NCT06189053

A Study to Assess Long-term Outcomes of Myocarditis Following Administration of COVID-19 mRNA Vaccine (SPIKEVAX)

Long-term Outcomes of Myocarditis Following Administration of SPIKEVAX (COVID-19 Vaccine mRNA)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (actual)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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

Timeline

• Start date: 2022-04-30
• Primary completion: 2027-10-31
• Completion: 2028-10-31
• First posted: 2024-01-03
• Last updated: 2025-08-01

Locations

1 site across 1 country: United States