Influenza, Human, COVID-19
Conditions
Keywords
SARS-Cov-2, COVID-19, Influenza, Grippe, Flu, Vaccine, RNA vaccine
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).
Interventions
Intramuscular injection
BIOLOGICALqIRV (22/23)
Intramuscular injection
BIOLOGICALQIV
Intramuscular injection
BIOLOGICALbIRV
Intramuscular injection
BIOLOGICALtIRV
Intramuscular injection
Sponsors
Pfizer
BioNTech SE
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Substudy A: Open-label unblinded. Substudy B: Participants are blinded to their assigned study intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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:
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SSA: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18-64 Years) | SSA: From Day 1 to Day 7 after Vaccination | 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: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (>=65 Years) | SSA: From Day 1 to Day 7 after Vaccination | 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: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18-64 Years) | SSA: From Day 1 to Day 7 after Vaccination | 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: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (>=65 Years) | SSA: From Day 1 to Day 7 after Vaccination | 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: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination (18-64 Years) | SSA: From Vaccination on Day 1 through 4 Weeks after Vaccination | 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: Percentage of Participants Reporting Adverse Events From Vaccination Through 4 Weeks After Vaccination (>=65 Years) | SSA: From Vaccination on Day 1 through 4 Weeks after Vaccination | 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: Percentage of Participants Reporting Serious Adverse Events (SAEs) From Vaccination Through 6 Months After Vaccination (18-64 Years) | SSA: From Vaccination on Day 1 through 6 Months after Vaccination | 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: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination (>=65 Years) | SSA: From Vaccination on Day 1 through 6 Months after Vaccination | 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: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (18-64 Years) | SSA: 2 Days after Vaccination | An abnormal troponin 1 result was defined as any troponin 1 level \>=0.30 nanogram per milliliter. |
| SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (>=65 Years) | SSA: 2 Days after Vaccination | An abnormal troponin 1 result was defined as any troponin 1 level \>=0.30 nanogram per milliliter. |
| SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (18-64 Years) | SSA: 1 Week After Vaccination | An abnormal troponin 1 result was defined as any troponin 1 level \>=0.30 nanogram per milliliter. |
| SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (>=65 Years) | SSA: 1 Week After Vaccination | An abnormal troponin 1 result was defined as any troponin 1 level \>=0.30 nanogram per milliliter. |
| SSA: Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination (18-64 Years) | SSA: 2 Days after Vaccination | 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: Percentage of Participants With New ECG Abnormalities at 2 Days After Vaccination (>=65 Years) | SSA: 2 Days after Vaccination | 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: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (18-64 Years) | SSA: 1 Week after Vaccination | 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: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (>=65 Years) | SSA: 1 Week after Vaccination | 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: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (18- 64 Years) | SSB: 2 Days after Vaccination | An abnormal troponin 1 result was defined as any troponin 1 level \>=0.30 nanogram per milliliter. |
| SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (18- 64 Years) | SSB: 1 Week after Vaccination | An abnormal troponin 1 result was defined as any troponin 1 level \>=0.30 nanogram per milliliter. |
| SSB: Percentage of Participants With New ECG Abnormalities at 2 Days After Vaccination (18- 64 Years) | SSB: 2 Days after Vaccination | 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: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (18- 64 Years) | SSB: 1 Week after Vaccination | 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: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18- 64 Years) | SSB: From Day 1 to Day 7 after Vaccination | 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: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18- 64 Years) | SSB: From Day 1 to Day 7 after Vaccination | 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: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination (18- 64 Years) | SSB: From Vaccination on Day 1 through 4 Weeks after Vaccination | 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: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination (18- 64 Years) | SSB: From Vaccination on Day 1 through 6 Months after Vaccination | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | SSA: Before Vaccination and 4 Weeks after Vaccination | 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. |
| 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) | SSB: 4 Weeks after Vaccination | 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: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | SSA: Before Vaccination and 4 Weeks after Vaccination | 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: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | SSA: Before Vaccination to 4 Weeks after Vaccination | 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: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years) | SSA: Before Vaccination to 4 Weeks after Vaccination | 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: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | SSA: 4 Weeks after Vaccination | 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: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years) | SSA: 4 Weeks after Vaccination | 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: 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) | SSA: Before Vaccination and at 4 Weeks after Vaccination | 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: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | SSA: Before Vaccination and at 4 Weeks After Vaccination | 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: Percentage of Participants Achieving HAI Seroconversion for All Strains at 4 Weeks After Vaccination (18- 64 Years) | SSA: 4 Weeks after Vaccination | 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: Percentage of Participants Achieving HAI Seroconversion for All Strains at 4 Weeks After Vaccination (>=65 Years) | SSA: 4 Weeks after Vaccination | 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: Percentage of Participants With HAI Titers >= 1.40 for All Strain at 4 Weeks After Vaccination (18- 64 Years) | SSA: 4 Weeks after Vaccination | 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: Percentage of Participants With HAI Titers >= 1.40 for All Strain at 4 Weeks After Vaccination (>=65 Years) | SSA: 4 Weeks after Vaccination | 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: 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) | SSA: Before Vaccination and 4 Weeks after Vaccination | 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: 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) | SSA: Before Vaccination and 4 Weeks after Vaccination | 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: 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) | SSA: Before Vaccination to 4 Weeks after Vaccination | 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: 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) | SSA: Before Vaccination to 4 Weeks after Vaccination | 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: 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) | SSA: 4 Weeks after Vaccination | 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: 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) | SSA:4 Weeks after Vaccination | 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: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | SSB: Before Vaccination and 4 Weeks after Vaccination | 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: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | SSB: Before Vaccination to 4 Weeks after Vaccination | 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: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | SSB: 4 Weeks after Vaccination | 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: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | SSB: Before Vaccination and at 4 Weeks after Vaccination | 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: 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) | SSB: Before Vaccination and at 4 Weeks after Vaccination | 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: 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) | SSB: 4 Weeks after Vaccination | 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. |
Countries
United States
Participant flow
Recruitment details
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).
Pre-assignment details
Interventions administered: quadrivalent influenza modRNA vaccine (qIRV), trivalent influenza modRNA vaccine (tIRV), Bivalent BNT162b2 (Original/Omi BA.4/BA.5) and quadrivalent influenza vaccine (QIV).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 28 |
| 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. | 30 |
| Substudy A, 18-64 Years: qIRV 30 mcg Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1. | 30 |
| Substudy A, 18-64 Years: qIRV 60 mcg Participants aged 18-64 years were administered qIRV 60 mcg intramuscularly on Day 1. | 30 |
| 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. | 32 |
| 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. | 33 |
| 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. | 32 |
| 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. | 33 |
| Substudy A, >=65 Years: qIRV 30 mcg Participants aged \>=65 years were administered qIRV 30 mcg intramuscularly on Day 1. | 33 |
| Substudy A, >=65 Years: qIRV 60 mcg Participants aged \>=65 years were administered qIRV 60 mcg intramuscularly on Day 1. | 33 |
| 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. | 33 |
| 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. | 29 |
| 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. | 32 |
| Substudy B, 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) (OMI BA.4/BA.5) intramuscularly on Day 1. | 124 |
| Substudy B, 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) (OMI BA.4/BA.5) intramuscularly on Day 1. | 122 |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 1) Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 1- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1. | 114 |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (75 mcg) Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1. | 31 |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1. | 30 |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 2- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1. | 33 |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 4- 90 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1. | 30 |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) Participants aged 18-64 years were administered qIRV and Bivalent BNT162b2 (Combination 3- 60 mcg) (OMI BA.4/BA.5) intramuscularly on Day 1. | 26 |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) Participants aged 18-64 years were administered tIRV and Bivalent BNT162b2 75 mcg (OMI BA.4/BA.5) intramuscularly on Day 1. | 32 |
| Substudy B, 18-64 Years: qIRV (30 mcg) Participants aged 18-64 years were administered qIRV 30 mcg intramuscularly on Day 1. | 29 |
| Total | 1,009 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 | FG020 | FG021 | FG022 | FG023 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Substudy A | Lost to Follow-up | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Substudy A | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Substudy B | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Substudy B | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Substudy B | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 2 | 2 | 1 | 2 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | Substudy A, 18-64 Years: qIRV 30 mcg | Substudy A, 18-64 Years: qIRV 60 mcg | Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (60 mcg) | Substudy A, >=65 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | Substudy A, >=65 Years: qIRV 30 mcg | Substudy A, >=65 Years: qIRV 60 mcg | Substudy A, >=65 Years: Bivalent BNT162b2 (30 mcg) /QIV | Substudy B, 18-64 Years: QIV and Bivalent BNT162b2 (30 mcg) | Substudy B, 18-64 Years: QIV and bIRV /Bivalent BNT162b2 (45mcg) | Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 1) | Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (75 mcg) | Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | Substudy B, 18-64 Years: qIRV (30 mcg) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 46.1 Years STANDARD_DEVIATION 11.68 | 44.4 Years STANDARD_DEVIATION 12.75 | 43.1 Years STANDARD_DEVIATION 12.45 | 42.9 Years STANDARD_DEVIATION 10.53 | 46.2 Years STANDARD_DEVIATION 11.78 | 40.5 Years STANDARD_DEVIATION 12.7 | 71.5 Years STANDARD_DEVIATION 5.33 | 71.2 Years STANDARD_DEVIATION 5.53 | 71.4 Years STANDARD_DEVIATION 4.32 | 70.8 Years STANDARD_DEVIATION 4.27 | 71.6 Years STANDARD_DEVIATION 4.55 | 71.7 Years STANDARD_DEVIATION 4.67 | 40.9 Years STANDARD_DEVIATION 11.99 | 44.1 Years STANDARD_DEVIATION 12.86 | 46.4 Years STANDARD_DEVIATION 12.13 | 45.9 Years STANDARD_DEVIATION 12.56 | 44.9 Years STANDARD_DEVIATION 14.25 | 47.0 Years STANDARD_DEVIATION 11.64 | 48.6 Years STANDARD_DEVIATION 10.17 | 47.1 Years STANDARD_DEVIATION 11.79 | 47.9 Years STANDARD_DEVIATION 9.75 | 46.9 Years STANDARD_DEVIATION 12.96 | 46.0 Years STANDARD_DEVIATION 11.93 | 47.1 Years STANDARD_DEVIATION 12.94 | 58.2 Years STANDARD_DEVIATION 16.43 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants | 22 Participants | 22 Participants | 23 Participants | 24 Participants | 26 Participants | 3 Participants | 8 Participants | 9 Participants | 7 Participants | 9 Participants | 15 Participants | 18 Participants | 18 Participants | 47 Participants | 42 Participants | 47 Participants | 11 Participants | 8 Participants | 10 Participants | 9 Participants | 8 Participants | 12 Participants | 9 Participants | 432 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 6 Participants | 8 Participants | 7 Participants | 6 Participants | 6 Participants | 27 Participants | 24 Participants | 24 Participants | 24 Participants | 24 Participants | 18 Participants | 11 Participants | 14 Participants | 77 Participants | 79 Participants | 67 Participants | 20 Participants | 22 Participants | 23 Participants | 21 Participants | 18 Participants | 20 Participants | 20 Participants | 571 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 11 Participants | 8 Participants | 5 Participants | 2 Participants | 2 Participants | 2 Participants | 4 Participants | 3 Participants | 2 Participants | 3 Participants | 51 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 1 Participants | 5 Participants | 1 Participants | 3 Participants | 5 Participants | 1 Participants | 1 Participants | 0 Participants | 5 Participants | 2 Participants | 1 Participants | 3 Participants | 8 Participants | 12 Participants | 6 Participants | 12 Participants | 0 Participants | 5 Participants | 6 Participants | 7 Participants | 7 Participants | 5 Participants | 3 Participants | 103 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) White | 24 Participants | 27 Participants | 24 Participants | 29 Participants | 25 Participants | 27 Participants | 32 Participants | 30 Participants | 33 Participants | 26 Participants | 30 Participants | 32 Participants | 24 Participants | 23 Participants | 100 Participants | 104 Participants | 95 Participants | 28 Participants | 22 Participants | 24 Participants | 19 Participants | 14 Participants | 25 Participants | 22 Participants | 839 Participants |
| Sex: Female, Male Female | 15 Participants | 15 Participants | 18 Participants | 16 Participants | 15 Participants | 17 Participants | 19 Participants | 13 Participants | 20 Participants | 13 Participants | 15 Participants | 19 Participants | 16 Participants | 20 Participants | 84 Participants | 74 Participants | 59 Participants | 19 Participants | 23 Participants | 20 Participants | 18 Participants | 16 Participants | 22 Participants | 13 Participants | 579 Participants |
| Sex: Female, Male Male | 15 Participants | 13 Participants | 12 Participants | 14 Participants | 15 Participants | 15 Participants | 14 Participants | 19 Participants | 13 Participants | 20 Participants | 18 Participants | 14 Participants | 13 Participants | 12 Participants | 40 Participants | 48 Participants | 55 Participants | 12 Participants | 7 Participants | 13 Participants | 12 Participants | 10 Participants | 10 Participants | 16 Participants | 430 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 28 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 32 | 0 / 33 | 0 / 32 | 0 / 33 | 0 / 33 | 0 / 33 | 0 / 33 | 0 / 29 | 0 / 32 | 0 / 124 | 0 / 122 | 0 / 114 | 0 / 31 | 0 / 30 | 0 / 33 | 0 / 30 | 0 / 26 | 0 / 32 | 0 / 29 |
| other Total, other adverse events | 26 / 30 | 27 / 28 | 24 / 30 | 22 / 30 | 24 / 30 | 27 / 32 | 31 / 33 | 22 / 32 | 29 / 33 | 25 / 33 | 27 / 33 | 20 / 33 | 19 / 29 | 23 / 32 | 107 / 124 | 104 / 122 | 95 / 114 | 26 / 31 | 27 / 30 | 29 / 33 | 23 / 30 | 20 / 26 | 24 / 32 | 20 / 29 |
| serious Total, serious adverse events | 0 / 30 | 1 / 28 | 0 / 30 | 0 / 30 | 0 / 30 | 1 / 32 | 0 / 33 | 0 / 32 | 0 / 33 | 2 / 33 | 0 / 33 | 0 / 33 | 0 / 29 | 0 / 32 | 0 / 124 | 0 / 122 | 0 / 114 | 1 / 31 | 0 / 30 | 0 / 33 | 0 / 30 | 0 / 26 | 0 / 32 | 0 / 29 |
Outcome results
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.
Time frame: SSA: From Vaccination on Day 1 through 4 Weeks after Vaccination
Population: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants Reporting Adverse Events From Vaccination Through 4 Weeks After Vaccination (>=65 Years) | 24.2 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants Reporting Adverse Events From Vaccination Through 4 Weeks After Vaccination (>=65 Years) | 9.4 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants Reporting Adverse Events From Vaccination Through 4 Weeks After Vaccination (>=65 Years) | 6.1 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants Reporting Adverse Events From Vaccination Through 4 Weeks After Vaccination (>=65 Years) | 6.1 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants Reporting Adverse Events From Vaccination Through 4 Weeks After Vaccination (>=65 Years) | 9.1 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants Reporting Adverse Events From Vaccination Through 4 Weeks After Vaccination (>=65 Years) | 0 Percentage of participants |
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.
Time frame: SSA: From Vaccination on Day 1 through 4 Weeks after Vaccination
Population: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination (18-64 Years) | 3.3 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination (18-64 Years) | 10.7 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination (18-64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination (18-64 Years) | 3.3 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination (18-64 Years) | 6.7 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination (18-64 Years) | 3.1 Percentage of participants |
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.
Time frame: SSA: From Vaccination on Day 1 through 6 Months after Vaccination
Population: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination (>=65 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination (>=65 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination (>=65 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination (>=65 Years) | 6.1 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination (>=65 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination (>=65 Years) | 0 Percentage of participants |
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.
Time frame: SSA: From Vaccination on Day 1 through 6 Months after Vaccination
Population: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants Reporting Serious Adverse Events (SAEs) From Vaccination Through 6 Months After Vaccination (18-64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants Reporting Serious Adverse Events (SAEs) From Vaccination Through 6 Months After Vaccination (18-64 Years) | 3.6 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants Reporting Serious Adverse Events (SAEs) From Vaccination Through 6 Months After Vaccination (18-64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants Reporting Serious Adverse Events (SAEs) From Vaccination Through 6 Months After Vaccination (18-64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants Reporting Serious Adverse Events (SAEs) From Vaccination Through 6 Months After Vaccination (18-64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants Reporting Serious Adverse Events (SAEs) From Vaccination Through 6 Months After Vaccination (18-64 Years) | 3.1 Percentage of participants |
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.
Time frame: SSA: 1 Week After Vaccination
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (18-64 Years) | 3.3 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (18-64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (18-64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (18-64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (18-64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (18-64 Years) | 0 Percentage of participants |
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.
Time frame: SSA: 1 Week After Vaccination
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (>=65 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (>=65 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (>=65 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (>=65 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (>=65 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (>=65 Years) | 0 Percentage of participants |
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.
Time frame: SSA: 2 Days after Vaccination
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (18-64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (18-64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (18-64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (18-64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (18-64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (18-64 Years) | 0 Percentage of participants |
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.
Time frame: SSA: 2 Days after Vaccination
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (>=65 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (>=65 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (>=65 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (>=65 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (>=65 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (>=65 Years) | 0 Percentage of participants |
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.
Time frame: SSA: From Day 1 to Day 7 after Vaccination
Population: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18-64 Years) | 83.3 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18-64 Years) | 89.3 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18-64 Years) | 80.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18-64 Years) | 63.3 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18-64 Years) | 73.3 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18-64 Years) | 71.9 Percentage of participants |
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.
Time frame: SSA: From Day 1 to Day 7 after Vaccination
Population: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (>=65 Years) | 84.8 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (>=65 Years) | 53.1 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (>=65 Years) | 84.8 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (>=65 Years) | 63.6 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (>=65 Years) | 72.7 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (>=65 Years) | 51.5 Percentage of participants |
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.
Time frame: SSA: 1 Week after Vaccination
Population: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (18-64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (18-64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (18-64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (18-64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (18-64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (18-64 Years) | 0 Percentage of participants |
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.
Time frame: SSA: 1 Week after Vaccination
Population: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (>=65 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (>=65 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (>=65 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (>=65 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (>=65 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (>=65 Years) | 0 Percentage of participants |
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.
Time frame: SSA: 2 Days after Vaccination
Population: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants With New ECG Abnormalities at 2 Days After Vaccination (>=65 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants With New ECG Abnormalities at 2 Days After Vaccination (>=65 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants With New ECG Abnormalities at 2 Days After Vaccination (>=65 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants With New ECG Abnormalities at 2 Days After Vaccination (>=65 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants With New ECG Abnormalities at 2 Days After Vaccination (>=65 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants With New ECG Abnormalities at 2 Days After Vaccination (>=65 Years) | 0 Percentage of participants |
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.
Time frame: SSA: 2 Days after Vaccination
Population: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination (18-64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination (18-64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination (18-64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination (18-64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination (18-64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination (18-64 Years) | 0 Percentage of participants |
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.
Time frame: SSA: From Day 1 to Day 7 after Vaccination
Population: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18-64 Years) | 76.7 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18-64 Years) | 78.6 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18-64 Years) | 70.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18-64 Years) | 53.3 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18-64 Years) | 63.3 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18-64 Years) | 68.8 Percentage of participants |
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.
Time frame: SSA: From Day 1 to Day 7 after Vaccination
Population: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (>=65 Years) | 72.7 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (>=65 Years) | 50.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (>=65 Years) | 69.7 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (>=65 Years) | 45.5 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (>=65 Years) | 60.6 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (>=65 Years) | 45.5 Percentage of participants |
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.
Time frame: SSB: From Vaccination on Day 1 through 4 Weeks after Vaccination
Population: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination (18- 64 Years) | 3.1 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination (18- 64 Years) | 4.8 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination (18- 64 Years) | 6.6 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination (18- 64 Years) | 6.1 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination (18- 64 Years) | 9.7 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination (18- 64 Years) | 6.7 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination (18- 64 Years) | 6.1 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination (18- 64 Years) | 6.7 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | SSB: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination (18- 64 Years) | 9.4 Percentage of participants |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination (18- 64 Years) | 0 Percentage of participants |
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.
Time frame: SSB: From Vaccination on Day 1 through 6 Months after Vaccination
Population: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination (18- 64 Years) | 3.2 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | SSB: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination (18- 64 Years) | 0 Percentage of participants |
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.
Time frame: SSB: 1 Week after Vaccination
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 1 Week After Vaccination (18- 64 Years) | 0 Percentage of participants |
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.
Time frame: SSB: 2 Days after Vaccination
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: Percentage of Participants With Abnormal Serum Troponin 1 Laboratory Values at 2 Days After Vaccination (18- 64 Years) | 0 Percentage of participants |
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.
Time frame: SSB: From Day 1 to Day 7 after Vaccination
Population: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18- 64 Years) | 58.6 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18- 64 Years) | 71.9 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18- 64 Years) | 78.2 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18- 64 Years) | 82.8 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18- 64 Years) | 75.4 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18- 64 Years) | 80.6 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18- 64 Years) | 80.0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18- 64 Years) | 81.8 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18- 64 Years) | 66.7 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18- 64 Years) | 73.1 Percentage of participants |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | SSB: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18- 64 Years) | 71.9 Percentage of participants |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18- 64 Years) | 69.0 Percentage of participants |
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.
Time frame: SSB: 1 Week after Vaccination
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | SSB: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: Percentage of Participants With New ECG Abnormalities at 1 Week After Vaccination (18- 64 Years) | 0 Percentage of participants |
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.
Time frame: SSB: 2 Days after Vaccination
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: Percentage of Participants With New ECG Abnormalities at 2 Days After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: Percentage of Participants With New ECG Abnormalities at 2 Days After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: Percentage of Participants With New ECG Abnormalities at 2 Days After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: Percentage of Participants With New ECG Abnormalities at 2 Days After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: Percentage of Participants With New ECG Abnormalities at 2 Days After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: Percentage of Participants With New ECG Abnormalities at 2 Days After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: Percentage of Participants With New ECG Abnormalities at 2 Days After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: Percentage of Participants With New ECG Abnormalities at 2 Days After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: Percentage of Participants With New ECG Abnormalities at 2 Days After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: Percentage of Participants With New ECG Abnormalities at 2 Days After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | SSB: Percentage of Participants With New ECG Abnormalities at 2 Days After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: Percentage of Participants With New ECG Abnormalities at 2 Days After Vaccination (18- 64 Years) | 0 Percentage of participants |
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.
Time frame: SSB: From Day 1 to Day 7 after Vaccination
Population: Safety population included all participants who received the study intervention. Participants were analyzed according to the treatment which they received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18- 64 Years) | 51.7 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18- 64 Years) | 62.5 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18- 64 Years) | 74.2 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18- 64 Years) | 77.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18- 64 Years) | 71.1 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18- 64 Years) | 80.6 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18- 64 Years) | 80.0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18- 64 Years) | 72.7 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18- 64 Years) | 73.3 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18- 64 Years) | 65.4 Percentage of participants |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | SSB: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18- 64 Years) | 68.8 Percentage of participants |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: Percentage of Participants With Systemic Events up to 7 Days Following Vaccination (18- 64 Years) | 48.3 Percentage of participants |
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.
Time frame: SSA: Before Vaccination to 4 Weeks after Vaccination
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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 4.1 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 1.3 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 1.2 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 8.5 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 1.8 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 3.9 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 9.8 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 1.3 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 4.7 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 8.2 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 2.2 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 1.4 Fold Rise |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 1.7 Fold Rise |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 9.7 Fold Rise |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 5.9 Fold Rise |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 1.9 Fold Rise |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 5.7 Fold Rise |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 1.6 Fold Rise |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 2.6 Fold Rise |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 11.0 Fold Rise |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 2.7 Fold Rise |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 7.5 Fold Rise |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 2.5 Fold Rise |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Geometric Mean Fold Rise (GMFRs) of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 2.6 Fold Rise |
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.
Time frame: SSA: Before Vaccination and 4 Weeks after Vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: Before vaccination | 32.0 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: Before vaccination | 32.0 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: Before vaccination | 18.1 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: 4 Weeks after vaccination | 165.5 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: 4 Weeks after vaccination | 341.6 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: Before vaccination | 10.5 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: 4 Weeks after vaccination | 26.9 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: 4 Weeks after vaccination | 14.9 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: 4 Weeks after vaccination | 20.0 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: Before vaccination | 16.7 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: 4 Weeks after vaccination | 201.6 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: Before vaccination | 14.7 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: Before vaccination | 31.2 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: 4 Weeks after vaccination | 36.1 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: 4 Weeks after vaccination | 141.9 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: Before vaccination | 12.0 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: Before vaccination | 11.0 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: 4 Weeks after vaccination | 160.0 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: Before vaccination | 31.2 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: 4 Weeks after vaccination | 18.6 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: Before vaccination | 12.8 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: 4 Weeks after vaccination | 35.3 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: 4 Weeks after vaccination | 282.7 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: Before vaccination | 30.9 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: Before vaccination | 23.6 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: 4 Weeks after vaccination | 259.9 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: 4 Weeks after vaccination | 167.6 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: Before vaccination | 9.8 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: 4 Weeks after vaccination | 17.8 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: Before vaccination | 21.0 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: 4 Weeks after vaccination | 45.9 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: Before vaccination | 26.0 Titers |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: Before vaccination | 10.5 Titers |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: Before vaccination | 12.2 Titers |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: 4 Weeks after vaccination | 129.1 Titers |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: Before vaccination | 16.4 Titers |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: Before vaccination | 16.4 Titers |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: 4 Weeks after vaccination | 41.0 Titers |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: 4 Weeks after vaccination | 249.8 Titers |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: 4 Weeks after vaccination | 20.0 Titers |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: 4 Weeks after vaccination | 40.0 Titers |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: 4 Weeks after vaccination | 97.8 Titers |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: Before vaccination | 34.2 Titers |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: Before vaccination | 12.0 Titers |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: Before vaccination | 24.5 Titers |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: 4 Weeks after vaccination | 78.2 Titers |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: Before vaccination | 36.6 Titers |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: 4 Weeks after vaccination | 294.7 Titers |
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.
Time frame: SSA: Before Vaccination to 4 Weeks after Vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 7.0 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | Reference-Strain Neutralizing Titers | 4.1 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | Reference-Strain Neutralizing Titers | 5.5 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 7.6 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | Reference-Strain Neutralizing Titers | 2.9 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 4.4 Fold Rise |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 8.7 Fold Rise |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | Reference-Strain Neutralizing Titers | 3.9 Fold Rise |
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.
Time frame: SSA: Before Vaccination to 4 Weeks after Vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | Reference-Strain Neutralizing Titers | 2.5 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 2.8 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 2.4 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | Reference-Strain Neutralizing Titers | 1.7 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 3.0 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | Reference-Strain Neutralizing Titers | 2.3 Fold Rise |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | Reference-Strain Neutralizing Titers | 2.0 Fold Rise |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 2.4 Fold Rise |
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.
Time frame: SSA: Before Vaccination to 4 Weeks after Vaccination
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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years) | A/Darwin | 1.8 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years) | B/Phuket | 1.2 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years) | B/Austria | 1.3 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin | 2.0 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years) | B/Phuket | 1.1 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years) | A/Darwin | 2.8 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin | 2.3 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years) | B/Austria | 1.4 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years) | A/Darwin | 2.1 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin | 2.7 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years) | B/Phuket | 1.4 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years) | B/Austria | 1.4 Fold Rise |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years) | A/Darwin | 1.9 Fold Rise |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin | 2.2 Fold Rise |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years) | B/Phuket | 1.2 Fold Rise |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years) | B/Austria | 1.3 Fold Rise |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin | 2.2 Fold Rise |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years) | B/Austria | 1.4 Fold Rise |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years) | A/Darwin | 2.6 Fold Rise |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years) | B/Phuket | 1.5 Fold Rise |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years) | B/Phuket | 1.4 Fold Rise |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years) | B/Austria | 1.7 Fold Rise |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin | 1.5 Fold Rise |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: GMFRs of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (>=65 Years) | A/Darwin | 1.4 Fold Rise |
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.
Time frame: SSA: Before Vaccination and 4 Weeks after Vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | SARS-CoV-2-Reference-Strain Neutralizing Titers: 4 Weeks After Vaccination | 12713.5 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers: 4 Weeks After Vaccination | 3676.8 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers: Before Vaccination | 499.0 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | SARS-CoV-2-Reference-Strain Neutralizing Titers: Before Vaccination | 3068.0 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers: 4 Weeks After Vaccination | 2202.4 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | SARS-CoV-2-Reference-Strain Neutralizing Titers: Before Vaccination | 1466.1 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers: Before Vaccination | 240.9 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | SARS-CoV-2-Reference-Strain Neutralizing Titers: 4 Weeks After Vaccination | 8069.0 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers: Before Vaccination | 466.9 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers: 4 Weeks After Vaccination | 2139.4 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | SARS-CoV-2-Reference-Strain Neutralizing Titers: Before Vaccination | 2487.1 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | SARS-CoV-2-Reference-Strain Neutralizing Titers: 4 Weeks After Vaccination | 7166.0 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers: 4 Weeks After Vaccination | 3890.4 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | SARS-CoV-2 Omicron (BA.4/BA.5)- Neutralizing Titers: Before Vaccination | 415.8 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | SARS-CoV-2-Reference-Strain Neutralizing Titers: 4 Weeks After Vaccination | 10719.9 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | SARS-CoV-2-Reference-Strain Neutralizing Titers: Before Vaccination | 2719.1 Titers |
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.
Time frame: SSA: Before Vaccination and 4 Weeks after Vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers: Before Vaccination | 1233.2 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | Reference-Strain Neutralizing Titers: 4 Weeks After Vaccination | 15305.0 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers: 4 Weeks After Vaccination | 3627.4 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | Reference-Strain Neutralizing Titers: Before Vaccination | 6045.7 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers: 4 Weeks After Vaccination | 1841.1 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | Reference-Strain Neutralizing Titers: Before Vaccination | 4567.0 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers: Before Vaccination | 678.7 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | Reference-Strain Neutralizing Titers: 4 Weeks After Vaccination | 7821.2 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers: 4 Weeks After Vaccination | 2770.7 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | Reference-Strain Neutralizing Titers: 4 Weeks After Vaccination | 10280.2 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers: Before Vaccination | 866.0 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | Reference-Strain Neutralizing Titers: Before Vaccination | 4461.1 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | Reference-Strain Neutralizing Titers: 4 Weeks After Vaccination | 15646.0 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | Reference-Strain Neutralizing Titers: Before Vaccination | 7654.1 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers: Before Vaccination | 1472.6 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers: 4 Weeks After Vaccination | 3774.4 Titers |
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.
Time frame: SSA: Before Vaccination and 4 Weeks after Vaccination
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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Darwin: Before vaccination | 57.2 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Phuket: Before vaccination | 14.8 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin: Before vaccination | 56.6 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Austria: Before vaccination | 37.5 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin: 4 Weeks after vaccination | 113.1 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Phuket: 4 Weeks after vaccination | 20.0 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Austria: 4 Weeks after vaccination | 49.7 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Darwin: 4 Weeks after vaccination | 107.5 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Darwin: 4 Weeks after vaccination | 115.6 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Darwin: Before vaccination | 40.9 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Austria: 4 Weeks after vaccination | 44.6 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Phuket: Before vaccination | 11.9 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin: Before vaccination | 38.3 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Phuket: 4 Weeks after vaccination | 14.5 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Austria: Before vaccination | 28.3 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin: 4 Weeks after vaccination | 97.2 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Austria: Before vaccination | 27.1 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin: Before vaccination | 57.8 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin: 4 Weeks after vaccination | 156.6 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Darwin: Before vaccination | 62.0 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Darwin: 4 Weeks after vaccination | 134.5 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Austria: 4 Weeks after vaccination | 40.9 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Phuket: Before vaccination | 12.4 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Phuket: 4 Weeks after vaccination | 20.4 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin: 4 Weeks after vaccination | 119.6 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Darwin: 4 Weeks after vaccination | 81.8 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Austria: Before vaccination | 28.0 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Phuket: 4 Weeks after vaccination | 15.0 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Austria: 4 Weeks after vaccination | 40.9 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin: Before vaccination | 53.5 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Phuket: Before vaccination | 10.7 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Darwin: Before vaccination | 41.8 Titers |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Austria: 4 Weeks after vaccination | 64.5 Titers |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Phuket: 4 Weeks after vaccination | 26.0 Titers |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin: 4 Weeks after vaccination | 150.1 Titers |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Phuket: Before vaccination | 15.0 Titers |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Darwin: 4 Weeks after vaccination | 181.7 Titers |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin: Before vaccination | 69.3 Titers |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Darwin: Before vaccination | 71.0 Titers |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Austria: Before vaccination | 44.0 Titers |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Darwin: 4 Weeks after vaccination | 83.5 Titers |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Austria: Before vaccination | 22.8 Titers |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin: 4 Weeks after vaccination | 80.0 Titers |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Darwin: Before vaccination | 56.6 Titers |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Phuket: 4 Weeks after vaccination | 15.4 Titers |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Austria: 4 Weeks after vaccination | 41.8 Titers |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Phuket: Before vaccination | 10.4 Titers |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin: Before vaccination | 50.8 Titers |
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).
Time frame: SSA: 4 Weeks after Vaccination
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants Achieving HAI Seroconversion for All Strains at 4 Weeks After Vaccination (18- 64 Years) | 3.7 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants Achieving HAI Seroconversion for All Strains at 4 Weeks After Vaccination (18- 64 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants Achieving HAI Seroconversion for All Strains at 4 Weeks After Vaccination (18- 64 Years) | 7.4 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants Achieving HAI Seroconversion for All Strains at 4 Weeks After Vaccination (18- 64 Years) | 3.4 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants Achieving HAI Seroconversion for All Strains at 4 Weeks After Vaccination (18- 64 Years) | 10.7 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants Achieving HAI Seroconversion for All Strains at 4 Weeks After Vaccination (18- 64 Years) | 6.5 Percentage of participants |
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).
Time frame: SSA: 4 Weeks after Vaccination
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants Achieving HAI Seroconversion for All Strains at 4 Weeks After Vaccination (>=65 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants Achieving HAI Seroconversion for All Strains at 4 Weeks After Vaccination (>=65 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants Achieving HAI Seroconversion for All Strains at 4 Weeks After Vaccination (>=65 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants Achieving HAI Seroconversion for All Strains at 4 Weeks After Vaccination (>=65 Years) | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants Achieving HAI Seroconversion for All Strains at 4 Weeks After Vaccination (>=65 Years) | 3.4 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants Achieving HAI Seroconversion for All Strains at 4 Weeks After Vaccination (>=65 Years) | 3.1 Percentage of participants |
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.
Time frame: SSA: 4 Weeks after Vaccination
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 63.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 75.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 14.3 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 17.9 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 77.8 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 3.7 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 60.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 18.5 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 21.4 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 70.4 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 71.4 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 32.1 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 86.2 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 69.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 34.5 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 17.2 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 25.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 89.3 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 75.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 50.0 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 35.5 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 38.7 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 38.7 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 61.3 Percentage of participants |
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.
Time frame: SSA: 4 Weeks after Vaccination
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin | 15.6 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years) | B/Austria | 9.4 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years) | B/Phuket | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years) | A/Darwin | 12.9 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years) | A/Darwin | 43.8 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years) | B/Austria | 6.3 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin | 25.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years) | B/Phuket | 3.1 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin | 46.9 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years) | A/Darwin | 30.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years) | B/Austria | 6.3 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years) | B/Phuket | 9.4 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years) | B/Phuket | 0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin | 32.3 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years) | A/Darwin | 19.4 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years) | B/Austria | 6.5 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin | 34.5 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years) | B/Phuket | 13.8 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years) | B/Austria | 6.9 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years) | A/Darwin | 41.4 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years) | B/Phuket | 12.5 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin | 12.5 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years) | A/Darwin | 12.5 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (>=65 Years) | B/Austria | 15.6 Percentage of participants |
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).
Time frame: SSA: 4 Weeks after Vaccination
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants With HAI Titers >= 1.40 for All Strain at 4 Weeks After Vaccination (18- 64 Years) | 18.5 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants With HAI Titers >= 1.40 for All Strain at 4 Weeks After Vaccination (18- 64 Years) | 22.2 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants With HAI Titers >= 1.40 for All Strain at 4 Weeks After Vaccination (18- 64 Years) | 21.4 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants With HAI Titers >= 1.40 for All Strain at 4 Weeks After Vaccination (18- 64 Years) | 26.7 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants With HAI Titers >= 1.40 for All Strain at 4 Weeks After Vaccination (18- 64 Years) | 28.6 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants With HAI Titers >= 1.40 for All Strain at 4 Weeks After Vaccination (18- 64 Years) | 51.6 Percentage of participants |
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).
Time frame: SSA: 4 Weeks after Vaccination
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants With HAI Titers >= 1.40 for All Strain at 4 Weeks After Vaccination (>=65 Years) | 21.9 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants With HAI Titers >= 1.40 for All Strain at 4 Weeks After Vaccination (>=65 Years) | 15.6 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants With HAI Titers >= 1.40 for All Strain at 4 Weeks After Vaccination (>=65 Years) | 28.1 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants With HAI Titers >= 1.40 for All Strain at 4 Weeks After Vaccination (>=65 Years) | 22.6 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants With HAI Titers >= 1.40 for All Strain at 4 Weeks After Vaccination (>=65 Years) | 41.4 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants With HAI Titers >= 1.40 for All Strain at 4 Weeks After Vaccination (>=65 Years) | 21.9 Percentage of participants |
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.
Time frame: SSA: 4 Weeks after Vaccination
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 67.9 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | Reference-Strain Neutralizing Titers | 46.4 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | Reference-Strain Neutralizing Titers | 63.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 85.2 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 42.9 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | Reference-Strain Neutralizing Titers | 32.1 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 74.2 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | Reference-Strain Neutralizing Titers | 48.4 Percentage of participants |
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.
Time frame: SSA:4 Weeks after Vaccination
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 34.4 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | Reference-Strain Neutralizing Titers | 21.9 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | Reference-Strain Neutralizing Titers | 15.6 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 28.1 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 35.5 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | Reference-Strain Neutralizing Titers | 25.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 25.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | Reference-Strain Neutralizing Titers | 18.8 Percentage of participants |
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.
Time frame: SSA: Before Vaccination and at 4 Weeks After Vaccination
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Austria: Before Vaccination | 62.5 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Austria: 4 Weeks After Vaccination | 75.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Phuket: 4 Weeks After Vaccination | 31.3 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Phuket: Before Vaccination | 25.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Darwin: Before Vaccination | 83.9 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Darwin: 4 Weeks After Vaccination | 93.8 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin: Before Vaccination | 68.8 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin: 4 Weeks After Vaccination | 90.6 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Phuket: Before Vaccination | 15.6 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Darwin: 4 Weeks After Vaccination | 100.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin: Before Vaccination | 59.4 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Darwin: Before Vaccination | 81.3 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Phuket: 4 Weeks After Vaccination | 21.9 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Austria: Before Vaccination | 56.3 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Austria: 4 Weeks After Vaccination | 62.5 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin: 4 Weeks After Vaccination | 96.9 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Austria: 4 Weeks After Vaccination | 65.6 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin: 4 Weeks After Vaccination | 87.5 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Phuket: 4 Weeks After Vaccination | 31.3 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin: Before Vaccination | 62.5 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Austria: Before Vaccination | 53.1 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Darwin: 4 Weeks After Vaccination | 96.9 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Phuket: Before Vaccination | 15.6 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Darwin: Before Vaccination | 86.7 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Phuket: Before Vaccination | 9.7 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Phuket: 4 Weeks After Vaccination | 25.8 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin: 4 Weeks After Vaccination | 93.5 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Darwin: Before Vaccination | 74.2 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Darwin: 4 Weeks After Vaccination | 87.1 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin: Before Vaccination | 71.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Austria: Before Vaccination | 54.8 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Austria: 4 Weeks After Vaccination | 64.5 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Austria: Before Vaccination | 62.1 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Phuket: Before Vaccination | 31.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Austria: 4 Weeks After Vaccination | 75.9 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Darwin: 4 Weeks After Vaccination | 100.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin: 4 Weeks After Vaccination | 93.1 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Darwin: Before Vaccination | 89.7 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Phuket: 4 Weeks After Vaccination | 51.7 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin: Before Vaccination | 75.9 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Phuket: 4 Weeks After Vaccination | 31.3 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin: Before Vaccination | 75.0 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Wisconsin: 4 Weeks After Vaccination | 93.8 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Darwin: Before Vaccination | 78.1 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | A/Darwin: 4 Weeks After Vaccination | 90.6 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Austria: Before Vaccination | 43.8 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Austria: 4 Weeks After Vaccination | 68.8 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSA: Percentage of Participants With Strain Specific HAI Titers >= 1:40 Before Vaccination and at 4 Weeks After Vaccination (>=65 Years) | B/Phuket: Before Vaccination | 12.5 Percentage of participants |
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.
Time frame: SSA: Before Vaccination and at 4 Weeks after Vaccination
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | A/Wisconsin: Before Vaccination | 53.6 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | B/Phuket: Before Vaccination | 32.1 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | A/Wisconsin: 4 Weeks After Vaccination | 96.4 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | A/Darwin: 4 Weeks After Vaccination | 85.2 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | A/Darwin: Before Vaccination | 60.7 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | B/Austria: 4 Weeks After Vaccination | 28.6 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | B/Phuket: 4 Weeks After Vaccination | 57.1 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | B/Austria: Before Vaccination | 14.3 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | A/Darwin: Before Vaccination | 56.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | A/Darwin: 4 Weeks After Vaccination | 92.6 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | B/Phuket: 4 Weeks After Vaccination | 55.6 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | A/Wisconsin: Before Vaccination | 25.9 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | B/Phuket: Before Vaccination | 25.9 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | A/Wisconsin: 4 Weeks After Vaccination | 92.6 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | B/Austria: 4 Weeks After Vaccination | 33.3 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | B/Austria: Before Vaccination | 25.9 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | A/Wisconsin: 4 Weeks After Vaccination | 92.9 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | A/Wisconsin: Before Vaccination | 46.4 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | A/Darwin: Before Vaccination | 66.7 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | A/Darwin: 4 Weeks After Vaccination | 96.4 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | B/Austria: Before Vaccination | 17.9 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | B/Austria: 4 Weeks After Vaccination | 42.9 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | B/Phuket: Before Vaccination | 14.3 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | B/Phuket: 4 Weeks After Vaccination | 53.6 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | B/Phuket: Before Vaccination | 48.3 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | A/Wisconsin: Before Vaccination | 44.8 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | A/Wisconsin: 4 Weeks After Vaccination | 96.7 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | A/Darwin: 4 Weeks After Vaccination | 96.7 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | A/Darwin: Before Vaccination | 51.7 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | B/Phuket: 4 Weeks After Vaccination | 70.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | B/Austria: 4 Weeks After Vaccination | 33.3 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | B/Austria: Before Vaccination | 13.8 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | 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) | A/Wisconsin: Before Vaccination | 32.1 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | 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) | A/Wisconsin: 4 Weeks After Vaccination | 100.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | 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) | B/Phuket: 4 Weeks After Vaccination | 67.9 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | 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) | A/Darwin: Before Vaccination | 42.9 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | 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) | B/Austria: 4 Weeks After Vaccination | 39.3 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | 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) | B/Austria: Before Vaccination | 21.4 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | 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) | A/Darwin: 4 Weeks After Vaccination | 85.7 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | 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) | B/Phuket: Before Vaccination | 21.4 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | 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) | A/Darwin: 4 Weeks After Vaccination | 87.1 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | 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) | A/Wisconsin: 4 Weeks After Vaccination | 96.8 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | 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) | B/Phuket: 4 Weeks After Vaccination | 90.3 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | 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) | B/Austria: Before Vaccination | 22.6 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | 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) | B/Austria: 4 Weeks After Vaccination | 54.8 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | 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) | A/Wisconsin: Before Vaccination | 58.1 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | 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) | B/Phuket: Before Vaccination | 51.6 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | 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) | A/Darwin: Before Vaccination | 67.7 Percentage of participants |
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.
Time frame: SSB: 4 Weeks after Vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 4.1 Fold rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | Reference-Strain Neutralizing Titers | 2.4 Fold rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 2.7 Fold rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | Reference-Strain Neutralizing Titers | 2.1 Fold rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 3.0 Fold rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | Reference-Strain Neutralizing Titers | 2.6 Fold rise |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 2.6 Fold rise |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | Reference-Strain Neutralizing Titers | 2.5 Fold rise |
| Substudy A, 18-64 Years: qIRV 60 mcg | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 2.8 Fold rise |
| Substudy A, 18-64 Years: qIRV 60 mcg | 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) | Reference-Strain Neutralizing Titers | 2.8 Fold rise |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | 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) | Reference-Strain Neutralizing Titers | 2.5 Fold rise |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 2.6 Fold rise |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | 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) | Reference-Strain Neutralizing Titers | 1.8 Fold rise |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 2.5 Fold rise |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 2.9 Fold rise |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | 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) | Reference-Strain Neutralizing Titers | 2.7 Fold rise |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 4.6 Fold rise |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | 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) | Reference-Strain Neutralizing Titers | 3.1 Fold rise |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 2.8 Fold rise |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | 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) | Reference-Strain Neutralizing Titers | 2.0 Fold rise |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 3.7 Fold rise |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | 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) | Reference-Strain Neutralizing Titers | 3.8 Fold rise |
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.
Time frame: SSB: Before Vaccination to 4 Weeks after Vaccination
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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 1.3 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 2.3 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 1.4 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 3.1 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 2.2 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 6.9 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 1.8 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 4.2 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 1.6 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 4.4 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 4.5 Fold Rise |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 1.7 Fold Rise |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 4.4 Fold Rise |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 4.8 Fold Rise |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 1.8 Fold Rise |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 1.5 Fold Rise |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 1.4 Fold Rise |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 3.8 Fold Rise |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 1.7 Fold Rise |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 4.4 Fold Rise |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 3.5 Fold Rise |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 4.5 Fold Rise |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 1.6 Fold Rise |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 1.3 Fold Rise |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 1.9 Fold Rise |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 1.7 Fold Rise |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 2.8 Fold Rise |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 1.8 Fold Rise |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 3.3 Fold Rise |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 2.7 Fold Rise |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 1.7 Fold Rise |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 1.6 Fold Rise |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 2.8 Fold Rise |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 2.4 Fold Rise |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 1.4 Fold Rise |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 1.3 Fold Rise |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 1.6 Fold Rise |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Cambodia | 3.5 Fold Rise |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 3.3 Fold Rise |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 3.6 Fold Rise |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 3.5 Fold Rise |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 4.7 Fold Rise |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 1.9 Fold Rise |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 1.8 Fold Rise |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Cambodia | 2.4 Fold Rise |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 4.3 Fold Rise |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 1.4 Fold Rise |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: GMFR of Strain-Specific HAI From Before Vaccination to 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 4.0 Fold Rise |
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.
Time frame: SSB: Before Vaccination and at 4 Weeks after Vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers: 4 Weeks After Vaccination | 4353.8 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | Reference-Strain Neutralizing Titers: 4 Weeks After Vaccination | 8132.5 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers: Before Vaccination | 989.5 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | Reference-Strain Neutralizing Titers: Before Vaccination | 3396.1 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | Reference-Strain Neutralizing Titers: Before Vaccination | 3569.4 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers: 4 Weeks After Vaccination | 2960.9 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers: Before Vaccination | 1081.4 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | Reference-Strain Neutralizing Titers: 4 Weeks After Vaccination | 7499.8 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | Reference-Strain Neutralizing Titers: Before Vaccination | 4128.9 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers: 4 Weeks After Vaccination | 3606.3 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers: Before Vaccination | 1127.6 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | Reference-Strain Neutralizing Titers: 4 Weeks After Vaccination | 10769.8 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | Reference-Strain Neutralizing Titers: Before Vaccination | 4335.7 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers: 4 Weeks After Vaccination | 3555.6 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | Reference-Strain Neutralizing Titers: 4 Weeks After Vaccination | 10818.7 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers: Before Vaccination | 1289.6 Titers |
| Substudy A, 18-64 Years: qIRV 60 mcg | 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) | Reference-Strain Neutralizing Titers: Before Vaccination | 4260.5 Titers |
| Substudy A, 18-64 Years: qIRV 60 mcg | 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) | Reference-Strain Neutralizing Titers: 4 Weeks After Vaccination | 12081.5 Titers |
| Substudy A, 18-64 Years: qIRV 60 mcg | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers: Before Vaccination | 1361.4 Titers |
| Substudy A, 18-64 Years: qIRV 60 mcg | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers: 4 Weeks After Vaccination | 3997.9 Titers |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers: Before Vaccination | 1805.5 Titers |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | 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) | Reference-Strain Neutralizing Titers: Before Vaccination | 4846.4 Titers |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers: 4 Weeks After Vaccination | 4131.7 Titers |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | 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) | Reference-Strain Neutralizing Titers: 4 Weeks After Vaccination | 11319.8 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | 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) | Reference-Strain Neutralizing Titers: 4 Weeks After Vaccination | 9991.0 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | 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) | Reference-Strain Neutralizing Titers: Before Vaccination | 5693.9 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers: Before Vaccination | 1527.8 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers: 4 Weeks After Vaccination | 3878.7 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers: 4 Weeks After Vaccination | 3999.6 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | 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) | Reference-Strain Neutralizing Titers: Before Vaccination | 4255.8 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers: Before Vaccination | 1343.6 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | 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) | Reference-Strain Neutralizing Titers: 4 Weeks After Vaccination | 11632.2 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers: 4 Weeks After Vaccination | 6018.8 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | 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) | Reference-Strain Neutralizing Titers: Before Vaccination | 4840.6 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | 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) | Reference-Strain Neutralizing Titers: 4 Weeks After Vaccination | 14921.6 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers: Before Vaccination | 1207.8 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers: Before Vaccination | 1688.9 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | 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) | Reference-Strain Neutralizing Titers: Before Vaccination | 5380.6 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers: 4 Weeks After Vaccination | 4659.7 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | 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) | Reference-Strain Neutralizing Titers: 4 Weeks After Vaccination | 10981.2 Titers |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | 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) | Reference-Strain Neutralizing Titers: 4 Weeks After Vaccination | 14605.4 Titers |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers: Before Vaccination | 1054.2 Titers |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | 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) | Reference-Strain Neutralizing Titers: Before Vaccination | 3678.1 Titers |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers: 4 Weeks After Vaccination | 4385.7 Titers |
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.
Time frame: SSB: Before Vaccination and 4 Weeks after Vaccination
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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: Before vaccination | 21.0 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: 4 Weeks after vaccination | 52.5 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: Before vaccination | 51.2 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: 4 Weeks after vaccination | 82.1 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: Before vaccination | 35.3 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: 4 Weeks after vaccination | 181.1 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: 4 Weeks after vaccination | 36.2 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: Before vaccination | 33.7 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: Before vaccination | 26.5 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: Before vaccination | 13.3 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: 4 Weeks after vaccination | 37.4 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: 4 Weeks after vaccination | 343.9 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: Before vaccination | 44.6 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: 4 Weeks after vaccination | 49.7 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: Before vaccination | 35.1 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: 4 Weeks after vaccination | 172.3 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: Before vaccination | 17.3 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: 4 Weeks after vaccination | 110.0 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: 4 Weeks after vaccination | 44.3 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: Before vaccination | 22.6 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: Before vaccination | 44.4 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: 4 Weeks after vaccination | 213.4 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: 4 Weeks after vaccination | 32.2 Titers |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: Before vaccination | 24.0 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: Before vaccination | 36.2 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: 4 Weeks after vaccination | 48.0 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: Before vaccination | 19.2 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: Before vaccination | 53.3 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: 4 Weeks after vaccination | 173.4 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: 4 Weeks after vaccination | 33.1 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: Before vaccination | 25.3 Titers |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: 4 Weeks after vaccination | 277.3 Titers |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: Before vaccination | 25.6 Titers |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: Before vaccination | 53.5 Titers |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: Before vaccination | 31.3 Titers |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: 4 Weeks after vaccination | 30.7 Titers |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: 4 Weeks after vaccination | 46.2 Titers |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: 4 Weeks after vaccination | 215.8 Titers |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: Before vaccination | 20.1 Titers |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: 4 Weeks after vaccination | 149.6 Titers |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: 4 Weeks after vaccination | 26.9 Titers |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: Before vaccination | 46.4 Titers |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: 4 Weeks after vaccination | 217.1 Titers |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: Before vaccination | 51.7 Titers |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: 4 Weeks after vaccination | 172.3 Titers |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: Before vaccination | 14.9 Titers |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: Before vaccination | 18.6 Titers |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: 4 Weeks after vaccination | 27.6 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: 4 Weeks after vaccination | 66.4 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: 4 Weeks after vaccination | 125.9 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: Before vaccination | 20.0 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: Before vaccination | 62.9 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: Before vaccination | 55.1 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: 4 Weeks after vaccination | 36.0 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: Before vaccination | 33.2 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: 4 Weeks after vaccination | 155.8 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: 4 Weeks after vaccination | 110.7 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: 4 Weeks after vaccination | 149.9 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: Before vaccination | 51.9 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: Before vaccination | 23.3 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: 4 Weeks after vaccination | 22.3 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: 4 Weeks after vaccination | 46.5 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: Before vaccination | 31.5 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: Before vaccination | 12.2 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: 4 Weeks after vaccination | 120.1 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: 4 Weeks after vaccination | 106.6 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: Before vaccination | 20.0 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: 4 Weeks after vaccination | 28.6 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: Before vaccination | 45.3 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: Before vaccination | 15.0 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: 4 Weeks after vaccination | 23.1 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: Before vaccination | 38.1 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: 4 Weeks after vaccination | 23.5 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: 4 Weeks after vaccination | 80.0 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Cambodia: 4 Weeks after vaccination | 60.6 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: Before vaccination | 12.7 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: 4 Weeks after vaccination | 139.3 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: Before vaccination | 18.4 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: Before vaccination | 31.5 Titers |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Cambodia: Before vaccination | 13.1 Titers |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: 4 Weeks after vaccination | 141.4 Titers |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: 4 Weeks after vaccination | 36.4 Titers |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: Before vaccination | 26.9 Titers |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: 4 Weeks after vaccination | 173.2 Titers |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: Before vaccination | 16.9 Titers |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: Before vaccination | 46.2 Titers |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: 4 Weeks after vaccination | 27.1 Titers |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: Before vaccination | 18.4 Titers |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Cambodia: Before vaccination | 27.2 Titers |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Cambodia: 4 Weeks after vaccination | 77.7 Titers |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: 4 Weeks after vaccination | 38.9 Titers |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: Before vaccination | 16.0 Titers |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: Before vaccination | 18.9 Titers |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: Before vaccination | 37.8 Titers |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: 4 Weeks after vaccination | 99.9 Titers |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: GMTs of Strain-Specific HAI Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: 4 Weeks after vaccination | 178.8 Titers |
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,
Time frame: SSB: 4 Weeks after Vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 17.9 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 40.7 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 42.9 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 7.1 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 61.3 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 25.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 25.8 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 65.6 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 16.5 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 14.9 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 64.2 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 64.5 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 12.7 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 64.4 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 18.6 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 62.7 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 56.1 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 64.5 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 9.3 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 14.2 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 59.3 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 7.1 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 64.3 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 14.3 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 11.5 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 19.2 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 23.1 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 34.6 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 21.9 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 6.3 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 34.4 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 56.3 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 13.8 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 39.3 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 10.3 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 25.0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 15.4 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 50.0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Cambodia | 60.0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 40.0 Percentage of participants |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 70.4 Percentage of participants |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 44.8 Percentage of participants |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 20.7 Percentage of participants |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin | 64.0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin | 68.0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | A/Cambodia | 35.3 Percentage of participants |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket | 16.7 Percentage of participants |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination (18- 64 Years) | B/Austria | 4.0 Percentage of participants |
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.
Time frame: SSB: 4 Weeks after Vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 50.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | 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) | Reference-Strain Neutralizing Titers | 33.3 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | Reference-Strain Neutralizing Titers | 25.8 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 37.5 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 35.8 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | 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) | Reference-Strain Neutralizing Titers | 33.6 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | Reference-Strain Neutralizing Titers | 30.8 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 29.9 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 30.6 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | 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) | Reference-Strain Neutralizing Titers | 31.5 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 38.5 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | 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) | Reference-Strain Neutralizing Titers | 25.9 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | 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) | Reference-Strain Neutralizing Titers | 23.1 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 30.8 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 38.7 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | 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) | Reference-Strain Neutralizing Titers | 25.0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | 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) | Reference-Strain Neutralizing Titers | 41.4 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 46.4 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 26.9 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | 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) | Reference-Strain Neutralizing Titers | 23.1 Percentage of participants |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | 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) | Omicron (BA.4/BA.5)- Neutralizing Titers | 44.8 Percentage of participants |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | 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) | Reference-Strain Neutralizing Titers | 42.9 Percentage of participants |
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.
Time frame: SSB: Before Vaccination and at 4 Weeks after Vaccination
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: 4 weeks after vaccination | 53.6 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: Before Vaccination | 64.3 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: Before Vaccination | 42.9 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: Before Vaccination | 60.7 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: 4 weeks after vaccination | 81.5 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: 4 weeks after vaccination | 78.6 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: Before Vaccination | 40.7 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 1) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: 4 weeks after vaccination | 92.9 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: 4 weeks after vaccination | 68.8 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: 4 weeks after vaccination | 100.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: Before Vaccination | 65.6 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: Before Vaccination | 43.8 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: Before Vaccination | 25.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: 4 weeks after vaccination | 100.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: 4 weeks after vaccination | 58.1 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 60 mcg | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: Before Vaccination | 62.5 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: 4 weeks after vaccination | 55.4 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: Before Vaccination | 30.6 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: 4 weeks after vaccination | 61.2 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: Before Vaccination | 64.2 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: 4 weeks after vaccination | 95.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: Before Vaccination | 45.5 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: 4 weeks after vaccination | 92.6 Percentage of participants |
| Substudy A, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 2) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: Before Vaccination | 44.6 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: Before Vaccination | 64.4 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: Before Vaccination | 69.5 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: Before Vaccination | 33.9 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: Before Vaccination | 45.8 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: 4 weeks after vaccination | 96.6 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: 4 weeks after vaccination | 72.0 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: 4 weeks after vaccination | 53.4 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 30 mcg | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: 4 weeks after vaccination | 99.2 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: Before Vaccination | 43.4 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: 4 weeks after vaccination | 70.8 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: Before Vaccination | 61.1 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: 4 weeks after vaccination | 97.2 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: 4 weeks after vaccination | 52.3 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: 4 weeks after vaccination | 95.3 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: Before Vaccination | 32.4 Percentage of participants |
| Substudy A, 18-64 Years: qIRV 60 mcg | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: Before Vaccination | 71.0 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: 4 weeks after vaccination | 53.6 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: Before Vaccination | 39.3 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: 4 weeks after vaccination | 50.0 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: Before Vaccination | 74.1 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: Before Vaccination | 71.4 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: 4 weeks after vaccination | 96.4 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: Before Vaccination | 39.3 Percentage of participants |
| Substudy A, 18-64 Years: Bivalent BNT162b2 (30 mcg) /QIV | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: 4 weeks after vaccination | 92.9 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: Before Vaccination | 50.0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: Before Vaccination | 34.6 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: 4 weeks after vaccination | 96.2 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: 4 weeks after vaccination | 80.8 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: 4 weeks after vaccination | 53.8 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: 4 weeks after vaccination | 96.2 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: Before Vaccination | 84.6 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 3) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: Before Vaccination | 61.5 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: Before Vaccination | 50.0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: Before Vaccination | 56.3 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: Before Vaccination | 15.6 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: 4 weeks after vaccination | 68.8 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: Before Vaccination | 78.1 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: 4 weeks after vaccination | 96.9 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: 4 weeks after vaccination | 40.6 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 2) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: 4 weeks after vaccination | 93.8 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: 4 weeks after vaccination | 96.6 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: Before Vaccination | 71.4 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: 4 weeks after vaccination | 41.4 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: 4 weeks after vaccination | 96.6 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: Before Vaccination | 31.0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: Before Vaccination | 41.4 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: 4 weeks after vaccination | 55.2 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (90 mcg Combination 4) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: Before Vaccination | 67.9 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: 4 weeks after vaccination | 88.0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: Before Vaccination | 19.2 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: Before Vaccination | 50.0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: Before Vaccination | 44.0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: 4 weeks after vaccination | 88.0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Cambodia: Before Vaccination | 30.8 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Cambodia: 4 weeks after vaccination | 88.0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV /Bivalent BNT162b2 (60 mcg Combination 3) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: 4 weeks after vaccination | 34.6 Percentage of participants |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: Before Vaccination | 31.0 Percentage of participants |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: 4 weeks after vaccination | 89.7 Percentage of participants |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: 4 weeks after vaccination | 92.9 Percentage of participants |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: Before Vaccination | 65.5 Percentage of participants |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: Before Vaccination | 46.4 Percentage of participants |
| Substudy B, 18-64 Years: tIRV /Bivalent BNT162b2 (75 mcg) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: 4 weeks after vaccination | 58.6 Percentage of participants |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: Before Vaccination | 44.0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: 4 weeks after vaccination | 92.0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Wisconsin: Before Vaccination | 64.0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Phuket: 4 weeks after vaccination | 58.3 Percentage of participants |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: 4 weeks after vaccination | 48.0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | B/Austria: Before Vaccination | 36.0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Cambodia: 4 weeks after vaccination | 91.7 Percentage of participants |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Cambodia: Before Vaccination | 61.1 Percentage of participants |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: 4 weeks after vaccination | 88.0 Percentage of participants |
| Substudy B, 18-64 Years: qIRV (30 mcg) | SSB: Percentage of Participants With Strain Specific HAI Titers >=1:40 Before Vaccination and at 4 Weeks After Vaccination (18- 64 Years) | A/Darwin: Before Vaccination | 44.0 Percentage of participants |