A Study to Learn About COVID‑19 RNA‑Based Variant‑Adapted Vaccine Candidate(s) Against SARS‑CoV‑2 in Participants Ages 12 Through 64 Years Considered at Higher Risk of Severe COVID‑19, and Participants Ages ≥65 Years

Trial status:Recruitment Complete
Trial ID:
C4591076
NCT ID:
NCT07069309
EudraCT ID:
N/A
EU Trial (CTIS) Number:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Collaborator:
Pfizer
Recruitment Complete

Trial Details

The purpose of this study is to learn about the safety, tolerability, and immunogenicity of an updated vaccine against COVID-19.

This study is seeking participants 12 through 64 years of age who are considered to be at higher risk for severe COVID-19 disease per study protocol and those 65 years of age and older. All participants in this study will receive 1 shot to their arm of a BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg RNA-based vaccine which targets a circulating variant of SARS-CoV-2 and is selected for the 2025-2026 COVID-19 respiratory virus season. This study is about 6 months for each participant. Participants will either be enrolled in Cohort 1 (Groups 1 and 2) or Cohort 2 (Groups 3 and 4). Participants enrolled in Cohort 1 will have at least 4 visits and participants enrolled in Cohort 2 will have at least 3 visits.

Medical Condition
  • COVID-19
    • Study Drug
  • BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)
    • Phase
    Phase 3
    Type
    Interventional
    Estimated Enrolment
    760
    Estimated Trial Date
    Jul 2025 - May 2026

    Trial Participant Requirements

    Age
    12+ years
    Sex
    Female & Male
    Healthy Volunteers
    Yes
    Inclusion and Exclusion Criteria
    Inclusion criteria
    • Cohort 1: Participants 18 years of age or older.
    • Cohort 2: Participants 12 years of age or older.
    • Participants 12 through 64 years of age with at least 1 underlying medical condition that increases their risk of severe COVID-19.
    Exclusion criteria
    • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
    • History of myocarditis or pericarditis.
    • Cohort 2: Receipt of a COVID-19 vaccine or a confirmed case of COVID-19 (confirmed by signs/symptoms and/or a positive test result based on local testing) less than 5 months (150 days) prior to study enrollment.

      • Refer to the study contact for further eligibility details.

    Trial Locations

    Location
    Status
    Location
    Diablo Clinical Research, Inc.
    Walnut Creek, California, United States, 94598
    Status
    Location
    Clinical Research Consulting
    Milford, Connecticut, United States, 06460
    Status
    Location
    GW Vaccine Research Unit
    Washington D.C., District of Columbia, United States, 20037
    Status
    Location
    The GW Medical Faculty Associates
    Washington D.C., District of Columbia, United States, 20037
    Status
    Location
    Indago Research & Health Center, Inc
    Hialeah, Florida, United States, 33012
    Status
    Location
    Palm Springs Community Health Center
    Miami Lakes, Florida, United States, 33014
    Status
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