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

Trial status:Recruitment Complete
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
Recruitment Complete

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
5240
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
Location
North Alabama Research Center
Athens, Alabama, United States, 35611
Status
Location
Simon Williamson Clinic / Synexus Clinical Research US, Inc.
Birmingham, Alabama, United States, 35211
Status
Location
Accel Research Sites - Birmingham Clinical Research Unit
Birmingham, Alabama, United States, 35216
Status
Location
Cullman Clinical Trials
Cullman, Alabama, United States, 35055
Status
Location
AMR Clinical
Daphne, Alabama, United States, 36526
Status
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