NCT00718237已完成3 期
A Phase III Randomized, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of V260 in Healthy Infants in Japan
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 762
- 主要终点
- Number of Participants With Rotavirus Gastroenteritis of Any Severity Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A
研究概览
简要总结
The purpose of the study is to evaluate whether V260 is effective and well tolerated in Japanese healthy infants.
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
- •Healthy Japanese Infants, 6 Weeks Through 12 Weeks Of Age
排除标准
- •History Of Known Prior Rotavirus Gastroenteritis
- •Subjects Who Are Concurrently Participating In Or Are Anticipated To Participate In Other Studies Of Investigational Products At Any Time During The Study Period
研究组 & 干预措施
1
Experimental
RotaTeq™
干预措施: Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™) (Biological)
2
Placebo Comparator
Placebo
干预措施: Comparator: Comparator: Placebo (unspecified) (Biological)
结局指标
主要结局
Number of Participants With Rotavirus Gastroenteritis of Any Severity Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A
时间窗: At least 14 days following the 3rd vaccination
Any severity cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition
次要结局
- Number of Participants With Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A(At least 14 days following the 3rd vaccination)
- Number of Participants With Moderate to Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A(At least 14 days following the 3rd vaccination)
研究者
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