
Florida
33176
United States
Jackson Medical Group Cardiac Care
Miami
Florida
33176
United States
Miami Dade Medical Research Institute, LLC
Miami
Florida
33176
United States
Palm Springs Community Health Center
Miami Lakes
Florida
33014
United States
Panax Clinical Research
Miami Lakes
Florida
33014
United States
Palm Springs Community Health Center
Miami Lakes
Florida
33016
United States
Innovation Medical Research Center
Palmetto Bay
Florida
33157
United States
DBC Research USA
Pembroke Pines
Florida
33029
United States
United Medical Research
Port Orange
Florida
32127
United States
Velocity Clinical Research, Savannah
Savannah
Georgia
31406
United States
Savannah Medical Group
Savannah
Georgia
31419
United States
Clinical Research Atlanta
Stockbridge
Georgia
30281
United States
East-West Medical Research Institute
Honolulu
Hawaii
96814
United States
Great Lakes Clinical Trials - Ravenswood
Chicago
Illinois
60640
United States
Retina Associates
Elmhurst
Illinois
60126
United States
Affinity Health
Oak Brook
Illinois
60523
United States
Alliance for Multispecialty Research, LLC
Oak Brook
Illinois
60523
United States
Alliance for Multispecialty Research, LLC
Wichita
Kansas
67207
United States
Jadestone Clinical Research
Silver Spring
Maryland
20904
United States
Michigan Center of Medical Research (MICHMER)
Farmington Hills
Michigan
48334
United States
Pradeep Chandra, DO, FACC
Bridgeton
Missouri
63044
United States
Clinical Research Professionals
Chesterfield
Missouri
63005
United States
Sundance Clinical Research
St Louis
Missouri
63141
United States
Pioneer Heart Institute
Lincoln
Nebraska
68506
United States
Quality Clinical Research
Omaha
Nebraska
68114
United States
Velocity Clinical Research, Omaha
Omaha
Nebraska
68134
United States
ActivMed Practices & Research, LLC.
Portsmouth
New Hampshire
03801
United States
SUNY Upstate Medical University Institute for Global Health
Syracuse
New York
13215
United States
Monroe Biomedical Research
Monroe
North Carolina
28112
United States
M3 Wake Research, Inc.
Raleigh
North Carolina
27612
United States
CTI Clinical Research Center
Cincinnati
Ohio
45212
United States
Centricity Research Columbus Ohio Multispecialty
Columbus
Ohio
43213
United States
Lynn Health Science Institute
Oklahoma City
Oklahoma
73112
United States
Velocity Clinical Research, Providence
East Greenwich
Rhode Island
02818
United States
Main Street Physician's Care
Little River
South Carolina
29566
United States
McLeod Cardiology Associates - Little River
Little River
South Carolina
29566
United States
Alliance for Multispecialty Research, LLC
Knoxville
Tennessee
37909
United States
Alliance for Multispecialty Research, LLC
Knoxville
Tennessee
37920
United States
University of Texas Medical Branch
Galveston
Texas
77555
United States
Prolato Clinical Research Center
Houston
Texas
77054
United States
DM Clinical Research, Martin Diagnostic Clinic
Tomball
Texas
77375
United States
DM Clinical Research
Tomball
Texas
77375
United States
Charlottesville Medical Research
Charlottesville
Virginia
22911
United States
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
FG002
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
FG003
Substudy A, 18-64 Years: qIRV 30 mcg
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
FG004
Substudy A, 18-64 Years: qIRV 60 mcg
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
FG005
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
FG006
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged greater than or equal to (>=) 65 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
FG007
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 60 mcg
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
FG008
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
FG009
Substudy A, >=65 Years: qIRV 30 mcg
Participants aged >=65 years were administered qIRV 30 mcg intramuscularly on Day 1.
FG010
Substudy A, >=65 Years: qIRV 60 mcg
Participants aged >=65 years were administered qIRV 60 mcg intramuscularly on Day 1.
FG011
Substudy A, >=65 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged >=65 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
FG012
Substudy B, 18-64 Years: QIV and Bivalent BNT162b2 (30 mcg)
Participants aged 18-64 years were administered bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
FG013
Substudy B, 18-64 Years: QIV and bIRV/Bivalent BNT162b2 (45 mcg)
Participants aged 18-64 years were administered bIRV and Bivalent BNT162b2 45 mcg (OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
FG023
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
FG00030 subjects
FG00128 subjects
FG00230 subjects
FG00330 subjects
FG00430 subjects
FG00532 subjects
FG00633 subjects
FG00732 subjects
FG00833 subjects
FG00933 subjects
FG01033 subjects
FG01133 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
COMPLETED
FG00028 subjects
FG00128 subjects
FG00229 subjects
FG00330 subjects
FG00430 subjects
FG00532 subjects
FG00632 subjects
FG00732 subjects
FG00833 subjects
FG00933 subjects
FG01033 subjects
FG01133 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
NOT COMPLETED
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Substudy B
Type
Comment
Milestone Data
STARTED
(as vaccinated)
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG01229 subjects
FG01332 subjects
FG014124 subjects
FG015122 subjects
FG016114 subjects
FG01731 subjects
FG01830 subjects
FG01933 subjects
FG02030 subjects
FG02126 subjects
FG02232 subjects
FG02329 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
BG001
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
BG002
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
BG003
Substudy A, 18-64 Years: qIRV 30 mcg
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
BG004
Substudy A, 18-64 Years: qIRV 60 mcg
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
BG005
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
BG006
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged greater than or equal to (>=) 65 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
BG007
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (60 mcg)
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
BG008
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
BG009
Substudy A, >=65 Years: qIRV 30 mcg
Participants aged >=65 years were administered qIRV 30 mcg intramuscularly on Day 1.
BG010
Substudy A, >=65 Years: qIRV 60 mcg
Participants aged >=65 years were administered qIRV 60 mcg intramuscularly on Day 1.
BG011
Substudy A, >=65 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged >=65 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
BG012
Substudy B, 18-64 Years: QIV and Bivalent BNT162b2 (30 mcg)
Participants aged 18-64 years were administered bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
BG013
Substudy B, 18-64 Years: QIV and bIRV /Bivalent BNT162b2 (45mcg)
Participants aged 18-64 years were administered bIRV and Bivalent BNT162b2 45 mcg (OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
BG023
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
BG024
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00030
BG00128
BG00230
BG00330
BG00430
BG00532
BG00633
BG00732
BG00833
BG00933
BG01033
BG01133
BG01229
BG01332
BG014124
BG015122
BG016114
BG01731
BG01830
BG01933
BG02030
BG02126
BG02232
BG02329
BG0241009
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00046.1± 11.68
BG00144.4± 12.75
BG00243.1± 12.45
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00015
BG00115
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00025
BG00122
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
SSA: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18-64 Years)
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 centimeter (cm). Redness and swelling were graded as mild (Grade 1): greater than (>) 2.0 cm to 5.0 cm; moderate (Grade 2): >5.0 cm to 10.0 cm; severe (Grade 3): >10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Percentage of participants with any local reactions were reported in this outcome measure.
Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
Posted
Number
95% Confidence Interval
Percentage of participants
SSA: From Day 1 to Day 7 after Vaccination
ID
Title
Description
OG000
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG002
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG003
Substudy A, 18-64 Years: qIRV 30 mcg
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
OG004
Substudy A, 18-64 Years: qIRV 60 mcg
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
OG005
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00030
OG00128
OG00230
OG003
Title
Denominators
Categories
Title
Measurements
OG00083.3(65.3 to 94.4)
OG00189.3(71.8 to 97.7)
OG00280.0(61.4 to 92.3)
OG003
Primary
SSA: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (>=65 Years)
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild (Grade 1): >2.0 cm to 5.0 cm; moderate (Grade 2): >5.0 cm to 10.0 cm; severe (Grade 3): >10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis. Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Percentage of participants with any local reactions were reported in this outcome measure.
Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
Posted
Number
95% Confidence Interval
Percentage of participants
SSA: From Day 1 to Day 7 after Vaccination
ID
Title
Description
OG000
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged greater than or equal to (>=) 65 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 60 mcg
Primary
SSA: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18-64 Years)
Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain. Events were recorded by participants in an electronic diary. Fever defined as oral temperature >=38.0 deg C and categorized as>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Vomiting graded as: G1: 1-2 times in 24 h; G2: >2 times in 24h; G3: required IV hydration. Diarrhea graded as: G1: 2-3 loose stools in 24h; G2: 4-5 loose stools in 24h; G3: 6 or more loose stools in 24h.Headache, fatigue, chills, new/worsened muscle pain and new/worsened joint pain: G1: didn't interfere with activity; G2: some interference with activity; G3: prevented daily routine activity. For all systemic events except fever, Grade 4=emergency room visit or hospitalization. Grade 4 events were classified by the investigator. Percentage of participants with any systemic events were reported in this outcome measure.
Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
Posted
Number
95% Confidence Interval
Percentage of participants
SSA: From Day 1 to Day 7 after Vaccination
ID
Title
Description
OG000
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Primary
SSA: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (>=65 Years)
Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain. Events were recorded by participants in an electronic diary. Fever defined as oral temperature >=38.0 deg C and categorized as>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Vomiting graded as: G1: 1-2 times in 24 h; G2: >2 times in 24h; G3: required IV hydration. Diarrhea graded as: G1: 2-3 loose stools in 24h; G2: 4-5 loose stools in 24h; G3: 6 or more loose stools in 24h.Headache, fatigue, chills, new/worsened muscle pain and new/worsened joint pain: G1: didn't interfere with activity; G2: some interference with activity; G3: prevented daily routine activity. For all systemic events except fever, Grade 4=emergency room visit or hospitalization. Grade 4 events were classified by the investigator. Percentage of participants with any systemic events were reported in this outcome measure.
Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
Posted
Number
95% Confidence Interval
Percentage of participants
SSA: From Day 1 to Day 7 after Vaccination
ID
Title
Description
OG000
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged greater than or equal to (>=) 65 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
Primary
SSA: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination (18-64 Years)
An adverse event (AE) was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
Posted
Number
95% Confidence Interval
Percentage of participants
SSA: From Vaccination on Day 1 through 4 Weeks after Vaccination
ID
Title
Description
OG000
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
Primary
SSA: Percentage of Participants Reporting Adverse Events From Vaccination Through 4 Weeks After Vaccination (>=65 Years)
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
Posted
Number
95% Confidence Interval
Percentage of participants
SSA: From Vaccination on Day 1 through 4 Weeks after Vaccination
ID
Title
Description
OG000
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged greater than or equal to (>=) 65 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 60 mcg
Primary
SSA: Percentage of Participants Reporting Serious Adverse Events (SAEs) From Vaccination Through 6 Months After Vaccination (18-64 Years)
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event.
Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
Posted
Number
95% Confidence Interval
Percentage of participants
SSA: From Vaccination on Day 1 through 6 Months after Vaccination
ID
Title
Description
OG000
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG002
Primary
SSA: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination (>=65 Years)
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event.
Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
Posted
Number
95% Confidence Interval
Percentage of participants
SSA: From Vaccination on Day 1 through 6 Months after Vaccination
ID
Title
Description
OG000
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged greater than or equal to (>=) 65 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 60 mcg
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG002
Primary
SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (18-64 Years)
An abnormal troponin 1 result was defined as any troponin 1 level >=0.30 nanogram per milliliter.
Safety population included all participants who received the study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Participants were analyzed according to the treatment which they received.
Posted
Number
95% Confidence Interval
Percentage of participants
SSA: 2 Days after Vaccination
ID
Title
Description
OG000
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG002
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
Primary
SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (>=65 Years)
An abnormal troponin 1 result was defined as any troponin 1 level >=0.30 nanogram per milliliter.
Safety population included all participants who received the study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Participants were analyzed according to the treatment to which they were received.
Posted
Number
95% Confidence Interval
Percentage of participants
SSA: 2 Days after Vaccination
ID
Title
Description
OG000
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged greater than or equal to (>=) 65 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 60 mcg
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG002
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
Primary
SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (18-64 Years)
An abnormal troponin 1 result was defined as any troponin 1 level >=0.30 nanogram per milliliter.
Safety population included all participants who received the study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Participants were analyzed according to the treatment which they received.
Posted
Number
95% Confidence Interval
Percentage of participants
SSA: 1 Week After Vaccination
ID
Title
Description
OG000
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG002
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
Primary
SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (>=65 Years)
An abnormal troponin 1 result was defined as any troponin 1 level >=0.30 nanogram per milliliter.
Safety population included all participants who received the study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Participants were analyzed according to the treatment which they received.
Posted
Number
95% Confidence Interval
Percentage of participants
SSA: 1 Week After Vaccination
ID
Title
Description
OG000
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged greater than or equal to (>=) 65 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 60 mcg
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG002
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
Primary
SSA: Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination (18-64 Years)
An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: sustained atrial or ventricular arrhythmias, second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.
Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
Posted
Number
95% Confidence Interval
Percentage of participants
SSA: 2 Days after Vaccination
ID
Title
Description
OG000
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG002
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Primary
SSA: Percentage of Participants With New ECG Abnormalities at 2 Days After Vaccination (>=65 Years)
An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: sustained atrial or ventricular arrhythmias, second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.
Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
Posted
Number
95% Confidence Interval
Percentage of participants
SSA: 2 Days after Vaccination
ID
Title
Description
OG000
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged greater than or equal to (>=) 65 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 60 mcg
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG002
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Primary
SSA: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (18-64 Years)
An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: sustained atrial or ventricular arrhythmias, second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.
Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
Posted
Number
95% Confidence Interval
Percentage of participants
SSA: 1 Week after Vaccination
ID
Title
Description
OG000
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG002
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Primary
SSA: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (>=65 Years)
An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: sustained atrial or ventricular arrhythmias, second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.
Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
Posted
Number
95% Confidence Interval
Percentage of participants
SSA: 1 Week after Vaccination
ID
Title
Description
OG000
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged greater than or equal to (>=) 65 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 60 mcg
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG002
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Primary
SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (18- 64 Years)
An abnormal troponin 1 result was defined as any troponin 1 level >=0.30 nanogram per milliliter.
Safety population included all participants who received the study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Participants were analyzed according to the treatment which they received.
Posted
Number
95% Confidence Interval
Percentage of participants
SSB: 2 Days after Vaccination
ID
Title
Description
OG000
Substudy B, 18-64 Years: QIV and Bivalent BNT162b2 (30 mcg)
Participants aged 18-64 years were administered bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
OG001
Substudy B, 18-64 Years: QIV and bIRV /Bivalent BNT162b2 (45mcg)
Participants aged 18-64 years were administered bIRV and Bivalent BNT162b2 45 mcg (OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
OG002
Primary
SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (18- 64 Years)
An abnormal troponin 1 result was defined as any troponin 1 level >=0.30 nanogram per milliliter.
Safety population included all participants who received the study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Participants were analyzed according to the treatment which they received.
Posted
Number
95% Confidence Interval
Percentage of participants
SSB: 1 Week after Vaccination
ID
Title
Description
OG000
Substudy B, 18-64 Years: QIV and Bivalent BNT162b2 (30 mcg)
Participants aged 18-64 years were administered bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
OG001
Substudy B, 18-64 Years: QIV and bIRV /Bivalent BNT162b2 (45mcg)
Participants aged 18-64 years were administered bIRV and Bivalent BNT162b2 45 mcg (OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
OG002
Primary
SSB: Percentage of Participants With New ECG Abnormalities at 2 Days After Vaccination (18- 64 Years)
An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: sustained atrial or ventricular arrhythmias, second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.
Safety population included all participants who received the study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Participants were analyzed according to the treatment which they received.
Posted
Number
95% Confidence Interval
Percentage of participants
SSB: 2 Days after Vaccination
ID
Title
Description
OG000
Substudy B, 18-64 Years: QIV and Bivalent BNT162b2 (30 mcg)
Participants aged 18-64 years were administered bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
OG001
Substudy B, 18-64 Years: QIV and bIRV /Bivalent BNT162b2 (45mcg)
Participants aged 18-64 years were administered bIRV and Bivalent BNT162b2 45 mcg (OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Primary
SSB: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (18- 64 Years)
An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: sustained atrial or ventricular arrhythmias, second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.
Safety population included all participants who received the study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Participants were analyzed according to the treatment which they received.
Posted
Number
95% Confidence Interval
Percentage of participants
SSB: 1 Week after Vaccination
ID
Title
Description
OG000
Substudy B, 18-64 Years: QIV and Bivalent BNT162b2 (30 mcg)
Participants aged 18-64 years were administered bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
OG001
Substudy B, 18-64 Years: QIV and bIRV /Bivalent BNT162b2 (45mcg)
Participants aged 18-64 years were administered bIRV and Bivalent BNT162b2 45 mcg (OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Primary
SSB: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18- 64 Years)
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild (Grade 1): >2.0 cm to 5.0 cm; moderate (Grade 2): >5.0 cm to 10.0 cm; severe (Grade 3): >10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis. Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Percentage of participants with any local reactions were reported in this outcome measure.
Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
Posted
Number
95% Confidence Interval
Percentage of participants
SSB: From Day 1 to Day 7 after Vaccination
ID
Title
Description
OG000
Substudy B, 18-64 Years: QIV and Bivalent BNT162b2 (30 mcg)
Participants aged 18-64 years were administered bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Primary
SSB: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18- 64 Years)
Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain. Events were recorded by participants in an electronic diary. Fever defined as oral temperature >=38.0 deg C and categorized as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Vomiting graded as: G1: 1-2 times in 24 h; G2: >2 times in 24h; G3: required IV hydration. Diarrhea graded as: G1: 2-3 loose stools in 24h; G2: 4-5 loose stools in 24h; G3: 6 or more loose stools in 24h. Headache, fatigue, chills, new/worsened muscle pain and new/worsened joint pain: G1: didn't interfere with activity; G2: some interference with activity; G3: prevented daily routine activity. For all systemic events except fever, Grade 4=emergency room visit or hospitalization. Grade 4 events were classified by the investigator. Percentage of participants with any systemic events were reported in this outcome measure.
Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
Posted
Number
95% Confidence Interval
Percentage of participants
SSB: From Day 1 to Day 7 after Vaccination
ID
Title
Description
OG000
Substudy B, 18-64 Years: QIV and Bivalent BNT162b2 (30 mcg)
Participants aged 18-64 years were administered bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Primary
SSB: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination (18- 64 Years)
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
Posted
Number
95% Confidence Interval
Percentage of participants
SSB: From Vaccination on Day 1 through 4 Weeks after Vaccination
ID
Title
Description
OG000
Substudy B, 18-64 Years: QIV and Bivalent BNT162b2 (30 mcg)
Participants aged 18-64 years were administered bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Primary
SSB: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination (18- 64 Years)
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event.
Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
Posted
Number
95% Confidence Interval
Percentage of participants
SSB: From Vaccination on Day 1 through 6 Months after Vaccination
ID
Title
Description
OG000
Substudy B, 18-64 Years: QIV and Bivalent BNT162b2 (30 mcg)
Participants aged 18-64 years were administered bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
OG001
Substudy B, 18-64 Years: QIV and bIRV /Bivalent BNT162b2 (45mcg)
Participants aged 18-64 years were administered bIRV and Bivalent BNT162b2 45 mcg (OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Secondary
SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations 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. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.
Evaluable immunogenicity population (EIP) included all eligible participants who receive the study intervention to which they were randomized; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
95% Confidence Interval
Titers
SSA: Before Vaccination and 4 Weeks after Vaccination
ID
Title
Description
OG000
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
Secondary
SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years)
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.
EIP included all eligible participants who receive the study intervention to which they were randomized; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
95% Confidence Interval
Titers
SSA: Before Vaccination and 4 Weeks after Vaccination
ID
Title
Description
OG000
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged greater than or equal to (>=) 65 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (60 mcg)
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
Secondary
SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years)
GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. When pre-vaccination assay results were lower than the LLOQ and the post-vaccination results were greater than or equal to the LLOQ, the pre-vaccination assay results were set to LLOQ for the GMFR calculation. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.
EIP included all eligible participants who receive the study intervention to which they were randomized; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
95% Confidence Interval
Fold Rise
SSA: Before Vaccination to 4 Weeks after Vaccination
ID
Title
Description
OG000
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
Secondary
SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years)
GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. When pre-vaccination assay results were lower than the LLOQ and the post-vaccination results were greater than or equal to the LLOQ, the pre-vaccination assay results were set to LLOQ for the GMFR calculation. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.
EIP included all eligible participants who receive the study intervention to which they were randomized; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
95% Confidence Interval
Fold Rise
SSA: Before Vaccination to 4 Weeks after Vaccination
ID
Title
Description
OG000
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged greater than or equal to (>=) 65 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (60 mcg)
Secondary
SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years)
Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.
EIP included all eligible participants who receive study intervention to which they were randomized;had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations."Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Number
95% Confidence Interval
Percentage of participants
SSA: 4 Weeks after Vaccination
ID
Title
Description
OG000
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
Secondary
SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years)
Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.
EIP included all eligible participants who receive study intervention to which they were randomized;had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Number
95% Confidence Interval
Percentage of participants
SSA: 4 Weeks after Vaccination
ID
Title
Description
OG000
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged greater than or equal to (>=) 65 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (60 mcg)
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
Secondary
SSA: Percentage of Participants With Strain Specific HAI Titers Greater Than or Equal to (>=) 1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
Percentage of participants with HAI titer >=1:40 for each strain before vaccination and 4 weeks after vaccination is presented in this outcome measure. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.
EIP included all eligible participants who receive the study intervention to which they were randomized; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Number
95% Confidence Interval
Percentage of participants
SSA: Before Vaccination and at 4 Weeks after Vaccination
ID
Title
Description
OG000
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
Secondary
SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years)
Percentage of participants with HAI titer >=1:40 for each strain before vaccination and 4 weeks after vaccination is presented in this outcome measure. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria and B/Phuket.
EIP included all eligible participants who receive the study intervention to which they were randomized; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Number
95% Confidence Interval
Percentage of participants
SSA: Before Vaccination and at 4 Weeks After Vaccination
ID
Title
Description
OG000
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged greater than or equal to (>=) 65 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (60 mcg)
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
Secondary
SSA: Percentage of Participants Achieving HAI Seroconversion for All Strains at 4 Weeks After Vaccination (18- 64 Years)
Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported combined for all strains (A/Wisconsin, A/Darwin, B/Austria and B/Phuket).
EIP included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations before vaccination. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
SSA: 4 Weeks after Vaccination
ID
Title
Description
OG000
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
Secondary
SSA: Percentage of Participants Achieving HAI Seroconversion for All Strains at 4 Weeks After Vaccination (>=65 Years)
Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported combined for all strains (A/Wisconsin, A/Darwin, B/Austria and B/Phuket).
EIP included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations before vaccination. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
SSA: 4 Weeks after Vaccination
ID
Title
Description
OG000
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged greater than or equal to (>=) 65 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (60 mcg)
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
Secondary
SSA: Percentage of Participants With HAI Titers >= 1.40 for All Strain at 4 Weeks After Vaccination (18- 64 Years)
Percentage of participants achieving HAI titers >= 1:40 for each strain at 4 weeks after last vaccination is reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method. Data is reported combined for all strains (A/Wisconsin, A/Darwin, B/Austria and B/Phuket).
EIP included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations before vaccination. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
SSA: 4 Weeks after Vaccination
ID
Title
Description
OG000
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
Secondary
SSA: Percentage of Participants With HAI Titers >= 1.40 for All Strain at 4 Weeks After Vaccination (>=65 Years)
Percentage of participants achieving HAI titers >= 1:40 for each strain at 4 weeks after last vaccination is reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method. Data is reported combined for all strains (A/Wisconsin, A/Darwin, B/Austria and B/Phuket).
EIP included all eligible participants who receive the study intervention to which they were randomized; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations.
Posted
Number
95% Confidence Interval
Percentage of participants
SSA: 4 Weeks after Vaccination
ID
Title
Description
OG000
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged greater than or equal to (>=) 65 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (60 mcg)
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG002
Secondary
SSA: GMTs of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
GMT of SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2 reference strain (BNT162b2 Original [ancestral strain: Wuhan-Hu-1; USA-WA1/2020]) neutralizing titers before study vaccination and at 4 week after vaccination were reported in this outcome measure. GMT and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
EIP included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations before vaccination. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Only arms which received covid vaccine (BNT162b2) were analyzed.
Posted
Geometric Mean
95% Confidence Interval
Titers
SSA: Before Vaccination and 4 Weeks after Vaccination
ID
Title
Description
OG000
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
Secondary
SSA: GMTs of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination and at 4 Weeks After Vaccination (>=65 Years)
GMT of SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2 reference strain (BNT162b2 Original [ancestral strain: Wuhan-Hu-1; USA-WA1/2020]) neutralizing titers before study vaccination and at 4 week after vaccination was reported in this outcome measure. GMT and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
EIP included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations before vaccination. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Only arms which received covid vaccine (BNT162b2) were analyzed.
Posted
Geometric Mean
95% Confidence Interval
Titers
SSA: Before Vaccination and 4 Weeks after Vaccination
ID
Title
Description
OG000
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged greater than or equal to (>=) 65 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (60 mcg)
Secondary
SSA: GMFR of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination to 4 Weeks After Vaccination (18- 64 Years)
GMFR of SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2 reference strain (BNT162b2 Original [ancestral strain: Wuhan-Hu-1; USA-WA1/2020]) neutralizing titers before study vaccination to 4 week after vaccination was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rise and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
EIP included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations before vaccination. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Only arms which received covid vaccine (BNT162b2) were analyzed.
Posted
Geometric Mean
95% Confidence Interval
Fold Rise
SSA: Before Vaccination to 4 Weeks after Vaccination
ID
Title
Description
OG000
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
Secondary
SSA: GMFR of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination to 4 Weeks After Vaccination (>=65 Years)
GMFR of SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2 reference strain (BNT162b2 Original [ancestral strain: Wuhan-Hu-1; USA-WA1/2020]) neutralizing titers before study vaccination to 4 week after vaccination was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rise and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
EIP included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations before vaccination. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Only arms which received covid vaccine (BNT162b2) were analyzed.
Posted
Geometric Mean
95% Confidence Interval
Fold Rise
SSA: Before Vaccination to 4 Weeks after Vaccination
ID
Title
Description
OG000
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged greater than or equal to (>=) 65 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (60 mcg)
Secondary
SSA: Percentage of Participants With Seroresponse Based on SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers at 4 Weeks After Vaccination (18- 64 Years)
Seroresponse was defined as achieving >= 4-fold rise from baseline (before study vaccination). If the baseline measurement was below the LLOQ, the postvaccination assay result of >= 4*LLOQ was considered a seroresponse. Exact 2-sided 95% CI, based on the Clopper and Pearson method. Percentage of participants achieving seroresponse Based on SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2-Reference-Strain (ancestral strain (Wuhan-Hu-1; USA-WA1/2020) neutralizing titers at 4 weeks after study vaccination was reported in this outcome measure.
EIP included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations before vaccination. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Only arms which received covid vaccine (BNT162b2) were analyzed.
Posted
Number
95% Confidence Interval
Percentage of participants
SSA: 4 Weeks after Vaccination
ID
Title
Description
OG000
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG001
Secondary
SSA: Percentage of Participants With Seroresponse Based on SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers at 4 Weeks After Vaccination (>=65 Years)
Seroresponse was defined as achieving >= 4-fold rise from baseline (before study vaccination). If the baseline measurement was below the LLOQ, the postvaccination assay result of >= 4*LLOQ was considered a seroresponse. Exact 2-sided 95% CI, based on the Clopper and Pearson method. Percentage of participants achieving seroresponse Based on SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2-Reference-Strain (ancestral strain (Wuhan-Hu-1; USA-WA1/2020) neutralizing titers at 4 weeks after study vaccination was reported in this outcome measure.
EIP included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations before vaccination. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Only arms which received covid vaccine (BNT162b2) were analyzed.
Posted
Number
95% Confidence Interval
Percentage of participants
SSA:4 Weeks after Vaccination
ID
Title
Description
OG000
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged greater than or equal to (>=) 65 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
Secondary
SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria, A/Cambodia and B/Phuket.
EIP included all eligible participants who receive the study intervention to which they were randomized; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
95% Confidence Interval
Titers
SSB: Before Vaccination and 4 Weeks after Vaccination
ID
Title
Description
OG000
Substudy B, 18-64 Years: QIV and Bivalent BNT162b2 (30 mcg)
Participants aged 18-64 years were administered bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
OG001
Substudy B, 18-64 Years: QIV and bIRV /Bivalent BNT162b2 (45mcg)
Participants aged 18-64 years were administered bIRV and Bivalent BNT162b2 45 mcg (OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Secondary
SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years)
GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. When pre-vaccination assay results were lower than the LLOQ and the post-vaccination results were greater than or equal to the LLOQ, the pre-vaccination assay results were set to LLOQ for the GMFR calculation. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria, A/Cambodia and B/Phuket.
EIP included all eligible participants who receive the study intervention to which they were randomized; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
95% Confidence Interval
Fold Rise
SSB: Before Vaccination to 4 Weeks after Vaccination
ID
Title
Description
OG000
Substudy B, 18-64 Years: QIV and Bivalent BNT162b2 (30 mcg)
Participants aged 18-64 years were administered bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
OG001
Substudy B, 18-64 Years: QIV and bIRV /Bivalent BNT162b2 (45mcg)
Secondary
SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years)
Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria,
EIP included all eligible participants who receive study intervention to which they were randomized;had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations."Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. And 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
95% Confidence Interval
Percentage of participants
SSB: 4 Weeks after Vaccination
ID
Title
Description
OG000
Substudy B, 18-64 Years: QIV and Bivalent BNT162b2 (30 mcg)
Participants aged 18-64 years were administered bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
OG001
Substudy B, 18-64 Years: QIV and bIRV /Bivalent BNT162b2 (45mcg)
Secondary
SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
Percentage of participants with HAI titer >=1:40 for each strain before vaccination and 4 weeks after vaccination is presented in this outcome measure. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Data is reported for following strains: A/Wisconsin, A/Darwin, B/Austria, A/Cambodia and B/Phuket.
EIP included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame after vaccination; had at least 1 valid and determinate assay result at the 4-week post-vaccination visit and had no major protocol deviations before vaccination. "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Number
95% Confidence Interval
Percentage of participants
SSB: Before Vaccination and at 4 Weeks after Vaccination
ID
Title
Description
OG000
Substudy B, 18-64 Years: QIV and Bivalent BNT162b2 (30 mcg)
Participants aged 18-64 years were administered bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
OG001
Substudy B, 18-64 Years: QIV and bIRV /Bivalent BNT162b2 (45mcg)
Secondary
SSB: GMTs of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years)
GMT of SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2 reference strain (BNT162b2 Original [ancestral strain: Wuhan-Hu-1; USA-WA1/2020]) neutralizing titers before study vaccination and at 4 week after vaccination was reported in this outcome measure. GMT and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
EIP included all eligible participants who receive study intervention to which they were randomized;had blood drawn for assay testing within specified time frame after vaccination;had at least 1 valid & determinate assay result at 4-week post-vaccination visit & had no major protocol deviations."Number of Participants Analyzed" =participants evaluable & 'Number Analyzed' = participants evaluable for specified rows. Only arms which received covid vaccine (BNT162b2) were analyzed.
Posted
Geometric Mean
95% Confidence Interval
Titers
SSB: Before Vaccination and at 4 Weeks after Vaccination
ID
Title
Description
OG000
Substudy B, 18-64 Years: QIV and Bivalent BNT162b2 (30 mcg)
Participants aged 18-64 years were administered bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Secondary
SSB: GMFR of SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years)
GMFR of SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2 reference strain (BNT162b2 Original [ancestral strain: Wuhan-Hu-1; USA-WA1/2020]) neutralizing titers before study vaccination to 4 week after vaccination was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rise and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ.
EIP included all eligible participants who receive study intervention to which they were randomized;had blood drawn for assay testing within specified time frame after vaccination;had at least 1 valid & determinate assay result at 4-week post-vaccination visit & had no major protocol deviations."Number of Participants Analyzed" =participants evaluable & 'Number Analyzed' = participants evaluable for specified rows. Only arms which received covid vaccine (BNT162b2) were analyzed.
Posted
Geometric Mean
95% Confidence Interval
Fold rise
SSB: 4 Weeks after Vaccination
ID
Title
Description
OG000
Substudy B, 18-64 Years: QIV and Bivalent BNT162b2 (30 mcg)
Participants aged 18-64 years were administered bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Secondary
SSB: Percentage of Participants With Seroresponse Based on SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers and SARS-CoV-2-Reference-Strain Neutralizing Titers at 4 Weeks After Vaccination (18- 64 Years)
Seroresponse was defined as achieving >= 4-fold rise from baseline (before study vaccination). If the baseline measurement was below the LLOQ, the postvaccination assay result of >= 4*LLOQ was considered a seroresponse. Exact 2-sided 95% CI, based on the Clopper and Pearson method. Percentage of participants achieving seroresponse Based on SARS-CoV-2 Omicron (BA.4/BA.5)- neutralizing titers and SARS-CoV-2-Reference-Strain (ancestral strain (Wuhan-Hu-1; USA-WA1/2020) neutralizing titers at 4 weeks after study vaccination was reported in this outcome measure.
EIP included all eligible participants who receive study intervention to which they were randomized;had blood drawn for assay testing within specified time frame after vaccination;had at least 1 valid & determinate assay result at 4-week post-vaccination visit & had no major protocol deviations."Number of Participants Analyzed" =participants evaluable & 'Number Analyzed' = participants evaluable for specified rows. Only arms which received covid vaccine (BNT162b2) were analyzed.
Posted
Geometric Mean
95% Confidence Interval
Percentage of participants
SSB: 4 Weeks after Vaccination
ID
Title
Description
OG000
Substudy B, 18-64 Years: QIV and Bivalent BNT162b2 (30 mcg)
Participants aged 18-64 years were administered bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Time Frame
Local reactions/systemic events (Systematic assessment): from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality/ SAEs: from vaccination up to 6 months after vaccination: other AEs: from vaccination up to 4 weeks after last vaccination.
Description
Same event may appear as both non-SAE 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 AE and non-SAE. Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
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
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
0
30
0
30
26
30
EG001
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
0
28
1
28
27
28
EG002
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
0
30
0
30
24
30
EG003
Substudy A, 18-64 Years: qIRV 30 mcg
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
0
30
0
30
22
30
EG004
Substudy A, 18-64 Years: qIRV 60 mcg
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
0
30
0
30
24
30
EG005
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
0
32
1
32
27
32
EG006
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1)
Participants aged greater than or equal to (>=) 65 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
0
33
0
33
31
33
EG007
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (60 mcg)
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
0
32
0
32
22
32
EG008
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
0
33
0
33
29
33
EG009
Substudy A, >=65 Years: qIRV 30 mcg
Participants aged >=65 years were administered qIRV 30 mcg intramuscularly on Day 1.
0
33
2
33
25
33
EG010
Substudy A, >=65 Years: qIRV 60 mcg
Participants aged >=65 years were administered qIRV 60 mcg intramuscularly on Day 1.
0
33
0
33
27
33
EG011
Substudy A, >=65 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged >=65 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
0
33
0
33
20
33
EG012
Substudy B, 18-64 Years: QIV and Bivalent BNT162b2 (30 mcg)
Participants aged 18-64 years were administered bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
0
29
0
29
19
29
EG013
Substudy B, 18-64 Years: QIV and bIRV /Bivalent BNT162b2 (45mcg)
Participants aged 18-64 years were administered bIRV and Bivalent BNT162b2 45 mcg (OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
0
32
0
32
24
32
EG023
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
0
29
0
29
20
29
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Appendicitis
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG0030 affected30 at risk
EG0040 affected30 at risk
EG0050 affected32 at risk
EG0060 affected33 at risk
EG0070 affected32 at risk
EG0080 affected33 at risk
EG0090 affected33 at risk
EG0100 affected33 at risk
EG0110 affected33 at risk
EG0120 affected29 at risk
EG0130 affected32 at risk
EG0140 affected124 at risk
EG0150 affected122 at risk
EG0160 affected114 at risk
EG0171 affected31 at risk
EG0180 affected30 at risk
EG0190 affected33 at risk
EG0200 affected30 at risk
EG0210 affected26 at risk
EG0220 affected32 at risk
EG0230 affected29 at risk
Gastric ulcer
Gastrointestinal disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0011 affected28 at risk
EG0020 affected30 at risk
EG003
Cervical spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Cholecystitis infective
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0011 affected28 at risk
EG0020 affected30 at risk
EG0030 affected30 at risk
EG0040 affected30 at risk
EG0050 affected32 at risk
EG0060 affected33 at risk
EG0070 affected32 at risk
EG0080 affected33 at risk
EG0090 affected33 at risk
EG0100 affected33 at risk
EG0110 affected33 at risk
EG0120 affected29 at risk
EG0130 affected32 at risk
EG0141 affected124 at risk
EG0151 affected122 at risk
EG0160 affected114 at risk
EG0171 affected31 at risk
EG0180 affected30 at risk
EG0190 affected33 at risk
EG0200 affected30 at risk
EG0210 affected26 at risk
EG0220 affected32 at risk
EG0230 affected29 at risk
Palpitations
Cardiac disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Chest pain
General disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Chills (CHILLS)
General disorders
MedDRA v26.1
Systematic Assessment
EG00016 affected30 at risk
EG00114 affected28 at risk
EG00216 affected30 at risk
EG003
Fatigue (FATIGUE)
General disorders
MedDRA v26.1
Systematic Assessment
EG00015 affected30 at risk
EG00114 affected28 at risk
EG00218 affected30 at risk
EG003
Injection site erythema
General disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Injection site erythema (REDNESS)
General disorders
MedDRA v26.1
Systematic Assessment
EG0004 affected30 at risk
EG0013 affected28 at risk
EG0023 affected30 at risk
EG003
Injection site pain
General disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Injection site pain (PAIN)
General disorders
MedDRA v26.1
Systematic Assessment
EG00025 affected30 at risk
EG00125 affected28 at risk
EG00224 affected30 at risk
EG003
Injection site swelling (SWELLING)
General disorders
MedDRA v26.1
Systematic Assessment
EG0005 affected30 at risk
EG0011 affected28 at risk
EG0022 affected30 at risk
EG003
Pyrexia (FEVER)
General disorders
MedDRA v26.1
Systematic Assessment
EG0004 affected30 at risk
EG0013 affected28 at risk
EG0028 affected30 at risk
EG003
Diarrhoea (DIARRHEA)
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0004 affected30 at risk
EG0011 affected28 at risk
EG0022 affected30 at risk
EG003
Vomiting (VOMITING)
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0002 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
COVID-19
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Viral infection
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
SARS-CoV-2 test positive
Investigations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Arthralgia (JOINT PAIN)
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Systematic Assessment
EG0005 affected30 at risk
EG0015 affected28 at risk
EG00210 affected30 at risk
EG003
Myalgia (MUSCLE PAIN)
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Systematic Assessment
EG00014 affected30 at risk
EG0019 affected28 at risk
EG00210 affected30 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Headache (HEADACHE)
Nervous system disorders
MedDRA v26.1
Systematic Assessment
EG00016 affected30 at risk
EG00116 affected28 at risk
EG00215 affected30 at risk
EG003
Menstruation irregular
Reproductive system and breast disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA v26.1
Non-systematic Assessment
EG0001 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
INFLUENZA LIKE ILLNESS
General disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0011 affected28 at risk
EG0020 affected30 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Rhinovirus infection
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Corneal abrasion
Injury, poisoning and procedural complications
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Blood pressure systolic increased
Investigations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Syncope
Nervous system disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Tension headache
Nervous system disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected30 at risk
EG0010 affected28 at risk
EG0020 affected30 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 >=65 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG002
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG003
Substudy A, >=65 Years: qIRV 30 mcg
Participants aged >=65 years were administered qIRV 30 mcg intramuscularly on Day 1.
OG004
Substudy A, >=65 Years: qIRV 60 mcg
Participants aged >=65 years were administered qIRV 60 mcg intramuscularly on Day 1.
OG005
Substudy A, >=65 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged >=65 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00033
OG00132
OG00233
OG00333
OG00433
OG00533
Title
Denominators
Categories
Title
Measurements
OG00084.8(68.1 to 94.9)
OG00153.1(34.7 to 70.9)
OG00284.8(68.1 to 94.9)
OG00363.6(45.1 to 79.6)
OG00472.7(54.5 to 86.7)
OG00551.5(33.5 to 69.2)
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG002
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG003
Substudy A, 18-64 Years: qIRV 30 mcg
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
OG004
Substudy A, 18-64 Years: qIRV 60 mcg
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
OG005
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00030
OG00128
OG00230
OG00330
OG00430
OG00532
Title
Denominators
Categories
Title
Measurements
OG00076.7(57.7 to 90.1)
OG00178.6(59.0 to 91.7)
OG00270.0(50.6 to 85.3)
OG00353.3(34.3 to 71.7)
OG00463.3(43.9 to 80.1)
OG00568.8(50.0 to 83.9)
OG001
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 60 mcg
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG002
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG003
Substudy A, >=65 Years: qIRV 30 mcg
Participants aged >=65 years were administered qIRV 30 mcg intramuscularly on Day 1.
OG004
Substudy A, >=65 Years: qIRV 60 mcg
Participants aged >=65 years were administered qIRV 60 mcg intramuscularly on Day 1.
OG005
Substudy A, >=65 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged >=65 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00033
OG00132
OG00233
OG00333
OG00433
OG00533
Title
Denominators
Categories
Title
Measurements
OG00072.7(54.5 to 86.7)
OG00150.0(31.9 to 68.1)
OG00269.7(51.3 to 84.4)
OG00345.5(28.1 to 63.6)
OG00460.6(42.1 to 77.1)
OG00545.5(28.1 to 63.6)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG002
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG003
Substudy A, 18-64 Years: qIRV 30 mcg
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
OG004
Substudy A, 18-64 Years: qIRV 60 mcg
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
OG005
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00030
OG00128
OG00230
OG00330
OG00430
OG00532
Title
Denominators
Categories
Title
Measurements
OG0003.3(0.1 to 17.2)
OG00110.7(2.3 to 28.2)
OG0020(0.0 to 11.6)
OG0033.3(0.1 to 17.2)
OG0046.7(0.8 to 22.1)
OG0053.1(0.1 to 16.2)
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG002
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG003
Substudy A, >=65 Years: qIRV 30 mcg
Participants aged >=65 years were administered qIRV 30 mcg intramuscularly on Day 1.
OG004
Substudy A, >=65 Years: qIRV 60 mcg
Participants aged >=65 years were administered qIRV 60 mcg intramuscularly on Day 1.
OG005
Substudy A, >=65 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged >=65 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00033
OG00132
OG00233
OG00333
OG00433
OG00533
Title
Denominators
Categories
Title
Measurements
OG00024.2(11.1 to 42.3)
OG0019.4(2.0 to 25.0)
OG0026.1(0.7 to 20.2)
OG0036.1(0.7 to 20.2)
OG0049.1(1.9 to 24.3)
OG0050(0.0 to 10.6)
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG003
Substudy A, 18-64 Years: qIRV 30 mcg
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
OG004
Substudy A, 18-64 Years: qIRV 60 mcg
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
OG005
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00030
OG00128
OG00230
OG00330
OG00430
OG00532
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 11.6)
OG0013.6(0.1 to 18.3)
OG0020(0.0 to 11.6)
OG0030(0.0 to 11.6)
OG0040(0.0 to 11.6)
OG0053.1(0.1 to 16.2)
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG003
Substudy A, >=65 Years: qIRV 30 mcg
Participants aged >=65 years were administered qIRV 30 mcg intramuscularly on Day 1.
OG004
Substudy A, >=65 Years: qIRV 60 mcg
Participants aged >=65 years were administered qIRV 60 mcg intramuscularly on Day 1.
OG005
Substudy A, >=65 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged >=65 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00033
OG00132
OG00233
OG00333
OG00433
OG00533
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 10.6)
OG0010(0.0 to 10.9)
OG0020(0.0 to 10.6)
OG0036.1(0.7 to 20.2)
OG0040(0.0 to 10.6)
OG0050(0.0 to 10.6)
OG003
Substudy A, 18-64 Years: qIRV 30 mcg
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
OG004
Substudy A, 18-64 Years: qIRV 60 mcg
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
OG005
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00028
OG00128
OG00228
OG00329
OG00429
OG00530
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 12.3)
OG0010(0.0 to 12.3)
OG0020(0.0 to 12.3)
OG0030(0.0 to 11.9)
OG0040(0.0 to 11.9)
OG0050(0.0 to 11.6)
OG003
Substudy A, >=65 Years: qIRV 30 mcg
Participants aged >=65 years were administered qIRV 30 mcg intramuscularly on Day 1.
OG004
Substudy A, >=65 Years: qIRV 60 mcg
Participants aged >=65 years were administered qIRV 60 mcg intramuscularly on Day 1.
OG005
Substudy A, >=65 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged >=65 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00033
OG00130
OG00231
OG00332
OG00431
OG00532
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 10.6)
OG0010(0.0 to 11.6)
OG0020(0.0 to 11.2)
OG0030(0.0 to 10.9)
OG0040(0.0 to 11.2)
OG0050(0.0 to 10.9)
OG003
Substudy A, 18-64 Years: qIRV 30 mcg
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
OG004
Substudy A, 18-64 Years: qIRV 60 mcg
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
OG005
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00030
OG00126
OG00229
OG00330
OG00430
OG00531
Title
Denominators
Categories
Title
Measurements
OG0003.3(0.1 to 17.2)
OG0010(0.0 to 13.2)
OG0020(0.0 to 11.9)
OG0030(0.0 to 11.6)
OG0040(0.0 to 11.6)
OG0050(0.0 to 11.2)
OG003
Substudy A, >=65 Years: qIRV 30 mcg
Participants aged >=65 years were administered qIRV 30 mcg intramuscularly on Day 1.
OG004
Substudy A, >=65 Years: qIRV 60 mcg
Participants aged >=65 years were administered qIRV 60 mcg intramuscularly on Day 1.
OG005
Substudy A, >=65 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged >=65 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00031
OG00132
OG00233
OG00333
OG00433
OG00533
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 11.2)
OG0010(0.0 to 10.9)
OG0020(0.0 to 10.6)
OG0030(0.0 to 10.6)
OG0040(0.0 to 10.6)
OG0050(0.0 to 10.6)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG003
Substudy A, 18-64 Years: qIRV 30 mcg
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
OG004
Substudy A, 18-64 Years: qIRV 60 mcg
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
OG005
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00030
OG00128
OG00230
OG00330
OG00430
OG00532
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 11.6)
OG0010(0.0 to 12.3)
OG0020(0.0 to 11.6)
OG0030(0.0 to 11.6)
OG0040(0.0 to 11.6)
OG0050(0.0 to 10.9)
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG003
Substudy A, >=65 Years: qIRV 30 mcg
Participants aged >=65 years were administered qIRV 30 mcg intramuscularly on Day 1.
OG004
Substudy A, >=65 Years: qIRV 60 mcg
Participants aged >=65 years were administered qIRV 60 mcg intramuscularly on Day 1.
OG005
Substudy A, >=65 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged >=65 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00033
OG00132
OG00233
OG00333
OG00433
OG00533
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 10.6)
OG0010(0.0 to 10.9)
OG0020(0.0 to 10.6)
OG0030(0.0 to 10.6)
OG0040(0.0 to 10.6)
OG0050(0.0 to 10.6)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG003
Substudy A, 18-64 Years: qIRV 30 mcg
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
OG004
Substudy A, 18-64 Years: qIRV 60 mcg
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
OG005
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00030
OG00128
OG00230
OG00330
OG00430
OG00532
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 11.6)
OG0010(0.0 to 12.3)
OG0020(0.0 to 11.6)
OG0030(0.0 to 11.6)
OG0040(0.0 to 11.6)
OG0050(0.0 to 10.9)
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG003
Substudy A, >=65 Years: qIRV 30 mcg
Participants aged >=65 years were administered qIRV 30 mcg intramuscularly on Day 1.
OG004
Substudy A, >=65 Years: qIRV 60 mcg
Participants aged >=65 years were administered qIRV 60 mcg intramuscularly on Day 1.
OG005
Substudy A, >=65 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged >=65 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
OG011
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
Units
Counts
Participants
OG00029
OG00132
OG002123
OG003122
OG004113
OG00531
OG00630
OG00733
OG00830
OG00926
OG01032
OG01128
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 11.9)
OG0010(0.0 to 10.9)
OG0020(0.0 to 3.0)
OG0030(0.0 to 3.0)
OG0040(0.0 to 3.2)
OG0050(0.0 to 11.2)
OG0060(0.0 to 11.6)
OG0070(0.0 to 10.6)
OG0080(0.0 to 11.6)
OG0090(0.0 to 13.2)
OG0100(0.0 to 10.9)
OG0110(0.0 to 12.3)
OG001
Substudy B, 18-64 Years: QIV and bIRV /Bivalent BNT162b2 (45mcg)
Participants aged 18-64 years were administered bIRV and Bivalent BNT162b2 45 mcg (OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
OG011
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
Units
Counts
Participants
OG00029
OG00132
OG002124
OG003122
OG004114
OG00531
OG00630
OG00733
OG00830
OG00926
OG01032
OG01129
Title
Denominators
Categories
Title
Measurements
OG00058.6(38.9 to 76.5)
OG00171.9(53.3 to 86.3)
OG00278.2(69.9 to 85.1)
OG00382.8(74.9 to 89.0)
OG00475.4(66.5 to 83.0)
OG00580.6(62.5 to 92.5)
OG00680.0(61.4 to 92.3)
OG00781.8(64.5 to 93.0)
OG00866.7(47.2 to 82.7)
OG00973.1(52.2 to 88.4)
OG01071.9(53.3 to 86.3)
OG01169.0(49.2 to 84.7)
OG001
Substudy B, 18-64 Years: QIV and bIRV /Bivalent BNT162b2 (45mcg)
Participants aged 18-64 years were administered bIRV and Bivalent BNT162b2 45 mcg (OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
OG011
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
Units
Counts
Participants
OG00029
OG00132
OG002124
OG003122
OG004114
OG00531
OG00630
OG00733
OG00830
OG00926
OG01032
OG01129
Title
Denominators
Categories
Title
Measurements
OG00051.7(32.5 to 70.6)
OG00162.5(43.7 to 78.9)
OG00274.2(65.6 to 81.6)
OG00377.0(68.6 to 84.2)
OG00471.1(61.8 to 79.2)
OG00580.6(62.5 to 92.5)
OG00680.0(61.4 to 92.3)
OG00772.7(54.5 to 86.7)
OG00873.3(54.1 to 87.7)
OG00965.4(44.3 to 82.8)
OG01068.8(50.0 to 83.9)
OG01148.3(29.4 to 67.5)
OG001
Substudy B, 18-64 Years: QIV and bIRV /Bivalent BNT162b2 (45mcg)
Participants aged 18-64 years were administered bIRV and Bivalent BNT162b2 45 mcg (OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
OG011
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
Units
Counts
Participants
OG00029
OG00132
OG002124
OG003122
OG004114
OG00531
OG00630
OG00733
OG00830
OG00926
OG01032
OG01129
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 11.9)
OG0010(0.0 to 10.9)
OG0020(0.0 to 2.9)
OG0030(0.0 to 3.0)
OG0040(0.0 to 3.2)
OG0053.2(0.1 to 16.7)
OG0060(0.0 to 11.6)
OG0070(0.0 to 10.6)
OG0080(0.0 to 11.6)
OG0090(0.0 to 13.2)
OG0100(0.0 to 10.9)
OG0110(0.0 to 11.9)
OG002
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG003
Substudy A, 18-64 Years: qIRV 30 mcg
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
OG004
Substudy A, 18-64 Years: qIRV 60 mcg
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
OG005
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00028
OG00127
OG00228
OG00330
OG00428
OG00531
Title
Denominators
Categories
A/Wisconsin: Before vaccination
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00228
ParticipantsOG00329
ParticipantsOG00428
ParticipantsOG00531
Title
Measurements
OG00032.0(16.6 to 61.8)
OG00114.7(8.8 to 24.7)
OG00231.2(18.4 to 53.0)
OG003
A/Wisconsin: 4 Weeks after vaccination
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00228
ParticipantsOG00330
A/Darwin: Before vaccination
ParticipantsOG00028
ParticipantsOG00125
ParticipantsOG00227
ParticipantsOG00329
A/Darwin: 4 Weeks after vaccination
ParticipantsOG00027
ParticipantsOG00127
ParticipantsOG00228
ParticipantsOG00330
B/Austria: Before vaccination
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00228
ParticipantsOG00329
B/Austria: 4 Weeks after vaccination
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00228
ParticipantsOG00330
B/Phuket: Before vaccination
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00228
ParticipantsOG00329
B/Phuket: 4 Weeks after vaccination
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00228
ParticipantsOG00330
OG002
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG003
Substudy A, >=65 Years: qIRV 30 mcg
Participants aged >=65 years were administered qIRV 30 mcg intramuscularly on Day 1.
OG004
Substudy A, >=65 Years: qIRV 60 mcg
Participants aged >=65 years were administered qIRV 60 mcg intramuscularly on Day 1.
OG005
Substudy A, >=65 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged >=65 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00032
OG00132
OG00232
OG00331
OG00429
OG00532
Title
Denominators
Categories
A/Wisconsin: Before vaccination
ParticipantsOG00032
ParticipantsOG00132
ParticipantsOG00232
ParticipantsOG00331
ParticipantsOG00429
ParticipantsOG00532
Title
Measurements
OG00056.6(35.5 to 90.2)
OG00138.3(24.3 to 60.3)
OG00257.8(36.1 to 92.6)
OG003
A/Wisconsin: 4 Weeks after vaccination
ParticipantsOG00032
ParticipantsOG00132
ParticipantsOG00232
ParticipantsOG00331
A/Darwin: Before vaccination
ParticipantsOG00031
ParticipantsOG00132
ParticipantsOG00230
ParticipantsOG00331
A/Darwin: 4 Weeks after vaccination
ParticipantsOG00032
ParticipantsOG00132
ParticipantsOG00232
ParticipantsOG00331
B/Austria: Before vaccination
ParticipantsOG00032
ParticipantsOG00132
ParticipantsOG00232
ParticipantsOG00331
B/Austria: 4 Weeks after vaccination
ParticipantsOG00032
ParticipantsOG00132
ParticipantsOG00232
ParticipantsOG00331
B/Phuket: Before vaccination
ParticipantsOG00032
ParticipantsOG00132
ParticipantsOG00232
ParticipantsOG00331
B/Phuket: 4 Weeks after vaccination
ParticipantsOG00032
ParticipantsOG00132
ParticipantsOG00232
ParticipantsOG00331
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG002
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG003
Substudy A, 18-64 Years: qIRV 30 mcg
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
OG004
Substudy A, 18-64 Years: qIRV 60 mcg
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
OG005
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00028
OG00127
OG00228
OG00330
OG00428
OG00531
Title
Denominators
Categories
A/Wisconsin
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00228
ParticipantsOG00329
ParticipantsOG00428
ParticipantsOG00531
Title
Measurements
OG0008.5(4.8 to 15.2)
OG0019.8(5.7 to 16.8)
OG0028.2(3.9 to 17.2)
OG003
A/Darwin
ParticipantsOG00027
ParticipantsOG00125
ParticipantsOG00227
ParticipantsOG00329
B/Austria
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00228
ParticipantsOG00329
B/Phuket
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00228
ParticipantsOG00329
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG002
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG003
Substudy A, >=65 Years: qIRV 30 mcg
Participants aged >=65 years were administered qIRV 30 mcg intramuscularly on Day 1.
OG004
Substudy A, >=65 Years: qIRV 60 mcg
Participants aged >=65 years were administered qIRV 60 mcg intramuscularly on Day 1.
OG005
Substudy A, >=65 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged >=65 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00032
OG00132
OG00232
OG00331
OG00429
OG00532
Title
Denominators
Categories
A/Wisconsin
ParticipantsOG00032
ParticipantsOG00132
ParticipantsOG00232
ParticipantsOG00331
ParticipantsOG00429
ParticipantsOG00532
Title
Measurements
OG0002.0(1.6 to 2.4)
OG0012.3(1.8 to 3.0)
OG0022.7(2.1 to 3.4)
OG003
A/Darwin
ParticipantsOG00031
ParticipantsOG00132
ParticipantsOG00230
ParticipantsOG00331
B/Austria
ParticipantsOG00032
ParticipantsOG00132
ParticipantsOG00232
ParticipantsOG00331
B/Phuket
ParticipantsOG00032
ParticipantsOG00132
ParticipantsOG00232
ParticipantsOG00331
OG002
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG003
Substudy A, 18-64 Years: qIRV 30 mcg
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
OG004
Substudy A, 18-64 Years: qIRV 60 mcg
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
OG005
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00028
OG00127
OG00228
OG00329
OG00428
OG00531
Title
Denominators
Categories
A/Wisconsin
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00228
ParticipantsOG00329
ParticipantsOG00428
ParticipantsOG00531
Title
Measurements
OG00075.0(55.1 to 89.3)
OG00177.8(57.7 to 91.4)
OG00271.4(51.3 to 86.8)
OG003
A/Darwin
ParticipantsOG00027
ParticipantsOG00125
ParticipantsOG00227
ParticipantsOG00329
B/Austria
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00228
ParticipantsOG00329
B/Phuket
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00228
ParticipantsOG00329
OG002
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG003
Substudy A, >=65 Years: qIRV 30 mcg
Participants aged >=65 years were administered qIRV 30 mcg intramuscularly on Day 1.
OG004
Substudy A, >=65 Years: qIRV 60 mcg
Participants aged >=65 years were administered qIRV 60 mcg intramuscularly on Day 1.
OG005
Substudy A, >=65 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged >=65 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00032
OG00132
OG00232
OG00331
OG00429
OG00532
Title
Denominators
Categories
A/Wisconsin
ParticipantsOG00032
ParticipantsOG00132
ParticipantsOG00232
ParticipantsOG00331
ParticipantsOG00429
ParticipantsOG00532
Title
Measurements
OG00015.6(5.3 to 32.8)
OG00125.0(11.5 to 43.4)
OG00246.9(29.1 to 65.3)
OG003
A/Darwin
ParticipantsOG00031
ParticipantsOG00132
ParticipantsOG00230
ParticipantsOG00331
B/Austria
ParticipantsOG00032
ParticipantsOG00132
ParticipantsOG00232
ParticipantsOG00331
B/Phuket
ParticipantsOG00032
ParticipantsOG00132
ParticipantsOG00232
ParticipantsOG00331
OG002
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG003
Substudy A, 18-64 Years: qIRV 30 mcg
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
OG004
Substudy A, 18-64 Years: qIRV 60 mcg
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
OG005
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00028
OG00127
OG00228
OG00330
OG00428
OG00531
Title
Denominators
Categories
A/Wisconsin: Before Vaccination
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00228
ParticipantsOG00329
ParticipantsOG00428
ParticipantsOG00531
Title
Measurements
OG00053.6(33.9 to 72.5)
OG00125.9(11.1 to 46.3)
OG00246.4(27.5 to 66.1)
OG003
A/Wisconsin: 4 Weeks After Vaccination
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00228
ParticipantsOG00330
A/Darwin: Before Vaccination
ParticipantsOG00028
ParticipantsOG00125
ParticipantsOG00227
ParticipantsOG00329
A/Darwin: 4 Weeks After Vaccination
ParticipantsOG00027
ParticipantsOG00127
ParticipantsOG00228
ParticipantsOG00330
B/Austria: Before Vaccination
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00228
ParticipantsOG00329
B/Austria: 4 Weeks After Vaccination
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00228
ParticipantsOG00330
B/Phuket: Before Vaccination
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00228
ParticipantsOG00329
B/Phuket: 4 Weeks After Vaccination
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00228
ParticipantsOG00330
OG002
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG003
Substudy A, >=65 Years: qIRV 30 mcg
Participants aged >=65 years were administered qIRV 30 mcg intramuscularly on Day 1.
OG004
Substudy A, >=65 Years: qIRV 60 mcg
Participants aged >=65 years were administered qIRV 60 mcg intramuscularly on Day 1.
OG005
Substudy A, >=65 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged >=65 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00032
OG00132
OG00232
OG00331
OG00429
OG00532
Title
Denominators
Categories
A/Wisconsin: Before Vaccination
ParticipantsOG00032
ParticipantsOG00132
ParticipantsOG00232
ParticipantsOG00331
ParticipantsOG00429
ParticipantsOG00532
Title
Measurements
OG00068.8(50.0 to 83.9)
OG00159.4(40.6 to 76.3)
OG00262.5(43.7 to 78.9)
OG003
A/Wisconsin: 4 Weeks After Vaccination
ParticipantsOG00032
ParticipantsOG00132
ParticipantsOG00232
ParticipantsOG00331
A/Darwin: Before Vaccination
ParticipantsOG00031
ParticipantsOG00132
ParticipantsOG00230
ParticipantsOG00331
A/Darwin: 4 Weeks After Vaccination
ParticipantsOG00032
ParticipantsOG00132
ParticipantsOG00232
ParticipantsOG00331
B/Austria: Before Vaccination
ParticipantsOG00032
ParticipantsOG00132
ParticipantsOG00232
ParticipantsOG00331
B/Austria: 4 Weeks After Vaccination
ParticipantsOG00032
ParticipantsOG00132
ParticipantsOG00232
ParticipantsOG00331
B/Phuket: Before Vaccination
ParticipantsOG00032
ParticipantsOG00132
ParticipantsOG00232
ParticipantsOG00331
B/Phuket: 4 Weeks After Vaccination
ParticipantsOG00032
ParticipantsOG00132
ParticipantsOG00232
ParticipantsOG00331
OG002
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG003
Substudy A, 18-64 Years: qIRV 30 mcg
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
OG004
Substudy A, 18-64 Years: qIRV 60 mcg
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
OG005
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00027
OG00125
OG00227
OG00329
OG00428
OG00531
Title
Denominators
Categories
Title
Measurements
OG0003.7(0.1 to 19.0)
OG0010(0.0 to 13.7)
OG0027.4(0.9 to 24.3)
OG0033.4(0.1 to 17.8)
OG00410.7(2.3 to 28.2)
OG0056.5(0.8 to 21.4)
OG002
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG003
Substudy A, >=65 Years: qIRV 30 mcg
Participants aged >=65 years were administered qIRV 30 mcg intramuscularly on Day 1.
OG004
Substudy A, >=65 Years: qIRV 60 mcg
Participants aged >=65 years were administered qIRV 60 mcg intramuscularly on Day 1.
OG005
Substudy A, >=65 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged >=65 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00031
OG00132
OG00230
OG00331
OG00429
OG00532
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 11.2)
OG0010(0.0 to 10.9)
OG0020(0.0 to 11.6)
OG0030(0.0 to 11.2)
OG0043.4(0.1 to 17.8)
OG0053.1(0.1 to 16.2)
OG002
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG003
Substudy A, 18-64 Years: qIRV 30 mcg
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
OG004
Substudy A, 18-64 Years: qIRV 60 mcg
Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1.
OG005
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00027
OG00127
OG00228
OG00330
OG00428
OG00531
Title
Denominators
Categories
Title
Measurements
OG00018.5(6.3 to 38.1)
OG00122.2(8.6 to 42.3)
OG00221.4(8.3 to 41.0)
OG00326.7(12.3 to 45.9)
OG00428.6(13.2 to 48.7)
OG00551.6(33.1 to 69.8)
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG003
Substudy A, >=65 Years: qIRV 30 mcg
Participants aged >=65 years were administered qIRV 30 mcg intramuscularly on Day 1.
OG004
Substudy A, >=65 Years: qIRV 60 mcg
Participants aged >=65 years were administered qIRV 60 mcg intramuscularly on Day 1.
OG005
Substudy A, >=65 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged >=65 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00032
OG00132
OG00232
OG00331
OG00429
OG00532
Title
Denominators
Categories
Title
Measurements
OG00021.9(9.3 to 40.0)
OG00115.6(5.3 to 32.8)
OG00228.1(13.7 to 46.7)
OG00322.6(9.6 to 41.1)
OG00441.4(23.5 to 61.1)
OG00521.9(9.3 to 40.0)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG002
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG003
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00028
OG00127
OG00228
OG00331
Title
Denominators
Categories
SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers: Before Vaccination
Title
Measurements
OG000499.0(298.2 to 835.0)
OG001240.9(134.6 to 431.3)
OG002466.9(277.8 to 784.7)
OG003415.8(252.0 to 686.1)
SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers: 4 Weeks After Vaccination
Title
Measurements
OG0003676.8(2660.6 to 5081.2)
OG0012202.4(1475.1 to 3288.4)
OG0022139.4(1483.5 to 3085.3)
OG003
SARS-CoV-2-Reference-Strain Neutralizing Titers: Before Vaccination
Title
Measurements
OG0003068.0(2056.4 to 4577.1)
OG0011466.1(869.2 to 2473.0)
OG0022487.1(1541.8 to 4012.0)
OG003
SARS-CoV-2-Reference-Strain Neutralizing Titers: 4 Weeks After Vaccination
Title
Measurements
OG00012713.5(9538.2 to 16945.9)
OG0018069.0(5808.1 to 11209.9)
OG0027166.0(5568.6 to 9221.6)
OG003
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG002
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG003
Substudy A, >=65 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged >=65 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00032
OG00132
OG00232
OG00332
Title
Denominators
Categories
Omicron (BA.4/BA.5)- Neutralizing Titers: Before Vaccination
Title
Measurements
OG0001233.2(635.1 to 2394.5)
OG001678.7(347.6 to 1325.1)
OG002866.0(434.5 to 1726.0)
OG0031472.6(742.6 to 2920.3)
Omicron (BA.4/BA.5)- Neutralizing Titers: 4 Weeks After Vaccination
Title
Measurements
OG0003627.4(2167.0 to 6071.8)
OG0011841.1(1113.0 to 3045.6)
OG0022770.7(1483.7 to 5174.3)
OG003
Reference-Strain Neutralizing Titers: Before Vaccination
Title
Measurements
OG0006045.7(3580.2 to 10209.0)
OG0014567.0(2725.1 to 7654.1)
OG0024461.1(2766.5 to 7193.9)
OG003
Reference-Strain Neutralizing Titers: 4 Weeks After Vaccination
Title
Measurements
OG00015305.0(10000.4 to 23423.4)
OG0017821.2(5348.8 to 11436.4)
OG00210280.2(6847.9 to 15432.9)
OG003
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG002
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG003
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00028
OG00127
OG00228
OG00331
Title
Denominators
Categories
Omicron (BA.4/BA.5)- Neutralizing Titers
Title
Measurements
OG0007.0(4.7 to 10.4)
OG0017.6(5.8 to 10.0)
OG0024.4(2.7 to 7.1)
OG0038.7(5.6 to 13.7)
Reference-Strain Neutralizing Titers
Title
Measurements
OG0004.1(3.0 to 5.8)
OG0015.5(3.8 to 7.9)
OG0022.9(1.9 to 4.5)
OG003
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG002
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG003
Substudy A, >=65 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged >=65 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00032
OG00132
OG00232
OG00332
Title
Denominators
Categories
Omicron (BA.4/BA.5)- Neutralizing Titers
Title
Measurements
OG0002.8(2.0 to 3.9)
OG0012.4(1.8 to 3.3)
OG0023.0(2.2 to 4.2)
OG0032.4(1.7 to 3.4)
Reference-Strain Neutralizing Titers
Title
Measurements
OG0002.5(1.9 to 3.4)
OG0011.7(1.3 to 2.3)
OG0022.3(1.8 to 3.0)
OG003
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG002
Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG003
Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged 18-64 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Units
Counts
Participants
OG00028
OG00127
OG00228
OG00331
Title
Denominators
Categories
Omicron (BA.4/BA.5)- Neutralizing Titers
Title
Measurements
OG00067.9(47.6 to 84.1)
OG00185.2(66.3 to 95.8)
OG00242.9(24.5 to 62.8)
OG00374.2(55.4 to 88.1)
Reference-Strain Neutralizing Titers
Title
Measurements
OG00046.4(27.5 to 66.1)
OG00163.0(42.4 to 80.6)
OG00232.1(15.9 to 52.4)
OG003
OG001
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (60 mcg)
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 60 mcg (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG002
Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2)
Participants aged >=65 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 90 mcg) (original/OMI BA.4/BA.5) intramuscularly on Day 1.
OG003
Substudy A, >=65 Years: Bivalent BNT162b2 (30 mcg) /QIV
Participants aged >=65 years were administered Bivalent BNT162b2 30 mcg (Original/OMI BA.4/BA.5) and concurrent administration of licensed QIV in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
OG011
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
Units
Counts
Participants
OG00028
OG00132
OG002122
OG003118
OG004109
OG00528
OG00626
OG00732
OG00829
OG00926
OG01030
OG01125
Title
Denominators
Categories
A/Wisconsin: Before vaccination
ParticipantsOG00028
ParticipantsOG00132
ParticipantsOG002120
ParticipantsOG003118
ParticipantsOG004107
ParticipantsOG00528
ParticipantsOG00626
ParticipantsOG00732
ParticipantsOG00828
ParticipantsOG00926
ParticipantsOG01029
ParticipantsOG01125
Title
Measurements
OG00051.2(27.2 to 96.6)
OG00144.6(26.4 to 75.3)
OG00244.4(35.0 to 56.2)
OG003
A/Wisconsin: 4 Weeks after vaccination
ParticipantsOG00028
ParticipantsOG00132
ParticipantsOG002121
ParticipantsOG003118
A/Darwin: Before vaccination
ParticipantsOG00027
ParticipantsOG00132
ParticipantsOG002121
ParticipantsOG003118
A/Darwin: 4 Weeks after vaccination
ParticipantsOG00027
ParticipantsOG00131
ParticipantsOG002121
ParticipantsOG003118
B/Austria: Before vaccination
ParticipantsOG00028
ParticipantsOG00132
ParticipantsOG002121
ParticipantsOG003118
B/Austria: 4 Weeks after vaccination
ParticipantsOG00028
ParticipantsOG00131
ParticipantsOG002121
ParticipantsOG003118
B/Phuket: Before vaccination
ParticipantsOG00028
ParticipantsOG00132
ParticipantsOG002121
ParticipantsOG003118
B/Phuket: 4 Weeks after vaccination
ParticipantsOG00028
ParticipantsOG00132
ParticipantsOG002121
ParticipantsOG003118
A/Cambodia: Before vaccination
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
A/Cambodia: 4 Weeks after vaccination
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participants aged 18-64 years were administered bIRV and Bivalent BNT162b2 45 mcg (OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
OG011
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
Units
Counts
Participants
OG00028
OG00132
OG002122
OG003118
OG004109
OG00528
OG00626
OG00732
OG00829
OG00926
OG01030
OG01125
Title
Denominators
Categories
A/Wisconsin
ParticipantsOG00028
ParticipantsOG00132
ParticipantsOG002120
ParticipantsOG003118
ParticipantsOG004107
ParticipantsOG00528
ParticipantsOG00626
ParticipantsOG00732
ParticipantsOG00828
ParticipantsOG00925
ParticipantsOG01029
ParticipantsOG01125
Title
Measurements
OG0003.1(1.9 to 5.3)
OG0016.9(4.1 to 11.7)
OG0024.5(3.7 to 5.5)
OG003
A/Darwin
ParticipantsOG00027
ParticipantsOG00131
ParticipantsOG002121
ParticipantsOG003118
B/Austria
ParticipantsOG00028
ParticipantsOG00131
ParticipantsOG002121
ParticipantsOG003118
B/Phuket
ParticipantsOG00028
ParticipantsOG00132
ParticipantsOG002121
ParticipantsOG003118
A/Cambodia
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participants aged 18-64 years were administered bIRV and Bivalent BNT162b2 45 mcg (OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
OG011
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
Units
Counts
Participants
OG00028
OG00132
OG002121
OG003118
OG004107
OG00528
OG00626
OG00732
OG00829
OG00926
OG01029
OG01125
Title
Denominators
Categories
A/Wisconsin
ParticipantsOG00028
ParticipantsOG00132
ParticipantsOG002120
ParticipantsOG003118
ParticipantsOG004107
ParticipantsOG00528
ParticipantsOG00626
ParticipantsOG00732
ParticipantsOG00829
ParticipantsOG00925
ParticipantsOG01029
ParticipantsOG01125
Title
Measurements
OG00042.9(24.5 to 62.8)
OG00165.6(46.8 to 81.4)
OG00264.2(54.9 to 72.7)
OG003
A/Darwin
ParticipantsOG00027
ParticipantsOG00131
ParticipantsOG002121
ParticipantsOG003118
A/Cambodia
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
B/Austria
ParticipantsOG00028
ParticipantsOG00131
ParticipantsOG002121
ParticipantsOG003118
B/Phuket
ParticipantsOG00028
ParticipantsOG00132
ParticipantsOG002121
ParticipantsOG003118
Participants aged 18-64 years were administered bIRV and Bivalent BNT162b2 45 mcg (OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
OG011
Substudy B, 18-64 Years: qIRV (30 mcg)
Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1.
Units
Counts
Participants
OG00028
OG00132
OG002121
OG003118
OG004108
OG00528
OG00626
OG00732
OG00829
OG00926
OG01029
OG01125
Title
Denominators
Categories
A/Wisconsin: Before Vaccination
ParticipantsOG00028
ParticipantsOG00132
ParticipantsOG002120
ParticipantsOG003118
ParticipantsOG004107
ParticipantsOG00528
ParticipantsOG00626
ParticipantsOG00732
ParticipantsOG00828
ParticipantsOG00926
ParticipantsOG01029
ParticipantsOG01125
Title
Measurements
OG00064.3(44.1 to 81.4)
OG00165.6(46.8 to 81.4)
OG00264.2(54.9 to 72.7)
OG003
A/Wisconsin: 4 weeks after vaccination
ParticipantsOG00028
ParticipantsOG00132
ParticipantsOG002121
ParticipantsOG003118
A/Darwin: Before Vaccination
ParticipantsOG00027
ParticipantsOG00132
ParticipantsOG002121
ParticipantsOG003118
A/Darwin: 4 weeks after vaccination
ParticipantsOG00027
ParticipantsOG00131
ParticipantsOG002121
ParticipantsOG003118
A/Cambodia: Before Vaccination
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
A/Cambodia: 4 weeks after vaccination
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
B/Austria: Before Vaccination
ParticipantsOG00028
ParticipantsOG00132
ParticipantsOG002121
ParticipantsOG003118
B/Austria: 4 weeks after vaccination
ParticipantsOG00028
ParticipantsOG00131
ParticipantsOG002121
ParticipantsOG003118
B/Phuket: Before Vaccination
ParticipantsOG00028
ParticipantsOG00132
ParticipantsOG002121
ParticipantsOG003118
B/Phuket: 4 weeks after vaccination
ParticipantsOG00028
ParticipantsOG00132
ParticipantsOG002121
ParticipantsOG003118
OG001
Substudy B, 18-64 Years: QIV and bIRV /Bivalent BNT162b2 (45mcg)
Participants aged 18-64 years were administered bIRV and Bivalent BNT162b2 45 mcg (OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
Units
Counts
Participants
OG00028
OG00132
OG002122
OG003118
OG004109
OG00528
OG00626
OG00732
OG00829
OG00926
OG01030
Title
Denominators
Categories
Omicron (BA.4/BA.5)- Neutralizing Titers: Before Vaccination
ParticipantsOG00028
ParticipantsOG00132
ParticipantsOG002120
ParticipantsOG003118
ParticipantsOG004108
ParticipantsOG00527
ParticipantsOG00626
ParticipantsOG00732
ParticipantsOG00828
ParticipantsOG00926
ParticipantsOG01029
Title
Measurements
OG000989.5(524.6 to 1866.2)
OG0011081.4(622.6 to 1878.2)
OG0021127.6(827.8 to 1535.9)
OG003
Omicron (BA.4/BA.5)- Neutralizing Titers: 4 Weeks After Vaccination
ParticipantsOG00028
ParticipantsOG00132
ParticipantsOG002122
ParticipantsOG003
Reference-Strain Neutralizing Titers: Before Vaccination
ParticipantsOG00028
ParticipantsOG00132
ParticipantsOG002120
ParticipantsOG003
Reference-Strain Neutralizing Titers: 4 Weeks After Vaccination
ParticipantsOG00027
ParticipantsOG00131
ParticipantsOG002121
ParticipantsOG003
OG001
Substudy B, 18-64 Years: QIV and bIRV /Bivalent BNT162b2 (45mcg)
Participants aged 18-64 years were administered bIRV and Bivalent BNT162b2 45 mcg (OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.
Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1.
Units
Counts
Participants
OG00028
OG00132
OG002122
OG003118
OG004109
OG00528
OG00626
OG00732
OG00829
OG00926
OG01030
Title
Denominators
Categories
Omicron (BA.4/BA.5)- Neutralizing Titers
ParticipantsOG00028
ParticipantsOG00132
ParticipantsOG002120
ParticipantsOG003117
ParticipantsOG004108
ParticipantsOG00526
ParticipantsOG00626
ParticipantsOG00731
ParticipantsOG00828
ParticipantsOG00926
ParticipantsOG01029
Title
Measurements
OG0004.1(2.4 to 6.9)
OG0012.7(1.6 to 4.5)
OG0023.0(2.5 to 3.7)
OG003
Reference-Strain Neutralizing Titers
ParticipantsOG00027
ParticipantsOG00131
ParticipantsOG002119
ParticipantsOG003117
OG001
Substudy B, 18-64 Years: QIV and bIRV /Bivalent BNT162b2 (45mcg)
Participants aged 18-64 years were administered bIRV and Bivalent BNT162b2 45 mcg (OMI BA.4/BA.5) and licensed QIV concurrently in opposite arm intramuscularly on Day 1. Dose strength for licensed QIV was not disclosed as it acted as comparator and was administered per local regulations.