A Study to Learn About COVID-19 RNA-Based Variant-Adapted Vaccine Candidate(s) Against SARS-CoV-2 in Adults, Including Those at Higher Risk of Severe COVID-19

Trial status:Recruiting
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
Recruiting

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 18 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 (Omi LP.8.1) 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, and participants will need to visit the clinical study site at least 4 times.

Medical Condition
  • COVID-19
    • Trial Drug
  • BNT162b2 (Omi LP.8.1)
    • Phase
    Phase 3
    Type
    Interventional
    Estimated Enrolment
    100
    Estimated Trial Date
    Jul 2025 - Jan 2026

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    Yes

    Trial Locations

    Location
    Status
    Location
    Diablo Clinical Research, Inc.
    Walnut Creek, California, United States, 94598
    Status
    Recruiting
    Location
    Indago Research & Health Center, Inc
    Hialeah, Florida, United States, 33012
    Status
    Recruiting
    Location
    Bio-Kinetic Clinical Applications, LLC dba QPS-MO
    Springfield, Missouri, United States, 65802
    Status
    Recruiting
    Location
    Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center
    Springfield, Missouri, United States, 65807
    Status
    Recruiting
    Location
    Accellacare - Wilmington
    Wilmington, North Carolina, United States, 28401
    Status
    Recruiting
    Location
    J. Lewis Research, Inc. / Foothill Family Clinic
    Salt Lake City, Utah, United States, 84109
    Status
    Recruiting