Study identification

PURI

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

EU PAS number

EUPAS105009

Study ID

105010

Official title and acronym

mRNA-1273-P910: 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
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 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
InstitutionNon-Pharmaceutical companyENCePP partner

Contact details

David Ong

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Moderna Tx
Study protocol
Initial protocol

Moderna Myocarditis_Nat History Study_Protocol_version 4.0_CLEAN fv_Final_redacted_pdfA_archive.pdf

English (2.06 MB - PDF)View document
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)