Study identification

PURI

https://redirect.ema.europa.eu/resource/50201

EU PAS number

EUPAS48979

Study ID

50201

Official title and acronym

Association between COVID-19 vaccines and paediatric safety outcomes in children and adolescents aged 5-19 years in the Nordic countries: Myocarditis, pericarditis and thromboembolic events

DARWIN EU® study

No

Study countries

Denmark
Finland
Norway
Sweden

Study status

Finalised
Research institutions and networks

Institutions

Danish Medicines Agency, Data Analytics Centre, Axel Heides Gade 1, DK-2300 Copenhagen S, Denmark, University of Copenhagen, Department of Drug Design and Pharmacology, Pharmacovigilance Research Center, Faculty of Health and Medical Sciences Universitetsparken 2, DK-2100 Copenhagen Ø, Denmark, Statens Serum Institut, Department of Epidemiology Research Artillerivej 5, DK-2300 Copenhagen S, Denmark, Finnish Institute for Health and Welfare POBox 30, FI-00271 Helsinki, Finland, Norwegian Institute of Public Health, Department of Infection, Control and Vaccines P.O.Box 222-Skøyen, NO-0213 Oslo, Norway, Swedish Medical Products Agency, Division of Use and Information SE3751 03 Uppsala, Sweden

Contact details

Anders Hviid

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Initial protocol
English (1.39 MB - PDF)View document
Updated protocol
English (1022.51 KB - 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