At a glance
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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
In Brief
A Phase 3 clinical trial evaluating RSVPreF3 OA investigational vaccine and Placebo (Saline solution) for Respiratory Syncytial Virus Infections. Completed, enrolled 2,620 participants across 40 sites in 7 countries.
Detailed 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.
Study Details
Timeline
Interventions
One dose of the RSVPreF3 OA investigational vaccine is administered intramuscularly at Day 1.
One dose of placebo is administered intramuscularly at Day 1.