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