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A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL STUDY EVALUATING THE SAFETY, TOLERABILITY, IMMUNOGENICITY AND EFFICACY OF A VARIANT-ADAPTED BNT162B2 VACCINE IN HEALTHY PARTICIPANTS 50 THROUGH 64 YEARS OF AGE

NCT07300839•BioNTech SE

View on ClinicalTrials.gov

Summary

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).

Detailed Description

The study is designed to evaluate if the COVID-19 vaccine reduces COVID-19 disease as compared to placebo given to healthy adults 50 to 64 years of age. Approximately 25,500 participants will be randomly chosen to get either one dose of COVID-19 vaccine or of a placebo.

Eligibility

Age

50 - 64 years

Sex

ALL

Healthy Volunteers

Yes

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.

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.

Locations (208)

Pinnacle Research Group, LLC

Anniston, Alabama, United States

North Alabama Research Center

Athens, Alabama, United States

Simon Williamson Clinic / Synexus Clinical Research US, Inc.

Birmingham, Alabama, United States

Accel Research Sites - Birmingham Clinical Research Unit

Birmingham, Alabama, United States

Cullman Clinical Trials

Cullman, Alabama, United States

AMR Clinical

Daphne, Alabama, United States

Medical Affiliated Research Center

Huntsville, Alabama, United States

AMR Clinical

Mobile, Alabama, United States

Chandler Clinical Trials

Chandler, Arizona, United States

Synexus Clinical Research US, Inc.

Phoenix, Arizona, United States

Key Dates

Start Date

December 10, 2025

Primary Completion Date

July 31, 2026

Completion Date

July 31, 2026

Last Updated

December 24, 2025

Enrollment

25,500

ESTIMATED participants

Conditions

COVID-19SARS-COV-2 Infection

Interventions

BNT162b2 Vaccine

BIOLOGICAL

Placebo

BIOLOGICAL

Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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