EUCTR2012-001611-23-CZ进行中（未招募）1 期
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)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 924
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
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