NCT00166517已完成3 期
Immunogenicity and Safety of V260 in Healthy Infants in Korea
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 178
- 主要终点
- Serum Anti-Rotavirus IgA Response
研究概览
简要总结
Immunogenicity and Safety of V260 in Healthy Infants in Korea
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At first study vaccination, age 6 weeks through exactly 12 weeks
排除标准
- •History of congenital abdominal disorders, intussusception, or abdominal surgery
- •History of known prior rotavirus disease
- •Ongoing chronic diarrhea or failure to thrive
- •Clinical evidence of active gastrointestinal illness
结局指标
主要结局
Serum Anti-Rotavirus IgA Response
时间窗: Baseline and 14 days Postdose 3
Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in Serum IgA 14 days Postdose 3
次要结局
- Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A(Baseline and 14 days Postdose 3)
研究者
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