To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine (VITHA-A)

Study Overview
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Brief Summary
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The objective of this study is to evaluate the safety and immunogenicity after one primary dose and one additional dose (administered twice at an interval of 6 months) of inactivated hepatitis A vaccine are administered in adolescents (16 years of age or older) or adults.

Detailed Description
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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 Healthy Youths Above 16 Years or Adults

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: Males and females aged 16 years or older on the day of the first vaccination No history of hepatitis A or having hepatitis A vaccination Provided consent to the participation in the study voluntarily after receiving explanations about the objective, method, effect, etc. of this clinical study Determined by the investigator to be able to be followed up during the study period Exclusion Criteria: A positive result (Anti-HAV 20 IU/L or above) in an hepatitis A antibody test at the time of screening Positive hepatitis type B antigen at the time of screening The following blood test results at the time of screening ALT: More than 1.5 times the upper limit of normal AST: More than 1.5 times the upper limit of normal Total bilirubin: More than 1.5 times the upper limit of normal Tympanic temperature of 38°C 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 Congenital or acquired immunodeficient disease, or receiving immunosuppressive therapy Received immunosuppressive dose of systemic corticosteroids therapy within 12weeks days before vaccination uncontrolled epilepsy or neurological disorders Administered with other vaccine within 4 weeks prior to the screening Planned with other vaccine within 4 weeks after the vaccination date Used immunoglobulin formulation or human plasma, or received a transfusion within 12 weeks prior to the screening Participated in another clinical study within 12 weeks prior to the screening, or currently participating Pregnant women or breast-feeding women Other reasons not specified above that, in the opinion of the principal investigator, may make the subject ineligible to participate in the study

Ages Eligible for Study
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Minimum Age: 16 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: inactivated hepatitis A vaccine<br>Inactivated hepatitis A virus antigen 500U(Name of viral strain: TZ84) | Biological: inactivated hepatitis A vaccine<br>* A single dose of the test vaccine or the control vaccine in the form of pre-filled syringe is injected intramuscularly into the deltoid muscle (not to be injected into the gluteal region), and additional vaccination is performed using the same vaccine and the same method at 6 months after the first vaccination.<br>|
| Active Comparator: Havrix Inj<br>1440 ELISA/mL_Adult Inj.(Name of Viral strain: HM175 Inj) | Biological: Havrix Inj<br>* A single dose of the test vaccine or the control vaccine in the form of pre-filled syringe is injected intramuscularly into the deltoid muscle (not to be injected into the gluteal region), and additional vaccination is performed using the same vaccine and the same method at 6 months after the first vaccination.<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 vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion rate | Seroconversion rate at 1 month after the first vaccination | 1 month after the first vaccination | 

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