ISRCTN57452882已完成不适用
A double-blind randomised placebo controlled dose escalating phase Ib/IIa study to evaluate the safety and immunogenicity of live attenuated rotavirus vaccine 116E in healthy non-malnourished infants eight to 20 weeks of age
Bharat Biotech International Ltd (India)0 个研究点目标入组 540 人开始时间: 2006年7月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 540
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Access to a telephone
- •2. Healthy male and female non-malnourished infants aged six weeks (till six weeks + two days)
- •3. Parents' permission to participate
- •4. No plans to travel over the next four months
排除标准
- •1. Gestational age less than 37 weeks
- •2. Any major physical congenital malformation
- •3. Contact with immunosuppressed individuals
- •4. Hospitalised once or more for the following illnesses since birth: heart disease, pneumonia, sepsis, meningitis, unconsciousness
- •5. Daily medications other than vitamins or herbal tonics
- •6. Evidence of cardiovascular disease
- •7. Evidence of gastrointestinal disease
- •9. Evidence of liver or reticuloendothelial disease
- •10. Evidence of hematologic, rheumatologic or immunologic disease
- •11. Evidence of renal disease
研究者
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