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

July 30, 2025 updated by: ModernaTX, Inc.

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60654
        • Veradigm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 5 years
Number of Participants with Persistent Cardiac Abnormality
Time Frame: Up to 5 years
Up to 5 years
Functional Assessment: Number of Participants Reporting Symptoms of Chest Pain, Dyspnea, Palpitations, and Syncope
Time Frame: Up to 5 years
Up to 5 years
Functional Assessment: Number of Participants Returning to Normal Activities
Time Frame: Up to 5 years
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ModernaTX, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2022

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2028

Study Registration Dates

First Submitted

January 1, 2024

First Submitted That Met QC Criteria

January 1, 2024

First Posted (Actual)

January 3, 2024

Study Record Updates

Last Update Posted (Actual)

August 1, 2025

Last Update Submitted That Met QC Criteria

July 30, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mRNA-1273-P911

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocarditis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe