Return to Search Results
Print

Purpose

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).

Conditions

Eligibility

Eligible Ages
Between 50 Years and 64 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BNT162b2 Vaccine
  • Biological: BNT162b2 Vaccine
    Single dose
Placebo Comparator
Placebo
  • Biological: Placebo
    Single dose

Recruiting Locations

Medical Affiliated Research Center
Huntsville 4068590, Alabama 4829764 35801

Velocity Clinical Research, San Bernardino
San Bernardino 5391710, California 5332921 92408

Artemis Institute for Clinical Research
San Diego 5391811, California 5332921 92103

Diablo Clinical Research, Inc.
Walnut Creek 5406990, California 5332921 94598

Tekton Research, LLC.
Longmont 5579276, Colorado 5417618 80501

Clinical Research Consulting
Milford 4838652, Connecticut 4831725 06460

Las Mercedes Medical Research
Hialeah 4158476, Florida 4155751 33012

Miami Dade Medical Research Institute, LLC
Miami 4164138, Florida 4155751 33176

Palm Springs Community Health Center
Miami Lakes 4164186, Florida 4155751 33014

East-West Medical Research Institute
Honolulu 5856195, Hawaii 5855797 96814

AMR Clinical
Newton 4276248, Kansas 4273857 67114

DelRicht Research
New Orleans 4335045, Louisiana 4331987 70115

Clinical Research Professionals
Chesterfield 4381072, Missouri 4398678 63005

Accellacare - Raleigh
Raleigh 4487042, North Carolina 4482348 27609

CTI Clinical Research Center
Cincinnati 4508722, Ohio 5165418 45212

Tekton Research, LLC.
Yukon 4556165, Oklahoma 4544379 73099

Orion Clinical Research
Austin 4671654, Texas 4736286 78759

SMS Clinical Research
Mesquite 4710826, Texas 4736286 75149

DM Clinical Research - Sugar Land
Sugar Land 4734825, Texas 4736286 77478

J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City 5780993, Utah 5549030 84109

J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City 5780993, Utah 5549030 84121

Charlottesville Medical Research
Charlottesville 4752031, Virginia 6254928 22911

AMR Clinical
Norfolk 4776222, Virginia 6254928 23502

More Details

NCT ID
NCT07300839
Status
Recruiting
Sponsor
BioNTech SE

Study Contact

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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.