Clinical Trial to Assess the Immunogenicity and Safety of the Vero Cell-derived JE Vaccine in Korea

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

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-02-28

Brief Summary

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To assess the immunogenicity and safety of the vero cell-derived inactivated JE vaccine in Korean healthy children aged 12\~23 months

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Detailed Description

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To compare the Vero cell-derived inactivated Japanese encephalitis(JE) vaccine 'KD-287(JEIMMUGEN INJ.)' with the mouse brain-derived inactivated JE vaccine in terms of the immunogenicity and safety, in Korean healthy children aged 12\~23 months

Conditions

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Japanese Encephalitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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vero cell-derived JE vaccine

vero cell-derived vaccine group

Group Type EXPERIMENTAL

JE vaccine

Intervention Type BIOLOGICAL

3 times, IM

Mouse brain-derived JE vaccine

Mouse brain-derived JE vaccine group

Group Type ACTIVE_COMPARATOR

JE vaccine

Intervention Type BIOLOGICAL

3 times, IM

Interventions

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JE vaccine

3 times, IM

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy children aged 12-23 months
* Written informed consent

Exclusion Criteria

* History of documented HIV
* Known or suspected impairment of immunologic function
* History of serious chronic disease
* Received any JE vaccine prior to enrollment

Minimum Eligible Age

12 Months

Maximum Eligible Age

23 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes