Immunogenicity and Safety of Inactivated and Live-attenuated HAV Vaccine Among Thai Healthy Child… (NCT06298708) | Clinical Trial Compass
CompletedPhase 3
Immunogenicity and Safety of Inactivated and Live-attenuated HAV Vaccine Among Thai Healthy Children and Adolescents
Thailand120 participantsStarted 2024-04-27
Plain-language 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.
Who can participate
Age range18 Months – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age between 18 months and 18 years
* Has healthy status
* Has no history of hepatitis A infection or previous hepatitis A disease
* Has never received hepatitis A vaccine (from vaccine booklet or parental history)
* Participants and/or caregivers gives written inform consent/assent form
Exclusion Criteria:
* Has acute illness within 4 weeks before enrollment
* Has fever with jaundice within 4 weeks before enrollment
* Has underlying disease of thrombocytopenia, coagulopathy, hemophilia A or B, neurologic disease, immunocompromised condition, chronic liver disease, chronic hepatitis B or C infection
* Has received immunosuppressive agents or immunomodulatory agents, corticosteroid \>2 mg/kg/day or 20 mg/day within 6 months before enrollment
* Has received blood or blood component, or intravenous immunoglobulin within 6 months before enrollment
* Has received any lived-attenuated vaccine within 30 days before enrollment
* Has history of severe allergy to vaccine or vaccine component, including aluminum hydroxide, 2-phenoxyethanol, neomycin, formaldehyde, gentamicin sulfate, or has history of anaphylaxis or severe allergic reactions following vaccination
* 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
* Ha…
What they're measuring
1
Anti-HAV immunoglobulin G (IgG) seroconversion rate
Timeframe: L-HAV group: 4 weeks after the first vaccination. I-HAV group: 4 weeks after the second vaccination