Study identification

PURI

https://redirect.ema.europa.eu/resource/49374

EU PAS number

EUPAS42328

Study ID

49374

Official title and acronym

id.DRIVE (former COVIDRIVE) study of brand-specific COVID-19 vaccine effectiveness against severe COVID-19 disease in Europe

DARWIN EU® study

No

Study countries

Austria
Germany
Italy
Spain

Study description

This protocol details a non-interventional study to estimate the effectiveness of COVID-19 vaccines against COVID-19-related hospitalisations through the COVIDRIVE partnership. In addition, the potential for vaccine-associated enhanced disease (VAED) will be studied as part of this vaccine effectiveness study as VAED relates to the efficacy/effectiveness outcomes. This is a prospective, multi-centre, hospital-based, case-control study with test-negative controls (test-negative case-control design). Data will be collected through a wide network of hospitals located in several European countries and the UK.

Study status

Ongoing
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
Valencia Hospital Network for the Study of Influenza and Other Respiratory Viruses (VAHNSI)
Centro Interuniversitario per la Ricerca sull’Influenza e le altre Infezioni (CIRI-IT)
Germans Trias i Pujol University Hospital
Klinik Favoriten
St Pierre University Hospital
Universitair Ziekenhuis Antwerpen
Grand Hôpital de Charleroi
Ospedale Luigi Sacco
Hospital Clínic de Barcelona
Hospital Clínico Universitario de Santiago de Compostela
Universitätsklinikum Frankfurt
Universitätsklinikum Ulm
Universitätsklinikum Freiburg

Networks

id.DRIVE (former COVIDRIVE)
Austria
Belgium
Croatia
Czechia
Denmark
France
Germany
Iceland
Italy
Poland
Romania
Spain
First published:
29/02/2024
Network
ENCePP partner

Contact details

Kaatje Bollaerts

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

AstraZeneca, Johnson & Johnson, Novavax, Valneva, Pfizer
Study protocol
Initial protocol

COVIDRIVE_TND-VE_MasterProtocol_v3.1

English (3.85 MB - PDF)View document
Updated protocol

Protocol_Master Final Protocol_V5.0_18 Sep 2023.pdf

English (957.04 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 3 (required)