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A Phase 1/2, Randomized, Observer-Blind, Dose-Finding, Active-Controlled, Parallel-Group, Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 31-Valent Pneumococcal Conjugate Vaccine (VAX-31) in Healthy Adults Aged 50 Years and Older

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Trial Profile

A Phase 1/2, Randomized, Observer-Blind, Dose-Finding, Active-Controlled, Parallel-Group, Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 31-Valent Pneumococcal Conjugate Vaccine (VAX-31) in Healthy Adults Aged 50 Years and Older

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 01 Oct 2025

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At a glance

  • Drugs VAX 31 (Primary) ; Pneumococcal 20-valent conjugate vaccine
  • Indications Pneumococcal infections
  • Focus Adverse reactions
  • Sponsors Vaxcyte

Most Recent Events

  • 06 Aug 2025 According to a Vaxcyte media release, In May 2025, the FDA expanded the adult BTD for VAX-31 to include the prevention of pneumonia in addition to the prevention of IPD based on the positive topline results from the VAX-31 adult Phase 1/2 study, indicating that VAX-31 may demonstrate substantial improvement over existing therapies.
  • 07 May 2025 According to a Vaxcyte media release, company will announce topline safety, tolerability and immunogenicity data in 2026.
  • 12 Nov 2024 According to a Vaxcyte media release, the FDA clearance of the VAX-31 infant IND application was supported by the positive topline safety, tolerability and immunogenicity results from the VAX-31 adult Phase 1/2 study.

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