Hep A, Hepatitis A
Conditions
Keywords
Hepatitis A, Hepatitis A vaccine, Vaccine, Hep A, HAV
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.
Interventions
BIOLOGICALBoryung Hepatitis A Vaccine Pre-Filled Syringe Inj. 0.5 mL
Dosage and administration: pre-iflled syringe, IM injection of 0.5mL will be given for 2 times with 6-months interval.
BIOLOGICALHAVRIX 720 Junior 0.5 mL
Dosage and administration: pre-filled syringe, IM injection of 0.5mL will be given for 2 times with 6-months interval.
Sponsors
Boryung Biopharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
24 Months to 15 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female children ≥ 24 months and ≤ 15 years old on the day of first vaccination 2. Subjects with no history of hepatitis A and no previous vaccination against hepatitis A 3. Written informed consent obtained from the subject's legal representative (parents or representative) 4. Children who no health issues based on medical history and physical examination as judged by the investigator
Exclusion criteria
1. Tympanic temperature of 38.0℃ or above within 48 hours prior to vaccination or on the day of vaccination 2. Uncontrolled epilepsy or neurological disorder 3. History of thrombocytopenia or has a risk of bleeding 4. History of hypersensitivity to the following: neomycin, formaldehyde, gentamicin sulfate, any vaccine 5. Severe acute or chronic infectious disease on the day of vaccination 6. Congenital / acquired immunodeficiency or receiving immunosuppressive therapy 7. 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) 8. Administration of any other vaccine within 4 weeks prior to Screening 9. Planned administration of any other vaccine within 4 weeks after the last vaccination of the investigational product 10. Administration of immunoglobulins or blood products or received blood transfusion within 12 weeks prior to Screening 11. Currently participating in another clinical trial or administered / applied other investigational product / medical device within 6 months prior to Screening 12. Ineligibility for participate in the study for other reasons as determined by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea, Thailand
Contacts
Primary ContactSeoyeon Hong, BS
Backup ContactHari Jeon, PharmD
Outcome results
None listed