Assess the Risk of Solid Organ Transplant Rejection Following Vaccination With Pandemrix™ in UK
Risk of Solid Organ Transplant Rejection Following Vaccination With Pandemrix™ in the United Kingdom
研究概览
详细说明
Data on the safety of pandemic H1N1 vaccination in transplanted patients is relatively limited; to date, although some studies showed transient increases in alloreactivity, there is no evidence that H1N1 vaccines caused clinical rejection or organ dysfunction. In addition, studies have shown that influenza infection is a known independent risk factors for rejection. Considering that transplant recipients are a target population for immunisation with future pandemic vaccines, it is important to investigate the risk of rejection following vaccination in this patient population.
Using the self-controlled case series design that allows to control implicitly for potential confounding factors, this study aims at investigating the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas) following vaccination with Pandemrix™ in the United Kingdom Clinical Practice Research Datalink GP Online Database (CPRD GOLD). Data from the Hospital Episodes Statistics database will also be used. The effect of seasonal influenza vaccination and of various infections including influenza H1N1 will also be explored.
研究类型
注册 (实际的)
联系人和位置
学习地点
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London、英国、SW1W 9SZ
- GSK Investigational Site
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Subject defined as acceptable in the CPRD GOLD.
- Subject with at least one solid organ transplant rejection reported in the CPRD GOLD and/or HES during the overall study periods (01 September 2006 to 31 October 2010).
Exclusion Criteria:
• Subject from HES matched to more than one subject in the CPRD GOLD.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Group 1
Subject defined as acceptable in the CPRD GOLD with at least one solid organ transplant rejection reported during the overall study period (01 September to 31 October 2010).
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Data extraction from the CPRD GOLD and HES, and additional data obtained from complementary information provided by the GPs using a standardised questionnaire.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Assessment of the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas).
大体时间：Within one month after vaccination with Pandemrix™ (from 01 October 2009 to 31 October 2010).
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Assessed by case data collection from CPRD GOLD and HES, and additional data obtained from complementary information provided by the GPs using a standardised questionnaire.
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Within one month after vaccination with Pandemrix™ (from 01 October 2009 to 31 October 2010).
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Assessment of the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas).
大体时间：Within two months after vaccination with Pandemrix™ ( from 01 October 2009 to 31 October 2010).
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Assessed by case data collection from CPRD GOLD and HES, and additional data obtained from complementary information provided by the GPs using a standardised questionnaire.
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Within two months after vaccination with Pandemrix™ ( from 01 October 2009 to 31 October 2010).
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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