A Study to Learn About a COVID‑19 Vaccine in Healthy Adults 50 Through 64 Years of Age

Trial status:Recruiting
Trial ID:
C4591081
NCT ID:
NCT07300839
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
Recruiting

Trial Details

This study is designed to find out how well the COVID-19 vaccine protects people 50 to 64, who don't have any serious health problems, compared to a group that receives a vaccine that doesn't contain an ingredient to protect against COVID-19 (placebo).

Medical Condition
  • COVID-19
    • Study Drug
  • BNT162b2 Vaccine
    • See more
  • Placebo
    • Phase
    Phase 3
    Type
    Interventional
    Estimated Enrolment
    25500
    Estimated Trial Date
    Dec 2025 - Jul 2026

    Trial Participant Requirements

    Age
    50 - 64 Years
    Sex
    Female & Male
    Healthy Volunteers
    Yes
    Inclusion and Exclusion Criteria
    Inclusion criteria

      Key Inclusion Criteria

    • People who are between 50 and 64 years old at their first appointment.
    • People who are healthy and, based on their medical history and a doctor's judgment, are considered suitable to join the study.

      • Key Exclusion Criteria

    • People who had COVID-19 in the past 3 months (90 days) before their first visit.
    • People who got a COVID-19 vaccine, either as part of a research study or an approved vaccine, in the last 3 months-or plans to get one during the study.

    Trial Locations

    Location
    Status
    Location
    Pinnacle Research Group, LLC
    Anniston, Alabama, United States, 36207
    Status
    Not yet recruiting
    Location
    North Alabama Research Center
    Athens, Alabama, United States, 35611
    Status
    Not yet recruiting
    Location
    Simon Williamson Clinic / Synexus Clinical Research US, Inc.
    Birmingham, Alabama, United States, 35211
    Status
    Not yet recruiting
    Location
    Accel Research Sites - Birmingham Clinical Research Unit
    Birmingham, Alabama, United States, 35216
    Status
    Not yet recruiting
    Location
    Cullman Clinical Trials
    Cullman, Alabama, United States, 35055
    Status
    Not yet recruiting
    Location
    AMR Clinical
    Daphne, Alabama, United States, 36526
    Status
    Not yet recruiting
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