Study identification

PURI

https://redirect.ema.europa.eu/resource/107880

EU PAS number

EUPAS107708

Study ID

107880

Official title and acronym

DARWIN EU® Age specific incidence rates of RSV related disease in Europe

DARWIN EU® study

Yes

Study countries

Estonia
France
Germany
Spain
United Kingdom

Study description

Rationale and Background: Severe acute respiratory infection caused by respiratory syncytial virus (RSV) poses a global health threat, especially impacting children under 5 and older adults, leading to significant morbidity and mortality. The ongoing development of RSV vaccines underscores the critical need for accurate information on RSV burden in high-risk groups, essential for continuous benefit/risk profile assessment. This study aims to provide crucial insights into age-specific incidence rates of RSV-related disease in Europe, contributing to ongoing efforts in comprehending and managing RSV infection burdens.

Research question: What are the age-specific disease frequencies, hospitalisation rates, and mortality rates of RSV infection in European countries over the past decade?

Study objectives: To estimate RSV-related hospitalization rates and duration, proportions of RSV-related ICU admissions and co-infection with other respiratory pathogens, as well as RSV-related mortality rates.

Study status

Finalised
Research institution and networks

Networks

Contact details

Johnmary Arinze

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Updated protocol

DARWIN_EU_D2.2.3_Protocol_P2_C1-011_RSV_v2.1.pdf

English (1.02 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable