Study of the Efficacy, Safety, and Immunogenicity of V260 at Expiry
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,312
- 主要终点
- Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose.
研究概览
简要总结
This study was designed to evaluate the safety of the investigational Rotavirus Vaccine and the efficacy to prevent Rotavirus Gastroenteritis.
详细描述
The duration of treatment is 10 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
- 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 infants
排除标准
- •History of abdominal disorders from a birth defect, intussusception, or abdominal surgery
- •Known or suspected problems with immune system
- •Fever at time of immunization
- •Prior administration of a rotavirus vaccine
- •History of known prior rotavirus disease
- •Chronic diarrhea, or failure to thrive
研究组 & 干预措施
RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)
Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent)
administered 28 to 70 days apart.
干预措施: RotaTeq™, rotavirus vaccine, live, oral, pentavalent (Biological)
Placebo matching RotaTeq™
Placebo matching RotaTeq™ administered 28 to 70 days apart.
干预措施: Comparator: Placebo matching RotaTeq™ (Biological)
结局指标
主要结局
Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose.
时间窗: At least 14 days following the 3rd vaccination
G1, G2, G3, and G4 Serotype Rotavirus Gastroenteritis Cases Occurring at Least 14 Days Postdose 3 Through the First Rotavirus Season Postvaccination in the Per-Protocol Population Using Per-Protocol Case Definition
次要结局
- Number of Subjects With ≥3 Fold Rise in Antibody Titer(14 days following the 3rd vaccination)