NCT00425737已完成2 期
A Study to Assess the Efficacy, Immunogenicity and Safety of Two Doses of Oral Live Attenuated Human Rotavirus (HRV) Vaccine (Rotarix) in Healthy Infants.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 405
- 主要终点
- Occurrence of RV GE
研究概览
简要总结
To assess the efficacy, immune response and safety of the oral live attenuated HRV vaccine (Rotarix) in healthy infants approximately 2 months of age and previously uninfected with human rotavirus
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
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 6 and 12 weeks of age at the time of the first vaccination.
- •Written informed consent obtained from the parents or guardians of the subject.
- •Born after a normal gestation period (between 36 and 42 weeks).
排除标准
- •Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the study vaccine or placebo or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs since birth. (Topical steroids are allowed.)
- •Use of antibiotics during the period starting from 7 days before each dose of vaccine(s) and ending 7 days after.
- •Any clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- •History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
- •Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
- •Household contact with an immunosuppressed individual or pregnant woman.
- •Abnormal stool pattern.
- •Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
- •Previous confirmed occurrence of rotavirus gastroenteritis.
结局指标
主要结局
Occurrence of RV GE
次要结局
- Occurrence of severe RV GE, solicited symptoms (Day 0-14), unsolicited Adverse Events (Day 0-42), Serious Adverse Events (full study), presence of rotavirus antigen in stool samples, immunogenicity
研究者
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