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
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.
Eligibility
- Age range
- 18–64 years
- Sex
- All
- Healthy volunteers
- Yes
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.