Status: Finalised First registered on: 05/06/2020
Last updated on: 05/11/2020
1. Study identification
EU PAS Register NumberEUPAS35685
Official titleBrand-specific influenza vaccine effectiveness in Europe, season 2019/20
Study title acronymDRIVE 2019/20
Study typeObservational study
Brief description of the studyThe 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsP95
Department/Research group
Organisation/affiliationP95
Website/Homepagewww.P-95.com
Details of (Primary) lead investigator
Title Dr
Last name Riera
First name Margarita
Is this study being carried out with the collaboration of a research network?
Yes

DRIVE
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?13
Centro Interuniversitario di Ricerca sull’Influenza e sulle altre infezioni trasmissibili (CIRI-IT), Italy
Helsinki University Hospital (HUS), Finland
National Institute for Infectious Diseases “Prof. Dr. Matei Balș” (NIID), Romania
Italian Hospital Network (BIVE), Italy
Medical University Vienna (MUV), Austria
Laboratoire National de Santé (LNS), Luxembourg
Hospital Universitario La Paz (LPUH), Spain
Hospital Universitario Germans Trias i Pujol (GTPUH), Spain
Vall d’Hebron University Hospital (VHUH), Spain
Countries in which this study is being conducted
International study

Austria
Finland
France
Italy
Luxembourg
Romania
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed23/05/201723/05/2017
Start date of data collection16/09/201916/09/2019
Start date of data analysis
Date of interim report, if expected
Date of final study report30/09/202014/09/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAbbott, GSK, SP, Seqirus50
Charities
Government body
Research councils
EU funding schemeInnovative Medicines Initiative (IMI)50
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Riera
First name Margarita
Address line 1Koning Leopold III laan 1
Address line 2 
Address line 3 
CityLeuven 
Postcode3001 
CountryBelgium
Phone number (incl. country code)34622471182 
Alternative phone number 
Fax number (incl. country code) 
Email address margarita.riera@p-95.com
Public Enquiries
Title Dr 
Last name Diez Domingo 
First name Javier 
Address line 1Avda Cataluña 21 
Address line 2 
Address line 3 
CityValencia 
Postcode46020 
CountrySpain 
Phone number (incl. country code)34961925948 
Alternative phone number 
Fax number (incl. country code) 
Email address jdiezdomingo@gmail.com 
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