Study identification

PURI

https://redirect.ema.europa.eu/resource/43939

EU PAS number

EUPAS40875

Study ID

43939

Official title and acronym

DRIVE Brand-specific influenza vaccine effectiveness in Europe, season 2020/21 (DRIVE 2020/21)

DARWIN EU® study

No

Study countries

Austria
Finland
France
Iceland
Italy
Romania
United Kingdom (Northern Ireland)

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 2019/20 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 2019/20 influenza season. The DRIVE platform is still expanding, and not all vaccine brands used in Europe will be covered during the 2019/20 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
InstitutionLaboratory/Research/Testing facilityNon-Pharmaceutical companyENCePP partner
Medical University Vienna (MUV) Austria, Istituto Superiore di Sanità (ISS) Italy, Royal College of General Practitioners Research and Surveillance Centre (RCGPRSC) & University of Oxford (OX) United Kingdom, Centro Interuniversitario di Ricerca sull’Influenza e sulle altre infezioni trasmissibili Italian Hospital Network (CIRI-IT BIVE) Italy, National Institute for Infectious Disease “Prof. Dr. Matei Balș”, Bucharest Romania, Vall d’Hebron University Hospital (HUVH), Barcelona, Spain & Hospital Universitari Doctor Josep Trueta (HUJT), Gerona Spain, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO) Spain, Hospital Universitario La Paz (LPUH), Madrid Spain, Germans Trias i Pujol University Hospital (GTPUH), Badalona Spain, Institut National de la Santé et de la Recherche Médicale (INSERM) France

Networks

Contact details

Anke Stuurman

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Actual:
Sources of funding
Non-for-profit organisation (e.g. charity)
Pharmaceutical company and other private sector 

More details on funding

Abbott, GSK, SP, Seqirus, Innovative Medicines Initiative 2 (IMI-2)
Study protocol
Initial protocol

DRIVE_SAP_Season2021_v1.3_clean-

English (1.26 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable