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Antibody Persistence And Long Term Safety Of A Chikungunya Virus Vaccine (VLA1553)

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 0 → 1 primary endpoints
See other at-risk trials from Valneva Austria GmbH

Record History

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  1. Primary endpoint(s) modified
    • Results first posted: Jul 9, 2026
    v12
  2. Primary completion date changed from estimate of Dec 2025 to Mar 3, 2023
    • Secondary endpoints revised (6)
    • Primary endpoint revised
    v11
  3. Re-verified, no change to tracked fieldsv10
  4. Study sites revised (10)v9
  5. Primary endpoint revisedv8 Show 6 more changesShow less
    • Study sites: 11 to 10
    • Study completion date: Dec 2025 to May 2031
    • Eligibility criteria revised
    • Secondary endpoints revised (6)
    • Study description expanded, about 5 words
    • Study title shortened, about 1 word
Show 6 earlier versionsHide 6 earlier versions
  1. Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Enrollment target: estimated 375 to confirmed 363
    v7
  2. Eligibility criteria expanded, about 7 wordsv6
  3. 4 versions Re-verified since Apr 16, 2021, no change to tracked fieldsv2-v5
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
In this open-label Phase 3b, single arm trial, persistence of antibodies and long term safety will be evaluated in up to 375 participants rolled over from trial VLA1553-301 (NCT number: NCT04546724).
Trial Details
NCT Number NCT04838444
Lead Sponsor Valneva Austria GmbH
Conditions
(from sponsor)		 Chikungunya Virus Infection
Related terms Chikungunya Fever
Enrollment 363 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov