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

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

Julius Clinical Research

Netherlands

Aarhus University & Aarhus University Hospital DEPARTMENT OF CLINICAL EPIDEMIOLOGY

Denmark

Drug Safety Research Unit (DSRU)

United Kingdom

Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, IDIAPJGol

Spain

The Foundation for the Promotion of Health and Biomedical Research of Valencia Region (FISABIO)

Spain

University of Oslo

FISABIO Spain, University of Oslo Norway

Contact details

David Ong

Study contact

[e-mail]

Ong David

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned: 23/03/2022

Actual: 23/03/2022

Data collection

Planned: 31/03/2023

Actual: 31/03/2023

Date of final study report

Planned: 30/06/2025

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)