EUCTR2012-001611-23-DK进行中（未招募）不适用
A Double-Blind, Randomized, COntrolled, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq(TM) - Evaluation of Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq(TM)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Healthy infants between ages of 6-12 weeks whose parent/guardian give written consent for study participation.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 800
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •History of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic diarrhea, failure to thrive, abdominal surgery, intussusception; known or suspected impairment of immunological function, including Severe Combined Immunodeficiency (SCID); prior administration of any rotavirus vaccine; Clinical evidence of active gastrointestinal illness, with the exception of well-controlled gastroesophageal reflux disease (GERD); residing in a household with immunocompromised individual(s); Certain restrictions applied to receipt of investigational vaccines, systemic corticosteroids, and blood products; restrictions on other study participation.
研究者
相似试验
进行中（未招募）
不适用
Evaluation of Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq(TM)Prevention of rotavirus gastroenteritis in infants and children caused by serotypes G1, G2, G3, G4, and G serotypes that contain P1A[8] (e.g., G9)EUCTR2012-001611-23-SEMerck & Co., Inc.924
进行中（未招募）
不适用
A Double-Blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq?Prevention of rotavirus gastroenteritis in infants and children caused by serotypes G1, G2, G3, G4, and G serotypes that contain P1A[8] (e.g., G9)MedDRA version: 14.1Level: LLTClassification code 10039232Term: Rotavirus gastroenteritisSystem Organ Class: 10021881 - Infections and infestationsEUCTR2012-001611-23-ESMerck Sharp & Dohme Corp., una filial de Merck & Co., Inc.800
进行中（未招募）
1 期
Evaluation of Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq(TM)EUCTR2012-001611-23-CZMerck & Co., Inc.924
进行中（未招募）
不适用
Evaluation of Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq(TM)Prevention of rotavirus gastroenteritis in infants and children caused by serotypes G1, G2, G3, G4, and G serotypes that contain P1A[8] (e.g., G9)MedDRA version: 16.0Level: PTClassification code 10017913Term: Gastroenteritis rotavirusSystem Organ Class: 10021881 - Infections and infestationsEUCTR2012-001611-23-PLMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.924
进行中（未招募）
不适用
Evaluation of Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq(TM)EUCTR2012-001611-23-FIMerck & Co., Inc.924