To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in Healthy Children Aged From 24mons-15yrs

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Double-blind, Multicenter, Multinational, Active-controlled, Parallel-designed Phase 3 Clinical Trial to Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in Healthy Children Aged From 24months to 15yrs

Conditions
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Hepatitis A, Hep A

Intervention / Treatment
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* Biological: Boryung Hepatitis A Vaccine Pre-Filled Syringe Inj. 0.5 mL
* Biological: HAVRIX 720 Junior 0.5 mL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 24 Months
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>Inactivated Hepatitis A vaccine | Biological: Boryung Hepatitis A Vaccine Pre-Filled Syringe Inj. 0.5 mL<br>* Dosage and administration: pre-iflled syringe, IM injection of 0.5mL will be given for 2 times with 6-months interval.<br>|
| Active Comparator: Control group<br>Inactivated Hepatitis A vaccine | Biological: HAVRIX 720 Junior 0.5 mL<br>* Dosage and administration: pre-filled syringe, IM injection of 0.5mL will be given for 2 times with 6-months interval.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HAV seroconversion rate at 4 weeks after the second vaccination | Seroconversion: anti-HAV ≥ 20 mIU/mL after the second vaccination in subjects with anti-HAV < 20 mIU/mL at baseline | At Visit 6 (7 months after Day 1: first vaccination) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GMCs (Geometric Mean Concentrations) measured with anti-HAV antibody titers at before the first vaccination and 4 weeks after the second vaccination | 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) | 
| 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HAV, Hepatitis A, Hepatitis A vaccine, Vaccine, Hep A