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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (实际的)
11530
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Surrey、英国、GU2 7XH
- GSK Investigational Site
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
6个月 及以上 (孩子、成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Registered patients in 9 GP practices in England and who are immunized against seasonal influenza between 1 September 2015 and 30 November 2015
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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.
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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.
其他名称：
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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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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)
大体时间：Up to 3 months (between 1 September 2015 and 30 November 2015)
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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|
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Proportions of total registered patients vaccinated by age strata, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
大体时间：Up to 3 months (between 1 September 2015 and 30 November 2015)
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Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
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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)
大体时间：Up to 3 months (between 1 September 2015 and 30 November 2015)
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Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
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Proportions of total registered patients vaccinated by co-morbidity, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
大体时间：Up to 3 months (between 1 September 2015 and 30 November 2015)
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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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)
大体时间：Up to 3 months (between 1 September 2015 and 30 November 2015)
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- 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.
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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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)
大体时间：Up to 3 months (between 1 September 2015 and 30 November 2015)
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- 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.
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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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)
大体时间：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.
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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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)
大体时间：Up to 3 months (between 1 September 2015 and 30 November 2015)
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- 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.
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Completeness of vaccination data in the computerized medical record system.
大体时间：Up to 3 months (between 1 September 2015 and 30 November 2015)
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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Completeness of AEI reporting in the computerized medical record system.
大体时间：Up to 3 months (between 1 September 2015 and 30 November 2015)
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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Timeliness of vaccination data in the computerized medical record system.
大体时间：Up to 3 months (between 1 September 2015 and 30 November 2015)
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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Timeliness of AEI reporting in the computerized medical record system.
大体时间：Up to 3 months (between 1 September 2015 and 30 November 2015)
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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Completeness of vaccination data in the card-based adverse event reporting system.
大体时间：Up to 3 months (between 1 September 2015 and 30 November 2015)
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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Completeness of AEI reporting in the card-based adverse event reporting system.
大体时间：Up to 3 months (between 1 September 2015 and 30 November 2015)
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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Timeliness of vaccination data in the card-based adverse event reporting system.
大体时间：Up to 3 months (between 1 September 2015 and 30 November 2015)
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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Timeliness of AEI reporting in the card-based adverse event reporting system.
大体时间：Up to 3 months (between 1 September 2015 and 30 November 2015)
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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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.
大体时间：Up to 3 months (between 1 September 2015 and 30 November 2015)
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Up to 3 months (between 1 September 2015 and 30 November 2015)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年10月1日
初级完成 (实际的)
2015年11月1日
研究完成 (实际的)
2015年11月1日
研究注册日期
首次提交
2015年9月18日
首先提交符合 QC 标准的
2015年10月1日
首次发布 (估计)
2015年10月5日
研究记录更新
最后更新发布 (估计)
2016年2月12日
上次提交的符合 QC 标准的更新
2016年2月11日
最后验证
2016年2月1日
更多信息
与本研究相关的术语
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