NCT00385320已完成2 期
To Assess the Efficacy, Immuno & Safety of 2 Doses of GSK HRV Vaccine at Different Virus Concentrations in Healthy Infants Aged 2 Months & Previously Uninfected With HRV, Concurrently Given With DTPw-HBV, Hib.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2,640
- 主要终点
- Occurrence of RV GE
研究概览
简要总结
The purpose of this study is to test how infants respond to different strengths of the human rotavirus vaccine.
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 male or female infant between, and including, 6 and 12 weeks of age born after a gestation period of 36 to 42 weeks or a birth weight of >2000g.
- •Written informed consent obtained from the parent or guardian of the subject.
排除标准
- •Planned administration of oral polio vaccine during the period starting from 2 weeks before each dose of study vaccine(s) and ending 2 weeks after.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
- •History of diphtheria, tetanus, pertussis, Hib disease and/ or hepatitis B.
- •Previous vaccination against diphtheria, tetanus, pertussis, and/or Haemophilus influenzae type b.
- •History of allergic disease
- •Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator.
- •Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination)
- •Previous confirmed occurrence of RV GE.
- •Household contact with an immunosuppressed individual or pregnant women.
- •Administration of immunoglobulins and/or blood products since birth or planned administration during the study period
结局指标
主要结局
Occurrence of RV GE
次要结局
- Serum RV IgA antibody titre, Viral shedding, Seroprotection/seropositivity status for DTPwHBVHib antigens, Solicited, unsolicited & SAE
研究者
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