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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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London、イギリス、SW1W 9SZ
- GSK Investigational Site
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Assessment of the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas).
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Assessment of the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas).
時間枠：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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協力者と研究者
スポンサー
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 116602
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