Post-authorisation Safety Study (PASS) of Influenza Vaccine in United Kingdom (UK)
2016年2月11日 更新者：GlaxoSmithKline
European Medicines Agency (EMA) Post-authorisation Safety Study of Influenza Vaccine
The purpose of this study is to conduct a pilot study to explore the potential use of routinely collected data in General Practitioner (GP) practices to conduct enhanced safety surveillance of seasonal influenza vaccines in the UK, as recommended in the EMA interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU.
調査の概要
詳細な説明
Data routinely collected as part of clinical consultations in primary care will be extracted from nine General Practitioner (GP) practices in order to estimate medically attended Adverse Events of Interest (AEIs), for people who have received an influenza vaccine.
This study will also actively follow patients who were exposed to seasonal influenza vaccination for 7 days in three of the nine GP practices using a customised card-based adverse drug reaction reporting system, in order to determine whether a more active approach to surveillance can capture higher rates of AEIs.
研究の種類
観察的
入学 (実際)
11530
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Surrey、イギリス、GU2 7XH
- GSK Investigational Site
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
6ヶ月歳以上 (子、大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
Registered patients in 9 GP practices in England and who are immunized against seasonal influenza between 1 September 2015 and 30 November 2015
説明
Inclusion Criteria:
- All individuals (aged 6 months and above) who will receive seasonal influenza vaccination in the 9 GP practices between 1 September 2015 and 30 November 2015.
- Pregnant women are also included in this study.
Exclusion Criteria:
• Only registered patients who have explicitly opted out of data sharing will be excluded from the analysis.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Study Cohort
Subjects who will receive influenza vaccination between 1 September 2015 and 30 November 2015 in the 9 GP practices from who clinical data routinely collected as part of clinical consultations in primary care will be extracted.
|
Extraction of routinely collected primary care data from nine GP practices and an active surveillance approach in 3 of the 9 GP practices, by using an existing card-based ADR reporting system (MHRA Yellow Card), to estimate proportions of AEIs among seasonal influenza-vaccinated individuals.
他の名前：
|
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 |
|---|---|---|
|
Number of patient counts of the total registered patients vaccinated by age strata, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
時間枠：Up to 3 months (between 1 September 2015 and 30 November 2015)
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
|
Proportions of total registered patients vaccinated by age strata, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
時間枠：Up to 3 months (between 1 September 2015 and 30 November 2015)
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
|
Number of patient counts of the total registered patients vaccinated by co-morbidity, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
時間枠：Up to 3 months (between 1 September 2015 and 30 November 2015)
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
|
Proportions of total registered patients vaccinated by co-morbidity, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
時間枠：Up to 3 months (between 1 September 2015 and 30 November 2015)
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
|
Number of patient counts of the vaccinated patients with reported endpoints of interest by age strata, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
時間枠：Up to 3 months (between 1 September 2015 and 30 November 2015)
|
- Presentation with fever or other febrile illness, - Presentation related to local reaction, - Presentation related to general reaction (fatigue, myalgia, etc.), - All other presentations that could plausibly be related to vaccination.
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
Proportions of vaccinated patients with reported endpoints of interest by age strata, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
時間枠：Up to 3 months (between 1 September 2015 and 30 November 2015)
|
- Presentation with fever or other febrile illness, - Presentation related to local reaction, - Presentation related to general reaction (fatigue, myalgia, etc.), - All other presentations that could plausibly be related to vaccination.
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
Number of patient counts of the vaccinated patients with reported endpoints of interest by co-morbidity, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
時間枠：Up to 3 months (between 1 September 2015 and 30 November 2015)
|
- Presentation with fever or other febrile illness, - Presentation related to local reaction, - Presentation related to general reaction (fatigue, myalgia, etc.), - All other presentations that could plausibly be related to vaccination.
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
Proportions of vaccinated patients with reported endpoints of interest by co-morbidity, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
時間枠：Up to 3 months (between 1 September 2015 and 30 November 2015)
|
- Presentation with fever or other febrile illness, - Presentation related to local reaction, - Presentation related to general reaction (fatigue, myalgia, etc.), - All other presentations that could plausibly be related to vaccination.
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Completeness of vaccination data in the computerized medical record system.
時間枠：Up to 3 months (between 1 September 2015 and 30 November 2015)
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
Completeness of AEI reporting in the computerized medical record system.
時間枠：Up to 3 months (between 1 September 2015 and 30 November 2015)
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
Timeliness of vaccination data in the computerized medical record system.
時間枠：Up to 3 months (between 1 September 2015 and 30 November 2015)
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
Timeliness of AEI reporting in the computerized medical record system.
時間枠：Up to 3 months (between 1 September 2015 and 30 November 2015)
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
Completeness of vaccination data in the card-based adverse event reporting system.
時間枠：Up to 3 months (between 1 September 2015 and 30 November 2015)
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
Completeness of AEI reporting in the card-based adverse event reporting system.
時間枠：Up to 3 months (between 1 September 2015 and 30 November 2015)
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
Timeliness of vaccination data in the card-based adverse event reporting system.
時間枠：Up to 3 months (between 1 September 2015 and 30 November 2015)
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
Timeliness of AEI reporting in the card-based adverse event reporting system.
時間枠：Up to 3 months (between 1 September 2015 and 30 November 2015)
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
Incidence rates for the 5 most frequently reported AEs reported alongside those available in the literature from a similar population (vaccinated or general population if vaccinated not available) within the same risk period and stratified by age.
時間枠：Up to 3 months (between 1 September 2015 and 30 November 2015)
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2015年10月1日
一次修了 (実際)
2015年11月1日
研究の完了 (実際)
2015年11月1日
試験登録日
最初に提出
2015年9月18日
QC基準を満たした最初の提出物
2015年10月1日
最初の投稿 (見積もり)
2015年10月5日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年2月12日
QC基準を満たした最後の更新が送信されました
2016年2月11日
最終確認日
2016年2月1日
詳しくは
本研究に関する用語
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。