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A Phase III, Randomized, Controlled, Observer-blind Study to Demonstrate Effectiveness, Immunogenicity and Safety of GSK's Meningococcal Group B and Combined ABCWY Vaccines When Administered to Healthy Adolescents and Young Adults

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Trial Profile

A Phase III, Randomized, Controlled, Observer-blind Study to Demonstrate Effectiveness, Immunogenicity and Safety of GSK's Meningococcal Group B and Combined ABCWY Vaccines When Administered to Healthy Adolescents and Young Adults

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 May 2025

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At a glance

  • Drugs Meningococcal vaccine groups A B C Y W-135 conjugate (Primary) ; Meningococcal vaccine group B OMV Novartis
  • Indications Meningococcal group B infections; Meningococcal infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational; Therapeutic Use
  • Acronyms MENB REC 2ND GEN-038 (V72_72)
  • Sponsors GlaxoSmithKline; GlaxoSmithKline Biologicals; GSK

Most Recent Events

  • 01 May 2025 Results (n=3651) published in The Lancet Infectious Diseases.
  • 14 Feb 2025 According to GSK media release, company announced that the US Food and Drug Administration (FDA) has approved PENMENVY for use in individuals aged 10 through 25 years. The regulatory application was supported by positive results from this trial.
  • 16 Apr 2024 According to a GlaxoSmithKline media release, the company announced that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for its 5-in-1 meningococcal ABCWY (MenABCWY) vaccine candidate. And the Prescription Drug User Fee Act (PDUFA) action date for a regulatory decision by the US FDA on this application is 14 February 2025.

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