Study identification

PURI

https://redirect.ema.europa.eu/resource/46889

EU PAS number

EUPAS46888

Study ID

46889

Official title and acronym

DRIVE - Brand-specific influenza vaccine effectiveness in Europe, season 2021/22 (DRIVE 2021/22)

DARWIN EU® study

No

Study countries

Austria
Finland
France
Iceland
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 2021/22 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 2021/22 influenza season. 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
First published:
09/04/2024
Institution
Laboratory/Research/Testing facilityNon-Pharmaceutical companyENCePP partner
Medical University of Vienna
Austria
First published:
26/02/2024
Institution
Educational InstitutionHospital/Clinic/Other health care facility
Medical University Vienna Austria, Directorate of Health (Embætti landlæknis ) Iceland, Istituto Superiore di Sanità Italy, Royal College of General Practitioners Research and Surveillance Centre & University of Oxford United Kingdom, Innovative clinical research network in vaccinology (I-REIVAC INSERM) France, Centro Interuniversitario di Ricerca sull’Influenza e sulle altre infezioni trasmissibili Italian Hospital Network Italy, National Institute for Infectious Disease “Prof. Dr. Matei Balș” Romania, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO) Spain, Germans Trias i Pujol University Hospital Spain

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:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
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_Season2021-22_v3.0_20220408

English (1.29 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