To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in Healthy Children Aged From 24mons-15yrs
Hepatitis A, Hep A
About this trial
This is an interventional prevention trial for Hepatitis A focused on measuring Hepatitis A, Hepatitis A vaccine, Vaccine, Hep A, HAV
Eligibility Criteria
Inclusion Criteria: Healthy male or female children ≥ 24 months and ≤ 15 years old on the day of first vaccination Subjects with no history of hepatitis A and no previous vaccination against hepatitis A Written informed consent obtained from the subject's legal representative (parents or representative) Children who no health issues based on medical history and physical examination as judged by the investigator Exclusion Criteria Tympanic temperature of 38.0℃ or above within 48 hours prior to vaccination or on the day of vaccination Uncontrolled epilepsy or neurological disorder History of thrombocytopenia or has a risk of bleeding History of hypersensitivity to the following: neomycin, formaldehyde, gentamicin sulfate, any vaccine Severe acute or chronic infectious disease on the day of vaccination Congenital / acquired immunodeficiency or receiving immunosuppressive therapy Received immunosuppressive dose of systemic corticosteroids within 12 weeks prior to the first vaccination with the IP (Investigational Product) (equivalent potency of ≥ prednisolone 20 mg/day or equivalent potency of ≥ prednisolone 2.0 mg/kg/day in < 10kg of body weight for ≥ 14 consecutive days) Administration of any other vaccine within 4 weeks prior to Screening Planned administration of any other vaccine within 4 weeks after the last vaccination of the investigational product Administration of immunoglobulins or blood products or received blood transfusion within 12 weeks prior to Screening Currently participating in another clinical trial or administered / applied other investigational product / medical device within 6 months prior to Screening Ineligibility for participate in the study for other reasons as determined by the investigator
Sites / Locations
- The Catholic University of Korea, ST. Vincent's Hospital
- Maharaj Nakorn Chiang Mai Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Test group
Control group
Inactivated Hepatitis A vaccine
Inactivated Hepatitis A vaccine