Asthma UK Centre for Applied Research, Usher Institute of Population Health Sciences and Informatics, The University of Edinburgh, Edinburgh, UK.
Department of Mathematics and Statistics, University of Strathclyde, Glasgow, UK.
BMJ Open. 2017 Feb 28;7(2):e014200. doi: 10.1136/bmjopen-2016-014200.
Seasonal (inactivated) influenza vaccination is recommended for all individuals aged 65+ and in individuals under 65 who are at an increased risk of complications of influenza infection, for example, people with asthma Live attenuated influenza vaccine (LAIV) was recommended for children as they are thought to be responsible for much of the transmission of influenza to the populations at risk of serious complications from influenza. A phased roll-out of the LAIV pilot programme began in 2013/2014. There is limited evidence for vaccine effectiveness (VE) in the populations targeted for influenza vaccination. The aim of this study is to examine the safety and effectiveness of the live attenuated seasonal influenza vaccine programme in children and the inactivated seasonal influenza vaccination programme among different age and at-risk groups of people.
Test negative and cohort study designs will be used to estimate VE. A primary care database covering 1.25 million people in Scotland for the period 2000/2001 to 2015/2016 will be linked to the Scottish Immunisation Recall Service (SIRS), Health Protection Scotland virology database, admissions to Scottish hospitals and the Scottish death register. Vaccination status (including LAIV uptake) will be determined from the primary care and SIRS database. The primary outcome will be influenza-positive real-time PCR tests carried out in sentinel general practices and other healthcare settings. Secondary outcomes include influenza-like illness and asthma-related general practice consultations, hospitalisations and death. An instrumental variable analysis will be carried out to account for confounding. Self-controlled study designs will be used to estimate the risk of adverse events associated with influenza vaccination.
We obtained approval from the National Research Ethics Service Committee, West Midlands-Edgbaston. The study findings will be presented at international conferences and published in peer-reviewed journals.
ISRCTN88072400; Pre-results.
建议为所有 65 岁以上人群和患有流感感染并发症风险增加的 65 岁以下人群（例如患有哮喘的人群）接种季节性（灭活）流感疫苗。人们认为，减毒活流感疫苗（LAIV）可用于儿童，因为它们是导致流感传播到有严重流感并发症风险人群的主要原因。从 2013/2014 年开始，LAIV 试点计划分阶段推出。在接受流感疫苗接种的人群中，疫苗有效性（VE）的证据有限。本研究的目的是检验儿童使用减毒季节性流感疫苗计划和不同年龄和高危人群使用灭活季节性流感疫苗计划的安全性和有效性。
将使用阴性测试和队列研究设计来估计 VE。将一个覆盖苏格兰 125 万人的初级保健数据库与苏格兰免疫召回服务（SIRS）、苏格兰卫生保护局病毒学数据库、苏格兰医院入院和苏格兰死亡登记处进行链接。将从初级保健和 SIRS 数据库确定疫苗接种状态（包括 LAIV 接种率）。主要结局将是在哨点全科诊所和其他医疗保健场所进行的流感阳性实时 PCR 检测。次要结局包括流感样疾病和与哮喘相关的全科诊所就诊、住院和死亡。将进行工具变量分析以控制混杂因素。将使用自身对照研究设计来估计与流感疫苗接种相关的不良事件风险。
我们已获得国家研究伦理服务委员会（西米德兰兹-埃德巴斯顿）的批准。研究结果将在国际会议上进行报告，并在同行评议期刊上发表。
ISRCTN88072400；预结果。
