Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000193

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 institution and networks

Institutions

Pedianet network
Italy
First published:
01/02/2024
InstitutionOther
Teamit Institute
Spain
First published:
12/03/2024
InstitutionOtherENCePP 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
Study protocol
Initial protocol

SafetyVacProtocolObj1v1.0_FINAL.pdf

English (1.7 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