Study identification

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 institutions and networks

Institutions

P95 Clinical and Epidemiology Services
Belgium
Colombia
Netherlands
South Africa
Thailand
United States
First published:
21/02/2025
Institution Laboratory/Research/Testing facility Non-Pharmaceutical company ENCePP partner
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

Contact details

Riera Marga

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
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)
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable