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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Mar 2026

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At a glance

Most Recent Events

  • 10 Feb 2026 According to a GSK media release, the regulatory application for Arexvy has been accepted for review by China CDE based on the positive results from this study. A regulatory decision is expected in 2027.
  • 10 Feb 2026 According to a GSK media release, primary endpoint (Percentage of participants showing group seroresponse for RSV-B in RSV OA vaccine Group (Overseas) and RSV OA vaccine Group (China), and between-group differences) has been met.
  • 10 Feb 2026 According to a GSK media release, primary endpoint (RSV-B neutralization titers expressed as geometric mean titers (GMTs) in RSV OA vaccine Group (Overseas) and RSV OA vaccine Group (China), and between-group GMT ratios)) has been met.

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