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A Study to Learn About a COVID-19 Vaccine in Healthy Adults 18 Through 64 Years of Age
Sponsor: BioNTech SE
Summary
The purpose of this study is to learn about the safety and effects of an updated COVID-19 vaccine (called BNT162b2) in adults 18 to 64 years of age. This study is seeking participants who: * are medically stable * have not had a recent COVID-19 infection * have not had a recent vaccination * do not have medical conditions that increase their risk of complications from COVID-19 All participants in this study will randomly receive 1 injection into their arm of either: * BNT162b2 vaccine which targets COVID-19 and is selected for the 2026-2027 COVID-19 season, or * Tdap vaccine which targets tetanus, diphtheria, and pertussis (whooping cough). The study team and participants will not know which injection they receive. We will evaluate safety and SARS-CoV-2 spike protein levels in people receiving each of these vaccines. Participants will be in the study for about 12 months.
Official title: A PHASE 4, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY-UNBLINDED STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF A BNT162B2 RNA-BASED, VARIANT-ADAPTED VACCINE CANDIDATE AGAINST SARS-COV-2 AND EVALUATE THE CIRCULATING SARS-COV-2 SPIKE PROTEIN LEVEL IN HEALTHY PARTICIPANTS 18 THROUGH 64 YEARS OF AGE
Key Details
Gender
All
Age Range
18 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-07-23
Completion Date
2027-08-20
Last Updated
2026-08-07
Healthy Volunteers
Yes
Conditions
Interventions
BNT162b2 Vaccine
Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1.
Tdap Vaccine
Participants will receive a single injection containing Tdap on Day 1.
Locations (5)
Diablo Clinical Research, LLC dba Flourish Research
Walnut Creek, California, United States
Palm Springs Community Health Center
Miami Lakes, Florida, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Duke Vaccine and Trials Unit
Durham, North Carolina, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, United States