To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine

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

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-20

Study Completion Date

2019-06-24

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.

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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.

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

A 0.5ml dose is administered twice in total at an interval of 6 months to healthy children aged 12-23 months.

Group Type EXPERIMENTAL

Inactivated hepatitis A vaccine

Intervention Type BIOLOGICAL

Inactivated hepatitis A virus antigen 250 U (Name of viral strain: TZ84)

Havrix Inj

A 0.5ml dose is administered twice in total at an interval of 6 months to healthy children aged 12-23 months.

Group Type ACTIVE_COMPARATOR

Havrix Inj

Intervention Type BIOLOGICAL

720 ELISA/0.5 mL Junior (Inactivated hepatitis A virus antigen 160 U (Name of viral strain: HM175 Inj)

Interventions

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Inactivated hepatitis A vaccine

Inactivated hepatitis A virus antigen 250 U (Name of viral strain: TZ84)

Intervention Type BIOLOGICAL

Havrix Inj

720 ELISA/0.5 mL Junior (Inactivated hepatitis A virus antigen 160 U (Name of viral strain: HM175 Inj)

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

12 Months

Maximum Eligible Age

23 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes