Clinical Trial to Assess the Immunogenicity and Safety of the Vero Cell-derived JE Vaccine in Korea
A Multi-center, Active-control, Randomized, Double-blind Phase 3 Clinical Trial to Assess the Immunogenicity and Safety of the Vero Cell-derived Inactivated Japanese Encephalitis Vaccine 'KD-287(JEIMMUGEN INJ.) in Korean Healthy Children Aged 12~23 Months
1 other identifier
interventional
205
1 country
1
Brief Summary
To assess the immunogenicity and safety of the vero cell-derived inactivated JE vaccine in Korean healthy children aged 12\~23 months
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2010
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2010
CompletedFirst Posted
Study publicly available on registry
June 25, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedJanuary 30, 2014
February 1, 2011
2.1 years
June 24, 2010
January 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
immunogenicity
the seroconversion rates for JE antibodies 4 weeks after 3rd vaccination
pre-dose, after 3rd vaccination
Study Arms (2)
vero cell-derived JE vaccine
EXPERIMENTALvero cell-derived vaccine group
Mouse brain-derived JE vaccine
ACTIVE COMPARATORMouse brain-derived JE vaccine group
Interventions
Eligibility Criteria
You may qualify if:
- Healthy children aged 12-23 months
- Written informed consent
You may not qualify if:
- History of documented HIV
- Known or suspected impairment of immunologic function
- History of serious chronic disease
- Received any JE vaccine prior to enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boryung Pharmaceutical Co., Ltdlead
- Seoul National University Hospitalcollaborator
- Gachon University Gil Medical Centercollaborator
- Inha University Hospitalcollaborator
- Inje Universitycollaborator
- Korea Cancer Center Hospitalcollaborator
- Samsung Medical Centercollaborator
- The Catholic University of Koreacollaborator
- Ewha Womans Universitycollaborator
- Wonju Severance Christian Hospitalcollaborator
- Kyunghee University Medical Centercollaborator
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
Related Publications (1)
Yun KW, Lee HJ, Kang JH, Eun BW, Kim YJ, Kim KH, Kim NH, Hong YJ, Kim DH, Kim HM, Cha SH. Safety and immunogenicity of a freeze-dried, Vero cell culture-derived, inactivated Japanese encephalitis vaccine (KD-287, ENCEVAC(R)) versus a mouse brain-derived inactivated Japanese encephalitis vaccine in children: a phase III, multicenter, double-blinded, randomized trial. BMC Infect Dis. 2015 Jan 8;15:7. doi: 10.1186/s12879-014-0744-4.
PMID: 25567119DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hoan Jong Lee, PhD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2010
First Posted
June 25, 2010
Study Start
August 1, 2010
Primary Completion
September 1, 2012
Study Completion
February 1, 2013
Last Updated
January 30, 2014
Record last verified: 2011-02