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VAX-31 Phase 3 study

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Trial Profile

VAX-31 Phase 3 study

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 01 Oct 2025

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At a glance

  • Drugs VAX 31 (Primary)
  • Indications Pneumococcal infections
  • Focus Therapeutic Use

Most Recent Events

  • 06 Aug 2025 According to a Vaxcyte media release, subject to the results of the Phase 3 studies, which are expected to read out in 2026 and 2027, the Company plans to submit a BLA shortly following the completion of the last Phase 3 study.
  • 06 Aug 2025 According to a Vaxcyte media release, Initiation of the remaining Phase 3 studies, which are shorter in duration than the non-inferiority study, is planned for 2025 and 2026.
  • 06 Aug 2025 According to a Vaxcyte media release, following interactions with U.S. Food and Drug Administration (FDA) on VAX-31 adult program, including End-of-Phase 2 meeting, company finalizing Phase 3 clinical program to validate VAX-31 as potential new standard-of-Care adult PCV to prevent invasive pneumococcal disease (IPD) and pneumonia.

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