University of Surrey , Guildford, UK.
Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) , London, UK.
Hum Vaccin Immunother. 2020 Aug 2;16(8):1762-1771. doi: 10.1080/21645515.2019.1705112. Epub 2020 Mar 2.
In compliance with the European Medicine Agency guidance to detect any potential safety concerns associated with influenza vaccination, an enhanced safety surveillance study was conducted in England during the 2017/18 influenza season. The primary objective was to estimate the incidence rates of adverse events occurring within seven days of vaccination with Fluarix Tetra. In nine General Practices, seasonal influenza vaccine was administered to patients according to local guidelines. Events following immunization were collected using customized cards (enhanced component) combined with electronic health records [EHRs] (EHR component) to estimate incidence rates of adverse events experienced post vaccination. The study ran from 01-Sep-2017 to 30-Nov-2017. A total of 23,939 subjects were vaccinated of whom 16,433 received Fluarix Tetra. The cumulative incidence rates of adverse events of interest for Fluarix Tetra were 7.25% [95% CI, 5.95-8.73] for events reported by card alone, and 9.21% [95% CI, 7.37-11.34] when combined with EHR data. The type and frequency of events reported were consistent with the Fluarix Tetra Summary of Product Characteristics. The study supports and confirms the safety profile of Fluarix Tetra. ClinicalTrials.gov number: NCT03278067.
为了遵守欧洲药品管理局的指导方针，以检测与流感疫苗接种相关的任何潜在安全问题，在 2017/18 流感季节期间，在英格兰进行了一项强化安全性监测研究。主要目的是估计接种 Fluarix Tetra 后 7 天内发生不良事件的发生率。在 9 家普通诊所，根据当地指南向患者接种季节性流感疫苗。使用定制卡（强化组件）结合电子健康记录 [EHR]（EHR 组件）收集疫苗接种后发生的事件，以估计接种后发生不良事件的发生率。该研究于 2017 年 9 月 1 日至 11 月 30 日进行。共有 23939 名受试者接种疫苗，其中 16433 名接受了 Fluarix Tetra 接种。仅通过卡片报告的不良事件中 Fluarix Tetra 的累积不良事件发生率为 7.25% [95% CI，5.95-8.73]，当与 EHR 数据结合时，发生率为 9.21% [95% CI，7.37-11.34]。报告的事件的类型和频率与 Fluarix Tetra 产品特性总结一致。该研究支持并确认了 Fluarix Tetra 的安全性。ClinicalTrials.gov 编号：NCT03278067。
