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
1 other identifier
interventional
5,240
1 country
196
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 covid19
Started Dec 2025
196 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2025
CompletedStudy Start
First participant enrolled
December 10, 2025
CompletedFirst Posted
Study publicly available on registry
December 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
April 13, 2026
April 1, 2026
8 months
November 27, 2025
April 7, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Percentage of participants reporting local reactions or systemic events
From Day 1 up to 7 days after Vaccination
Percentage of participants reporting adverse events
From Day 1 through 4 weeks after vaccination
Percentage of participants reporting serious adverse events
From Day 1 through 6 months after vaccination
First episode of confirmed COVID-19 cases
From 0 days after vaccination through end of COVID-19 surveillance at least 6 months post-vaccination
Secondary Outcomes (2)
First episode of confirmed COVID-19 cases
From 7 days after vaccination through end of COVID-19 surveillance at least 6 months post-vaccination
Geometric Mean Ratio (GMR)
From before vaccination to 1 month after vaccination
Study Arms (2)
BNT162b2 Vaccine
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BioNTech SElead
- Pfizercollaborator
Study Sites (196)
Pinnacle Research Group, LLC
Anniston, Alabama, 36207, United States
North Alabama Research Center
Athens, Alabama, 35611, United States
Simon Williamson Clinic / Synexus Clinical Research US, Inc.
Birmingham, Alabama, 35211, United States
Accel Research Sites - Birmingham Clinical Research Unit
Birmingham, Alabama, 35216, United States
Cullman Clinical Trials
Cullman, Alabama, 35055, United States
AMR Clinical
Daphne, Alabama, 36526, United States
Medical Affiliated Research Center
Huntsville, Alabama, 35801, United States
AMR Clinical
Mobile, Alabama, 36608, United States
Chandler Clinical Trials
Chandler, Arizona, 85224, United States
Scottsdale Clinical Trials
Scottsdale, Arizona, 85260, United States
Epic Medical Research-Sun City
Sun City, Arizona, 85351, United States
Noble Clinical Research
Tucson, Arizona, 85704, United States
Synexus Clinical Research US, Inc./Orange Grove Family Practice
Tucson, Arizona, 85741, United States
Woodland International Research Group, LLC
Little Rock, Arkansas, 72211, United States
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
Velocity Clinical Research, Chula Vista
Chula Vista, California, 91911, United States
West Coast Research
Dublin, California, 94568, United States
Triallogix Medical Corporation
Fullerton, California, 92835, United States
Upper Echelon Medical
Fullerton, California, 92835, United States
Marvel Clinical Research
Huntington Beach, California, 92647, United States
Eximia Research-CA, LLC
La Mesa, California, 91942, United States
Velocity Clinical Research, Los Angeles
Los Angeles, California, 90057, United States
Leading Edge Research
Los Angeles, California, 91316, United States
ImmuniMet
Modesto, California, 95350, United States
Carbon Health - North Hollywood - NoHo West
North Hollywood, California, 91606, United States
Empire Clinical Research
Pomona, California, 91767, United States
Peninsula Research Associates
Rolling Hills Estates, California, 90274, United States
Northern California Research - Sacramento
Sacramento, California, 95821, United States
Velocity Clinical Research, San Bernardino
San Bernardino, California, 92408, United States
Artemis Institute for Clinical Research
San Diego, California, 92123, United States
Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.
Toluca Lake, California, 91602, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Legacy Clinical Trials
Colorado Springs, Colorado, 80909, United States
Tekton Research, LLC.
Fort Collins, Colorado, 80525, United States
Tekton Research, LLC.
Longmont, Colorado, 80501, United States
Paradigm Clinical Research Centers, LLC
Wheat Ridge, Colorado, 80033, United States
Clinical Research Consulting
Milford, Connecticut, 06460, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
Washington Health Institute
Washington D.C., District of Columbia, 20017, United States
International Clinical Research - FL, LLC
Altamonte Springs, Florida, 32701, United States
Tampa Bay Medical Research
Clearwater, Florida, 33761, United States
Hillcrest Medical Research
DeLand, Florida, 32720, United States
Universal Axon Clinical Research, LLC
Doral, Florida, 33166, United States
Suncoast Research Associates
Doral, Florida, 33172, United States
AMR Clinical
Fort Myers, Florida, 33912, United States
Robert B. Pritt, DO
Fort Myers, Florida, 33912, United States
Velocity Clinical Research, Hallandale Beach
Hallandale, Florida, 33009, United States
Indago Research & Health Center, Inc
Hialeah, Florida, 33012, United States
Las Mercedes Medical Research
Hialeah, Florida, 33012, United States
Research Centers of America
Hollywood, Florida, 33024, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Health Awareness, LLC
Jupiter, Florida, 33458, United States
M3 Wake Research - Lake City
Lake City, Florida, 32055, United States
SRA Trials North
Lauderdale Lakes, Florida, 33313, United States
Accel Research Sites - Maitland Clinical Research Unit
Maitland, Florida, 32751, United States
South Florida Research Organization
Medley, Florida, 33166, United States
Optimal Research
Melbourne, Florida, 32934, United States
Flourish Research - Miami, LLC
Miami, Florida, 33135, United States
Florida Pharmaceutical Research & Associates, Inc.
Miami, Florida, 33143, United States
Nuren Medical and Research Center
Miami, Florida, 33144, United States
Advanced Clinical Research - Miami - Southwest 92nd Street
Miami, Florida, 33156, United States
New Horizon Research Center
Miami, Florida, 33165, United States
Entrust Clinical Research
Miami, Florida, 33176, United States
IMIC Medical Research
Miami, Florida, 33176, United States
Miami Dade Medical Research Institute, LLC
Miami, Florida, 33176, United States
Pioneer Clinical Studies
Miami, Florida, 33176, United States
3Sync Research
Miami Lakes, Florida, 33014, United States
Palm Springs Community Health Center
Miami Lakes, Florida, 33014, United States
Angels Clinical Research Institute
Miami Lakes, Florida, 33016, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
Headlands Research Orlando
Orlando, Florida, 32806, United States
3Sync Research
Palm Springs, Florida, 33461, United States
Innovation Medical Research Center
Palmetto Bay, Florida, 33157, United States
Tropical Clinical Trials
Palmetto Bay, Florida, 33176, United States
Suncoast Research Associates
Pembroke Pines, Florida, 33024, United States
DBC Research USA
Pembroke Pines, Florida, 33029, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
GCP Research, Global Clinical professionals
St. Petersburg, Florida, 33705, United States
Precision Clinical Research
Sunrise, Florida, 33351, United States
Angels Clinical Research Institute
Tampa, Florida, 33614, United States
Santos Research Center
Tampa, Florida, 33615, United States
Synexus Clinical Research US, Inc.
The Villages, Florida, 32162, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
M3 Wake Research - Atlanta
Atlanta, Georgia, 30328, United States
DelRicht Research
Atlanta, Georgia, 30329, United States
AGILE Clinical Research Trials, LLC
Sandy Springs, Georgia, 30328, United States
Javara - Privia Medical Group Georgia - Savannah
Savannah, Georgia, 31406, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, 30291, United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814, United States
Chicago Clinical Research Institute Inc.
Chicago, Illinois, 60607, United States
DM Clinical Research - Chicago
Melrose Park, Illinois, 60160, United States
Koch Family Medicine
Morton, Illinois, 61550, United States
Accellacare - DuPage
Oak Lawn, Illinois, 60453, United States
The South Bend Clinic /Avacare
South Bend, Indiana, 46617, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Velocity Clinical Research, Sioux City
Sioux City, Iowa, 51106, United States
AMR Clinical
El Dorado, Kansas, 67042, United States
Johnson County Clinical Trials
Lenexa, Kansas, 66219, United States
AMR Clinical
Newton, Kansas, 67114, United States
Tekton Research, LLC.
Wichita, Kansas, 67218, United States
AMR Clinical
Wichita, Kansas, 67226, United States
AMR Clinical
Lexington, Kentucky, 40509, United States
DelRicht Research
New Orleans, Louisiana, 70115, United States
Velocity Clinical Research - New Orleans
New Orleans, Louisiana, 70119, United States
Pharmaron
Baltimore, Maryland, 21201, United States
Velocity Clinical Research, Rockville
Rockville, Maryland, 20854, United States
DM Clinical Research - Boston
Brookline, Massachusetts, 02446, United States
Walgreens Clinical Trials - Malden, MA
Malden, Massachusetts, 02148, United States
ActivMed Practices and Research
Methuen, Massachusetts, 01844, United States
Henry Ford St. John Hospital
Grosse Pointe Woods, Michigan, 48236, United States
Great Lakes Research Institute
Southfield, Michigan, 48075, United States
Revival Research Institute, LLC
Southfield, Michigan, 48075, United States
DM Clinical Research - Detroit
Southfield, Michigan, 48076, United States
Clinical Research Institute
Minneapolis, Minnesota, 55402, United States
Velocity Clinical Research, Gulfport
Gulfport, Mississippi, 39503, United States
Clinical Research Professionals
Chesterfield, Missouri, 63005, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Sundance Clinical Research, LLC
St Louis, Missouri, 63141, United States
Sundance Clinical Research
St Louis, Missouri, 63141, United States
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, 68803, United States
Be Well Clinical Studies - Lincoln
Lincoln, Nebraska, 68516, United States
Velocity Clinical Research, Norfolk
Norfolk, Nebraska, 68701, United States
Quality Clinical Research
Omaha, Nebraska, 68114, United States
M3 Wake Research - Las Vegas Wellness Way
Las Vegas, Nevada, 89106, United States
DM Clinical Research - Jersey City
Jersey City, New Jersey, 07306, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102, United States
DM Clinical Research - Albuquerque
Albuquerque, New Mexico, 87106, United States
AXCES Research Group, LLC
Santa Fe, New Mexico, 87505, United States
Drug Trials America
Hartsdale, New York, 10530, United States
Rochester Clinical Research, LLC
Rochester, New York, 14609, United States
Accellacare - Cary
Cary, North Carolina, 27518, United States
Javara - Tryon Medical Partners
Charlotte, North Carolina, 28210, United States
Duke Vaccine and Trials Unit
Durham, North Carolina, 27703, United States
Accellacare - Hickory
Hickory, North Carolina, 28601, United States
Monroe Biomedical Research
Monroe, North Carolina, 28112, United States
Centricity Research New Bern Multispecialty
New Bern, North Carolina, 28562, United States
Eximia Research - NC, LLC
Raleigh, North Carolina, 27607, United States
Accellacare - Raleigh
Raleigh, North Carolina, 27609, United States
M3 Wake Research, Inc.
Raleigh, North Carolina, 27612, United States
Accellacare - Rocky Mount
Rocky Mount, North Carolina, 27804, United States
Accellacare - Salisbury
Salisbury, North Carolina, 28144, United States
Accellacare - Piedmont
Statesville, North Carolina, 28625, United States
Trial Management Associates - Wilmington - Floral Parkway
Wilmington, North Carolina, 28403, United States
Accellacare - Winston-Salem
Winston-Salem, North Carolina, 27103, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
Cincinnati Children's Hospital Medical Center Vaccine Research Center
Cincinnati, Ohio, 45206, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060, United States
Epic Medical Research - Chickasha
Chickasha, Oklahoma, 73018, United States
Tekton Research, LLC.
Edmond, Oklahoma, 73013, United States
Tekton Research, LLC.
Moore, Oklahoma, 73160, United States
AMR Clinical
Norman, Oklahoma, 73069, United States
Tekton Research, LLC.
Yukon, Oklahoma, 73099, United States
Velocity Clinical Research, Medford
Medford, Oregon, 97504, United States
Central Erie Primary Care
Erie, Pennsylvania, 16508, United States
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, 02818, United States
TMA Headlands LLC (d/b/a Trial Management Associates)
Myrtle Beach, South Carolina, 29572, United States
Coastal Carolina Research Center
North Charleston, South Carolina, 29405, United States
M3 Wake Research - Chattanooga
Chattanooga, Tennessee, 37421, United States
AMR Clinical
Knoxville, Tennessee, 37909, United States
Accellacare US Inc., d/b/a Accellacare of Knoxville
Knoxville, Tennessee, 37912, United States
Elligo Clinical Research Center
Austin, Texas, 78704, United States
Orion Clinical Research
Austin, Texas, 78759, United States
Velocity Clinical Research, Austin
Austin, Texas, 78759, United States
Headlands Horizons, LLC dba Headlands Research-Brownsville
Brownsville, Texas, 78526, United States
Epic Medical Research - Carrollton
Carrollton, Texas, 75006, United States
Lonestar Clinical Research - Dallas
Dallas, Texas, 75243, United States
Headlands Research-El Paso
El Paso, Texas, 79902, United States
Cedar Health Research - Euless
Euless, Texas, 76040, United States
Mercury Clinical Research (Administrative Office - Archival Purposes)
Houston, Texas, 77054, United States
DM Clinical Research- Cyfair
Houston, Texas, 77065, United States
DM Clinical Research - Bellaire
Houston, Texas, 77081, United States
Mercury Clinical Research - Santa Clara Family Clinic
Houston, Texas, 77087, United States
DM Clinical Research - Dallas
Irving, Texas, 75061, United States
SMS Clinical Research
Mesquite, Texas, 75149, United States
Epic Medical Research - Mesquite
Mesquite, Texas, 75150, United States
LinQ Research
Pearland, Texas, 77584, United States
ACRC Trials
Plano, Texas, 75024, United States
ACRC Trials
Plano, Texas, 75093, United States
Avacare
San Angelo, Texas, 76903, United States
IMA Clinical Research San Antonio
San Antonio, Texas, 78229, United States
Endeavor Clinical Trials
San Antonio, Texas, 78240, United States
DM Clinical Research - Sugar Land
Sugar Land, Texas, 77478, United States
Sugar Lakes Family Practice, PA
Sugar Land, Texas, 77479, United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Tomball, Texas, 77375, United States
Cope Family Medicine / Avacare
Bountiful, Utah, 84010, United States
J. Lewis Research, Inc. / Foothill Family Clinic Draper
Draper, Utah, 84020, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, 84109, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, 84121, United States
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, 84088, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
AMR Clinical
Norfolk, Virginia, 23502, United States
Tidewater Clinical Research, LLC
Norfolk, Virginia, 23502, United States
Clinical Research Partners, LLC
Richmond, Virginia, 23226, United States
Eastside Research Associates
Redmond, Washington, 98052, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2025
First Posted
December 24, 2025
Study Start
December 10, 2025
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share