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A Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children.

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

Record History

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  1. Enrollment closed, study ongoing Show 5 more changesShow less
    • Primary and study completion moved earlier from Dec 2028 to Sep 2028
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: details revised at 10 of 11 entries
    • Site details revised at 15 of 15 sites
    • Publications: details revised at 3 of 3 entries
  2. Primary endpoints: 4 to 3
    • Study sites: 9 to 15
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: 10 to 11
    v3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary endpoints revised (4)
    • Study sites: 2 to 9
    • Start date changed from estimate of Jun 2025 to Jun 5, 2025
    • Secondary endpoints revised (10)
    • Study title revised
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this multi-center, randomized, double-blind, placebo-controlled study is to evaluate the safety and immunogenicity of CHIKV VLP Vaccine in children 1 to \<12 years of age.
Trial Details
NCT Number NCT07003984
Lead Sponsor Bavarian Nordic
Conditions
(from sponsor)		 Chikungunya Virus
Related terms Chikungunya Fever
Enrollment 720 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov