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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: 29 Dec 2024

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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

    • 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.
    • 12 Nov 2024 According to a Vaxcyte media release, FDA has granted Breakthrough Therapy Designation to VAX-31 in the adult population for the prevention of invasive pneumococcal disease (IPD) in adults positive topline results from the VAX-31 Phase 1/2 study in adults. Based on these results the Company selected VAX-31 to exclusively advance to an adult Phase 3 program.
    • 19 Sep 2024 Status changed from active, no longer recruiting to completed.

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