Evaluation of Safety and Effects of Updated BNT162b2 COVID-19 Vaccine Compared to Tdap Vaccine in Healthy Adults Ages 18 to 64

What this Trial Is About

Researchers are studying the safety and effects of an updated COVID-19 vaccine called BNT162b2 in healthy adults aged 18 to 64 years. This study compares the BNT162b2 vaccine to a Tdap vaccine, which protects against tetanus, diphtheria, and pertussis. Participants are medically stable adults without recent COVID-19 infection or vaccination and without conditions that increase their risk of severe COVID-19. Participants will be randomly assigned to receive a single injection of either the variant-adapted BNT162b2 vaccine or the Tdap vaccine on Day 1 of the study. Neither the participants nor the study team will know which injection is administered. The study uses a parallel design and lasts for about 12 months. During the study, participants will be monitored for local and systemic reactions within 7 days after vaccination, adverse events through 1 month, and serious adverse events for up to 12 months. Researchers will also measure SARS-CoV-2 spike protein levels up to 12 months post-vaccination. The study includes regular safety assessments and follow-up visits over the year-long participation period.

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