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A Phase 3, Randomized, Double-Blind, Active-Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Subjects 50 Years of Age and Older With Immunobridging to Subjects 18-49 Years of Age

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Trial Profile

A Phase 3, Randomized, Double-Blind, Active-Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Subjects 50 Years of Age and Older With Immunobridging to Subjects 18-49 Years of Age

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Apr 2026

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At a glance

  • Drugs VAX 31 (Primary)
  • Indications Pneumococcal infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Acronyms OPUS-1
  • Sponsors Vaxcyte

Most Recent Events

  • 23 Mar 2026 Status changed from recruiting to active, no longer recruiting.
  • 18 Mar 2026 According to a Vaxcyte media release, topline data from the OPUS-1 pivotal noninferiority trial is expected in Q4 2026.
  • 18 Mar 2026 According to a Vaxcyte media release, VAX-31 high dose has been advanced into Comprehensive Phase 3 Adult Program on the basis of positive results from Phase 1/2 Study in Adults Aged 50 and Older.

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