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

NCT07730450

RecruitingPhase 4

Sponsor: BioNTech SE

Conditions: COVID-19 Vaccines

Interventions: BNT162b2 Vaccine, Tdap Vaccine

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 64 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria

\- Healthy participants 18 through 64 years of age who do not have medical conditions that put them at a higher risk for severe COVID-19.

Key Exclusion Criteria

* Participants who tested positive for COVID-19 within 6 months (180 days) prior to Visit 1
* Participants who have recently received a vaccine, or plan to receive a nonstudy COVID-19 or comparator vaccine during participation.

The complete list of inclusion and exclusion criteria are listed in the protocol.
Locations (5)
  • Walnut Creek, California, United States
  • Miami Lakes, Florida, United States
  • Honolulu, Hawaii, United States
  • Durham, North Carolina, United States
  • Salt Lake City, Utah, United States