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Phase 3 trial assessing safety, tolerability and immunogenicity of VAX 24

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Trial Profile

Phase 3 trial assessing safety, tolerability and immunogenicity of VAX 24

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 08 Aug 2024

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At a glance

  • Drugs VAX-24 (Primary)
  • Indications Otitis media; Pneumococcal infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Sponsors Vaxcyte

Most Recent Events

  • 06 Aug 2024 According to a Vaxcyte media release, Initiate balance of expected Phase 3 studies in 2025 and 2026.
  • 27 Feb 2024 According to Vaxcyte media release, based on end of phase 2 meeting the the Company believes there is agreement with the FDA on the clinical design of the adult Phase 3 program, including the approximate overall number of subjects, the primary and secondary endpoints for the pivotal, non-inferiority study as well as confirmation that the planned immunogenicity analyses are sufficient to support licensure and an efficacy study is therefore not required.
  • 04 Jan 2024 According to Vaxcyte media release, Company is planning for initiation of VAX-24 adult Phase 3 Pivotal, Non-Inferiority Study in second half of 2024; Topline data expected in second half of 2025

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