ISRCTN58764892已完成不适用
An unblinded phase IV immunogenicity study of the Haemophilus influenzae type b (Hib) conjugate vaccine (Act-Hib®) given as part of the routine infant schedule to children in Kathmandu, Nepal
niversity of Oxford (UK)0 个研究点目标入组 165 人开始时间: 2009年1月5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
- 165
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. Parent/carer of participant is willing and able to give informed consent for participation in the study
- •2. In good health as determined by:
- •2.1. Medical history
- •2.2. Physical examination
- •2.3. Clinical judgement of the investigator
- •3. Male or female, aged 40 - 60 days
- •4. Participants residing in Kathmandu
- •5. Parents able (in the investigators opinion) and willing to comply with all study requirements
- •1. Parent/carer of participant is willing and able to give informed consent for participation in the study
- •2. In good health as determined by:
- •2.1. Medical history
- •2.2. Physical examination
- •2.3. Clinical judgement of the investigator
- •3. Male or female, aged 48 - 56 weeks
- •4. Participants residing in Kathmandu
- •5. Parents able (in the investigators opinion) and willing to comply with all study requirements
排除标准
- •1. Parent/carer unwilling or unable to give written informed consent to participate in the study
- •2. Previous immunisation (excluding Bacillus Calmette-Guerin [BCG] and hepatitis B)
- •3. Premature birth (less than 37 weeks gestation)
- •4. Previous hospital admission
- •5. Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study
- •1. Parent/carer unwilling or unable to give written informed consent to participate in the study
- •2. Previous immunisation with Hib vaccine
- •3. Premature birth (less than 37 weeks gestation)
- •4. Previous hospital admission in the last one month
- •5. Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study
研究者
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