A Study to Assess Long-term Outcomes of Myocarditis Following Administration of COVID-19 mRNA Vaccine (SPIKEVAX)
← catalyst calendarNCT06189053 · readout in 437 d
Sponsored by ModernaTX, Inc. (industry) · MRNA — their whole pipeline →.
Phase
—
Status
Active, not recruiting
Study type
Observational
Enrollment
1,500actual
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-04-30 | actual | When the study began enrolling |
| Primary completion | 2027-10-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-10-31 | estimated | The whole study's end, after follow-up |
| First posted | 2024-01-03 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-08-01 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Myocarditis
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants with Major Adverse Clinical Outcomes
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
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