Phase 12 Study to Assess Safety and Immune Response of GSKs RSVhMPV Combination and hMPV Vaccines Given as a Single Dose in Adults Aged 18-49 and 60-80 Years

What this Trial Is About

Researchers are studying the safety, side effects, and immune responses of different versions of investigational vaccines targeting Respiratory Syncytial Virus RSV and Human Metapneumovirus hMPV in younger and older adults. The study is a Phase 12 clinical trial evaluating these vaccines in adults aged 18 to 49 years and 60 to 80 years. The goal is to understand how the vaccines perform in these age groups to help prevent RSV and hMPV infections. Participants receive a single intramuscular dose of one of several investigational RSVhMPV combination vaccines or hMPV vaccines at the start of the study. There are multiple vaccine formulations with varying doses for both younger and older adults. Control vaccines and placebos are also administered for comparison. The vaccines are given according to a single-dose schedule in two phases Phase 1 and Phase 2. Throughout the study, participants are monitored for local and systemic side effects from Day 1 to Day 7, and for any other adverse events up to 12 months or longer depending on their group. Blood tests measure immune responses to the vaccines at several time points including before vaccination and up to one month after. Researchers also evaluate serious side effects and immune-related disorders for up to 24 months in selected groups. Participants complete electronic diaries and attend follow-up visits to help track safety and immune responses over time.

A Study of Investigational RSV/hMPV Combination and Investigational hMPV Vaccines in Younger and Older Adults