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Long-term Immunogenicity of L-HAV Vaccine Among Healthy Thai Children and Adolescents

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial status: Not Yet Recruiting to Active, Not Recruitingv2 Show 4 more changesShow less
    • Primary completion date changed from estimate of Aug 31, 2025 to Jun 28, 2025
    • Study completion date: Sep 30, 2025 to Jul 31, 2026
    • Start date changed from estimate of Jun 22, 2025 to Jun 26, 2025
    • Site contact updated
  2. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 among Thai children. Two types of HAV vaccines are available in Thailand: an inactivated vaccine (I-HAV, administered in two doses 6 months apart) and a live-attenuated vaccine (L-HAV, administered as a single dose). However, neither vaccine is currently included in Thailand's Expanded Programme on Immunization (EPI). In 2024, a randomized, active-controlled, open-label, non-inferiority trial was conducted to compare the immunogenicity and safety of the two-dose I-HAV with the single-dose L-HAV in healthy Thai children and adolescents aged 18 months to 18 years. This study aims to evaluate the long-term seropositive rate and immunogenicity of anti-HAV antibodies in this population following a single dose of L-HAV.
Trial Details
NCT Number NCT07032610
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 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov