COVID-19, Influenza, Human, SARS-CoV-2 Infection
Conditions
Keywords
Grippe, Flu, Influenza Vaccine, RNA Vaccine, COVID-19, Coronavirus Vaccine, SARS-CoV-2, mRNA Vaccine
Brief summary
The purpose of this clinical trial is to see if combining a licensed COVID-19 vaccine and a licensed influenza vaccine into a single shot is safe and can help produce antibodies to defend the body against both SARS-CoV-2 (the virus that causes COVID-19) and influenza. Participants enrolled in this trial will be healthy adults, 50 years of age or older.
Detailed description
This is a Phase 1/2 study to evaluate the safety, tolerability, and immunogenicity of licensed BNT162b2 (Omi XBB.1.5) and recombinant influenza vaccine (RIV) administered together as a single injection (referred to as BNT162b2 \[Omi XBB.1.5\]/RIV) in healthy adults 50 years of age or older. The safety, tolerability, and immunogenicity of BNT162b2 (OmiXBB1.5)/RIV administered as a single injection will be compared to BNT162b2 (Omi XBB.1.5) and RIV administered simultaneously as 2 separate injections (coadministered), and to BNT162b2 (Omi XBB.1.5) or RIV when administered alone. Across Phases 1 and 2, approximately 640 participants in total will be randomized with an equal randomization ratio to 1 of 4 vaccine groups and stratified by age.
Interventions
BIOLOGICALBNT162b2 (Omi XBB.1.5)/RIV
Combination of BNT162b2 (Omi XBB.1.5) and RIV
BIOLOGICALBNT162b2 (Omi XBB.1.5)
Licensed COVID-19 vaccine
BIOLOGICALRIV
Licensed recombinant influenza vaccine
OTHERNormal saline placebo
Normal saline (solution for injection)
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Single-blind (site- and sponsor-unblinded)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or female participants aged 50 years or older at Visit 1 (Day 1). * Participants who are willing and able to comply with all scheduled visits, the 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, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in the protocol.
Exclusion criteria
* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. * Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV). * History of severe adverse reaction associated with any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study interventions. * Participants with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to systemic or cutaneous lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, idiopathic thrombocytopenia purpura, glomerulonephritis, autoimmune thyroiditis, temporal arteritis, psoriasis, and/or insulin-dependent diabetes mellitus. * Immunocompromised individuals with known or suspected immunodeficiency, determined by history and/or laboratory/physical examination. * Current heart disease, uncontrolled hypertension, or a prior history of myocarditis or pericarditis. * Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. * Women who are pregnant, plan to become pregnant during the study, or are breastfeeding. * Prior history of ischemic stroke or transient ischemic attack. * Prior history of Guillain-Barré syndrome (GBS). * Participants with a calculated BMI of ≥35. * Receipt of chronic medications with known systemic immunosuppressant effects (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 used for the treatment or prevention of COVID 19 or those that are considered immunosuppressive, from 90 days before study intervention administration, or planned receipt throughout the study. * Vaccination with any investigational or licensed influenza vaccine within 6 months (180 days) before study intervention administration, or ongoing receipt of chronic antiviral therapy with activity against influenza. * Vaccination with any investigational or licensed COVID-19 vaccine within 6 months (180 days) before study intervention administration. * Participation in other studies involving administration of an investigational product within 28 days prior to, and/or during, participation in this study. * Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members. * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. * Current alcohol abuse or drug addiction that in the opinion of the investigator might interfere with the study conduct or completion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Reported Any Local Reaction up to 7 Days Following Vaccination | Day 1 to Day 7 following Vaccination on Day 1 | Local reactions included redness, swelling and pain at injection site, recorded by participants in an electronic diary (e-diary). Severity of all local reactions were evaluated as mild, moderate, severe or potentially life-threatening. In this outcome measure local reactions with any severity were reported for each left arm's deltoid and right arm's deltoid of each vaccine Group 1, 2, 3 and 4. |
| Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | Day 1 to Day 7 following Vaccination on Day 1 | Systemic events: fever, fatigue, headache, vomiting, diarrhea, chills, new/worsened muscle pain, new/worsened joint pain were recorded by participants in e-diary. Severity of all systemic events were evaluated as mild, moderate, severe or potentially life-threatening. In this outcome measure systemic events with any severity were reported. |
| Percentage of Participants Who Reported Any Adverse Events (AEs) From Vaccination Through 4 Weeks After Vaccination | 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. Events collected by systematic assessment (local reactions and systemic events) were excluded from evaluation. |
| Percentage of Participants Who Reported Any Serious Adverse Events (SAEs) From Vaccination Through 6 Months After Vaccination | From Vaccination on Day 1 through 6 months after Vaccination | An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 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 other important medical events per protocol of the study. Events collected by systematic assessment (local reactions and systemic events) were excluded from evaluation. |
| Geometric Mean Titers (GMTs) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Omicron (XBB.1.5)-Neutralizing Titers Before Vaccination | Before Vaccination on Day 1 | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). As planned, outcome measure evaluated GMTs of SARS-CoV-2 Omicron (XBB.1.5), hence results are reported only for those reporting groups where BNT162b2 (Omi XBB.1.5) was administered. Data was not collected and not reported for reporting group Group 4: RIV + Placebo, where BNT162b2 (Omi XBB.1.5) was not administered. |
| GMTs of SARS-CoV-2 Omicron (XBB.1.5)-Neutralizing Titers at 4 Weeks After Vaccination | At 4 weeks after Vaccination on Day 1 | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). As planned, outcome measure evaluated GMTs of SARS-CoV-2 Omicron (XBB.1.5), hence results are reported only for those reporting groups where BNT162b2 (Omi XBB.1.5) was administered. Data was not collected and not reported for reporting group Group 4: RIV + Placebo, where BNT162b2 (Omi XBB.1.5) was not administered. |
| Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Omicron (XBB.1.5)-Neutralizing Titers From Before Vaccination to 4 Weeks After Vaccination | From before Vaccination on Day 1 to 4 weeks after Vaccination | GMFR was the ratio of the geometric mean titre values 4 weeks after vaccination to before vaccination. GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). As planned, outcome measure evaluated GMTs of SARS-CoV-2 Omicron (XBB.1.5), hence results are reported only for those reporting groups where BNT162b2 (Omi XBB.1.5) was administered. Data was not collected and not reported for reporting group Group 4: RIV + Placebo, where BNT162b2 (Omi XBB.1.5) was not administered. |
| Percentages of Participants With Seroresponse to SARS-CoV-2 Omicron (XBB.1.5) at 4 Weeks After Vaccination | At 4 weeks after Vaccination on Day 1 | Seroresponse was defined as achieving a \>=4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the lower limit of quantification (LLOQ), the postvaccination measure of \>=4\*LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method. As planned, outcome measure evaluated GMTs of SARS-CoV-2 Omicron (XBB.1.5), hence results are reported only for those reporting groups where BNT162b2 (Omi XBB.1.5) was administered. Data was not collected and not reported for reporting group Group 4: RIV + Placebo, where BNT162b2 (Omi XBB.1.5) was not administered. |
| GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers Before Vaccination | Before Vaccination on Day 1 | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). The 4 virus strains which were evaluated and reported in this outcome measure were A/Victoria/4897/2022 (H1N1) HAI, A/Darwin/9/2021 (H3N2) HAI, B/Michigan/1/2021 HAI and B/Phuket/3073/2013 HAI. As planned, outcome measure evaluated GMTs of strain specific HAI, hence results are reported only for those reporting groups where RIV was administered. Data was not collected and not reported for reporting group Group 3: BNT162b2 (Omi XBB.1.5) + Placebo, where RIV was not administered. |
| GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers at 4 Weeks After Vaccination | At 4 weeks after Vaccination on Day 1 | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). The 4 virus strains which were evaluated and reported in this outcome measure were A/Victoria/4897/2022 (H1N1) HAI, A/Darwin/9/2021 (H3N2) HAI, B/Michigan/1/2021 HAI and B/Phuket/3073/2013 HAI. As planned, outcome measure evaluated GMTs of strain specific HAI, hence results are reported only for those reporting groups where RIV was administered. Data was not collected and not reported for reporting group Group 3: BNT162b2 (Omi XBB.1.5) + Placebo, where RIV was not administered. |
| GMFR of Strain Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination | From before Vaccination to 4 weeks after Vaccination on Day 1 | GMFR was the ratio of the geometric mean titre values 4 weeks after vaccination to before vaccination. GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). The 4 virus strains which were evaluated and reported in this outcome measure were A/Victoria/4897/2022 (H1N1) HAI, A/Darwin/9/2021 (H3N2) HAI, B/Michigan/1/2021 HAI and B/Phuket/3073/2013 HAI. As planned, outcome measure evaluated GMFRs of strain specific HAI, hence results are reported only for those reporting groups where RIV was administered. Data was not collected and not reported for reporting group Group 3: BNT162b2 (Omi XBB.1.5) + Placebo, where RIV was not administered. |
| Percentages of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination | At 4 weeks after Vaccination on Day 1 | 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 minimum 4-fold rise at the time point of interest. Exact 2-sided CI, based on the Clopper and Pearson method. The 4 virus strains which were evaluated and reported in this outcome measure were A/Victoria/4897/2022 (H1N1) HAI, A/Darwin/9/2021 (H3N2) HAI, B/Michigan/1/2021 HAI and B/Phuket/3073/2013 HAI. As planned, outcome measure evaluated seroconversion of strain specific HAI, hence results are reported only for those reporting groups where RIV was administered. Data was not collected and not reported for reporting group Group 3: BNT162b2 (Omi XBB.1.5) + Placebo, where RIV was not administered. |
| Percentages of Participants With HAI Titers >= 1:40 Before Vaccination | Before Vaccination on Day 1 | Percentages of participants with HAI titers \>= 1:40 before vaccination along with the associated 2-sided 95% CIs, was provided for each vaccine group in this outcome measure. Exact 2-sided CI, based on the Clopper and Pearson method. The 4 virus strains which were evaluated and reported in this outcome measure were A/Victoria/4897/2022 (H1N1) HAI, A/Darwin/9/2021 (H3N2) HAI, B/Michigan/1/2021 HAI and B/Phuket/3073/2013 HAI. As planned, outcome measure evaluated of strain specific HAI, hence results are reported only for those reporting groups where RIV was administered. Data was not collected and not reported for reporting group Group 3: BNT162b2 (Omi XBB.1.5) + Placebo, where RIV was not administered. |
| Percentages of Participants With HAI Titers >= 1:40 at 4 Weeks After Vaccination | At 4 Weeks after Vaccination on Day 1 | Percentages of participants with HAI titers \>= 1:40 at 4 weeks after vaccination along with the associated 2-sided 95% CIs, was provided for each vaccine group in this outcome measure. Exact 2-sided CI, based on the Clopper and Pearson method. The 4 virus strains which were evaluated and reported in this outcome measure were A/Victoria/4897/2022 (H1N1) HAI, A/Darwin/9/2021 (H3N2) HAI, B/Michigan/1/2021 HAI and B/Phuket/3073/2013 HAI. As outcome measure evaluated of strain specific HAI, hence results are reported only for those reporting groups where RIV was administered. Data was not collected and not reported for reporting group Group 3: BNT162b2 (Omi XBB.1.5) + Placebo, where RIV was not administered. |
Countries
United States
Participant flow
Pre-assignment details
Participants were randomized to receive licensed Pfizer-BioNTech COVID-19 vaccine (BNT162b2 \[Omi XBB.1.5\]) 30 microgram (mcg) and recombinant influenza virus (RIV) vaccine 180 mcg together as a single injection or as 2 separate injections co-administered or BNT162b2 (Omi XBB.1.5) 30 mcg administered alone or RIV 180 mcg administered alone.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: BNT162b2 (Omi XBB.1.5)/ RIV + Placebo Participants were randomized to receive BNT162b2 (Omi XBB.1.5)/RIV together as a single IM injection in the left deltoid and normal saline placebo IM injection in the right deltoid on Day 1. | 160 |
| Group 2: BNT162b2 (Omi XBB.1.5) + RIV Participants were randomized to receive BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid and RIV IM injection in the right deltoid on Day 1. | 161 |
| Group 3: BNT162b2 (Omi XBB.1.5) + Placebo Participants were randomized to receive BNT162b2 (Omi XBB.1.5) IM injection in the left deltoid and normal saline placebo IM injection in the right deltoid on Day 1. | 160 |
| Group 4: RIV + Placebo Participants were randomized to receive RIV IM injection in the left deltoid and normal saline placebo IM injection in the right deltoid on Day 1. | 160 |
| Total | 641 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 11 | 5 | 8 | 8 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | Group 1: BNT162b2 (Omi XBB.1.5)/ RIV + Placebo | Group 2: BNT162b2 (Omi XBB.1.5) + RIV | Group 3: BNT162b2 (Omi XBB.1.5) + Placebo | Group 4: RIV + Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 63.9 Years STANDARD_DEVIATION 8.4 | 63.9 Years STANDARD_DEVIATION 9.06 | 62.9 Years STANDARD_DEVIATION 7.73 | 63.9 Years STANDARD_DEVIATION 7.66 | 63.7 Years STANDARD_DEVIATION 8.22 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants | 28 Participants | 29 Participants | 21 Participants | 106 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 132 Participants | 133 Participants | 131 Participants | 137 Participants | 533 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 6 Participants | 3 Participants | 6 Participants | 20 Participants |
| Race (NIH/OMB) Black or African American | 37 Participants | 38 Participants | 30 Participants | 30 Participants | 135 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 117 Participants | 111 Participants | 124 Participants | 117 Participants | 469 Participants |
| Sex: Female, Male Female | 87 Participants | 92 Participants | 100 Participants | 83 Participants | 362 Participants |
| Sex: Female, Male Male | 73 Participants | 69 Participants | 60 Participants | 77 Participants | 279 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 160 | 0 / 161 | 0 / 160 | 1 / 160 |
| other Total, other adverse events | 114 / 160 | 117 / 161 | 115 / 160 | 88 / 160 |
| serious Total, serious adverse events | 3 / 160 | 1 / 161 | 0 / 160 | 3 / 160 |
Outcome results
Primary
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Omicron (XBB.1.5)-Neutralizing Titers From Before Vaccination to 4 Weeks After Vaccination
GMFR was the ratio of the geometric mean titre values 4 weeks after vaccination to before vaccination. GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). As planned, outcome measure evaluated GMTs of SARS-CoV-2 Omicron (XBB.1.5), hence results are reported only for those reporting groups where BNT162b2 (Omi XBB.1.5) was administered. Data was not collected and not reported for reporting group Group 4: RIV + Placebo, where BNT162b2 (Omi XBB.1.5) was not administered.
Time frame: From before Vaccination on Day 1 to 4 weeks after Vaccination
Population: EIP included all eligible participants who received study intervention, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 27 to 42 days after vaccination, and had no other important protocol deviations as determined by the clinician. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Omicron (XBB.1.5)-Neutralizing Titers From Before Vaccination to 4 Weeks After Vaccination | 6.1 Ratio |
| Group 1, BNT162b2/RIV + Placebo: Placebo | Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Omicron (XBB.1.5)-Neutralizing Titers From Before Vaccination to 4 Weeks After Vaccination | 8.0 Ratio |
| Group 2, BNT162b2 + RIV: BNT162b2 | Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Omicron (XBB.1.5)-Neutralizing Titers From Before Vaccination to 4 Weeks After Vaccination | 9.4 Ratio |
Primary
Geometric Mean Titers (GMTs) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Omicron (XBB.1.5)-Neutralizing Titers Before Vaccination
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). As planned, outcome measure evaluated GMTs of SARS-CoV-2 Omicron (XBB.1.5), hence results are reported only for those reporting groups where BNT162b2 (Omi XBB.1.5) was administered. Data was not collected and not reported for reporting group Group 4: RIV + Placebo, where BNT162b2 (Omi XBB.1.5) was not administered.
Time frame: Before Vaccination on Day 1
Population: Evaluable immunogenicity population (EIP) included all eligible participants who received study intervention, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 27 to 42 days after vaccination, and had no other important protocol deviations as determined by the clinician. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | Geometric Mean Titers (GMTs) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Omicron (XBB.1.5)-Neutralizing Titers Before Vaccination | 311.2 Titer |
| Group 1, BNT162b2/RIV + Placebo: Placebo | Geometric Mean Titers (GMTs) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Omicron (XBB.1.5)-Neutralizing Titers Before Vaccination | 285.4 Titer |
| Group 2, BNT162b2 + RIV: BNT162b2 | Geometric Mean Titers (GMTs) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Omicron (XBB.1.5)-Neutralizing Titers Before Vaccination | 338.5 Titer |
Primary
GMFR of Strain Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination
GMFR was the ratio of the geometric mean titre values 4 weeks after vaccination to before vaccination. GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). The 4 virus strains which were evaluated and reported in this outcome measure were A/Victoria/4897/2022 (H1N1) HAI, A/Darwin/9/2021 (H3N2) HAI, B/Michigan/1/2021 HAI and B/Phuket/3073/2013 HAI. As planned, outcome measure evaluated GMFRs of strain specific HAI, hence results are reported only for those reporting groups where RIV was administered. Data was not collected and not reported for reporting group Group 3: BNT162b2 (Omi XBB.1.5) + Placebo, where RIV was not administered.
Time frame: From before Vaccination to 4 weeks after Vaccination on Day 1
Population: EIP included all eligible participants who received study intervention, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 27 to 42 days after vaccination, and had no other important protocol deviations as determined by the clinician.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | GMFR of Strain Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination | A/Darwin/9/ 2021 (H3N2) HAI | 9.9 Ratio |
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | GMFR of Strain Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination | B/Phuket/3073/ 2013 HAI | 3.6 Ratio |
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | GMFR of Strain Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination | A/Victoria/4897/ 2022 (H1N1) HAI | 6.6 Ratio |
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | GMFR of Strain Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination | B/Michigan/1/ 2021 HAI | 4.3 Ratio |
| Group 1, BNT162b2/RIV + Placebo: Placebo | GMFR of Strain Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination | B/Michigan/1/ 2021 HAI | 4.1 Ratio |
| Group 1, BNT162b2/RIV + Placebo: Placebo | GMFR of Strain Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination | A/Victoria/4897/ 2022 (H1N1) HAI | 5.7 Ratio |
| Group 1, BNT162b2/RIV + Placebo: Placebo | GMFR of Strain Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination | B/Phuket/3073/ 2013 HAI | 3.5 Ratio |
| Group 1, BNT162b2/RIV + Placebo: Placebo | GMFR of Strain Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination | A/Darwin/9/ 2021 (H3N2) HAI | 10.1 Ratio |
| Group 2, BNT162b2 + RIV: BNT162b2 | GMFR of Strain Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination | B/Phuket/3073/ 2013 HAI | 3.4 Ratio |
| Group 2, BNT162b2 + RIV: BNT162b2 | GMFR of Strain Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination | A/Victoria/4897/ 2022 (H1N1) HAI | 5.7 Ratio |
| Group 2, BNT162b2 + RIV: BNT162b2 | GMFR of Strain Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination | A/Darwin/9/ 2021 (H3N2) HAI | 11.0 Ratio |
| Group 2, BNT162b2 + RIV: BNT162b2 | GMFR of Strain Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination | B/Michigan/1/ 2021 HAI | 4.2 Ratio |
Primary
GMTs of SARS-CoV-2 Omicron (XBB.1.5)-Neutralizing Titers at 4 Weeks After Vaccination
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). As planned, outcome measure evaluated GMTs of SARS-CoV-2 Omicron (XBB.1.5), hence results are reported only for those reporting groups where BNT162b2 (Omi XBB.1.5) was administered. Data was not collected and not reported for reporting group Group 4: RIV + Placebo, where BNT162b2 (Omi XBB.1.5) was not administered.
Time frame: At 4 weeks after Vaccination on Day 1
Population: EIP included all eligible participants who received study intervention, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 27 to 42 days after vaccination, and had no other important protocol deviations as determined by the clinician. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | GMTs of SARS-CoV-2 Omicron (XBB.1.5)-Neutralizing Titers at 4 Weeks After Vaccination | 2162.4 Titer |
| Group 1, BNT162b2/RIV + Placebo: Placebo | GMTs of SARS-CoV-2 Omicron (XBB.1.5)-Neutralizing Titers at 4 Weeks After Vaccination | 2581.3 Titer |
| Group 2, BNT162b2 + RIV: BNT162b2 | GMTs of SARS-CoV-2 Omicron (XBB.1.5)-Neutralizing Titers at 4 Weeks After Vaccination | 3644.7 Titer |
Primary
GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers at 4 Weeks After Vaccination
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). The 4 virus strains which were evaluated and reported in this outcome measure were A/Victoria/4897/2022 (H1N1) HAI, A/Darwin/9/2021 (H3N2) HAI, B/Michigan/1/2021 HAI and B/Phuket/3073/2013 HAI. As planned, outcome measure evaluated GMTs of strain specific HAI, hence results are reported only for those reporting groups where RIV was administered. Data was not collected and not reported for reporting group Group 3: BNT162b2 (Omi XBB.1.5) + Placebo, where RIV was not administered.
Time frame: At 4 weeks after Vaccination on Day 1
Population: EIP included all eligible participants who received study intervention, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 27 to 42 days after vaccination, and had no other important protocol deviations as determined by the clinician.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers at 4 Weeks After Vaccination | B/Phuket/3073/ 2013 HAI | 669.7 Titer |
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers at 4 Weeks After Vaccination | A/Victoria/4897/ 2022 (H1N1) HAI | 324.4 Titer |
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers at 4 Weeks After Vaccination | B/Michigan/1/ 2021 HAI | 464.0 Titer |
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers at 4 Weeks After Vaccination | A/Darwin/9/ 2021 (H3N2) HAI | 397.7 Titer |
| Group 1, BNT162b2/RIV + Placebo: Placebo | GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers at 4 Weeks After Vaccination | B/Phuket/3073/ 2013 HAI | 769.5 Titer |
| Group 1, BNT162b2/RIV + Placebo: Placebo | GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers at 4 Weeks After Vaccination | A/Darwin/9/ 2021 (H3N2) HAI | 489.7 Titer |
| Group 1, BNT162b2/RIV + Placebo: Placebo | GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers at 4 Weeks After Vaccination | B/Michigan/1/ 2021 HAI | 427.5 Titer |
| Group 1, BNT162b2/RIV + Placebo: Placebo | GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers at 4 Weeks After Vaccination | A/Victoria/4897/ 2022 (H1N1) HAI | 374.7 Titer |
| Group 2, BNT162b2 + RIV: BNT162b2 | GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers at 4 Weeks After Vaccination | A/Victoria/4897/ 2022 (H1N1) HAI | 389.6 Titer |
| Group 2, BNT162b2 + RIV: BNT162b2 | GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers at 4 Weeks After Vaccination | B/Michigan/1/ 2021 HAI | 496.0 Titer |
| Group 2, BNT162b2 + RIV: BNT162b2 | GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers at 4 Weeks After Vaccination | B/Phuket/3073/ 2013 HAI | 775.7 Titer |
| Group 2, BNT162b2 + RIV: BNT162b2 | GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers at 4 Weeks After Vaccination | A/Darwin/9/ 2021 (H3N2) HAI | 557.2 Titer |
Primary
GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers Before Vaccination
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). The 4 virus strains which were evaluated and reported in this outcome measure were A/Victoria/4897/2022 (H1N1) HAI, A/Darwin/9/2021 (H3N2) HAI, B/Michigan/1/2021 HAI and B/Phuket/3073/2013 HAI. As planned, outcome measure evaluated GMTs of strain specific HAI, hence results are reported only for those reporting groups where RIV was administered. Data was not collected and not reported for reporting group Group 3: BNT162b2 (Omi XBB.1.5) + Placebo, where RIV was not administered.
Time frame: Before Vaccination on Day 1
Population: EIP included all eligible participants who received study intervention, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 27 to 42 days after vaccination, and had no other important protocol deviations as determined by the clinician.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers Before Vaccination | B/Michigan/1/ 2021 HAI | 105.9 Titer |
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers Before Vaccination | A/Darwin/9/ 2021 (H3N2) HAI | 34.8 Titer |
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers Before Vaccination | B/Phuket/3073/ 2013 HAI | 186.6 Titer |
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers Before Vaccination | A/Victoria/4897/ 2022 (H1N1) HAI | 43.8 Titer |
| Group 1, BNT162b2/RIV + Placebo: Placebo | GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers Before Vaccination | A/Darwin/9/ 2021 (H3N2) HAI | 42.3 Titer |
| Group 1, BNT162b2/RIV + Placebo: Placebo | GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers Before Vaccination | B/Phuket/3073/ 2013 HAI | 218.5 Titer |
| Group 1, BNT162b2/RIV + Placebo: Placebo | GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers Before Vaccination | A/Victoria/4897/ 2022 (H1N1) HAI | 60.7 Titer |
| Group 1, BNT162b2/RIV + Placebo: Placebo | GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers Before Vaccination | B/Michigan/1/ 2021 HAI | 101.8 Titer |
| Group 2, BNT162b2 + RIV: BNT162b2 | GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers Before Vaccination | A/Victoria/4897/ 2022 (H1N1) HAI | 62.6 Titer |
| Group 2, BNT162b2 + RIV: BNT162b2 | GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers Before Vaccination | B/Phuket/3073/ 2013 HAI | 228.8 Titer |
| Group 2, BNT162b2 + RIV: BNT162b2 | GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers Before Vaccination | B/Michigan/1/ 2021 HAI | 114.9 Titer |
| Group 2, BNT162b2 + RIV: BNT162b2 | GMTs of Strain Specific Hemagglutinin Inhibition Assay (HAI) Titers Before Vaccination | A/Darwin/9/ 2021 (H3N2) HAI | 44.3 Titer |
Primary
Percentage of Participants Who Reported Any Adverse Events (AEs) From Vaccination 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. Events collected by systematic assessment (local reactions and systemic events) were excluded from evaluation.
Time frame: From Vaccination on Day 1 through 4 weeks after Vaccination
Population: SAS consisted of all participants who received at least 1 dose of the study intervention. Data is presented for each vaccine group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | Percentage of Participants Who Reported Any Adverse Events (AEs) From Vaccination Through 4 Weeks After Vaccination | 4.4 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: Placebo | Percentage of Participants Who Reported Any Adverse Events (AEs) From Vaccination Through 4 Weeks After Vaccination | 3.7 Percentage of participants |
| Group 2, BNT162b2 + RIV: BNT162b2 | Percentage of Participants Who Reported Any Adverse Events (AEs) From Vaccination Through 4 Weeks After Vaccination | 5.6 Percentage of participants |
| Group 2, BNT162b2 + RIV: RIV | Percentage of Participants Who Reported Any Adverse Events (AEs) From Vaccination Through 4 Weeks After Vaccination | 5.6 Percentage of participants |
Primary
Percentage of Participants Who Reported Any Local Reaction up to 7 Days Following Vaccination
Local reactions included redness, swelling and pain at injection site, recorded by participants in an electronic diary (e-diary). Severity of all local reactions were evaluated as mild, moderate, severe or potentially life-threatening. In this outcome measure local reactions with any severity were reported for each left arm's deltoid and right arm's deltoid of each vaccine Group 1, 2, 3 and 4.
Time frame: Day 1 to Day 7 following Vaccination on Day 1
Population: SAS consisted of all participants who received at least 1 dose of the study intervention. As planned, results of this outcome measure are reported for vaccination in each arm (left and right deltoid- as separate reporting arm) of each vaccine group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | Percentage of Participants Who Reported Any Local Reaction up to 7 Days Following Vaccination | Pain at injection site | 56.3 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | Percentage of Participants Who Reported Any Local Reaction up to 7 Days Following Vaccination | Redness | 8.8 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | Percentage of Participants Who Reported Any Local Reaction up to 7 Days Following Vaccination | Swelling | 9.4 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: Placebo | Percentage of Participants Who Reported Any Local Reaction up to 7 Days Following Vaccination | Redness | 1.3 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: Placebo | Percentage of Participants Who Reported Any Local Reaction up to 7 Days Following Vaccination | Pain at injection site | 11.9 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: Placebo | Percentage of Participants Who Reported Any Local Reaction up to 7 Days Following Vaccination | Swelling | 1.3 Percentage of participants |
| Group 2, BNT162b2 + RIV: BNT162b2 | Percentage of Participants Who Reported Any Local Reaction up to 7 Days Following Vaccination | Swelling | 6.2 Percentage of participants |
| Group 2, BNT162b2 + RIV: BNT162b2 | Percentage of Participants Who Reported Any Local Reaction up to 7 Days Following Vaccination | Redness | 5.0 Percentage of participants |
| Group 2, BNT162b2 + RIV: BNT162b2 | Percentage of Participants Who Reported Any Local Reaction up to 7 Days Following Vaccination | Pain at injection site | 59.0 Percentage of participants |
| Group 2, BNT162b2 + RIV: RIV | Percentage of Participants Who Reported Any Local Reaction up to 7 Days Following Vaccination | Redness | 3.1 Percentage of participants |
| Group 2, BNT162b2 + RIV: RIV | Percentage of Participants Who Reported Any Local Reaction up to 7 Days Following Vaccination | Pain at injection site | 38.5 Percentage of participants |
| Group 2, BNT162b2 + RIV: RIV | Percentage of Participants Who Reported Any Local Reaction up to 7 Days Following Vaccination | Swelling | 3.1 Percentage of participants |
| Group 3, BNT162b2 + Placebo: BNT162b2 | Percentage of Participants Who Reported Any Local Reaction up to 7 Days Following Vaccination | Pain at injection site | 62.5 Percentage of participants |
| Group 3, BNT162b2 + Placebo: BNT162b2 | Percentage of Participants Who Reported Any Local Reaction up to 7 Days Following Vaccination | Swelling | 5.6 Percentage of participants |
| Group 3, BNT162b2 + Placebo: BNT162b2 | Percentage of Participants Who Reported Any Local Reaction up to 7 Days Following Vaccination | Redness | 5.0 Percentage of participants |
| Group 3, BNT162b2 + Placebo: Placebo | Percentage of Participants Who Reported Any Local Reaction up to 7 Days Following Vaccination | Swelling | 0.6 Percentage of participants |
| Group 3, BNT162b2 + Placebo: Placebo | Percentage of Participants Who Reported Any Local Reaction up to 7 Days Following Vaccination | Redness | 0.6 Percentage of participants |
| Group 3, BNT162b2 + Placebo: Placebo | Percentage of Participants Who Reported Any Local Reaction up to 7 Days Following Vaccination | Pain at injection site | 9.4 Percentage of participants |
| Group 4, RIV + Placebo: RIV | Percentage of Participants Who Reported Any Local Reaction up to 7 Days Following Vaccination | Swelling | 5.0 Percentage of participants |
| Group 4, RIV + Placebo: RIV | Percentage of Participants Who Reported Any Local Reaction up to 7 Days Following Vaccination | Pain at injection site | 36.9 Percentage of participants |
| Group 4, RIV + Placebo: RIV | Percentage of Participants Who Reported Any Local Reaction up to 7 Days Following Vaccination | Redness | 6.3 Percentage of participants |
| Group 4, RIV + Placebo: Placebo | Percentage of Participants Who Reported Any Local Reaction up to 7 Days Following Vaccination | Pain at injection site | 8.1 Percentage of participants |
| Group 4, RIV + Placebo: Placebo | Percentage of Participants Who Reported Any Local Reaction up to 7 Days Following Vaccination | Redness | 0.6 Percentage of participants |
| Group 4, RIV + Placebo: Placebo | Percentage of Participants Who Reported Any Local Reaction up to 7 Days Following Vaccination | Swelling | 0.6 Percentage of participants |
Primary
Percentage of Participants Who Reported Any Serious Adverse Events (SAEs) From Vaccination Through 6 Months After Vaccination
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 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 other important medical events per protocol of the study. Events collected by systematic assessment (local reactions and systemic events) were excluded from evaluation.
Time frame: From Vaccination on Day 1 through 6 months after Vaccination
Population: SAS consisted of all participants who received at least 1 dose of the study intervention. Data is presented for each vaccine group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | Percentage of Participants Who Reported Any Serious Adverse Events (SAEs) From Vaccination Through 6 Months After Vaccination | 1.9 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: Placebo | Percentage of Participants Who Reported Any Serious Adverse Events (SAEs) From Vaccination Through 6 Months After Vaccination | 0.6 Percentage of participants |
| Group 2, BNT162b2 + RIV: BNT162b2 | Percentage of Participants Who Reported Any Serious Adverse Events (SAEs) From Vaccination Through 6 Months After Vaccination | 0 Percentage of participants |
| Group 2, BNT162b2 + RIV: RIV | Percentage of Participants Who Reported Any Serious Adverse Events (SAEs) From Vaccination Through 6 Months After Vaccination | 1.9 Percentage of participants |
Primary
Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination
Systemic events: fever, fatigue, headache, vomiting, diarrhea, chills, new/worsened muscle pain, new/worsened joint pain were recorded by participants in e-diary. Severity of all systemic events were evaluated as mild, moderate, severe or potentially life-threatening. In this outcome measure systemic events with any severity were reported.
Time frame: Day 1 to Day 7 following Vaccination on Day 1
Population: SAS consisted of all participants who received at least 1 dose of the study intervention. Data is presented for each vaccine group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | Diarrhea | 8.1 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | Vomiting | 0 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | Chills | 8.8 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | Fever | 1.9 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | New or worsened joint pain | 7.5 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | Fatigue | 36.3 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | New or worsened muscle pain | 13.1 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | Headache | 24.4 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: Placebo | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | New or worsened joint pain | 13.7 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: Placebo | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | Chills | 14.9 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: Placebo | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | New or worsened muscle pain | 22.4 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: Placebo | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | Vomiting | 3.1 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: Placebo | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | Diarrhea | 11.2 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: Placebo | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | Headache | 31.1 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: Placebo | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | Fatigue | 39.1 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: Placebo | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | Fever | 6.2 Percentage of participants |
| Group 2, BNT162b2 + RIV: BNT162b2 | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | Headache | 26.9 Percentage of participants |
| Group 2, BNT162b2 + RIV: BNT162b2 | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | New or worsened muscle pain | 15.0 Percentage of participants |
| Group 2, BNT162b2 + RIV: BNT162b2 | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | New or worsened joint pain | 10.0 Percentage of participants |
| Group 2, BNT162b2 + RIV: BNT162b2 | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | Fever | 6.3 Percentage of participants |
| Group 2, BNT162b2 + RIV: BNT162b2 | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | Fatigue | 40.6 Percentage of participants |
| Group 2, BNT162b2 + RIV: BNT162b2 | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | Vomiting | 1.9 Percentage of participants |
| Group 2, BNT162b2 + RIV: BNT162b2 | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | Diarrhea | 11.3 Percentage of participants |
| Group 2, BNT162b2 + RIV: BNT162b2 | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | Chills | 15.0 Percentage of participants |
| Group 2, BNT162b2 + RIV: RIV | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | Vomiting | 0 Percentage of participants |
| Group 2, BNT162b2 + RIV: RIV | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | Headache | 16.9 Percentage of participants |
| Group 2, BNT162b2 + RIV: RIV | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | New or worsened joint pain | 4.4 Percentage of participants |
| Group 2, BNT162b2 + RIV: RIV | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | Chills | 6.9 Percentage of participants |
| Group 2, BNT162b2 + RIV: RIV | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | Fatigue | 33.1 Percentage of participants |
| Group 2, BNT162b2 + RIV: RIV | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | Fever | 0 Percentage of participants |
| Group 2, BNT162b2 + RIV: RIV | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | New or worsened muscle pain | 8.1 Percentage of participants |
| Group 2, BNT162b2 + RIV: RIV | Percentage of Participants Who Reported Any Systemic Events up to 7 Days Following Vaccination | Diarrhea | 7.5 Percentage of participants |
Primary
Percentages of Participants Achieving HAI Seroconversion at 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 minimum 4-fold rise at the time point of interest. Exact 2-sided CI, based on the Clopper and Pearson method. The 4 virus strains which were evaluated and reported in this outcome measure were A/Victoria/4897/2022 (H1N1) HAI, A/Darwin/9/2021 (H3N2) HAI, B/Michigan/1/2021 HAI and B/Phuket/3073/2013 HAI. As planned, outcome measure evaluated seroconversion of strain specific HAI, hence results are reported only for those reporting groups where RIV was administered. Data was not collected and not reported for reporting group Group 3: BNT162b2 (Omi XBB.1.5) + Placebo, where RIV was not administered.
Time frame: At 4 weeks after Vaccination on Day 1
Population: EIP included all eligible participants who received study intervention, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 27 to 42 days after vaccination, and had no other important protocol deviations as determined by the clinician.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | Percentages of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination | A/Darwin/9/2021 (H3N2) | 76.5 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | Percentages of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination | A/Victoria/4897/ 2022 (H1N1) HAI | 62.7 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | Percentages of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination | B/Michigan/1/2021 | 54.9 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | Percentages of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination | B/Phuket/3073/2013 | 49.7 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: Placebo | Percentages of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination | A/Darwin/9/2021 (H3N2) | 79.1 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: Placebo | Percentages of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination | B/Michigan/1/2021 | 53.2 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: Placebo | Percentages of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination | A/Victoria/4897/ 2022 (H1N1) HAI | 67.7 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: Placebo | Percentages of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination | B/Phuket/3073/2013 | 53.8 Percentage of participants |
| Group 2, BNT162b2 + RIV: BNT162b2 | Percentages of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination | B/Michigan/1/2021 | 51.0 Percentage of participants |
| Group 2, BNT162b2 + RIV: BNT162b2 | Percentages of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination | A/Darwin/9/2021 (H3N2) | 76.1 Percentage of participants |
| Group 2, BNT162b2 + RIV: BNT162b2 | Percentages of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination | B/Phuket/3073/2013 | 46.5 Percentage of participants |
| Group 2, BNT162b2 + RIV: BNT162b2 | Percentages of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination | A/Victoria/4897/ 2022 (H1N1) HAI | 61.3 Percentage of participants |
Primary
Percentages of Participants With HAI Titers >= 1:40 at 4 Weeks After Vaccination
Percentages of participants with HAI titers \>= 1:40 at 4 weeks after vaccination along with the associated 2-sided 95% CIs, was provided for each vaccine group in this outcome measure. Exact 2-sided CI, based on the Clopper and Pearson method. The 4 virus strains which were evaluated and reported in this outcome measure were A/Victoria/4897/2022 (H1N1) HAI, A/Darwin/9/2021 (H3N2) HAI, B/Michigan/1/2021 HAI and B/Phuket/3073/2013 HAI. As outcome measure evaluated of strain specific HAI, hence results are reported only for those reporting groups where RIV was administered. Data was not collected and not reported for reporting group Group 3: BNT162b2 (Omi XBB.1.5) + Placebo, where RIV was not administered.
Time frame: At 4 Weeks after Vaccination on Day 1
Population: EIP included all eligible participants who received study intervention, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 27 to 42 days after vaccination, and had no other important protocol deviations as determined by the clinician.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | Percentages of Participants With HAI Titers >= 1:40 at 4 Weeks After Vaccination | B/Phuket/3073/2013 | 99.3 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | Percentages of Participants With HAI Titers >= 1:40 at 4 Weeks After Vaccination | B/Michigan/1/2021 | 98.0 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | Percentages of Participants With HAI Titers >= 1:40 at 4 Weeks After Vaccination | A/Darwin/9/2021 (H3N2) | 95.4 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | Percentages of Participants With HAI Titers >= 1:40 at 4 Weeks After Vaccination | A/Victoria/4897/ 2022 (H1N1) HAI | 90.8 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: Placebo | Percentages of Participants With HAI Titers >= 1:40 at 4 Weeks After Vaccination | A/Victoria/4897/ 2022 (H1N1) HAI | 95.6 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: Placebo | Percentages of Participants With HAI Titers >= 1:40 at 4 Weeks After Vaccination | A/Darwin/9/2021 (H3N2) | 97.5 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: Placebo | Percentages of Participants With HAI Titers >= 1:40 at 4 Weeks After Vaccination | B/Michigan/1/2021 | 100.0 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: Placebo | Percentages of Participants With HAI Titers >= 1:40 at 4 Weeks After Vaccination | B/Phuket/3073/2013 | 100.0 Percentage of participants |
| Group 2, BNT162b2 + RIV: BNT162b2 | Percentages of Participants With HAI Titers >= 1:40 at 4 Weeks After Vaccination | B/Phuket/3073/2013 | 100.0 Percentage of participants |
| Group 2, BNT162b2 + RIV: BNT162b2 | Percentages of Participants With HAI Titers >= 1:40 at 4 Weeks After Vaccination | A/Darwin/9/2021 (H3N2) | 96.1 Percentage of participants |
| Group 2, BNT162b2 + RIV: BNT162b2 | Percentages of Participants With HAI Titers >= 1:40 at 4 Weeks After Vaccination | A/Victoria/4897/ 2022 (H1N1) HAI | 96.8 Percentage of participants |
| Group 2, BNT162b2 + RIV: BNT162b2 | Percentages of Participants With HAI Titers >= 1:40 at 4 Weeks After Vaccination | B/Michigan/1/2021 | 99.4 Percentage of participants |
Primary
Percentages of Participants With HAI Titers >= 1:40 Before Vaccination
Percentages of participants with HAI titers \>= 1:40 before vaccination along with the associated 2-sided 95% CIs, was provided for each vaccine group in this outcome measure. Exact 2-sided CI, based on the Clopper and Pearson method. The 4 virus strains which were evaluated and reported in this outcome measure were A/Victoria/4897/2022 (H1N1) HAI, A/Darwin/9/2021 (H3N2) HAI, B/Michigan/1/2021 HAI and B/Phuket/3073/2013 HAI. As planned, outcome measure evaluated of strain specific HAI, hence results are reported only for those reporting groups where RIV was administered. Data was not collected and not reported for reporting group Group 3: BNT162b2 (Omi XBB.1.5) + Placebo, where RIV was not administered.
Time frame: Before Vaccination on Day 1
Population: EIP included all eligible participants who received study intervention, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 27 to 42 days after vaccination, and had no other important protocol deviations as determined by the clinician.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | Percentages of Participants With HAI Titers >= 1:40 Before Vaccination | B/Phuket/3073/2013 | 89.5 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | Percentages of Participants With HAI Titers >= 1:40 Before Vaccination | B/Michigan/1/2021 | 74.5 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | Percentages of Participants With HAI Titers >= 1:40 Before Vaccination | A/Victoria/4897/ 2022 (H1N1) HAI | 55.6 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | Percentages of Participants With HAI Titers >= 1:40 Before Vaccination | A/Darwin/9/2021 (H3N2) | 49.7 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: Placebo | Percentages of Participants With HAI Titers >= 1:40 Before Vaccination | B/Phuket/3073/2013 | 94.3 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: Placebo | Percentages of Participants With HAI Titers >= 1:40 Before Vaccination | A/Victoria/4897/ 2022 (H1N1) HAI | 69.6 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: Placebo | Percentages of Participants With HAI Titers >= 1:40 Before Vaccination | A/Darwin/9/2021 (H3N2) | 57.6 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: Placebo | Percentages of Participants With HAI Titers >= 1:40 Before Vaccination | B/Michigan/1/2021 | 81.6 Percentage of participants |
| Group 2, BNT162b2 + RIV: BNT162b2 | Percentages of Participants With HAI Titers >= 1:40 Before Vaccination | B/Phuket/3073/2013 | 93.5 Percentage of participants |
| Group 2, BNT162b2 + RIV: BNT162b2 | Percentages of Participants With HAI Titers >= 1:40 Before Vaccination | B/Michigan/1/2021 | 81.3 Percentage of participants |
| Group 2, BNT162b2 + RIV: BNT162b2 | Percentages of Participants With HAI Titers >= 1:40 Before Vaccination | A/Darwin/9/2021 (H3N2) | 54.8 Percentage of participants |
| Group 2, BNT162b2 + RIV: BNT162b2 | Percentages of Participants With HAI Titers >= 1:40 Before Vaccination | A/Victoria/4897/ 2022 (H1N1) HAI | 70.3 Percentage of participants |
Primary
Percentages of Participants With Seroresponse to SARS-CoV-2 Omicron (XBB.1.5) at 4 Weeks After Vaccination
Seroresponse was defined as achieving a \>=4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the lower limit of quantification (LLOQ), the postvaccination measure of \>=4\*LLOQ is considered a seroresponse. Exact 2-sided CI, based on the Clopper and Pearson method. As planned, outcome measure evaluated GMTs of SARS-CoV-2 Omicron (XBB.1.5), hence results are reported only for those reporting groups where BNT162b2 (Omi XBB.1.5) was administered. Data was not collected and not reported for reporting group Group 4: RIV + Placebo, where BNT162b2 (Omi XBB.1.5) was not administered.
Time frame: At 4 weeks after Vaccination on Day 1
Population: EIP included all eligible participants who received study intervention, had at least 1 valid and determinate immunogenicity result from the blood sample collected within 27 to 42 days after vaccination, and had no other important protocol deviations as determined by the clinician. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1, BNT162b2/RIV + Placebo: BNT162b2/RIV | Percentages of Participants With Seroresponse to SARS-CoV-2 Omicron (XBB.1.5) at 4 Weeks After Vaccination | 53.7 Percentage of participants |
| Group 1, BNT162b2/RIV + Placebo: Placebo | Percentages of Participants With Seroresponse to SARS-CoV-2 Omicron (XBB.1.5) at 4 Weeks After Vaccination | 60.5 Percentage of participants |
| Group 2, BNT162b2 + RIV: BNT162b2 | Percentages of Participants With Seroresponse to SARS-CoV-2 Omicron (XBB.1.5) at 4 Weeks After Vaccination | 63.8 Percentage of participants |