Study of brand-specific COVID-19 vaccine effectiveness against severe COVID-19 disease in Europe (former COVIDRIVE)

02/08/2021
25/09/2026
EU PAS number:
EUPAS42328
Study
Ongoing
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Study summary
No information provided.
Study identification

EU PAS number

EUPAS42328

Study ID

49374

Official title and acronym

Study of brand-specific COVID-19 vaccine effectiveness against severe COVID-19 disease in Europe (former COVIDRIVE)

DARWIN EU® study

No

Study countries

Austria
Belgium
Finland
France
Germany
Iceland
Italy
Luxembourg
Poland
Romania
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.

- - Update 01 Sep 2026- -
From 01 Sep 2026 (start of the id.DRIVE epidemiological year 2026-2027), the three id.DRIVE master study protocols (EUPAS1000000012, EUPAS42328, and EUPAS1000000035) are merged into one common master protocol (EUPAS1000000012; V3.0 02 Mar 2026).

New, common study title:
Surveillance of Respiratory Pathogens and Brand-Specific Vaccine Effectiveness in Adults Hospitalised with SARI: An Observational Study
This means that the respiratory pathogen surveillance protocol (EUPAS1000000012; ongoing) now also incorporates the RSV vaccine effectiveness (EUPAS1000000035; ongoing; RSV VE module) and COVID-19 vaccine effectiveness (EUPAS42328; paused; CVE module) studies. EUPAS42328 and EUPAS1000000035 are updated accordingly in this register (the reader of those two is now referred to EUPAS1000000012).

Study status

Ongoing
Research institutions and networks

Institutions

Imperial College London
United Kingdom
First published:
01/02/2024
Institution Educational Institution
Valencia Hospital Network for the Study of Influenza and Other Respiratory Viruses (VAHNSI)
Germans Trias i Pujol University Hospital
Hospital Clínico Universitario de Santiago de Compostela
Hospital Universitario La Paz
Hospital Clínic Universitari Barcelona

Grand Hôpital de Charleroi
UZA University Hospital Antwerp
CHU Saint-Pierre Hospital Brussels

Klinik Favoriten Hospital

Centro Interuniversitario per la Ricerca sull’Influenza e le altre Infezioni (CIRI-IT)
Ospedale Luigi Sacco

Universitätsklinikum Freiburg
Universitätsklinikum Ulm
Universitätsklinikum Frankfurt
Charité - Universitätsmedizin Berlin

Manchester University NHS Foundation Trust (MFT)
NHS Lothian

Hôpitaux Universitaires Henri-Mondor
Centre Hospitalier Annecy Genevois and St Julien

Networks

id.DRIVE (former COVIDRIVE)
Austria
Belgium
Canada
Croatia
Czechia
Denmark
France
Germany
Iceland
Italy
Poland
Romania
Spain
United Kingdom
First published:
04/05/2026
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

Current and former partners of COVIDRIVE and id.DRIVE:
AstraZeneca, Bavarian Nordic, CureVac, GSK, Johnson & Johnson, Moderna, Novavax, Pfizer, Sanofi, and Valneva
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)