Status:
COMPLETED
Clinical Trial to Assess the Immunogenicity and Safety of the Vero Cell-derived JE Vaccine in Korea
Lead Sponsor:
Boryung Pharmaceutical Co., Ltd
Collaborating Sponsors:
Seoul National University Hospital
Gachon University Gil Medical Center
Conditions:
Japanese Encephalitis
Eligibility:
All Genders
12-23 years
Phase:
PHASE3
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, i...
Eligibility Criteria
Inclusion
- Healthy children aged 12-23 months
- Written informed consent
Exclusion
- History of documented HIV
- Known or suspected impairment of immunologic function
- History of serious chronic disease
- Received any JE vaccine prior to enrollment
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT01150942
Start Date
August 1 2010
End Date
February 1 2013
Last Update
January 30 2014
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea