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
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
immunogenicity
the seroconversion rates for JE antibodies 4 weeks after 3rd vaccination
pre-dose, after 3rd vaccination
Yes
Hoan Jong Lee, PhD
Principal Investigator
Seoul National University Hospital
South Korea: Korea Food and Drug Administration (KFDA)
KD287-BR-CT-301
NCT01150942
August 2010
August 2012
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