GSK, Wavre, Belgium.
VPN Consultancy Ltd, London, UK.
Adv Ther. 2019 Dec;36(12):3340-3355. doi: 10.1007/s12325-019-01105-2. Epub 2019 Oct 8.
Influenza is an important cause of morbidity and mortality in Europe. Prevention by annual vaccination is most effective but with yearly vaccine reformulation to match circulating virus strains, vaccine safety must be continuously monitored. The European Medicines Agency published guidance on safety monitoring of influenza vaccines.
An enhanced safety surveillance study of GSK's inactivated quadrivalent influenza vaccine (IIV4) was conducted in Belgium, Germany, and Spain in influenza season 2018/19. The objective was to collect adverse event (AE) reports from subjects within 7 days of vaccination. A customized AE reporting card (AERC) with predefined AEs of interest was used to rapidly detect and evaluate potential new safety concerns. Interim results are presented here.
Between week 40 and 52, 1060 vaccinated subjects were enrolled (31.0% Belgium, 26.2% Germany, and 42.7% Spain) covering all ages for which IIV4 is indicated (32.0% aged 6 months-17 years, 33.8% 18-65 years, and 34.2% over 65 years). Pediatric subjects less than 9 years old (n = 139) received two doses. Following dose 1 and dose 2, 98.2% and 100%, respectively, returned the completed AERC recording any AEs. Following dose 1 and dose 2, 454 and 34 subjects, respectively, reported at least one AE (most frequently expected general and injection site symptoms and respiratory symptoms).
All reported AEs were expected as per summary product characteristics (smPC). No safety signals that impact public health or alter the benefit-risk profile of GSK's IIV4 were identified. Subjects from all vaccinated age groups were enrolled and the use of AERCs allowed rapid monitoring and analysis of reported AEs.
ClinicalTrials.gov identifier, NCT03688620.
GlaxoSmithKline Biologicals SA.
流感是欧洲发病率和死亡率的重要原因。通过每年接种疫苗进行预防最为有效，但由于需要每年对疫苗进行配方改革以匹配流行病毒株，因此必须持续监测疫苗安全性。欧洲药品管理局发布了有关流感疫苗安全性监测的指南。
在 2018/19 流感季节，在比利时、德国和西班牙进行了葛兰素史克公司（GSK）灭活四价流感疫苗（IIV4）的强化安全性监测研究。目的是在接种后 7 天内收集受试者的不良事件（AE）报告。使用具有预定义关注不良事件的定制不良事件报告卡（AERC）快速检测和评估潜在的新安全问题。这里介绍的是中期结果。
在第 40 周至第 52 周期间，共招募了 1060 名接种疫苗的受试者（31.0%来自比利时、26.2%来自德国、42.7%来自西班牙），涵盖了 IIV4 适用的所有年龄段（32.0%为 6 个月至 17 岁、33.8%为 18-65 岁、34.2%为 65 岁以上）。儿科受试者（n=139）年龄小于 9 岁，接受了两剂接种。接种第 1 剂和第 2 剂后，分别有 98.2%和 100%的受试者返回填写完整的 AERC，记录任何不良事件。接种第 1 剂和第 2 剂后，分别有 454 名和 34 名受试者报告了至少一种不良事件（最常见的是预期的全身和注射部位症状以及呼吸道症状）。
所有报告的不良事件均符合总结产品特性（SmPC）。未发现影响公共健康或改变 GSK 的 IIV4 获益风险状况的安全信号。所有接种年龄组的受试者均被纳入研究，使用 AERCs 可快速监测和分析报告的不良事件。
ClinicalTrials.gov 标识符，NCT03688620。
葛兰素史克生物制品有限公司。
