Official Title
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
Brief Summary

This study is designed to find out how well the COVID-19 vaccine protects people 50 to64, who don't have any serious health problems, compared to a group that receives avaccine 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.

Recruiting
COVID-19
SARS-CoV-2 Infection

Biological: BNT162b2 Vaccine

Single dose

Biological: Placebo

Single dose

Eligibility 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.

Eligibility Gender
All
Eligibility Age
Minimum: 50 Years ~ Maximum: 64 Years
Countries
United States
Locations

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

Contacts

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Pfizer CT.gov Call Center, Study Director
Pfizer

NCT Number
MeSH Terms
COVID-19
BNT162 Vaccine