ISRCTN07731234已完成不适用
Immunogenicity of pneumococcal vaccine in liver transplant recipients: a randomised, double-blind, placebo-controlled, safety/efficacy study, single centre trial
niversity Health Network (Canada)0 个研究点目标入组 130 人开始时间: 2008年5月21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
- 130
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
- •Male or female outpatients who fulfill the following criteria will be eligible for the study:
- •1. Liver transplant recipients greater than three months post-transplant
- •2. No prior pneumococcal vaccination within the last five years
- •3. Stable allograft function as evidenced by a alanine aminotransferase less than 10 times the upper limit of normal (umol/L) that is not worsening
- •4. Able to provide written informed consent and comply with study protocol
- •5. Aged greater than 16 years
排除标准
- •1. Unable to provide informed consent or comply with protocol
- •2. Prior pneumococcal vaccination within five years of enrolment
- •3. Splenectomy
- •4. Admitted to hospital for acute illness
- •5. Febrile illness in the past two weeks
- •6. Intravenous immunoglobulin in the last six months
- •7. Current episode of allograft rejection
- •8. Currently on full-dose anticoagulation as a contraindication to intramuscular injection
研究者
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