MyocarditisNCT06189053
A Study to Assess Long-term Outcomes of Myocarditis Following Administration of COVID-19 mRNA Vaccine (SPIKEVAX)
An observational study of Myocarditis, run by ModernaTX, Inc. at 1 site in United States.
Trial summary
The main goal of this study is to characterize presentation, clinical course, and long-term outcomes of myocarditis temporally associated with administration of mRNA-1273 (SPIKEVAX) COVID-19 vaccine. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocarditis
- Type of treatment
- Vaccines
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2022to 31 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The source population for this study will include participants with a diagnosis of myocarditis or a relevant combination of laboratory and clinical findings meeting the Centers for Disease Control and Prevention (CDC) case definition for probable or confirmed myocarditis occurring during the study window for case ascertainment.
Who may be able to join
- Participants with a diagnosis of myocarditis between December 18, 2020, and October 31, 2026, will be identified or who have a relevant combination of laboratory and clinical findings meeting the CDC case definition for probable or confirmed myocarditis will be included in the study.
- Participants will be required to have at least 30 days of medical history to assess SPIKEVAX exposure.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Outcomes of Myocarditis Following Administration of SPIKEVAX (COVID-19 Vaccine mRNA)
The main goal of this study is to characterize presentation, clinical course, and long-term outcomes of myocarditis temporally associated with administration of mRNA-1273 (SPIKEVAX) COVID-19 vaccine.
Read the detailed description
This is an observational cohort study that combines data collected directly from healthcare providers (HCP) with existing retrospective real-world data as captured in clinical electronic health record (EHR) and administrative claims data. Vaccine exposure and case identification information will be obtained retrospectively from existing real-world data to identify cases of post-vaccine myocarditis (PVM) and ultimately vaccine-associated myocarditis (VAM) for potential study inclusion. Eligible participants will be identified and followed for up to 5 years until the end of the study period or loss to follow-up or death.
- Conditions
- Myocarditis
- Keywords
- mRNA-1273, mRNA-1273 vaccine, SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus, Virus Diseases, Messenger RNA, COVID-19, COVID-19 Vaccine, Moderna
- Medical subject headings
- Myocarditis, 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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Post-vaccine Myocarditis (PVM) | Cohort 1 will include participants with a myocarditis event diagnosis or service date within 30 days on/after a SPIKEVAX vaccination and participants with at least 1 dose of SPIKEVAX in the 7 days prior to and including the index date. | |
| Cohort 2: All Other Myocarditis | Cohort 2 will include participants with no evidence of SPIKEVAX and no evidence of other vaccines targeting SARS CoV-2 within 30 days on/after a SPIKEVAX vaccination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Major Adverse Clinical Outcomes
Adverse clinical outcomes may include myocardial infarction, heart failure, stroke, and cardiovascular hospitalization.
Measured: Up to 5 years
Number of Participants with Persistent Cardiac Abnormality
Measured: Up to 5 years
Functional Assessment: Number of Participants Reporting Symptoms of Chest Pain, Dyspnea, Palpitations, and Syncope
Measured: Up to 5 years
Functional Assessment: Number of Participants Returning to Normal Activities
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start30 Apr 2022
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyocarditisStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189053
- Sponsor's protocol ID
- mRNA-1273-P911
- Status last verified
- Jul 2025
- First submitted
- 1 Jan 2024
- 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
- Long-term Outcomes of Myocarditis Following Administration of SPIKEVAX (COVID-19 Vaccine mRNA)
- ClinicalTrials.gov ID
- NCT06189053
- Acronym / sponsor ID
- mRNA-1273-P911
- Conditions
- Myocarditis
- 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
- Active, not recruiting
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2022 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 3 Jan 2024 (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 characterize presentation, clinical course, and long-term outcomes of myocarditis temporally associated with administration of mRNA-1273 (SPIKEVAX) COVID-19 vaccine.
Detailed description
This is an observational cohort study that combines data collected directly from healthcare providers (HCP) with existing retrospective real-world data as captured in clinical electronic health record (EHR) and administrative claims data. Vaccine exposure and case identification information will be obtained retrospectively from existing real-world data to identify cases of post-vaccine myocarditis (PVM) and ultimately vaccine-associated myocarditis (VAM) for potential study inclusion. Eligible participants will be identified and followed for up to 5 years until the end of the study period or loss to follow-up or death.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Post-vaccine Myocarditis (PVM) | – | –Cohort 1 will include participants with a myocarditis event diagnosis or service date within 30 days on/after a SPIKEVAX vaccination and participants with at least 1 dose of SPIKEVAX in the 7 days prior to and including the index date. |
| Cohort 2: All Other Myocarditis | – | –Cohort 2 will include participants with no evidence of SPIKEVAX and no evidence of other vaccines targeting SARS CoV-2 within 30 days on/after a SPIKEVAX vaccination. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The source population for this study will include participants with a diagnosis of myocarditis or a relevant combination of laboratory and clinical findings meeting the Centers for Disease Control and Prevention (CDC) case definition for probable or confirmed myocarditis occurring during the study window for case ascertainment.
Key inclusion criteria (2 listed)
- Participants with a diagnosis of myocarditis between December 18, 2020, and October 31, 2026, will be identified or who have a relevant combination of laboratory and clinical findings meeting the CDC case definition for probable or confirmed myocarditis will be included in the study.
- Participants will be required to have at least 30 days of medical history to assess SPIKEVAX exposure.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants with Major Adverse Clinical Outcomes
Time frame: Up to 5 years
Adverse clinical outcomes may include myocardial infarction, heart failure, stroke, and cardiovascular hospitalization.
Number of Participants with Persistent Cardiac Abnormality
Time frame: Up to 5 years
Functional Assessment: Number of Participants Reporting Symptoms of Chest Pain, Dyspnea, Palpitations, and Syncope
Time frame: Up to 5 years
Functional Assessment: Number of Participants Returning to Normal Activities
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocarditis, run by ModernaTX, Inc. at 1 site in United States.
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 0 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: under way, not looking for participants, 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 1 site in United States. 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?
This study is still under way. Results are not available in the source record yet.
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 Major Adverse Clinical Outcomes (time frame: Up to 5 years). The study lists 4 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.