Study identification

PURI

https://redirect.ema.europa.eu/resource/105010

EU PAS number

EUPAS105009

Study ID

105010

Official title and acronym

Clinical course, outcomes and risk factors of myocarditis and pericarditis following administration of Moderna vaccines targeting SARS-CoV-2.

DARWIN EU® study

No

Study countries

Denmark
Netherlands
Norway
Spain
United Kingdom

Study description

The overarching goal of this study is to describe the clinical course, outcomes and risk factors for myocarditis and pericarditis associated with Moderna vaccination targeting SARS-CoV-2. We will investigate the clinical course in terms of morbidity and to identify the relevant prognostic factors using the study objectives

Study status

Ongoing
Research institution and networks

Institutions

Julius Clinical Research
Netherlands
First published:
06/03/2024
Institution
Non-Pharmaceutical company
ENCePP partner
Julius Clinical Research
Netherlands
First published:
06/03/2024
Institution
Non-Pharmaceutical company
ENCePP partner
FISABIO Spain, University of Oslo Norway

Contact details

Ong David

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Moderna Tx
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 3 (required)