A Study on the Clinical Course, Outcomes and Risk Factors of Myocarditis and Pericarditis After Moderna COVID-19 Vaccine
Key facts
- Who runs it
- ModernaTX, Inc.
- Where
- Denmark, Norway, Spain, and United Kingdom5 sites in 4 countriesChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 1,169 people enrolled
- Started
- 31 Mar 2023
- Ended
- 30 Jun 2025
- Type of study
- Observational, 2 groups
- Treatments tested
- mRNA-1273
- Record updated
- 1 August 2025
Who can take part
- Age
- 6 months and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- For the Elasomeran-Moderna vaccination targeting SARS-CoV-2-exposed case-cohort study, a cohort will be defined including participants of all ages with (1) at least one dose of Moderna vaccination targeting SARS-CoV-2 administered during the study period, (2) at least one year of enrolment in the applicable database prior to the index vaccine dose to allow for ascertainment of baseline covariables and potential risk factors, and (3) no myocarditis or pericarditis events within 6 months prior to Moderna vaccination targeting SARS-CoV-2 receipt. Myocarditis and pericarditis cases are defined when adjudication criteria similar to Centers for Disease Control and Prevention (CDC) case definition for probable or definite myocarditis or pericarditis is fulfilled
- For the cohort study, participants will be included if they: (1) meet the adjudication criteria similar to the CDC case definition for probable or definite myocarditis or pericarditis, (2) have at least one year of enrolment in the applicable database prior to the index myocarditis or pericarditis event to allow for ascertainment of baseline covariates and potential risk factors, and (3) have not received a COVID-19 vaccine other than Moderna vaccination targeting SARS-CoV-2 within 30 days prior to the index myocarditis or pericarditis event
Who cannot take part
- Participants who have evidence of myocarditis or pericarditis in structured data (for example: ICD-10 codes) where review of clinical data is incompatible with adjudication criteria similar to CDC case definition for myocarditis or pericarditis will be described but will not be included as cases in primary analyses
- In the Moderna vaccination targeting SARS-CoV-2-exposed case-cohort design, these non-confirmed myocarditis/pericarditis cases will be censored at the onset of the false positive myocarditis/ pericarditis diagnosis
This trial has no sites in United States.
It has sites in 4 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Moderna vaccination targeting SARS-CoV-2-exposed Case Cohort
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.
Treatment: mRNA-1273
- Myocarditis/Pericarditis Cohort
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.
Treatment: mRNA-1273
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Clinical Course, Outcomes and Risk Factors of Myocarditis and Pericarditis Following Administration of mRNA- 1273 (ELASOMERAN)
- Record updated
- 1 August 2025