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

Boryung Pharmaceutical Co., Ltd205 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

205

Conditions

Japanese Encephalitis

Interventions

JE vaccineBIOLOGICAL

3 times, IM

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 23 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

immunogenicity

the seroconversion rates for JE antibodies 4 weeks after 3rd vaccination

Time frame: pre-dose, after 3rd vaccination

Data from ClinicalTrials.gov

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