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

Last updated: October 2, 2024
Sponsor: Pfizer
Overall Status: Completed

Phase

2

Condition

Corona Virus

Covid-19

Treatment

Normal saline placebo

BNT162b2 (Omi XBB.1.5)

RIV

Clinical Study ID

NCT06237049
C5681001
  • Ages > 50
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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, theinvestigational plan, laboratory tests, lifestyle considerations, and other studyprocedures.

  • Healthy participants who are determined by medical history, physical examination (ifrequired), and clinical judgment of the investigator to be eligible for inclusion inthe study.

  • Capable of giving signed informed consent as described in the protocol, whichincludes compliance with the requirements and restrictions listed in the informedconsent document (ICD) and in the protocol.

Exclusion

Exclusion Criteria:

  • Any medical or psychiatric condition including recent (within the past year) oractive suicidal ideation/behavior or laboratory abnormality that may increase therisk of study participation or, in the investigator's judgment, make the participantinappropriate for the study.

  • Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), orhepatitis B virus (HBV).

  • History of severe adverse reaction associated with any vaccine and/or severeallergic reaction (eg, anaphylaxis) to any component of the study interventions.

  • Participants with a history of autoimmune disease or an active autoimmune diseaserequiring therapeutic intervention, including but not limited to systemic orcutaneous lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, multiplesclerosis, Sjögren's syndrome, idiopathic thrombocytopenia purpura,glomerulonephritis, autoimmune thyroiditis, temporal arteritis, psoriasis, and/orinsulin-dependent diabetes mellitus.

  • Immunocompromised individuals with known or suspected immunodeficiency, determinedby history and/or laboratory/physical examination.

  • Current heart disease, uncontrolled hypertension, or a prior history of myocarditisor pericarditis.

  • Bleeding diathesis or condition associated with prolonged bleeding that would, inthe opinion of the investigator, contraindicate intramuscular injection.

  • Women who are pregnant, plan to become pregnant during the study, or arebreastfeeding.

  • 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 60days before enrollment through conclusion of the study.

  • Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies used forthe treatment or prevention of COVID 19 or those that are consideredimmunosuppressive, from 90 days before study intervention administration, or plannedreceipt throughout the study.

  • Vaccination with any investigational or licensed influenza vaccine within 6 months (180 days) before study intervention administration, or ongoing receipt of chronicantiviral 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 investigationalproduct within 28 days prior to, and/or during, participation in this study.

  • Investigator site staff directly involved in the conduct of the study and theirfamily members, site staff otherwise supervised by the investigator, and sponsor andsponsor delegate employees directly involved in the conduct of the study and theirfamily 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 investigatormight interfere with the study conduct or completion.

Study Design

Total Participants: 645
Treatment Group(s): 4
Primary Treatment: Normal saline placebo
Phase: 2
Study Start date:
January 31, 2024
Estimated Completion Date:
September 13, 2024

Study 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.

Connect with a study center

  • Orange County Research Center

    Lake Forest, California 92630
    United States

    Site Not Available

  • Orange County Research Center

    Tustin, California 92780
    United States

    Site Not Available

  • Diablo Clinical Research, Inc.

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Clinical Research Consulting

    Milford, Connecticut 06460
    United States

    Site Not Available

  • GW Medical Faculty Associates

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • GW Vaccine Research Unit

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • JEM Research Institute

    Atlantis, Florida 33462
    United States

    Site Not Available

  • Indago Research & Health Center, Inc

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Optimal Research

    Melbourne, Florida 32934
    United States

    Site Not Available

  • Headlands Research Orlando

    Orlando, Florida 32819
    United States

    Site Not Available

  • Clinical Site Partners, LLC dba Flourish Research

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Clinical Research Atlanta

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • East-West Medical Research Institute

    Honolulu, Hawaii 96814
    United States

    Site Not Available

  • Optimal Research

    Peoria, Illinois 61614
    United States

    Site Not Available

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

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Bio-Kinetic Clinical Applications, LLC dba QPS-MO

    Springfield, Missouri 65802
    United States

    Site Not Available

  • Bio-Kinetic Clinical Applications, LLD dba QPS-MO

    Springfield, Missouri 65802
    United States

    Site Not Available

  • Las Vegas Clinical Trials

    Las Vegas, Nevada 89030
    United States

    Site Not Available

  • Las Vegas Clinical Trials

    North Las Vegas, Nevada 89030
    United States

    Site Not Available

  • ActivMed Practices & Research, LLC.

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • Rochester Clinical Research, LLC

    Rochester, New York 14609
    United States

    Site Not Available

  • Centricity Research Columbus Ohio Multispecialty

    Columbus, Ohio 43213
    United States

    Site Not Available

  • Clinical Research Associates Inc

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • DM Clinical Research - Bellaire

    Houston, Texas 77081
    United States

    Site Not Available

  • DM Clinical Research- Cyfair

    Houston, Texas 77065
    United States

    Site Not Available

  • SMS Clinical Research

    Mesquite, Texas 75149
    United States

    Site Not Available

  • Clinical Trials of Texas, LLC

    San Antonio, Texas 78229
    United States

    Site Not Available

  • IMA Clinical Research San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • DM Clinical Research

    Tomball, Texas 77375
    United States

    Site Not Available

  • DM Clinical Research - MDC

    Tomball, Texas 77375
    United States

    Site Not Available

  • Charlottesville Medical Research

    Charlottesville, Virginia 22911
    United States

    Site Not Available

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