DRIVE - Brand-specific influenza vaccine effectiveness in Europe, season 2018/19 (DRIVE 2018/19)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40889
• EU PAS number:
  EUPAS29817
• Study ID:
  40889
• Official title and acronym:
  DRIVE - Brand-specific influenza vaccine effectiveness in Europe, season 2018/19 (DRIVE 2018/19)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Finland

  Greece

  Italy

  Romania

  Spain

  United Kingdom
• Study description:
  The Development of Robust and Innovative Vaccine Effectiveness (DRIVE) project is a public-private partnership aiming to build capacity in Europe for estimating brand-specific influenza vaccine effectiveness (IVE). The DRIVE Project, which is funded by the Innovative Medicines Initiative (IMI), was initiated as a response to the changes for licensing of influenza vaccines in Europe. The new guidance on influenza vaccines by the European Medicines Agency (EMA) came into effect in the beginning of 2017. This guidance states that the performance of influenza vaccines should no longer be assessed based on serological assays, but should be based on post-authorization effectiveness studies 1. The main objective of the 2018/19 season is to estimate brand-specific seasonal IVE in Europe by health care setting and age group. In DRIVE, data from several independently operating national or regional study sites is analysed jointly to obtain sufficient geographical coverage and sample size for brand-specific IVE estimates. This document describes the characteristics of the participating study sites, the site-specific statistical analysis as well as the statistical analysis to pool data across study sites for the 2018/19 influenza season. The DRIVE platform is still expanding, and not all vaccine brands used in Europe will be covered during the 2018/19 season. 1 Committee for Medicinal Products for Human Use. Guideline on Influenza Vaccines - Non-clinical and Clinical Module. EMA/CHMP/BWP/310834/2012. In. London: Eur Med Agency, 2016.
• Study status:
  Finalised

Research institution and networks

Institutions

P95 Epidemiology & Pharmacovigilance

Belgium

Colombia

Netherlands

South Africa

Thailand

United States

Medical University Vienna Austria, Centro Interuniversitario di Ricerca sull’Influenza e sulle altre infezioni trasmissibili (CIRI-IT), Italy, Royal College of General Practitioners (RCGP) & University of Surrey (UNIS) UK, Istituto Superiore di Sanita (ISS) Italy, Helsinki University Central Hospital (HUCH) Finland, Italian Hospital Network (IT-BIVE-HOSP) Italy, Vall d’Hebron University Hospital (VHUH) Spain, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO) Spain, The National Institute for Health and Welfare (THL) Finland

Networks

Development of Robust and Innovative Vaccine Effectiveness (DRIVE)

Belgium

European Union

Finland

France

Italy

Netherlands

Spain

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 23/05/2017

Actual: 23/05/2017

Study start date

Planned: 15/09/2018

Actual: 15/09/2018

Data analysis start date

Planned: 15/05/2019

Actual: 15/05/2019

Date of final study report

Planned: 15/07/2019

Actual: 30/08/2019

Sources of funding

Pharmaceutical company and other private sector 

EU institutional research programme

More details on funding

Abbott, GSK, SP, Seqirus, Innovative Medicines Initiative (IMI)

Study protocol

Initial protocol

DRIVE1819_WP7_4_Season1819SAPpooledv06_clean2

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable