ACTRN12617001567314终止4 期
Validating the optimal dose of normal immunoglobulin for protection against hepatitis A: pharmacokinetics in healthy volunteers
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 17 Years 至 o limit（—）
- 性别
- All
入选标准
- •Healthy adult volunteers who provide informed consent, and meet the following criteria will be eligible:
- •o are immune to measles and rubella according to commercial serology test
- •o are not immune to hepatitis A according to commercial serology test
- •o are not eligible for free hepatitis A vaccination and unlikely to require hepatitis A vaccination during the course of study (ie no planned overseas travel)
- •o weigh at least 51kg
- •Healthy 17 year olds who provide informed consent, meet the same criteria, and whose parent or guardian also consents will also be eligible.
排除标准
- •o have been in another clinical trial within the last 3 months prior to recruitment to this study
- •o have history of hypersensitivity, allergy to blood products or haematological disorder
- •o have received a blood product with the 3 months prior to recruitment to this study
- •o have been / are to be administered a live virus vaccine within the three weeks prior to NHIG administration
- •o are pregnant
- •o have a low platelet count or abnormal results that have not been previously investigated on screening Full blood count.
研究者
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