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

Germany
Italy
Spain
United Kingdom

Study description

This Master Protocol describes a non-interventional study to estimate the effectiveness of coronavirus
disease 2019 (COVID-19) vaccines against severe COVID-19 in Europe. The study is a multi-country,
hospital-based, case-control study with test-negative controls (test-negative case-control design,
TNCC). This Master Protocol will be used to create Study Requestor-specific protocols that meet the
requirements of the Study Requestors (Pharmaceutical Company Partners) and to create site-specific
protocols that reflect the data collection and requirements at the specific study sites (Study
Contributors). This Master Protocol is set up to harmonise study methods (e.g., study objectives,
subject inclusion/exclusion criteria, case definitions, exposures, outcomes, and data collection) and to
mutualise healthcare providers/study site resources.

Study status

Ongoing
Research institution and networks

Institutions

P95 Epidemiology & Pharmacovigilance
Belgium
Colombia
Netherlands
South Africa
Thailand
United States
First published:
09/04/2024
InstitutionLaboratory/Research/Testing facilityNon-Pharmaceutical companyENCePP partner
Imperial College London
United Kingdom
First published:
01/02/2024
InstitutionEducational Institution
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
Universitätsklinikum Ulm
Universitätsklinikum Frankfurt
Ospedale Luigi Sacco
Hospital Clínic de Barcelona
Hospital Clínico Universitario de Santiago de Compostela
Hospital Universitario La Paz
Manchester University NHS Foundation Trust (MFT)

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
English (3.85 MB - PDF)View document
Updated protocol
English (883.8 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)