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

Phase 3

Completed

• Conditions: Japanese Encephalitis
• Interventions: Biological: JE vaccine

• Registration Number: NCT01150942
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2010-06-24
• Study First Submitted QC: 2010-06-24
• Study First Posted: 2010-06-25
• Study Start: 2010-08
• Status Verified: 2011-02
• Primary Completion: 2012-09
• Study Completion: 2013-02
• Last Update Submitted: 2014-01-29
• Last Update Posted: 2014-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vero cell-derived JE vaccine	JE vaccine	vero cell-derived vaccine group
Mouse brain-derived JE vaccine	JE vaccine	Mouse brain-derived JE vaccine group

Primary Outcome Measures

Name	Time	Method
immunogenicity	pre-dose, after 3rd vaccination	the seroconversion rates for JE antibodies 4 weeks after 3rd vaccination

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of