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RECRUITING
NCT06978621
PHASE3

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

Sponsor: Chiang Mai University

View on ClinicalTrials.gov

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.

Official title: Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in Healthy Thai Children and Adolescents Lacking Protective Antibody Levels After a Single Dose of Live-attenuated Hepatitis A Vaccine

Key Details

Gender

All

Age Range

18 Months - 20 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2025-05-25

Completion Date

2025-09-30

Last Updated

2025-06-17

Healthy Volunteers

Yes

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.

Locations (1)

Department of Pediatrics, Faculty of Medicine, Chiang Mai University

Chiang Mai, Thailand