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Post-authorisation passive enhanced safety surveillance of seasonal influenza vaccines: protocol of a pilot study in England

de Lusignan, Simon, Dos Santos, G, Correa, Ana, Haguinet, F, Yonova, Ivelina, Lair, F, Byford, Rachel, Ferreira, Filipa, Stuttard, K and Chan T, T (2017) Post-authorisation passive enhanced safety surveillance of seasonal influenza vaccines: protocol of a pilot study in England BMJ Open, 78 (5). pp. 1-11.

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To pilot enhanced safety surveillance of seasonal influenza vaccine meeting the European Medicines Agency (EMA) requirement to rapidly detect a significant increase in the frequency or severity of adverse events of interest (AEIs), which may indicate risk from the new season’s vaccine.

Study design

A prospective passive enhanced safety surveillance combining data collection from adverse drug reaction (ADR) cards with automated collection of pseudonymised routinely collected electronic health record (EHR) data. This study builds on a feasibility study carried out at the start of the 2015/2016 influenza season. We will report influenza vaccine exposure and any AEIs reported via ADR card or recorded directly into the EHR, from the commencement of influenza vaccination and ends as specified by EMA (30 November 2016).


Ten volunteer English general practices, primarily using the GSK influenza vaccines. They had selected this vaccine in advance of the study.


People who receive a seasonal influenza vaccine, in each age group defined in EMA interim guidance: 6 months to 5 years, 6–12 years, 13–17 years, 18–65 years and >65 years.

Outcome measures

The primary outcome measure is the rate of AEIs occurring within 7 days postvaccination, using passive surveillance of general practitioner (GP) EHR systems enhanced by a card-based ADR reporting system. Extracted data will be presented overall by brand (Fluarix Tetra vs others), by age strata and risk groups. The secondary outcome measure is the vaccine uptake among the subjects registered in the enrolled general practices.

Item Type: Article
Divisions : Faculty of Health and Medical Sciences > School of Biosciences and Medicine
Authors :
de Lusignan,
Dos Santos, G
Haguinet, F
Lair, F
Stuttard, K
Chan T, T
Date : 17 May 2017
DOI : 10.1136/bmjopen-2016-015469
Copyright Disclaimer : © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
Depositing User : Jane Hindle
Date Deposited : 15 Sep 2017 10:39
Last Modified : 16 Jan 2019 18:56

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