mRNA-1273-P910: Clinical course, outcomes and risk factors of myocarditis and pericarditis following administration of Moderna vaccines targeting SARS-CoV-2.

Study identification

• 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:
  Finalised

Research institutions and networks

Institutions

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

Study timelines

Date when funding contract was signed

Planned: 23/03/2022

Actual: 23/03/2022

Study start date

Planned: 31/03/2023

Actual: 31/03/2023

Date of final study report

Planned: 30/06/2025

Actual: 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)

Other study registration identification numbers and links

mRNA-1273-P910