202055 - European Medicines Agency (EMA) post-authorisation safety study of influenza vaccine

Study identification

• EU PAS number:
  EUPAS10632
• Study ID:
  31683
• Official title and acronym:
  202055 - European Medicines Agency (EMA) post-authorisation safety study of influenza vaccine
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  The purpose of this study is to conduct a pilot study to explore the potential use of routinely collected data in General Practitioner (GP) practices to conduct enhanced safety surveillance of seasonal influenza vaccines in the UK, as recommended in the EMA interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU. Data routinely collected as part of clinical consultations in primary care will be extracted from nine General Practitioner (GP) practices in order to estimate medically attended Adverse Events of Interest (AEIs), for people who have received an influenza vaccine. This study will also actively follow patients who were exposed to seasonal influenza vaccination for 7 days in three of the nine GP practices using a customised card-based adverse drug reaction reporting system, in order to determine whether a more active approach to surveillance can capture higher rates of AEIs.
• Study status:
  Finalised

Research institutions and networks

Institutions

University of Surrey

Department of Health Care Management and Policy, University of Surrey, UK

Study timelines

Date when funding contract was signed

Actual:27/03/2015

Study start date

Actual:03/10/2015

Date of final study report

Actual:16/02/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GSK Biologicals

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)