Study identification

EU PAS number

EUPAS1000000193

Study ID

1000000193

Official title and acronym

SAFETY-VAC: Network of Data Sources for Vaccine Safety Evaluation

DARWIN EU® study

No

Study countries

Denmark
Finland
France
Italy
Norway
Spain
United Kingdom

Study description

This study aims to provide and describe a network of real-world data sources to evaluate vaccine safety signals and to assess its fitness for the purpose of conducting vaccine safety studies.
SAFETY-VAC will assess the capacity to conduct safety studies in a network of 10 different electronic health record data sources from the EU PE&PV and VAC4EU networks of seven EU-EEA countries.
The study will describe data quality of the included data sources, the data source population, coverage of routine immunizations of 13 different vaccines authorized in the EU-EEA, and incidence of 39 selected events that may be potentially associated with vaccination.

Study status

Finalised
Research institutions and networks

Institutions

Pedianet network
Italy
First published:
01/02/2024
Institution Other
Teamit Institute
Spain
First published:
12/03/2024
Institution Other ENCePP partner
Utretch University (UU)
University of Eastern Finland (UEF)

Networks

Contact details

Carlos Durán Salinas

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
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable