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

NCT06189053 | Active Not Recruiting

• 1 other identifier: mRNA-1273-P911
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (4)

• Number of Participants with Major Adverse Clinical Outcomes

  Adverse clinical outcomes may include myocardial infarction, heart failure, stroke, and cardiovascular hospitalization.

  Up to 5 years

• Number of Participants with Persistent Cardiac Abnormality

  Up to 5 years

• Functional Assessment: Number of Participants Reporting Symptoms of Chest Pain, Dyspnea, Palpitations, and Syncope

  Up to 5 years

• Functional Assessment: Number of Participants Returning to Normal Activities

  Up to 5 years

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (1)

Veradigm

Chicago, Illinois, 60654, United States

Location

MeSH Terms

Conditions

Myocarditis; Coronavirus Infections; Virus Diseases; COVID-19

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2024
• First Posted: January 3, 2024
• Study Start: April 30, 2022
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2028
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

US (1)