NCT01150942已完成3 期
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
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 1
- 主要终点
- immunogenicity
研究概览
简要总结
To assess the immunogenicity and safety of the vero cell-derived inactivated JE vaccine in Korean healthy children aged 12~23 months
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children aged 12-23 months
- •Written informed consent
排除标准
- •History of documented HIV
- •Known or suspected impairment of immunologic function
- •History of serious chronic disease
- •Received any JE vaccine prior to enrollment
研究组 & 干预措施
vero cell-derived JE vaccine
Experimental
vero cell-derived vaccine group
干预措施: JE vaccine (Biological)
Mouse brain-derived JE vaccine
Active Comparator
Mouse brain-derived JE vaccine group
干预措施: JE vaccine (Biological)
结局指标
主要结局
immunogenicity
时间窗: pre-dose, after 3rd vaccination
the seroconversion rates for JE antibodies 4 weeks after 3rd vaccination
次要结局
未报告次要终点
研究者
研究点 (1)
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