Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Disease epidemiology
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Case-series
Study drug and medical condition

Medical condition to be studied

Myocarditis

Additional medical condition(s)

Pericarditis
Population studied

Age groups

Infants and toddlers (28 days – 23 months)
Children (2 to < 12 years)
Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

1
Study design details

Main study objective

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.

Outcomes

To identify possible risk factors for myocarditis and pericarditis following Moderna vaccination targeting SARS-CoV-2, including demographic characteristics, medical history, and vaccination characteristics. To characterize the clinical course of myocarditis and pericarditis of varying origin and to identify prognostic factors in the course of myocarditis and pericarditis, To identify whether there are differences in the clinical course and risk factors between myocarditis and pericarditis associated with Moderna vaccination targeting SARS-CoV-2, and myocarditis and pericarditis not associated with vaccinations targeting SARS-CoV-2. For severe cases or cases with sequelae, to identify risk factors for severe myocarditis and pericarditis associated with Moderna vacci

Data analysis plan

For the case-cohort analysis, all cases of myocarditis and pericarditis and the full control cohort will be described: demographics, lifestyle factors, medical- and vaccination history. To identify differences in clinical course (Primary objective 2) and differences in risk factors (Secondary objective 1) for vaccine (un)related myocarditis/pericarditis, cases in the cohort analysis will be compared based on vaccination status. Outcomes and follow-up care will also characterized, where feasible. Standard descriptive statistics will be used to characterise clinical course, outcomes, and long-term outcomes following the initial myocarditis/pericarditis episode. Cox regression analysis will be utilized to compare the presence of sequelae following myocarditis/pericarditis.