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A Phase 3b, Open-label Study to Evaluate the Non-inferiority of the Immune Response and to Evaluate the Safety of the RSVPreF3 OA Investigational Vaccine in Adults 18-49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults ≥60 Years of Age

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Trial Profile

A Phase 3b, Open-label Study to Evaluate the Non-inferiority of the Immune Response and to Evaluate the Safety of the RSVPreF3 OA Investigational Vaccine in Adults 18-49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults ≥60 Years of Age

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Mar 2026

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At a glance

Most Recent Events

  • 13 Mar 2026 According to GSK media release, company announced that the US Food and Drug Administration (FDA) has expanded the approved age indication of AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) to adults aged 18 to 49 years at increased risk for lower respiratory tract disease (LRTD) caused by RSV.
  • 03 Apr 2025 Status changed from active, no longer recruiting to completed.
  • 24 Feb 2025 Planned End Date changed from 28 Apr 2025 to 14 Apr 2025.

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