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RECRUITING
NCT07730450
PHASE4

A Study to Learn About a COVID-19 Vaccine in Healthy Adults 18 Through 64 Years of Age

Sponsor: BioNTech SE

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

BNT162b2 Vaccine

Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1.

BIOLOGICAL

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