drugset / Trial / NCT07220109

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

NCT07220109

Phase 3 Recruiting 750 enrolled GlaxoSmithKline
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The study will evaluate the immune response of the RSVPreF3 OA investigational vaccine in Chinese adults 18 to 59 years of age (YOA) who are at increased risk of respiratory syncytial virus (RSV) disease, in comparison with the immune response generated in older adults 60 YOA and above from the 219815 (RSV OA=ADJ-021; NCT06551181) study following a single dose of the RSVPreF3 OA vaccine. In addition, the safety and reactogenicity of the vaccine will also be assessed.

Timeline

Start
2025-10-29
Primary completion
2026-09-25
Completion
2027-03-12

Drugs

EvaluationDrugModalityDoseRoute
Subject RSVPreF3 OA vaccine Vaccine Intramuscular