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

NCT06978621 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-05-22

No results posted yet for this study

Summary

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.

Conditions

  • Hepatitis A
  • Hepatitis A Virus
  • Vaccine-Preventable Diseases

Interventions

BIOLOGICAL

Inactivated hepatitis A vaccine (I-HAV)

A formaldehyde-inactivated hepatitis A virus (HM175 hepatitis A virus strain) Dose and administration: 0.5 mL intramuscular injection for participants age \<=18 years, and 1.0 mL intramuscular injection for participants age 19 years and above.

Sponsors & Collaborators

  • Faculty of Medicine, Chiang Mai University

    collaborator UNKNOWN

  • Chiang Mai University

    lead OTHER

Principal Investigators

  • Tavitiya Sudjaritruk, MD, PhD · Department of Pediatrics, Faculty of Medicine, Chiang Mai University

  • Natchaya Kunanitthaworn, MD · Department of Pediatrics, Faculty of Medicine, Chiang Mai University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Months
Max Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-25
Primary Completion
2025-06-22
Completion
2026-07-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06978621 on ClinicalTrials.gov