RecruitingPhase 3NCT07300839

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


Sponsor

BioNTech SE

Enrollment

25,500 participants

Start Date

Dec 10, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 50 YearsMax Age: 64 Years

Inclusion Criteria2

  • 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 Criteria2

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALBNT162b2 Vaccine

Single dose

BIOLOGICALPlacebo

Single dose


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

Scottsdale Clinical Trials

Scottsdale, Arizona, United States

Epic Medical Research-Sun City

Sun City, Arizona, United States

Noble Clinical Research

Tucson, Arizona, United States

Synexus Clinical Research US, Inc./Orange Grove Family Practice

Tucson, Arizona, United States

Woodland International Research Group

Little Rock, Arkansas, United States

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Velocity Clinical Research, Chula Vista

Chula Vista, California, United States

West Coast Research

Dublin, California, United States

Leading Edge Research LA

Encino, California, United States

Leading Edge Research

Encino, California, United States

Triallogix Medical Corporation

Fullerton, California, United States

Marvel Clinical Research

Huntington Beach, California, United States

Eximia Research-CA, LLC

La Mesa, California, United States

Velocity Clinical Research, Los Angeles

Los Angeles, California, United States

ImmuniMet

Modesto, California, United States

Carbon Health - North Hollywood - NoHo West

North Hollywood, California, United States

Empire Clinical Research

Pomona, California, United States

Peninsula Research Associates

Rolling Hills Estates, California, United States

Northern California Research - Sacramento

Sacramento, California, United States

Velocity Clinical Research, San Bernardino

San Bernardino, California, United States

Artemis Institute for Clinical Research

San Diego, California, United States

UCSD AntiViral Research Center (AVRC)

San Diego, California, United States

Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.

Toluca Lake, California, United States

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Legacy Clinical Trials

Colorado Springs, Colorado, United States

Tekton Research, LLC.

Fort Collins, Colorado, United States

Tekton Research, LLC.

Longmont, Colorado, United States

Paradigm Clinical Research, LLC

Wheat Ridge, Colorado, United States

New England Research Associates, LLC

Bridgeport, Connecticut, United States

Clinical Research Consulting

Milford, Connecticut, United States

Stamford Therapeutics Consortium

Stamford, Connecticut, United States

Washington Health Institute

Washington D.C., District of Columbia, United States

Tampa Bay Medical Research

Clearwater, Florida, United States

Pioneer Clinical Studies - Coral Gables

Coral Gables, Florida, United States

Hillcrest Medical Research

DeLand, Florida, United States

Universal Axon Clinical Research, LLC

Doral, Florida, United States

Suncoast Research Associates

Doral, Florida, United States

AMR Clinical

Fort Myers, Florida, United States

Robert B. Pritt, DO

Fort Myers, Florida, United States

Velocity Clinical Research, Hallandale Beach

Hallandale, Florida, United States

Indago Research & Health Center, Inc

Hialeah, Florida, United States

Las Mercedes Medical Research

Hialeah, Florida, United States

Research Centers of America

Hollywood, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Health Awareness

Jupiter, Florida, United States

M3 Wake Research - Lake City

Lake City, Florida, United States

Accel Research Sites - Lakeland Clinical Research Unit

Lakeland, Florida, United States

SRA Trials North

Lauderdale Lakes, Florida, United States

Accel Research Sites - Maitland Clinical Research Unit

Maitland, Florida, United States

South Florida Research Organization

Medley, Florida, United States

Optimal Research

Melbourne, Florida, United States

Flourish Research - Miami, LLC

Miami, Florida, United States

Florida Pharmaceutical Research & Associates, Inc.

Miami, Florida, United States

Florida Pharmaceutical Research and Associates

Miami, Florida, United States

Nuren Medical and Research Center

Miami, Florida, United States

Advanced Clinical Research - Miami - Southwest 92nd Street

Miami, Florida, United States

New Horizon Research Center

Miami, Florida, United States

Entrust Clinical Research

Miami, Florida, United States

IMIC, Inc.

Miami, Florida, United States

Miami Dade Medical Research Institute, LLC

Miami, Florida, United States

3Sync - Hialeah

Miami Lakes, Florida, United States

Palm Springs Community Health Center

Miami Lakes, Florida, United States

Angels Clinical Research Institute

Miami Lakes, Florida, United States

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

Clinical Neuroscience Solutions - Orlando - South Delaney Avenue

Orlando, Florida, United States

Headlands Research Orlando

Orlando, Florida, United States

3SYNC Research - Palm Springs

Palm Springs, Florida, United States

Innovation Medical Research Center

Palmetto Bay, Florida, United States

Tropical Clinical Trials

Palmetto Bay, Florida, United States

Suncoast Research Associates

Pembroke Pines, Florida, United States

DBC Research USA

Pembroke Pines, Florida, United States

Progressive Medical Research

Port Orange, Florida, United States

International Clinical Research - Sanford

Sanford, Florida, United States

GCP Research, Global Clinical professionals

St. Petersburg, Florida, United States

Precision Clinical Research

Sunrise, Florida, United States

Angels Clinical Research Institute

Tampa, Florida, United States

Santos Research Center

Tampa, Florida, United States

Synexus Clinical Research US, Inc.

The Villages, Florida, United States

Palm Beach Research Center

West Palm Beach, Florida, United States

DelRicht Research

Atlanta, Georgia, United States

AGILE Clinical Research Trials, LLC

Sandy Springs, Georgia, United States

M3 Wake Research - Atlanta

Sandy Springs, Georgia, United States

Javara - Privia Medical Group Georgia - Savannah

Savannah, Georgia, United States

Clinical Research Atlanta

Stockbridge, Georgia, United States

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, United States

East-West Medical Research Institute

Honolulu, Hawaii, United States

Chicago Clinical Research Institute

Chicago, Illinois, United States

DM Clinical Research - Chicago

Melrose Park, Illinois, United States

Koch Family Medicine

Morton, Illinois, United States

Accellacare - DuPage

Oak Lawn, Illinois, United States

The South Bend Clinic, LLC

South Bend, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

Velocity Clinical Research, Sioux City

Sioux City, Iowa, United States

AMR Clinical

El Dorado, Kansas, United States

Johnson County Clinical Trials

Lenexa, Kansas, United States

AMR Clinical

Newton, Kansas, United States

AMR Clinical

Wichita, Kansas, United States

Tekton Research, LLC.

Wichita, Kansas, United States

AMR Clinical

Lexington, Kentucky, United States

DelRicht Research

New Orleans, Louisiana, United States

Velocity Clinical Research - New Orleans

New Orleans, Louisiana, United States

Pharmaron

Baltimore, Maryland, United States

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Velocity Clinical Research, Rockville

Rockville, Maryland, United States

DM Clinical Research - Boston

Brookline, Massachusetts, United States

Walgreens Clinical Trials - Malden, MA

Malden, Massachusetts, United States

ActivMed Practices and Research

Methuen, Massachusetts, United States

Henry Ford St. John Hospital

Grosse Pointe Woods, Michigan, United States

Great Lakes Research Institute

Southfield, Michigan, United States

Revival Research Institute, LLC

Southfield, Michigan, United States

DM Clinical Research - Detroit

Southfield, Michigan, United States

Clinical Research Institute

Minneapolis, Minnesota, United States

Velocity Clinical Research, Gulfport

Gulfport, Mississippi, United States

Clinical Research Professionals

Chesterfield, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Sundance Clinical Research, LLC

St Louis, Missouri, United States

Sundance Clinical Research

St Louis, Missouri, United States

Velocity Clinical Research, Grand Island

Grand Island, Nebraska, United States

Be Well Clinical Studies - Lincoln

Lincoln, Nebraska, United States

Velocity Clinical Research, Norfolk

Norfolk, Nebraska, United States

Quality Clinical Research

Omaha, Nebraska, United States

McGill Family Practice

Papillion, Nebraska, United States

M3 Wake Research - Las Vegas Wellness Way

Las Vegas, Nevada, United States

DM Clinical Research - Jersey City

Jersey City, New Jersey, United States

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, United States

DM Clinical Research - Albuquerque

Albuquerque, New Mexico, United States

Axces Research

Santa Fe, New Mexico, United States

Drug Trials America

Hartsdale, New York, United States

Rochester Clinical Research, LLC

Rochester, New York, United States

Accellacare - Cary

Cary, North Carolina, United States

Javara - Tryon Medical Partners

Charlotte, North Carolina, United States

Duke Vaccine and Trials Unit

Durham, North Carolina, United States

Accellacare - Hickory

Hickory, North Carolina, United States

Monroe Biomedical Research

Monroe, North Carolina, United States

Lucas Research, Inc.

New Bern, North Carolina, United States

Eximia Research - NC, LLC

Raleigh, North Carolina, United States

Accellacare - Raleigh

Raleigh, North Carolina, United States

M3 Wake Research, Inc.

Raleigh, North Carolina, United States

Eximia Research - NC, LLC

Raleigh, North Carolina, United States

Accellacare - Rocky Mount

Rocky Mount, North Carolina, United States

Accellacare - Salisbury

Salisbury, North Carolina, United States

Accellacare - Piedmont

Statesville, North Carolina, United States

Trial Management Associates - Wilmington - Floral Parkway

Wilmington, North Carolina, United States

Accellacare - Winston-Salem

Winston-Salem, North Carolina, United States

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

CTI Clinical Research Center

Cincinnati, Ohio, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, United States

Epic Medical Research - Oklahoma

Chickasha, Oklahoma, United States

Tekton Research, LLC.

Edmond, Oklahoma, United States

Tekton Research, LLC.

Moore, Oklahoma, United States

AMR Clinical

Norman, Oklahoma, United States

Tekton Research, LLC.

Yukon, Oklahoma, United States

Velocity Clinical Research, Medford

Medford, Oregon, United States

Central Erie Primary Care

Erie, Pennsylvania, United States

Velocity Clinical Research, Providence

East Greenwich, Rhode Island, United States

Trial Management Associates, LLC

Myrtle Beach, South Carolina, United States

Trial Management Associates

Myrtle Beach, South Carolina, United States

Coastal Carolina Research Center

North Charleston, South Carolina, United States

M3 Wake Research - Chattanooga

Chattanooga, Tennessee, United States

AMR Clinical

Knoxville, Tennessee, United States

Accellacare US Inc., d/b/a Accellacare of Knoxville

Knoxville, Tennessee, United States

Elligo Clinical Research Center

Austin, Texas, United States

Orion Clinical Research

Austin, Texas, United States

Velocity Clinical Research, Austin

Austin, Texas, United States

Headlands Horizons, LLC dba Headlands Research-Brownsville

Brownsville, Texas, United States

Epic Medical Research - Carrollton

Carrollton, Texas, United States

Lonestar Clinical Research - Dallas

Dallas, Texas, United States

Headlands Research-El Paso

El Paso, Texas, United States

Cedar Health Research - Euless

Euless, Texas, United States

Mercury Clinical Research (Administrative Office)

Houston, Texas, United States

DM Clinical Research- Cyfair

Houston, Texas, United States

DM Clinical Research - Bellaire

Houston, Texas, United States

Mercury Clinical Research - Santa Clara Family Clinic

Houston, Texas, United States

DM Clinical Research - Dallas

Irving, Texas, United States

SMS Clinical Research

Mesquite, Texas, United States

Epic Medical Research - Mesquite

Mesquite, Texas, United States

LinQ Research

Pearland, Texas, United States

ACRC Trials

Plano, Texas, United States

ACRC Trials

Plano, Texas, United States

Delricht Research - Prosper: Gen Med

Prosper, Texas, United States

Benchmark Research

San Angelo, Texas, United States

DM Clinical Research - San Antonio

San Antonio, Texas, United States

IMA Clinical Research San Antonio

San Antonio, Texas, United States

Endeavor Clinical Trials

San Antonio, Texas, United States

DM Clinical Research - Sugar Land

Sugar Land, Texas, United States

Sugar Lakes Family Practice, PA

Sugar Land, Texas, United States

Dynamed Clinical Research, LP d/b/a DM Clinical Research

Tomball, Texas, United States

Cope Family Medicine / CCT Research

Bountiful, Utah, United States

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, United States

J. Lewis Research, Inc. / Foothill Family Clinic South

Salt Lake City, Utah, United States

South Ogden Family Medicine/ CCT Research

South Ogden, Utah, United States

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, United States

Charlottesville Medical Research

Charlottesville, Virginia, United States

AMR Clinical

Norfolk, Virginia, United States

Clinical Research Partners, LLC

Richmond, Virginia, United States

Tidewater Clinical Research

Virginia Beach, Virginia, United States

Eastside Research Associates

Redmond, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT07300839


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