An observational study in Myocarditis, Pericarditis, sponsored by ModernaTX, Inc.. Completed at 5 sites in 4 countries. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2025-08-01.
Sponsored by ModernaTX, Inc. (part of Moderna, Inc.) · Observational
The main 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.
This study will use an "Moderna vaccination targeting SARS-CoV-2 - exposed case cohort design" to assess the risk factors other than Moderna vaccination targeting SARS-CoV-2 vaccination for the development of myocarditis and pericarditis in Moderna vaccination targeting SARS-CoV-2 recipients, to understand which characteristics increase or decrease the risk for the development of myocarditis and pericarditis after Moderna vaccination targeting SARS-CoV-2 vaccination.
The second design "a myocarditis/pericarditis cohort study design" will be used to describe the prognostic factors for a severe clinical course in participants with myocarditis or pericarditis regardless of vaccination status. As most myocarditis and pericarditis cases are mild in disease severity, it is clinically relevant to identify the participants who are at increased risk for severe clinical outcomes (such as acute coronary syndrome, acute myocardial infarction, heart failure, atrial fibrillation/flutter, ventricular arrhythmias/cardiac arrest, pulmonary embolism or deep venous thrombosis, stroke outcomes, peripheral arterial embolism, hospital readmission, intensive care unit [ICU] admission or death) as early as possible in order to provide appropriate care in a timely manner. Therefore, information available at the onset of myocarditis or pericarditis could be used to predict the clinical course including long-term outcomes.
174 studies on the registry are indexed under Myocarditis; 75 are open to participants now.
This study's enrollment of 1,169 is above the median of 208 across 120 observational studies indexed under Myocarditis.
Browse Myocarditis studies →ModernaTX, Inc. is the lead sponsor of 119 studies on the registry; 18 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 35 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Information regarding participants is collected from multiple databases, utilizing routinely collected health and administrative data of four European countries: Denmark, Norway, Spain, and the United Kingdom. The study databases are representative of the source population in each country.
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Exclusion Criteria:
All participants with myocarditis are selected among the participants who received at least 1 dose of Moderna vaccination targeting SARS-CoV-2. Cases are those participants who develop myocarditis or pericarditis any time during the follow-up after Moderna vaccination targeting SARS-CoV-2 vaccination.
Biological: mRNA-1273
All participants with myocarditis and/or pericarditis with or without prior Moderna vaccination targeting SARS-CoV-2 exposure will be selected from the available databases.
Biological: mRNA-1273
intramuscular injection
Also known as: Elasomeran, Imelasomeran, Davesomeran, Spikevax, Spikevax bivalent
Number of Participants With Myocarditis and/or Pericarditis within 30 Days After Moderna vaccination targeting SARS-CoV-2
Time frame: Up to 30 days post vaccination
Number of Participants With Severe Clinical Outcomes Within 30 Days After Onset of Myocarditis or Pericarditis
Clinical outcomes comprises of acute coronary syndrome, acute myocardial infarction, heart failure, atrial fibrillation/flutter, ventricular arrhythmias/cardiac arrest, pulmonary embolism or deep venous thrombosis, stroke outcomes, peripheral arterial embolism, hospital readmission, intensive care unit (ICU) admission or death.
Time frame: Up to 30 days after onset of myocarditis or pericarditis
Number of Participants With Long Term Clinical Outcomes After Onset of Myocarditis and/or Pericarditis
Time frame: Up to 12 months
Number of Participants With Severe Myocarditis or Pericarditis within 30 days After Moderna vaccination targeting SARS-CoV-2
Time frame: Up to 30 days post vaccination
Ran from Mar 2023 to primary completion in Aug 2024, 17 months.
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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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