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Immunogenicity and Safety of I-HAV in Healthy Thai Children and Adolescents Lacking Protective Antibody After L-HAV

Study acronym: HAV-2
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Aug 31, 2025 to Jun 22, 2025
    • Study completion date: Sep 30, 2025 to Jul 31, 2026
    • Site details revised
    v4
  2. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Start date changed from estimate of May 18, 2025 to May 25, 2025
    • Site details revised
    • Eligibility criteria shortened, about 1 word
    • Study description expanded, about 4 words
  3. Primary endpoints revised (2)
    • Eligibility criteria expanded, about 1 word
    • Study description expanded, about 2 words
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Hepatitis A virus (HAV) remains a common infection in Thai children. Two HAV vaccines are available: inactivated vaccine (I-HAV, 2 doses) and live-attenuated vaccine (L-HAV, single dose), but neither is included in Thailand's national immunization program. Our previous randomized, active-controlled, open-label, non-inferiority trial trial found that some participants remained seronegative after one L-HAV dose (anti-HAV IgG \<1 S/CO) (preliminary data). This study aims to evaluate the immunogenicity and safety of an additional dose of I-HAV in healthy Thai children and adolescents who did not develop protective antibody levels after a single dose of L-HAV.
Trial Details
NCT Number NCT06978621
Lead Sponsor Chiang Mai University
Collaborators: Faculty of Medicine, Chiang Mai University
Conditions
(from sponsor)		 Hepatitis A, Hepatitis A Virus, Vaccine-Preventable Diseases
Related terms Hepatitis, Hepatitis A, Vaccine-Preventable Diseases
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov