Myocarditis, PericarditisNCT06113692
A Study on the Clinical Course, Outcomes and Risk Factors of Myocarditis and Pericarditis After Moderna COVID-19 Vaccine
An observational study of Myocarditis, Pericarditis, run by ModernaTX, Inc. at 5 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Myocarditis, Pericarditis
- What is being tested?
- mRNA-1273
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 1,169 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 31 Mar 2023to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
About this study
Official title: Clinical Course, Outcomes and Risk Factors of Myocarditis and Pericarditis Following Administration of mRNA- 1273 (ELASOMERAN)
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.
Read the detailed description
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.
- Conditions
- Myocarditis, Pericarditis
- Being tested
- mRNA-1273
- Keywords
- mRNA-1273, mRNA-1273 vaccine, SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus, Virus Diseases, Messenger RNA, COVID-19, COVID-19 Vaccine, Moderna, Myocarditis, Pericarditis
- Medical subject headings
- Myocarditis, Pericarditis, Coronavirus Infections, Virus Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-1273Biological
Also called Elasomeran, Imelasomeran, Davesomeran, Spikevax
intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: 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. Receives: Biological: mRNA-1273 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Myocarditis and/or Pericarditis within 30 Days After Moderna vaccination targeting SARS-CoV-2
Measured: 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.
Measured: 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
Measured: Up to 12 months
Secondary outcomes (1)
Number of Participants With Severe Myocarditis or Pericarditis within 30 days After Moderna vaccination targeting SARS-CoV-2
Measured: Up to 30 days post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start31 Mar 2023
- Primary completion31 Aug 2024
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocarditis, PericarditisStudies of the same condition, open and under way.
- More trials run by ModernaTX, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,169 participants (actual)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Julius Clinical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113692
- Sponsor's protocol ID
- mRNA-1273-P910
- Status last verified
- Jul 2025
- First submitted
- 31 Oct 2023
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Course, Outcomes and Risk Factors of Myocarditis and Pericarditis Following Administration of mRNA- 1273 (ELASOMERAN)
- ClinicalTrials.gov ID
- NCT06113692
- Acronym / sponsor ID
- mRNA-1273-P910
- Conditions
- Myocarditis, Pericarditis
- Keywords
- mRNA-1273, mRNA-1273 vaccine, SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus, Virus Diseases, Messenger RNA, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,169 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Julius Clinical Research
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderna vaccination targeting SARS-CoV-2-exposed Case Cohort | – | Biological: mRNA-1273All 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. |
| Myocarditis/Pericarditis Cohort | – | Biological: mRNA-1273All participants with myocarditis and/or pericarditis with or without prior Moderna vaccination targeting SARS-CoV-2 exposure will be selected from the available databases. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA-1273Also: Elasomeran, Imelasomeran, Davesomeran, Spikevaxintramuscular injection | Biological | Moderna vaccination targeting SARS-CoV-2-exposed Case Cohort, Myocarditis/Pericarditis Cohort |
Primary outcome
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
Time frame: Up to 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.
Number of Participants With Long Term Clinical Outcomes After Onset of Myocarditis and/or Pericarditis
Time frame: Up to 12 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocarditis, Pericarditis, run by ModernaTX, Inc. at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain, Denmark, Norway, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.