Status:
RECRUITING
Immunogenicity and Safety of I-HAV in Healthy Thai Children and Adolescents Lacking Protective Antibody After L-HAV
Lead Sponsor:
Chiang Mai University
Collaborating Sponsors:
Faculty of Medicine, Chiang Mai University
Conditions:
Hepatitis A
Hepatitis A Virus
Eligibility:
All Genders
18-20 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Hepatitis A virus (HAV) infection remains a common cause of viral hepatitis among children and adolescents in developing countries, including Thailand. Currently, two types of HAV vaccines are availab...
Eligibility Criteria
Inclusion
- Thai children and adolescents who previously participated in the previous RCT study
- Previously randomized to receive one dose of L-HAV vaccine within the past 1 year (+/- 2 months)
- Have not demonstrate a seropositivity against HAV (anti-HAV IgG \<1 S/CO) at 1 month after L-HAV vaccination
- Participants and/or caregivers gives written inform consent/assent form
Exclusion
- History of acute illness within 4 weeks prior to study enrollment
- Has a history of illness or a diagnosis consistent with hepatitis A after receiving the live attenuated hepatitis A vaccine as part of participation in a previous research study
- Has a history of receiving any additional hepatitis A vaccine after participating in the previous research study
- Presence of fever (body temperature ≥38.0°C), jaundice, or yellowing of the eyes within 4 weeks prior to study enrollment
- Has underlying conditions including thrombocytopenia, coagulopathy, hemophilia A or B, neurological disorders, immunodeficiency disorders, chronic liver disease, or chronic hepatitis B or C infection
- Has received immunosuppressive agents, immunomodulatory agents, or high-dose corticosteroids (greater than 2 mg/kg/day or more than 20 mg/day) for more than 14 consecutive days within 6 months prior to study enrollment
- Has received blood products or blood components, including immunoglobulins, within 6 months prior to study enrollment
- Has received other live vaccines within 30 days prior to study enrollment
- Has history of allergy to vaccines or any vaccine components, such as aluminum hydroxide, 2-phenoxyethanol, neomycin, formaldehyde, or gentamicin sulfate, or has history of severe allergic reactions (e.g., anaphylaxis) to any vaccines
- Women planning for pregnancy, pregnant women or lactating women
- Women in childbearing age who cannot use contraceptive methods during study participation
- Is concurrently involved in other clinical trials in which receiving an investigational vaccine or study drug as part of study participation
- Have any condition that, in the opinion of the site investigator, would compromise the subject's ability to participate in the study
Key Trial Info
Start Date :
May 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06978621
Start Date
May 25 2025
End Date
September 30 2025
Last Update
June 17 2025
Active Locations (1)
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1
Department of Pediatrics, Faculty of Medicine, Chiang Mai University
Chiang Mai, Thailand, 50200