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

NCT06237049 | Completed Phase 2 Results FDA Drug

• 1 other identifier: C5681001
• Study Type: interventional
• Target: 644
• Locations: 1 country
• Sites: 30

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.

Conditions

Influenza, Human; SARS-CoV-2 Infection; COVID-19

Keywords

Grippe; Flu; Influenza Vaccine; RNA Vaccine; COVID-19; Coronavirus Vaccine; SARS-CoV-2; mRNA Vaccine

Outcome Measures

Primary Outcomes (14)

• 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

Study Arms (4)

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

Biological: BNT162b2 (Omi XBB.1.5)/RIV; Other: Normal saline placebo

BNT162b2 (Omi XBB.1.5) and RIV

EXPERIMENTAL

Participants will receive BNT162b2 (Omi XBB.1.5) and RIV

Biological: BNT162b2 (Omi XBB.1.5); Biological: RIV

BNT162b2 (Omi XBB.1.5) and placebo

ACTIVE COMPARATOR

Participants will receive BNT162b2 (Omi XBB.1.5) and normal saline placebo

Biological: BNT162b2 (Omi XBB.1.5); Other: Normal saline placebo

RIV and placebo

ACTIVE COMPARATOR

Participants will receive RIV and normal saline placebo

Biological: RIV; Other: Normal saline placebo

Interventions

BNT162b2 (Omi XBB.1.5)/RIV BIOLOGICAL

Combination of BNT162b2 (Omi XBB.1.5) and RIV

BNT162b2 (Omi XBB.1.5)/RIV and placebo

BNT162b2 (Omi XBB.1.5) BIOLOGICAL

Licensed COVID-19 vaccine

BNT162b2 (Omi XBB.1.5) and RIV; BNT162b2 (Omi XBB.1.5) and placebo

RIV BIOLOGICAL

Licensed recombinant influenza vaccine

BNT162b2 (Omi XBB.1.5) and RIV; RIV and placebo

Normal saline placebo OTHER

Normal saline (solution for injection)

BNT162b2 (Omi XBB.1.5) and placebo; BNT162b2 (Omi XBB.1.5)/RIV and placebo; RIV and placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (30)

Orange County Research Center

Lake Forest, California, 92630, United States

Location

Orange County Research Center

Tustin, California, 92780, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Clinical Research Consulting

Milford, Connecticut, 06460, United States

Location

GW Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

GW Vaccine Research Unit

Washington D.C., District of Columbia, 20037, United States

Location

JEM Research Institute

Atlantis, Florida, 33462, United States

Location

Indago Research & Health Center, Inc

Hialeah, Florida, 33012, United States

Location

Optimal Research

Melbourne, Florida, 32934, United States

Location

Headlands Research Orlando

Orlando, Florida, 32819, United States

Location

Clinical Site Partners, LLC dba Flourish Research

Winter Park, Florida, 32789, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

East-West Medical Research Institute

Honolulu, Hawaii, 96814, United States

Location

Optimal Research

Peoria, Illinois, 61614, United States

Location

Bio-Kinetic Clinical Applications, LLC dba QPS-MO

Springfield, Missouri, 65802, United States

Location

Bio-Kinetic Clinical Applications, LLD dba QPS-MO

Springfield, Missouri, 65802, United States

Location

Bio-Kinetic Clinical Applications LLC DBA QPS-MO(Patient Screening Center)

Springfield, Missouri, 65807, United States

Location

Las Vegas Clinical Trials

Las Vegas, Nevada, 89030, United States

Location

Las Vegas Clinical Trials

North Las Vegas, Nevada, 89030, United States

Location

ActivMed Practices & Research, LLC.

Portsmouth, New Hampshire, 03801, United States

Location

Rochester Clinical Research, LLC

Rochester, New York, 14609, United States

Location

Centricity Research Columbus Ohio Multispecialty

Columbus, Ohio, 43213, United States

Location

Clinical Research Associates Inc

Nashville, Tennessee, 37203, United States

Location

DM Clinical Research- Cyfair

Houston, Texas, 77065, United States

Location

DM Clinical Research - Bellaire

Houston, Texas, 77081, United States

Location

SMS Clinical Research

Mesquite, Texas, 75149, United States

Location

Clinical Trials of Texas, LLC

San Antonio, Texas, 78229, United States

Location

IMA Clinical Research San Antonio

San Antonio, Texas, 78229, United States

Location

DM Clinical Research - MDC

Tomball, Texas, 77375, United States

Location

Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States

Location

Related Links

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

MeSH Terms

Conditions

Influenza, Human; COVID-19

Interventions

BNT162 Vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Lung Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov.Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blind (site- and sponsor-unblinded)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 1, 2024
• Study Start: January 31, 2024
• Primary Completion: September 13, 2024
• Study Completion: September 13, 2024
• Last Updated: September 30, 2025
• Results First Posted: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (30)