Actively Recruiting
Immunogenicity and Safety of I-HAV in Healthy Thai Children and Adolescents Lacking Protective Antibody After L-HAV
Led by Chiang Mai University · Updated on 2025-06-17
36
Participants Needed
1
Research Sites
18 weeks
Total Duration
On this page
Sponsors
C
Chiang Mai University
Lead Sponsor
F
Faculty of Medicine, Chiang Mai University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Immunogenicity and Safety of I-HAV in Healthy Thai Children and Adolescents Lacking Protective Antibody After L-HAV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Thai children and adolescents who previously participated in the previous RCT study
- Previously randomized to receive one dose of live-attenuated hepatitis A vaccine within the past 1 year (+/- 2 months)
- Have not demonstrated seropositivity against hepatitis A virus (anti-HAV IgG <1 S/CO) at 1 month after L-HAV vaccination
- Participants and/or caregivers provide written informed consent or assent
You will not qualify if you...
- History of acute illness within 4 weeks prior to study enrollment
- History of hepatitis A illness after receiving live-attenuated hepatitis A vaccine in a previous study
- History of receiving any additional hepatitis A vaccine after the previous study
- Presence of fever (≥38.0°C), jaundice, or yellowing of the eyes within 4 weeks prior to enrollment
- Underlying conditions such as thrombocytopenia, coagulopathy, hemophilia A or B, neurological disorders, immunodeficiency, chronic liver disease, or chronic hepatitis B or C infection
- Use of immunosuppressive or immunomodulatory agents or high-dose corticosteroids for more than 14 days within 6 months prior to enrollment
- Received blood products or immunoglobulins within 6 months prior to enrollment
- Received other live vaccines within 30 days prior to enrollment
- History of allergy to vaccines or vaccine components or severe allergic reactions like anaphylaxis
- Women who are pregnant, lactating, planning pregnancy, or cannot use contraception during the study
- Concurrent participation in other clinical trials involving investigational vaccines or drugs
- Any condition that may compromise the ability to participate as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Pediatrics, Faculty of Medicine, Chiang Mai University
Chiang Mai, Thailand, 50200
Actively Recruiting
Research Team
T
Tavitiya Sudjaritruk, MD, PhD
CONTACT
N
Natchaya Kunanitthaworn, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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