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Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Immunobridging to Adults 18-49

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv4
  2. Trial status changed: Recruiting → Active, Not Recruiting
    • Enrollment target: estimated 4000 to confirmed 4049
    • Site details revised at 30 of 30 sites
    v3
  3. Site details revised at 4 of 30 sitesv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The primary objectives of this study are to evaluate the safety, tolerability, immunologic noninferiority (for shared serotypes) and immunologic superiority (for novel serotypes) of VAX-31 compared to PCV21 and PCV20 in adults ≥50 years of age, and to bridge the immune responses induced by VAX-31 in adults 50-64 years of age to adults 18-49 years of age.
Trial Details
NCT Number NCT07284654
Lead Sponsor Vaxcyte, Inc.
Conditions
(from sponsor)		 Pneumococcal Vaccines
Related terms Pneumococcal Infections, Pneumonia
Enrollment 4,049 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov