To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the immunogenicity and safety after one primary dose and one additional dose of inactivated hepatitis A vaccine are administered in Korean healthy children aged 12-23 months.

Detailed Description
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The objective of this study is to evaluate the immunogenicity and safety after one primary dose and one additional dose (administered twice in total at an interval of 6 months) of inactivated hepatitis A vaccine are administered in Korean healthy children aged 12-23 months. For this, a two-group comparison study will be conducted using a previously approved inactivated hepatitis A vaccine (Havrix Inj., manufactured by GSK) as the control vaccine to prove that the immunogenicity of the test vaccine treatment group is not inferior to the control vaccine treatment group and to statistically confirm that there is no difference in safety.

Official Title
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A Randomized, Double-blind, Multi-center, Active-controlled, Parallel-designed, Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in Korean Healthy Children Aged 12 23 Months

Conditions
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Hepatitis A Vaccine

Intervention / Treatment
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* Biological: Inactivated hepatitis A vaccine
* Biological: Havrix Inj


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A child whose parents or representative provided written consent A Korean child aged 12-23 months on the day of the first vaccination No history of hepatitis A or a having hepatitis A vaccination A child who was determined by the investigator that there is no problem with the participation in the clinical study according to the medical history and physical examination results Exclusion Criteria: Tympanic temperature of 38℃ or above within 48 hours prior to the vaccination or on the day of vaccination Moderate to severe acute or chronic infectious disease on the day of vaccination History of sensitivity to the following drugs: neomycin, formaldehyde, gentamicin sulfate, any preventive vaccines Disorders in the immune system, or congenital or acquired immunodeficient diseases Received immunosuppressive dose of systemic corticosteroids therapy within 12weeks days before vaccination A child with uncontrolled epilepsy or neurological disorders Planned with other vaccine within 4 weeks after the vaccination date Administered with other vaccine within 4 weeks prior to the vaccination date Used immunoglobulin formulation or human plasma, or received a transfusion within 12 weeks prior to the vaccination date A child who has participated or is participating in another clinical trial within 12 weeks prior to the vaccination date(systemic corticosteroids administered at doses corresponding to ≤0.5 mg/kg/day of prednisolone for 14 consecutive days or less is exceptionally allowed) Other reasons not specified above that, in the opinion of the investigator, may make the subject ineligible to participate in the study

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 23 Months

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: inactivated hepatitis A vaccine<br>A 0.5ml dose is administered twice in total at an interval of 6 months to healthy children aged 12-23 months. | Biological: Inactivated hepatitis A vaccine<br>* Inactivated hepatitis A virus antigen 250 U (Name of viral strain: TZ84)<br>|
| Active Comparator: Havrix Inj<br>A 0.5ml dose is administered twice in total at an interval of 6 months to healthy children aged 12-23 months. | Biological: Havrix Inj<br>* 720 ELISA/0.5 mL Junior (Inactivated hepatitis A virus antigen 160 U (Name of viral strain: HM175 Inj)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion rate | Seroconversion criteria: Anti-HAV 20 IU/L or above | 1 month after the second administration of the investigational product | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody titer (GMT) | The basic statistics of the antibody titer (GMT) at 1 month after the second vaccination | 1 month after the second vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis A vaccine