NCT06298708

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

Comparison of Immunogenicity and Safety of Inactivated and Live-attenuated Hepatitis A Virus Vaccine Among Thai Healthy Children and Adolescents: A Randomized, Active-controlled, Open-label, Non-inferiority Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Chiang Mai University · Academic / Other
• Sex: All
• Age: 18 Months – 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Hepatitis A virus (HAV) infection is one of the common cause of viral hepatitis in children and adolescents in developing countries, including Thailand. This virus is easily transmitted through ingestion of contaminated food and water or through direct contact with an infectious person. Generally, HAV causes acute hepatitis, ranging mild illness to severe fulminant hepatitis (acute liver failure), but does not cause chronic liver disease. HAV vaccine is an effective strategy to prevent natural HAV infection as well as serious consequences of the illness. Currently, there are 2 types of HAV vaccine available in Thailand, including (1) inactivated vaccine (I-HAV) which is recommended for 2 doses, 6 months apart and is approved for children age 1 year and above; and (2) live-attenuated vaccine (L-HAV) which is recommended for 1 dose and is approved for children age 18 months and above. However, these vaccines have not included in the Thailand Expanded Programme on Immunization (EPI) yet. Thus, vaccination coverage rate is suboptimal in the country. Moreover, the information regarding immunogenicity and safety of both vaccines is limited. This is a randomized, active-controlled, open-label, non-inferiority trial which aims to compare the immunogenicity and safety of a marketed inactivated (I-HAV) and a live-attenuated HAV vaccine (L-HAV) among Thai healthy children and adolescents age 18 months to 18 years. This study will provide important information about the immunogenicity and safety profiles of both vaccines in Thai healthy youth as well as demonstrate the associated factors of HAV vaccine-elicited immunity in this population.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-04-27
• Primary completion: 2024-12-09
• Completion: 2024-12-09
• First posted: 2024-03-07
• Last updated: 2025-05-04

Locations

1 site across 1 country: Thailand