To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in Healthy Children Aged From 24mons-15yrs
- Conditions
- Hep AHepatitis A
- Interventions
- Biological: HAVRIX 720 Junior 0.5 mLBiological: Boryung Hepatitis A Vaccine Pre-Filled Syringe Inj. 0.5 mL
- Registration Number
- NCT05613127
- Lead Sponsor
- Boryung Biopharma Co., Ltd.
- Brief Summary
The purpose of this study is to evaluate immunogenicity and safety of inactivated hepatitis A vaccine in healthy children aged from 24 months to 15 years when administered an initial dose followed by a booster dose (a total of 2 doses administered with 6 months interval).
- Detailed Description
The purpose of this study is to evaluate immunogenicity and safety of inactivated hepatitis A vaccine in healthy children aged from 24 months to 15 years when administered an initial dose followed by a booster dose (a total of 2 doses administered with 6 months interval).
This study is a two-group comparative study using a marketed inactivated hepatitis A vaccine (HAVRIX®, manufactured by GSK) as a control. The study will demonstrate non-inferiority of the test vaccine compared to the control vaccine.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 106
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group HAVRIX 720 Junior 0.5 mL Inactivated Hepatitis A vaccine Test group Boryung Hepatitis A Vaccine Pre-Filled Syringe Inj. 0.5 mL Inactivated Hepatitis A vaccine
- Primary Outcome Measures
Name Time Method Anti-HAV seroconversion rate at 4 weeks after the second vaccination At Visit 6 (7 months after Day 1: first vaccination) Seroconversion: anti-HAV ≥ 20 mIU/mL after the second vaccination in subjects with anti-HAV \< 20 mIU/mL at baseline
- Secondary Outcome Measures
Name Time Method GMCs (Geometric Mean Concentrations) measured with anti-HAV antibody titers at before the first vaccination and 4 weeks after the second vaccination At Visit 6 (7 months after Day 1: first vaccination) GMCs (Geometric Mean Concentrations) measured with anti-HAV antibody titers at before the first vaccination and 4 weeks after the second vaccination
GMR (Geometric Mean Ratio, GMC Visit 6/GMC Visit 1) measured with anti-HAV antibody titers at 4 weeks after the second vaccination compared to those before the first vaccination At Visit 6 (7 months after Day 1: first vaccination) GMR (Geometric Mean Ratio, GMC Visit 6/GMC Visit 1) measured with anti-HAV antibody titers at 4 weeks after the second vaccination compared to those before the first vaccination
Trial Locations
- Locations (2)
The Catholic University of Korea, ST. Vincent's Hospital
🇰🇷Suwon, Korea, Republic of
Maharaj Nakorn Chiang Mai Hospital
🇹🇭Chiang Mai, Thailand