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Immunogenicity and Safety of I-HAV in Healthy Thai Children and Adolescents Lacking Protective Antibody After L-HAV
Sponsor: Chiang Mai University
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
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