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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BNT162b2 (Omi XBB.1.5)/RIV and placebo | Experimental | Participants will receive a single injection combination of BNT162b2 (Omi XBB.1.5) and RIV and normal saline placebo |
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| BNT162b2 (Omi XBB.1.5) and RIV | Experimental | Participants will receive BNT162b2 (Omi XBB.1.5) and RIV |
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| BNT162b2 (Omi XBB.1.5) and placebo | Active Comparator | Participants will receive BNT162b2 (Omi XBB.1.5) and normal saline placebo |
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| RIV and placebo | Active Comparator | Participants will receive RIV and normal saline placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BNT162b2 (Omi XBB.1.5)/RIV | Biological | Combination of BNT162b2 (Omi XBB.1.5) and RIV |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 to Day 7 following Vaccination on Day 1 |
| 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. | Day 1 to Day 7 following Vaccination on Day 1 |
| 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. | From Vaccination on Day 1 through 4 weeks after Vaccination |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Research Center | Lake Forest | California | 92630 | United States | ||
| Orange County Research Center |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: BNT162b2 (Omi XBB.1.5)/ RIV + Placebo | Participants were randomized to receive BNT162b2 (Omi XBB.1.5)/RIV together as a single intramuscular (IM) injection in the left deltoid and normal saline placebo IM injection in the right deltoid on Day 1. |
| FG001 | Group 2: BNT162b2 (Omi XBB.1.5) + RIV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 18, 2023 | Sep 9, 2025 |
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Single-blind (site- and sponsor-unblinded)
| BNT162b2 (Omi XBB.1.5) | Biological | Licensed COVID-19 vaccine |
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| RIV | Biological | Licensed recombinant influenza vaccine |
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| Normal saline placebo | Other | Normal saline (solution for injection) |
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| From Vaccination on Day 1 through 6 months after Vaccination |
| 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. | Before Vaccination on Day 1 |
| 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. | At 4 weeks after Vaccination on Day 1 |
| 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. | From before Vaccination on Day 1 to 4 weeks after Vaccination |
| 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. | At 4 weeks after Vaccination on Day 1 |
| 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. | Before Vaccination on Day 1 |
| 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. | At 4 weeks after Vaccination on Day 1 |
| 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. | From before Vaccination to 4 weeks after Vaccination on Day 1 |
| 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. | At 4 weeks after Vaccination on Day 1 |
| 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. | Before Vaccination on Day 1 |
| 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. | At 4 Weeks after Vaccination on Day 1 |
| Tustin |
| California |
| 92780 |
| United States |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| Clinical Research Consulting | Milford | Connecticut | 06460 | United States |
| GW Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | United States |
| GW Vaccine Research Unit | Washington D.C. | District of Columbia | 20037 | United States |
| JEM Research Institute | Atlantis | Florida | 33462 | United States |
| Indago Research & Health Center, Inc | Hialeah | Florida | 33012 | United States |
| Optimal Research | Melbourne | Florida | 32934 | United States |
| Headlands Research Orlando | Orlando | Florida | 32819 | United States |
| Clinical Site Partners, LLC dba Flourish Research | Winter Park | Florida | 32789 | United States |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | United States |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | United States |
| Optimal Research | Peoria | Illinois | 61614 | United States |
| Bio-Kinetic Clinical Applications, LLC dba QPS-MO | Springfield | Missouri | 65802 | United States |
| Bio-Kinetic Clinical Applications, LLD dba QPS-MO | Springfield | Missouri | 65802 | United States |
| Bio-Kinetic Clinical Applications LLC DBA QPS-MO(Patient Screening Center) | Springfield | Missouri | 65807 | United States |
| Las Vegas Clinical Trials | Las Vegas | Nevada | 89030 | United States |
| Las Vegas Clinical Trials | North Las Vegas | Nevada | 89030 | United States |
| ActivMed Practices & Research, LLC. | Portsmouth | New Hampshire | 03801 | United States |
| Rochester Clinical Research, LLC | Rochester | New York | 14609 | United States |
| Centricity Research Columbus Ohio Multispecialty | Columbus | Ohio | 43213 | United States |
| Clinical Research Associates Inc | Nashville | Tennessee | 37203 | United States |
| DM Clinical Research- Cyfair | Houston | Texas | 77065 | United States |
| DM Clinical Research - Bellaire | Houston | Texas | 77081 | United States |
| SMS Clinical Research | Mesquite | Texas | 75149 | United States |
| Clinical Trials of Texas, LLC | San Antonio | Texas | 78229 | United States |
| IMA Clinical Research San Antonio | San Antonio | Texas | 78229 | United States |
| DM Clinical Research - MDC | Tomball | Texas | 77375 | United States |
| Charlottesville Medical Research | Charlottesville | Virginia | 22911 | United States |
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. |
| FG002 | 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. |
| FG003 | 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. |
| Vaccinated |
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| COMPLETED |
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| NOT COMPLETED |
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Safety analysis set (SAS) consisted of all participants who received at least 1 dose of the study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 to Day 7 following Vaccination on Day 1 |
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| 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. | SAS consisted of all participants who received at least 1 dose of the study intervention. Data is presented for each vaccine group. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 to Day 7 following Vaccination on Day 1 |
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| 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. | SAS consisted of all participants who received at least 1 dose of the study intervention. Data is presented for each vaccine group. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Vaccination on Day 1 through 4 weeks after Vaccination |
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| 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. | SAS consisted of all participants who received at least 1 dose of the study intervention. Data is presented for each vaccine group. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Vaccination on Day 1 through 6 months after Vaccination |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Before Vaccination on Day 1 |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At 4 weeks after Vaccination on Day 1 |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | From before Vaccination on Day 1 to 4 weeks after Vaccination |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 4 weeks after Vaccination on Day 1 |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Before Vaccination on Day 1 |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At 4 weeks after Vaccination on Day 1 |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | From before Vaccination to 4 weeks after Vaccination on Day 1 |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 4 weeks after Vaccination on Day 1 |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Before Vaccination on Day 1 |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 4 Weeks after Vaccination on Day 1 |
|
AEs by systematic assessment: Day 1 up to 7 Days following Vaccination; AEs by Non-systematic assessment: a) Serious AEs- Day 1 of Vaccination up to 6 months of follow-up after Vaccination, b) Other AEs- Day 1 of Vaccination up to 4 weeks of follow-up after Vaccination; All-cause mortality: Day 1 of Vaccination up to 6 months of follow-up after Vaccination
Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population consisted of all randomized participants who received study intervention. Data is reported for each vaccine Group.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 160 | 3 | 160 | 114 | 160 |
| EG001 | 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. | 0 | 161 | 1 | 161 | 117 | 161 |
| EG002 | 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. | 0 | 160 | 0 | 160 | 115 | 160 |
| EG003 | 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. | 1 | 160 | 3 | 160 | 88 | 160 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Non-systematic Assessment |
| |
| Metastatic squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Thyroid mass | Endocrine disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Vessel puncture site haemorrhage | General disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Norovirus infection | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Chills (CHILLS) | General disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Fatigue (FATIGUE) | General disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Injection site erythema (REDNESS) left deltoid | General disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Injection site erythema (REDNESS) right deltoid | General disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Injection site pain (PAIN AT THE INJECTION SITE) left deltoid | General disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Injection site pain (PAIN AT THE INJECTION SITE) right deltoid | General disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Injection site swelling (SWELLING) left deltoid | General disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Injection site swelling (SWELLING) right deltoid | General disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Pyrexia (FEVER) | General disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Diarrhoea (DIARRHEA) | Gastrointestinal disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Vomiting (VOMITING) | Gastrointestinal disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Arthralgia (NEW OR WORSENED JOINT PAIN) | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Myalgia (NEW OR WORSENED MUSCLE PAIN) | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Headache (HEADACHE) | Nervous system disorders | MedDRA v27.1 | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov.Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 22, 2024 | Sep 9, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D008171 | Lung Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000090982 | BNT162 Vaccine |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Redness |
|
| Swelling |
|
| OG003 | 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. |
|
|
| OG003 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
|
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.
| OG002 | 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. |
|
|
| OG002 | 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. |
|
|
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. |
| OG002 | 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. |
|
|
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. |
| OG002 | 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. |
|
|
| OG002 | 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. |
|
|
| OG002 | 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. |
|
|
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. |
| OG002 | 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. |
|
|
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. |
| OG002 | 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. |
|
|
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.
| OG002 | 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. |
|
|
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.
| OG002 | 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. |
|
|