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

Phase 3

Active, not recruiting

• Conditions: HAV; Hepatitis A; Hep A; Vaccine-Preventable Diseases

• Registration Number: NCT06298708
• Lead Sponsor: Chiang Mai University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-3-1
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Age between 18 months and 18 years<br><br> - Has healthy status<br><br> - Has no history of hepatitis A infection or previous hepatitis A disease<br><br> - Has never received hepatitis A vaccine (from vaccine booklet or parental history)<br><br> - Participants and/or caregivers gives written inform consent/assent form<br><br>Exclusion Criteria:<br><br> - Has acute illness within 4 weeks before enrollment<br><br> - Has fever with jaundice within 4 weeks before enrollment<br><br> - Has underlying disease of thrombocytopenia, coagulopathy, hemophilia A or B,<br> neurologic disease, immunocompromised condition, chronic liver disease, chronic<br> hepatitis B or C infection<br><br> - Has received immunosuppressive agents or immunomodulatory agents, corticosteroid >2<br> mg/kg/day or 20 mg/day within 6 months before enrollment<br><br> - Has received blood or blood component, or intravenous immunoglobulin within 6 months<br> before enrollment<br><br> - Has received any lived-attenuated vaccine within 30 days before enrollment<br><br> - Has history of severe allergy to vaccine or vaccine component, including aluminum<br> hydroxide, 2-phenoxyethanol, neomycin, formaldehyde, gentamicin sulfate, or has<br> history of anaphylaxis or severe allergic reactions following vaccination<br><br> - Women planning for pregnancy, pregnant women or lactating women<br><br> - Women in childbearing age who cannot use contraceptive methods during study<br> participation<br><br> - Is concurrently involved in other clinical trials in which receiving an<br> investigational vaccine or study drug as part of study participation<br><br> - Have any condition that, in the opinion of the site investigator, would compromise<br> the subject's ability to participate in the study

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anti-HAV immunoglobulin G (IgG) seroconversion rate

Secondary Outcome Measures

Name	Time	Method
Geometric mean concentration (GMC) of anti-HAV IgG level