COVID-19Phase 3NCT07300839
A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age
A Phase 3 study testing BNT162b2 Vaccine in people with COVID-19 and SARS-COV-2 Infection, run by BioNTech SE at 196 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-COV-2 Infection
- What is being tested?
- BNT162b2 Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5,240 participants
- Where
- 196 sitesUnited States
- Study dates
- 10 Dec 2025to 22 Sep 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 and contacts
196 sites in 1 country.
196 sites in 1 country
United States196 sites
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102
DM Clinical Research - Albuquerque
Albuquerque, New Mexico, 87106
International Clinical Research - FL, LLC
Altamonte Springs, Florida, 32701
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Pinnacle Research Group, LLC
Anniston, Alabama, 36207
North Alabama Research Center
Athens, Alabama, 35611
M3 Wake Research - Atlanta
Atlanta, Georgia, 30328
DelRicht Research
Atlanta, Georgia, 30329
Elligo Clinical Research Center
Austin, Texas, 78704
Orion Clinical Research
Austin, Texas, 78759
Velocity Clinical Research, Austin
Austin, Texas, 78759
Pharmaron
Baltimore, Maryland, 21201
Simon Williamson Clinic / Synexus Clinical Research US, Inc.
Birmingham, Alabama, 35211
Accel Research Sites - Birmingham Clinical Research Unit
Birmingham, Alabama, 35216
Cope Family Medicine / Avacare
Bountiful, Utah, 84010
DM Clinical Research - Boston
Brookline, Massachusetts, 02446
Headlands Horizons, LLC dba Headlands Research-Brownsville
Brownsville, Texas, 78526
Epic Medical Research - Carrollton
Carrollton, Texas, 75006
Accellacare - Cary
Cary, North Carolina, 27518
Chandler Clinical Trials
Chandler, Arizona, 85224
Javara - Tryon Medical Partners
Charlotte, North Carolina, 28210
Charlottesville Medical Research
Charlottesville, Virginia, 22911
M3 Wake Research - Chattanooga
Chattanooga, Tennessee, 37421
Clinical Research Professionals
Chesterfield, Missouri, 63005
Chicago Clinical Research Institute Inc.
Chicago, Illinois, 60607
Epic Medical Research - Chickasha
Chickasha, Oklahoma, 73018
Velocity Clinical Research, Chula Vista
Chula Vista, California, 91911
Cincinnati Children's Hospital Medical Center Vaccine Research Center
Cincinnati, Ohio, 45206
CTI Clinical Research Center
Cincinnati, Ohio, 45212
Tampa Bay Medical Research
Clearwater, Florida, 33761
Legacy Clinical Trials
Colorado Springs, Colorado, 80909
Cullman Clinical Trials
Cullman, Alabama, 35055
Lonestar Clinical Research - Dallas
Dallas, Texas, 75243
AMR Clinical
Daphne, Alabama, 36526
Hillcrest Medical Research
DeLand, Florida, 32720
Universal Axon Clinical Research, LLC
Doral, Florida, 33166
Suncoast Research Associates
Doral, Florida, 33172
J. Lewis Research, Inc. / Foothill Family Clinic Draper
Draper, Utah, 84020
West Coast Research
Dublin, California, 94568
Duke Vaccine and Trials Unit
Durham, North Carolina, 27703
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, 02818
Tekton Research, LLC.
Edmond, Oklahoma, 73013
AMR Clinical
El Dorado, Kansas, 67042
Headlands Research-El Paso
El Paso, Texas, 79902
Central Erie Primary Care
Erie, Pennsylvania, 16508
Cedar Health Research - Euless
Euless, Texas, 76040
Tekton Research, LLC.
Fort Collins, Colorado, 80525
AMR Clinical
Fort Myers, Florida, 33912
Robert B. Pritt, DO
Fort Myers, Florida, 33912
Triallogix Medical Corporation
Fullerton, California, 92835
Upper Echelon Medical
Fullerton, California, 92835
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, 68803
Henry Ford St. John Hospital
Grosse Pointe Woods, Michigan, 48236
Velocity Clinical Research, Gulfport
Gulfport, Mississippi, 39503
Velocity Clinical Research, Hallandale Beach
Hallandale, Florida, 33009
Drug Trials America
Hartsdale, New York, 10530
Indago Research & Health Center, Inc
Hialeah, Florida, 33012
Las Mercedes Medical Research
Hialeah, Florida, 33012
Accellacare - Hickory
Hickory, North Carolina, 28601
Research Centers of America
Hollywood, Florida, 33024
East-West Medical Research Institute
Honolulu, Hawaii, 96814
Mercury Clinical Research (Administrative Office - Archival Purposes)
Houston, Texas, 77054
DM Clinical Research- Cyfair
Houston, Texas, 77065
DM Clinical Research - Bellaire
Houston, Texas, 77081
Mercury Clinical Research - Santa Clara Family Clinic
Houston, Texas, 77087
Marvel Clinical Research
Huntington Beach, California, 92647
Medical Affiliated Research Center
Huntsville, Alabama, 35801
University of Iowa
Iowa City, Iowa, 52242
DM Clinical Research - Dallas
Irving, Texas, 75061
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
DM Clinical Research - Jersey City
Jersey City, New Jersey, 07306
Health Awareness, LLC
Jupiter, Florida, 33458
AMR Clinical
Knoxville, Tennessee, 37909
Accellacare US Inc., d/b/a Accellacare of Knoxville
Knoxville, Tennessee, 37912
Eximia Research-CA, LLC
La Mesa, California, 91942
M3 Wake Research - Lake City
Lake City, Florida, 32055
M3 Wake Research - Las Vegas Wellness Way
Las Vegas, Nevada, 89106
SRA Trials North
Lauderdale Lakes, Florida, 33313
Johnson County Clinical Trials
Lenexa, Kansas, 66219
AMR Clinical
Lexington, Kentucky, 40509
Be Well Clinical Studies - Lincoln
Lincoln, Nebraska, 68516
Woodland International Research Group, LLC
Little Rock, Arkansas, 72211
Tekton Research, LLC.
Longmont, Colorado, 80501
Velocity Clinical Research, Los Angeles
Los Angeles, California, 90057
Leading Edge Research
Los Angeles, California, 91316
Accel Research Sites - Maitland Clinical Research Unit
Maitland, Florida, 32751
Walgreens Clinical Trials - Malden, MA
Malden, Massachusetts, 02148
Velocity Clinical Research, Medford
Medford, Oregon, 97504
South Florida Research Organization
Medley, Florida, 33166
Optimal Research
Melbourne, Florida, 32934
DM Clinical Research - Chicago
Melrose Park, Illinois, 60160
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060
SMS Clinical Research
Mesquite, Texas, 75149
Epic Medical Research - Mesquite
Mesquite, Texas, 75150
ActivMed Practices and Research
Methuen, Massachusetts, 01844
Flourish Research - Miami, LLC
Miami, Florida, 33135
Florida Pharmaceutical Research & Associates, Inc.
Miami, Florida, 33143
Nuren Medical and Research Center
Miami, Florida, 33144
Advanced Clinical Research - Miami - Southwest 92nd Street
Miami, Florida, 33156
New Horizon Research Center
Miami, Florida, 33165
Entrust Clinical Research
Miami, Florida, 33176
IMIC Medical Research
Miami, Florida, 33176
Miami Dade Medical Research Institute, LLC
Miami, Florida, 33176
Pioneer Clinical Studies
Miami, Florida, 33176
3Sync Research
Miami Lakes, Florida, 33014
Palm Springs Community Health Center
Miami Lakes, Florida, 33014
Angels Clinical Research Institute
Miami Lakes, Florida, 33016
Clinical Research Consulting
Milford, Connecticut, 06460
Clinical Research Institute
Minneapolis, Minnesota, 55402
AMR Clinical
Mobile, Alabama, 36608
ImmuniMet
Modesto, California, 95350
Monroe Biomedical Research
Monroe, North Carolina, 28112
Tekton Research, LLC.
Moore, Oklahoma, 73160
Koch Family Medicine
Morton, Illinois, 61550
TMA Headlands LLC (d/b/a Trial Management Associates)
Myrtle Beach, South Carolina, 29572
Centricity Research New Bern Multispecialty
New Bern, North Carolina, 28562
DelRicht Research
New Orleans, Louisiana, 70115
Velocity Clinical Research - New Orleans
New Orleans, Louisiana, 70119
AMR Clinical
Newton, Kansas, 67114
Velocity Clinical Research, Norfolk
Norfolk, Nebraska, 68701
AMR Clinical
Norfolk, Virginia, 23502
Tidewater Clinical Research, LLC
Norfolk, Virginia, 23502
AMR Clinical
Norman, Oklahoma, 73069
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
Carbon Health - North Hollywood - NoHo West
North Hollywood, California, 91606
Accellacare - DuPage
Oak Lawn, Illinois, 60453
Quality Clinical Research
Omaha, Nebraska, 68114
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
Headlands Research Orlando
Orlando, Florida, 32806
3Sync Research
Palm Springs, Florida, 33461
Innovation Medical Research Center
Palmetto Bay, Florida, 33157
Tropical Clinical Trials
Palmetto Bay, Florida, 33176
LinQ Research
Pearland, Texas, 77584
Suncoast Research Associates
Pembroke Pines, Florida, 33024
DBC Research USA
Pembroke Pines, Florida, 33029
ACRC Trials
Plano, Texas, 75024
ACRC Trials
Plano, Texas, 75093
Empire Clinical Research
Pomona, California, 91767
Progressive Medical Research
Port Orange, Florida, 32127
Eximia Research - NC, LLC
Raleigh, North Carolina, 27607
Accellacare - Raleigh
Raleigh, North Carolina, 27609
M3 Wake Research, Inc.
Raleigh, North Carolina, 27612
Eastside Research Associates
Redmond, Washington, 98052
Clinical Research Partners, LLC
Richmond, Virginia, 23226
Rochester Clinical Research, LLC
Rochester, New York, 14609
Velocity Clinical Research, Rockville
Rockville, Maryland, 20854
Accellacare - Rocky Mount
Rocky Mount, North Carolina, 27804
Peninsula Research Associates
Rolling Hills Estates, California, 90274
Northern California Research - Sacramento
Sacramento, California, 95821
Accellacare - Salisbury
Salisbury, North Carolina, 28144
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, 84109
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, 84121
Avacare
San Angelo, Texas, 76903
IMA Clinical Research San Antonio
San Antonio, Texas, 78229
Endeavor Clinical Trials
San Antonio, Texas, 78240
Velocity Clinical Research, San Bernardino
San Bernardino, California, 92408
Artemis Institute for Clinical Research
San Diego, California, 92123
AGILE Clinical Research Trials, LLC
Sandy Springs, Georgia, 30328
AXCES Research Group, LLC
Santa Fe, New Mexico, 87505
Javara - Privia Medical Group Georgia - Savannah
Savannah, Georgia, 31406
Scottsdale Clinical Trials
Scottsdale, Arizona, 85260
Velocity Clinical Research, Sioux City
Sioux City, Iowa, 51106
The South Bend Clinic /Avacare
South Bend, Indiana, 46617
Great Lakes Research Institute
Southfield, Michigan, 48075
Revival Research Institute, LLC
Southfield, Michigan, 48075
DM Clinical Research - Detroit
Southfield, Michigan, 48076
Washington University School of Medicine
St Louis, Missouri, 63110
Sundance Clinical Research, LLC
St Louis, Missouri, 63141
Sundance Clinical Research
St Louis, Missouri, 63141
GCP Research, Global Clinical professionals
St. Petersburg, Florida, 33705
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905
Accellacare - Piedmont
Statesville, North Carolina, 28625
Clinical Research Atlanta
Stockbridge, Georgia, 30281
DM Clinical Research - Sugar Land
Sugar Land, Texas, 77478
Sugar Lakes Family Practice, PA
Sugar Land, Texas, 77479
Epic Medical Research-Sun City
Sun City, Arizona, 85351
Precision Clinical Research
Sunrise, Florida, 33351
Angels Clinical Research Institute
Tampa, Florida, 33614
Santos Research Center
Tampa, Florida, 33615
Synexus Clinical Research US, Inc.
The Villages, Florida, 32162
Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.
Toluca Lake, California, 91602
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Tomball, Texas, 77375
Noble Clinical Research
Tucson, Arizona, 85704
Synexus Clinical Research US, Inc./Orange Grove Family Practice
Tucson, Arizona, 85741
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, 30291
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Washington Health Institute
Washington D.C., District of Columbia, 20017
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, 84088
Palm Beach Research Center
West Palm Beach, Florida, 33409
Paradigm Clinical Research Centers, LLC
Wheat Ridge, Colorado, 80033
Tekton Research, LLC.
Wichita, Kansas, 67218
AMR Clinical
Wichita, Kansas, 67226
Trial Management Associates - Wilmington - Floral Parkway
Wilmington, North Carolina, 28403
Accellacare - Winston-Salem
Winston-Salem, North Carolina, 27103
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
Tekton Research, LLC.
Yukon, Oklahoma, 73099
About this study
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
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).
Read the 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.
- Conditions
- COVID-19, SARS-COV-2 Infection
- Being tested
- BNT162b2 Vaccine, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNT162b2 VaccineBiological
Single dose
PlaceboBiological
Single dose
| Study group | Role | What they receive |
|---|---|---|
| BNT162b2 Vaccine | Experimental | Not described Receives: Biological: BNT162b2 Vaccine |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants reporting local reactions or systemic events
Measured: From Day 1 up to 7 days after Vaccination
Percentage of participants reporting adverse events
Measured: From Day 1 through 4 weeks after vaccination
Percentage of participants reporting serious adverse events
Measured: From Day 1 through 6 months after vaccination
First episode of confirmed COVID-19 cases
Measured: 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
Measured: From 7 days after vaccination through end of COVID-19 surveillance at least 6 months post-vaccination
Geometric Mean Ratio (GMR)
Measured: From before vaccination to 1 month after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start10 Dec 2025
- Primary completion22 Sep 2026
- Study completion22 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by BioNTech SEThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5,240 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioNTech SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300839
- Sponsor's protocol ID
- C4591081
- Status last verified
- Oct 2026
- First submitted
- 27 Nov 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No