EMA post-authorisation safety study of influenza vaccine - Year 2

• Research type

  Research Study

• Full title

  European Medicines Agency (EMA) post-authorisation safety study of influenza vaccine - Year 2

• IRAS ID

  211560

• Contact name

  Simon de Lusignan

• Contact email

  s.lusignan@surrey.ac.uk

• Sponsor organisation

  GlaxoSmithKline Biologicals

• Duration of Study in the UK

  0 years, 11 months, 31 days

• Research summary

  Background:
  The European Medicines Agency (EMA) has set out new requirements for influenza vaccine safety surveillance that all Marketing Authorisation Holders (MAHs) providing vaccines in the EU must address. This study will work with practitioners and a MAH to assess if routinely collected data in primary care is fit for the purpose of supporting an enhanced surveillance, and to draw conclusions if additional data collection in primary care is needed to meet EMA standards for enhanced surveillance of seasonal influenza vaccination.

  Objective:
  To conduct a pilot exploring adverse event of interest (AEI) frequencies among flu-vaccinated subjects using routinely collected data and an Adverse Drug Reaction (ADR) card reporting system in ten primary care practices.
  
  Methods:
  We will recruit ten practices representing urban and rural localities across England and the three major computerised medical record suppliers in the UK.

  We will extract weekly data, using a method developed by the Research Team for use in national surveillance work sponsored by Public Health England, to allow observation of data. We will evaluate 7-day AEI frequencies from this data, but we will not exclude events recorded outside this window, which will be analysed separately.

  Expected outcomes:
  • Weekly data extraction that captures
  o Vaccination coverage by age strata and brand
  o Proportions of patients reporting pre-specified AEIs by age strata and brand
  o An assessment of data completeness and timeliness

  This is a pilot study, the results of which will be used to assess the whether the data collected in the study meet the requirements of enhanced safety surveillance as stipulated in the interim guidance issued by EMA in April 2014.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  16/NE/0271

• Date of REC Opinion

  5 Aug 2016

• REC opinion

  Favourable Opinion