At a glance
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A Phase 3, Randomized, Open-label, Multi-country Study to Evaluate the Immunogenicity, Safety, Reactogenicity and Persistence of a Single Dose of the RSVPreF3 OA Investigational Vaccine and Different Revaccination Schedules in Adults Aged 60 Years and Above
In Brief
A Phase 3 clinical trial evaluating RSVPreF3 OA investigational vaccine for Respiratory Syncytial Virus Infections. Active but no longer recruiting, targeting 1,720 participants across 45 sites in 5 countries.
Detailed Summary
The purpose of this study is to assess the safety, reactogenicity, immunogenicity and long-term persistence of immune response up to 5 years following a single dose vaccination of GSK's investigational vaccine RSVPreF3 OA, in adults aged 60 years and above. The study will also evaluate the immunogenicity, safety and reactogenicity of additional vaccine doses given according to different revaccination schedules.
Study Details
Timeline
Interventions
RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.