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
12 Months
23 Months
Both
Japanese Encephalitis
Trial Information
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
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
immunogenicity
Outcome Description:
the seroconversion rates for JE antibodies 4 weeks after 3rd vaccination
Outcome Time Frame:
pre-dose, after 3rd vaccination
Safety Issue:
Yes
Principal Investigator
Hoan Jong Lee, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Seoul National University Hospital
Authority:
South Korea: Korea Food and Drug Administration (KFDA)
Study ID:
KD287-BR-CT-301
NCT ID:
NCT01150942
Start Date:
August 2010
Completion Date:
August 2012
Related Keywords:
- Japanese Encephalitis
- JEV
- vero cell
- Encephalitis
- Encephalitis, Japanese
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