A Phase 3, Multicenter, Open-Label Study to Evaluate Safety, Tolerability, and Immune Response to RSVpreF Vaccine in Adults at High Risk of Severe RSV Disease in Japan

What this Trial Is About

Researchers are evaluating the immune response and safety of the RSVpreF vaccine in adults aged 18 to 59 years who have certain chronic health conditions putting them at higher risk of severe respiratory syncytial virus (RSV) disease. This Phase 3, multicenter, open-label study is conducted in Japan, aiming to better understand how this vaccine affects the immune system in this specific adult population. Participants will receive a single dose of the RSVpreF vaccine after screening and eligibility confirmation. The study involves one main treatment group where all enrolled participants receive the vaccine. Following vaccination, participants will report any side effects daily using an electronic device for a week or until symptoms resolve. They will return about one month later for a blood test and safety evaluation. Additionally, a follow-up phone call will be conducted approximately two months after vaccination to check on participants' health. Throughout the two-month study period, participants will undergo blood sampling before and one month after vaccination to measure immune responses. Safety is closely monitored by tracking local and systemic reactions within seven days, adverse events up to one month, and serious adverse events through the entire study. The study team also collects immunogenicity data comparing neutralizing antibody levels against RSV subgroups A and B. Overall, participants will need to visit the research site at least twice and complete a phone follow-up, ensuring comprehensive monitoring of vaccine effects and safety.

A Study to Learn Safety and Immune Response to Study Vaccine -RSVpreF in Adults at High Risk of Severe RSV Disease.