At a glance
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A Phase 3, Open-label, Randomized, Controlled, Multicountry Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With FLU HD Vaccine in Adults Aged 65 Years and Above
In Brief
A Phase 3 clinical trial evaluating RSVPreF3 OA investigational vaccine and FLU HD vaccine for Respiratory Syncytial Virus Infections. Completed, enrolled 1,029 participants across 46 sites.
Detailed Summary
The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when co-administered with the high dose quadrivalent influenza (FLU HD) vaccine in adults aged 65 years and above compared to separate administration of the vaccines.
Study Details
Timeline
Interventions
RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
FLU HD vaccine administered intramuscularly in the deltoid region of the dominant arm (Co-Ad Group) or the non-dominant arm (Control Group).