ISRCTN86632774已完成不适用
A phase II, double blind randomised, placebo controlled study to assess the safety reactogenicity and immunogenicity of three doses of GSK Biologicals (South Africa)
World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)0 个研究点目标入组 271 人开始时间: 2005年11月25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
- 271
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. Parents/guardians of subjects who could comply with the protocol requirements (e.g. completion of diary cards, return for follow-up visits)
- •2. Male or female 6 - 10 weeks of age at the time of first vaccination
- •3. Written informed consent from parents/guardians
- •4. Born after a gestation period of 36 - 42 weeks
排除标准
- •1. Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period
- •2. Previous routine vaccination except Bacillus Calmette-Guerin (BCG) and hepatits B virus (HBV)
- •3. Clinically significant history of chronic Gastrointestinal Tract (GIT) disease including any incorrected congenital malformation of GIT
- •4. History of allergic disease or reaction likely to be exacerbated by any component of the vaccine
- •5. Acute illness at the time of enrolment
- •6. Diarrhoea with in 7 days preceding the study vaccination
- •7. Administration of immunoglobulins and/or blood products since birth or planned during study period
- •8. Use of any investigational or non-registered drug or vaccine other than study vaccines during the study period
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