Clinical Trial to Assess the Immunogenicity and Safety of the Vero Cell-derived JE Vaccine in Korea
Phase 3
Completed
- Conditions
- Japanese Encephalitis
- 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
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
- Primary Outcome Measures
Name Time Method immunogenicity pre-dose, after 3rd vaccination the seroconversion rates for JE antibodies 4 weeks after 3rd vaccination
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of Vero cell-derived inactivated JE vaccines in eliciting immune responses in pediatric populations?
How does the immunogenicity of KD-287 compare to mouse brain-derived JE vaccines in 12-23 month old Korean children?
Which biomarkers correlate with enhanced antibody responses to Vero cell-based Japanese encephalitis vaccination in infants?
What adverse event profiles differentiate Vero cell-derived versus mouse brain-derived Japanese encephalitis vaccines in phase 3 trials?
Are there combination vaccine strategies involving KD-287 that improve Japanese encephalitis immunity in young children?
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital🇰🇷Seoul, Korea, Republic of