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COMPLETED
NCT06551181
PHASE3

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2620

Start Date

2024-08-05

Completion Date

2025-09-15

Last Updated

2026-05-19

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

RSVPreF3 OA investigational vaccine

One dose of the RSVPreF3 OA investigational vaccine is administered intramuscularly at Day 1.

DRUG

Placebo (Saline solution)

One dose of placebo is administered intramuscularly at Day 1.

Locations (40)

GSK Investigational Site

Shanghai, Putuo, China

GSK Investigational Site

Shanghai, Putuo, China

GSK Investigational Site

Shanghai, Shanghai Municipality, China

GSK Investigational Site

Shanghai, China

GSK Investigational Site

Shanghai, China

GSK Investigational Site

Shanghai, China

GSK Investigational Site

Shanghai, China

GSK Investigational Site

Espoo, Finland

GSK Investigational Site

Helsinki, Finland

GSK Investigational Site

Kokkola, Finland

GSK Investigational Site

Oulu, Finland

GSK Investigational Site

Seinäjoki, Finland

GSK Investigational Site

Tampere, Finland

GSK Investigational Site

Turku, Finland

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Elblag, Poland

GSK Investigational Site

Katowice, Poland

GSK Investigational Site

Katowice, Poland

GSK Investigational Site

Krakow, Poland

GSK Investigational Site

Lodz, Poland

GSK Investigational Site

Lublin, Poland

GSK Investigational Site

Sochaczew, Poland

GSK Investigational Site

Warsaw, Poland

GSK Investigational Site

Wroclaw, Poland

GSK Investigational Site

Guri-si, South Korea

GSK Investigational Site

Incheon, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Ávila, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Burgos, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Salamanca, Spain

GSK Investigational Site

Valladolid, Spain

GSK Investigational Site

Belfast, United Kingdom

GSK Investigational Site

Blackpool, United Kingdom

GSK Investigational Site

Bristol, United Kingdom

GSK Investigational Site

Cambridgeshire, United Kingdom

GSK Investigational Site

Eynsham, United Kingdom

GSK Investigational Site

Hounslow, United Kingdom

GSK Investigational Site

Witney, United Kingdom