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

Moderna

Status: Active, not recruiting

Conditions: Myocarditis

Study type: Observational

Funder types: Industry

Identifiers

NCT06189053

mRNA-1273-P911

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,500 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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.

Trial design

1,500 participants in 2 patient groups

Cohort 1: Post-vaccine Myocarditis (PVM)

Description:

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

Description:

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.