ISRCTN11877362已完成2 期
A phase II, double-blind, randomised, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of three doses of GlaxoSmithKline (GSK) Biologicals? oral live attenuated human rotavirus (HRV) vaccine (RIX4414 at 106.5 CCID50) administered to human immunodeficiency virus (HIV) infected infants at 6, 10 and 14 weeks of age in South Africa
World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)0 个研究点目标入组 100 人开始时间: 2005年11月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
2006 results in: http://www.ncbi.nlm.nih.gov/pubmed/16394298
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. Documented HIV status of the subject as confirmed by Polymerase Chain Reaction (PCR)
- •5. HIV asymptomatic and HIV mildly symptomatic
- •6. Categories N and A according to CDC HIV clinical classification
- •7. 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 enrolement
- •6. Diarrhea 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
研究者
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