NCT00362648已完成3 期
Efficacy, Safety, and Immunogenicity of RotaTeq™ Among Infants in Asia and Africa
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 7,504
- 主要终点
- Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose
研究概览
简要总结
The purpose of the current study is to evaluate whether the vaccine is effective, well-tolerated and immunogenic among infants in developing countries.
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
- 4 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 4 weeks through 12 weeks at Dose 1
- •Parent able to understand study procedures and give consent
排除标准
- •Clinical evidence of active gastrointestinal disease
- •Subjects who are currently or expected to participate in other studies of investigational products during the 6 weeks after receiving the last dose of RotaTeq™/placebo
结局指标
主要结局
Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose
时间窗: At least 14 days following the third vaccination
次要结局
- Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8](14 days following the 3rd vaccination)
- Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8](14 days following the 3rd vaccination)
研究者
相似试验
终止
1 期
A Study of the Safety and Immune Response to RotaTeq™ Vaccine in the Elderly (V260-027)RotavirusNCT00836498Merck Sharp & Dohme LLC66
已完成
3 期
Safety,Tolerability and Immunogenicity of Vaccination With Rotateq in Healthy Infants in India (V260-021)RotavirusGastroenteritisNCT00496054Merck Sharp & Dohme LLC110
已完成
4 期
Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.Infections, RotavirusNCT01198769GlaxoSmithKline15
已完成
3 期
A Study of the Immunogenicity, Tolerability, and Safety of a New Formulation of RotaTeq™ in Infants (V260-035)Rotavirus GastroenteritisNCT01600092Merck Sharp & Dohme LLC1,020
已完成
3 期
Dose Confirmation Efficacy Study (V260-007)Rotavirus InfectionsNCT00092443Merck Sharp & Dohme LLC1,312