A Study to Learn About a Combined COVID-19 and Influenza Shot in Healthy Adults

A Phase 1/2 Randomized Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Modified RNA COVID-19 Vaccine and a Recombinant Influenza Vaccine Administered as a Single Injection in Healthy Adults 50 Years of Age or Older

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Influenza, Human; SARS-CoV-2 Infection
• Intervention / Treatment: Biological: BNT162b2 (Omi XBB.1.5)/RIV; Other: Normal saline placebo; Biological: BNT162b2 (Omi XBB.1.5); Biological: RIV

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.

• Study Type: Interventional
• Enrollment (Actual): 644
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Lake Forest, California, United States, 92630
      • Orange County Research Center
    • Tustin, California, United States, 92780
      • Orange County Research Center
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research, Inc.
  • Connecticut
    • Milford, Connecticut, United States, 06460
      • Clinical Research Consulting
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20037
      • GW Medical Faculty Associates
    • Washington D.C., District of Columbia, United States, 20037
      • GW Vaccine Research Unit
  • Florida
    • Atlantis, Florida, United States, 33462
      • JEM Research Institute
    • Hialeah, Florida, United States, 33012
      • Indago Research & Health Center, Inc
    • Melbourne, Florida, United States, 32934
      • Optimal Research
    • Orlando, Florida, United States, 32819
      • Headlands Research Orlando
    • Winter Park, Florida, United States, 32789
      • Clinical Site Partners, LLC dba Flourish Research
  • Georgia
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Atlanta
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • East-West Medical Research Institute
  • Illinois
    • Peoria, Illinois, United States, 61614
      • Optimal Research
  • Missouri
    • Springfield, Missouri, United States, 65802
      • Bio-Kinetic Clinical Applications, LLD dba QPS-MO
    • Springfield, Missouri, United States, 65802
      • Bio-Kinetic Clinical Applications, LLC dba QPS-MO
    • Springfield, Missouri, United States, 65807
      • Bio-Kinetic Clinical Applications LLC DBA QPS-MO(Patient Screening Center)
  • Nevada
    • Las Vegas, Nevada, United States, 89030
      • Las Vegas Clinical Trials
    • North Las Vegas, Nevada, United States, 89030
      • Las Vegas Clinical Trials
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • ActivMed Practices & Research, LLC.
  • New York
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, LLC
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Centricity Research Columbus Ohio Multispecialty
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates Inc
  • Texas
    • Houston, Texas, United States, 77081
      • DM Clinical Research - Bellaire
    • Houston, Texas, United States, 77065
      • DM Clinical Research- Cyfair
    • Mesquite, Texas, United States, 75149
      • SMS Clinical Research
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, LLC
    • San Antonio, Texas, United States, 78229
      • IMA Clinical Research San Antonio
    • Tomball, Texas, United States, 77375
      • DM Clinical Research - MDC
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BNT162b2 (Omi XBB.1.5)/RIV and placebo; Participants will receive a single injection combination of BNT162b2 (Omi XBB.1.5) and RIV and normal saline placebo	Biological: BNT162b2 (Omi XBB.1.5)/RIV; Combination of BNT162b2 (Omi XBB.1.5) and RIV; Other: Normal saline placebo; Normal saline (solution for injection)
Experimental: BNT162b2 (Omi XBB.1.5) and RIV; Participants will receive BNT162b2 (Omi XBB.1.5) and RIV	Biological: BNT162b2 (Omi XBB.1.5); Licensed COVID-19 vaccine; Biological: RIV; Licensed recombinant influenza vaccine
Active Comparator: BNT162b2 (Omi XBB.1.5) and placebo; Participants will receive BNT162b2 (Omi XBB.1.5) and normal saline placebo	Other: Normal saline placebo; Normal saline (solution for injection); Biological: BNT162b2 (Omi XBB.1.5); Licensed COVID-19 vaccine
Active Comparator: RIV and placebo; Participants will receive RIV and normal saline placebo	Other: Normal saline placebo; Normal saline (solution for injection); Biological: RIV; Licensed recombinant influenza vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2024
• Primary Completion (Actual): September 13, 2024
• Study Completion (Actual): September 13, 2024

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Actual): February 1, 2024

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; RNA Vaccine; Flu; Influenza Vaccine; Grippe; Coronavirus Vaccine; mRNA Vaccine
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Influenza, Human; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Biological Products; Complex Mixtures; Vaccines; Viral Vaccines; mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; COVID-19 Vaccines; Antigens; BNT162 Vaccine
• Other Study ID Numbers: C5681001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No