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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

253 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-19

Study Completion Date

2019-01-31

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.

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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.

Conditions

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Hepatitis A Vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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inactivated hepatitis A vaccine

Inactivated hepatitis A virus antigen 500U(Name of viral strain: TZ84)

Group Type EXPERIMENTAL

inactivated hepatitis A vaccine

Intervention Type BIOLOGICAL

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.

Havrix Inj

1440 ELISA/mL\_Adult Inj.(Name of Viral strain: HM175 Inj)

Group Type ACTIVE_COMPARATOR

Havrix Inj

Intervention Type BIOLOGICAL

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.

Interventions

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inactivated hepatitis A vaccine

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.

Intervention Type BIOLOGICAL

Havrix Inj

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.

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes