A Study to Assess the Safety, Tolerability, and Immunogenicity of RSVpreF in Older Adults in Korea

Summary

The goal of this clinical trial is to quantify the immune response in older Korean adults after a RSVpreF vaccination. It will also learn about the safety and tolerability of RSVpreF vaccination. The main questions it aims to answer are: What local reactions and systemic events do participants have after a RSVpreF vaccination? What medical problems do participants have after a RSVpreF vaccination? Researchers will compare RSVpreF to a placebo (a look-alike substance that contains no RSVpreF) to see if RSVpreF is safe and well tolerated. It will also examine the change in antibody levels (immune responses) before and after vaccination. Participants will: Receive the RSVpreF vaccination or a placebo injection once at Visit 1. Visit the clinic a month later for a checkup and tests. Receive a phone call 1 week after vaccination, and 2 months after vaccination, for health checks. Keep a diary of their symptoms for 7 days after vaccination.

Timeline

Start

2024-10-07

Primary completion

2025-02-03

Completion

2025-02-03

Drugs

Indications