NCT06551181

A Study on the Immune Response, Safety and the Occurrence of Respiratory Syncytial Virus (RSV)-Associated Respiratory Tract Illness After Administration of RSV OA Vaccine in Adults 60 Years and Older

A Phase 3, Randomized, Controlled, Partially Blind, Immuno-bridging Study to Evaluate Immunogenicity, Reactogenicity, Safety and the Occurrence of RSV Associated Respiratory Tract Illness After Administration of a Single Dose of GSK's RSVPreF3 OA Investigational Vaccine in Adults Aged 60 Years and Older

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,621 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of the current study is to evaluate the immune response of the RSVPreF3 OA investigational vaccine in older adults (OA) at least (\>=) 60 years of age (YOA) in China compared to OA in the same age range to be enrolled from overseas countries that participated in the RSV OA=ADJ-006 (NCT04886596) study, since the vaccine efficacy against lower respiratory tract disease (LRTD) has been demonstrated following a single dose of the RSVPreF3 OA investigational vaccine in the global efficacy study RSV OA=ADJ-006. In addition, the safety (in all participants) , reactogenicity and occurrence of RSV-associated acute respiratory illness (ARI) (in study participants in China only) after administration of the vaccine are also assessed in the current study. No ARI surveillance will be conducted for the overseas participants.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
BIOLOGICAL	RSVPreF3 OA investigational vaccine	One dose of the RSVPreF3 OA investigational vaccine is administered intramuscularly at Day 1.
DRUG	Placebo	One dose of placebo is administered intramuscularly at Day 1.

Timeline

• Start date: 2024-08-05
• Primary completion: 2025-04-24
• Completion: 2025-09-15
• First posted: 2024-08-13
• Last updated: 2026-02-11

Locations

40 sites across 7 countries: China, Finland, Japan, Poland, South Korea, Spain, United Kingdom