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Immunogenicity and Safety of Inactivated and Live-attenuated HAV Vaccine Among Thai Healthy Children and Adolescents

NCT06298708 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-05-04

No results posted yet for this study

Summary

Hepatitis A virus (HAV) vaccine is an effective strategy to prevent natural HAV infection. In Thailand, there are 2 types of HAV vaccine available, including inactivated HAV vaccine and live-attenuated HAV vaccine. This study aims to compare the immunogenicity and safety of inactivated and lived-attenuated HAV vaccine among Thai healthy children and adolescents age 18 months to 18 years.

Conditions

  • HAV
  • Hepatitis A
  • Hep A
  • Vaccine-Preventable Diseases

Interventions

BIOLOGICAL

Mevac-A vaccine

Mevac-A: A freeze-dried live-attenuated hepatitis A vaccine. Dose and administration: a freeze-dried live-attenuated vaccine, subcutaneous injection of 0.5 ml will be administered for 1 time.

BIOLOGICAL

Havrix 720 Junior

Havrix 720 Junior: An inactivated hepatitis A vaccine, 720 ELISA units per 0.5 ml of formaldehyde-inactivated hepatitis A virus (HM175 hepatitis A virus strain). Dose and administration: a pre-filled syringe, intramuscular injection of 0.5 ml will be administered for 2 times with 6-month interval.

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
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-04-27
Primary Completion
2024-12-09
Completion
2024-12-09

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 NCT06298708 on ClinicalTrials.gov