Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000035

EU PAS number

EUPAS1000000035

Study ID

1000000035

Official title and acronym

id.DRIVE study of brand-specific respiratory syncytial virus (RSV) vaccine effectiveness in Europe

DARWIN EU® study

No

Study countries

France
Germany
Italy
Spain
United Kingdom

Study description

This is a European, non-interventional study to estimate the effectiveness of vaccines against respiratory syncytial virus (RSV). Of interest is the effectiveness against hospitalisation with severe acute respiratory infection (SARI) caused by RSV.

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
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)
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
Hôpitaux Universitaires Henri-Mondor
Manchester University NHS Foundation Trust (MFT)
NHS Lothian

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

Pfizer
Study protocol
Initial protocol

RSV_Master Protocol V2.0_07 Jun 2024.pdf

English (994.21 KB - 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