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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

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Trial Profile

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

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 31 Mar 2026

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At a glance

  • Drugs Respiratory syncytial virus vaccine adjuvanted (Primary)
  • Indications Respiratory syncytial virus infections
  • Focus Pharmacodynamics; Registrational
  • Acronyms AReSVi 004; RSV OA-ADJ-004
  • Sponsors GlaxoSmithKline; GlaxoSmithKline Biologicals; GSK

Most Recent Events

  • 20 Mar 2026 Planned End Date changed from 15 Feb 2027 to 19 Feb 2027.
  • 20 Dec 2023 Planned End Date changed from 24 May 2024 to 25 May 2026.
  • 14 Dec 2023 Interim Results on humoral and cell-mediated immunogenicity, reactogenicity, and safety until one year post-dose 1, published in the Journal of Infectious Diseases

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