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A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Enrollment target: 905 to 900
    • Site details revised at 1 of 48 sites
    v10
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 900 to confirmed 905
    • Study sites: 54 to 48
    v9
  3. Secondary endpoints: 9 to 3
    • Site details revised at 8 of 54 sites
    v8
  4. Study sites: 55 to 54v7
  5. Study sites revised (55)v6
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  1. Study sites: 48 to 55v5
  2. Enrollment target: 800 to 900v4 Show 5 more changesShow less
    • Primary and study completion dates: Jun 2027 to Dec 2027
    • Interventions: 0.5 mL dose of PCV20 (Biological), 0.5 mL of the high dose VAX-31 (Biological), 0.5 mL of the low dose VAX-31 (Biological), 0.5 mL of the… to 0.5 mL dose of PCV20 (Biological), 0.5 mL of the High-PFS dose VAX-31 (Biological), 0.5 mL of the high dose VAX-31 (Biological), 0.5 mL of…
    • Secondary endpoints: 13 to 9
    • Site details revised at 1 of 48 sites
    • Study arms: 4 to 5
  3. Study sites: 30 to 48v3
  4. Study sites: 10 to 30v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 objective of the study is to evaluate the safety, tolerability, and immunogenicity of 4 injections of VAX-31 (at 4 dose levels) compared to PCV20 in infants at 2, 4, 6, and 12-15 months of age, in addition to receiving routine US concomitant vaccines. Stage 1 of the study will comprise 3 dose ascending cohorts. Stage 2 of the study will enroll approximately 352 subjects. Stage 3 of the study will enroll approximately 500 subjects.
Trial Details
NCT Number NCT06720038
Lead Sponsor Vaxcyte, Inc.
Conditions
(from sponsor)		 Pneumococcal Vaccines
Related terms Pneumococcal Infections, Pneumonia
Enrollment 900 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov