European Medicines Agency (EMA) Post-authorisation Safety Study of Influenza Vaccine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11,530
- 试验地点
- 1
- 主要终点
- 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)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •Pregnant women are also included in this study.
排除标准
- •Only registered patients who have explicitly opted out of data sharing will be excluded from the analysis.
结局指标
主要结局
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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
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)
时间窗: 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.
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)
时间窗: 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.
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)
时间窗: 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.
次要结局
- Completeness of vaccination data in the computerized medical record system.(Up to 3 months (between 1 September 2015 and 30 November 2015))
- Completeness of AEI reporting in the computerized medical record system.(Up to 3 months (between 1 September 2015 and 30 November 2015))
- Timeliness of vaccination data in the computerized medical record system.(Up to 3 months (between 1 September 2015 and 30 November 2015))
- Timeliness of AEI reporting in the computerized medical record system.(Up to 3 months (between 1 September 2015 and 30 November 2015))
- Completeness of vaccination data in the card-based adverse event reporting system.(Up to 3 months (between 1 September 2015 and 30 November 2015))
- Completeness of AEI reporting in the card-based adverse event reporting system.(Up to 3 months (between 1 September 2015 and 30 November 2015))
- Timeliness of vaccination data in the card-based adverse event reporting system.(Up to 3 months (between 1 September 2015 and 30 November 2015))
- Timeliness of AEI reporting in the card-based adverse event reporting system.(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.(Up to 3 months (between 1 September 2015 and 30 November 2015))