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A Phase 3, observer-blind, randomized, placebo controlled study to evaluate the non inferiority of the immune response and safety of the RSVPreF3 OA investigational vaccine in adults 50-59 years of age, including adults at increased risk of respiratory syncytial virus lower respiratory tract disease, compared to older adults ≥60 years of age

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A Phase 3, observer-blind, randomized, placebo controlled study to evaluate the non inferiority of the immune response and safety of the RSVPreF3 OA investigational vaccine in adults 50-59 years of age, including adults at increased risk of respiratory syncytial virus lower respiratory tract disease, compared to older adults ≥60 years of age

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Mar 2025

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At a glance

  • Drugs Respiratory syncytial virus vaccine adjuvanted (Primary)
  • Indications Respiratory syncytial virus infections
  • Focus Pharmacodynamics; Registrational
  • Acronyms RSV OA-ADJ-018
  • Sponsors GlaxoSmithKline; GSK

    • Most Recent Events

    • 05 Nov 2024 According to a GSK plc media release, AREXVY (respiratory syncytial virus vaccine - recombinant, AS01E adjuvanted) has been approved in Canada for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 50-59 years of age who are at increased risk for RSV disease on basis of results of this trial.Approval of an expanded age indication for AREXVY in Canada follows similar approvals in the US and the EU.
    • 07 Jun 2024 According to a GSK plc media release, the US Food and Drug Administration (FDA) has approved AREXVY (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50 through 59 years of age who are at increased risk.
    • 02 May 2024 This trial has been completed in Germany, according to European Clinical Trials Database record.

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