A Study on the Clinical Course, Outcomes and Risk Factors of Myocarditis and Pericarditis After Moderna COVID-19 Vaccine

NCT06113692 | Completed

• 1 other identifier: mRNA-1273-P910
• Study Type: observational
• Target: 1,169
• Locations: 4 countries
• Sites: 5

Brief Summary

The main goal of this study is to describe the clinical course, outcomes and risk factors for myocarditis and pericarditis associated with Moderna vaccination targeting SARS-CoV-2.

Conditions

Myocarditis, Pericarditis

Keywords

mRNA-1273; mRNA-1273 vaccine; SARS-CoV-2; SARS-CoV-2 Vaccine; Coronavirus; Virus Diseases; Messenger RNA; COVID-19; COVID-19 Vaccine; Moderna; Myocarditis; Pericarditis

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Myocarditis and/or Pericarditis within 30 Days After Moderna vaccination targeting SARS-CoV-2

  Up to 30 days post vaccination

• Number of Participants With Severe Clinical Outcomes Within 30 Days After Onset of Myocarditis or Pericarditis

  Clinical outcomes comprises of acute coronary syndrome, acute myocardial infarction, heart failure, atrial fibrillation/flutter, ventricular arrhythmias/cardiac arrest, pulmonary embolism or deep venous thrombosis, stroke outcomes, peripheral arterial embolism, hospital readmission, intensive care unit (ICU) admission or death.

  Up to 30 days after onset of myocarditis or pericarditis

• Number of Participants With Long Term Clinical Outcomes After Onset of Myocarditis and/or Pericarditis

  Up to 12 months

Secondary Outcomes (1)

• Number of Participants With Severe Myocarditis or Pericarditis within 30 days After Moderna vaccination targeting SARS-CoV-2

  Up to 30 days post vaccination

Study Arms (2)

Moderna vaccination targeting SARS-CoV-2-exposed Case Cohort

All participants with myocarditis are selected among the participants who received at least 1 dose of Moderna vaccination targeting SARS-CoV-2. Cases are those participants who develop myocarditis or pericarditis any time during the follow-up after Moderna vaccination targeting SARS-CoV-2 vaccination.

Biological: mRNA-1273

Myocarditis/Pericarditis Cohort

All participants with myocarditis and/or pericarditis with or without prior Moderna vaccination targeting SARS-CoV-2 exposure will be selected from the available databases.

Biological: mRNA-1273

Interventions

mRNA-1273 BIOLOGICAL

intramuscular injection

Also known as: Elasomeran, Imelasomeran, Davesomeran, Spikevax, Spikevax bivalent

Moderna vaccination targeting SARS-CoV-2-exposed Case Cohort; Myocarditis/Pericarditis Cohort

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Information regarding participants is collected from multiple databases, utilizing routinely collected health and administrative data of four European countries: Denmark, Norway, Spain, and the United Kingdom. The study databases are representative of the source population in each country.

You may qualify if:

• For the Elasomeran-Moderna vaccination targeting SARS-CoV-2-exposed case-cohort study, a cohort will be defined including participants of all ages with (1) at least one dose of Moderna vaccination targeting SARS-CoV-2 administered during the study period, (2) at least one year of enrolment in the applicable database prior to the index vaccine dose to allow for ascertainment of baseline covariables and potential risk factors, and (3) no myocarditis or pericarditis events within 6 months prior to Moderna vaccination targeting SARS-CoV-2 receipt. Myocarditis and pericarditis cases are defined when adjudication criteria similar to Centers for Disease Control and Prevention (CDC) case definition for probable or definite myocarditis or pericarditis is fulfilled.
• For the cohort study, participants will be included if they: (1) meet the adjudication criteria similar to the CDC case definition for probable or definite myocarditis or pericarditis, (2) have at least one year of enrolment in the applicable database prior to the index myocarditis or pericarditis event to allow for ascertainment of baseline covariates and potential risk factors, and (3) have not received a COVID-19 vaccine other than Moderna vaccination targeting SARS-CoV-2 within 30 days prior to the index myocarditis or pericarditis event.

You may not qualify if:

• Participants who have evidence of myocarditis or pericarditis in structured data (for example: ICD-10 codes) where review of clinical data is incompatible with adjudication criteria similar to CDC case definition for myocarditis or pericarditis will be described but will not be included as cases in primary analyses.
• In the Moderna vaccination targeting SARS-CoV-2-exposed case-cohort design, these non-confirmed myocarditis/pericarditis cases will be censored at the onset of the false positive myocarditis/ pericarditis diagnosis.

Sponsors & Collaborators

• ModernaTX, Inc.: lead
• Julius Clinical Research: collaborator

Study Sites (5)

Aarhus University Hospital

Aarhus, Denmark

Location

University of Oslo

Oslo, Norway

Location

IDIAP Jordi Gol

Barcelona, Spain

Location

FISABIO

Valencia, Spain

Location

Drug Safety Research Unit (DSRU)

Southampton, United Kingdom

Location

MeSH Terms

Conditions

Myocarditis; Pericarditis; Coronavirus Infections; Virus Diseases; COVID-19

Interventions

2019-nCoV Vaccine mRNA-1273; Spikevax bivalent zero omicron

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

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Design

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

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 2, 2023
• Study Start: March 31, 2023
• Primary Completion: August 31, 2024
• Study Completion: June 30, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

GB (1); ES (2); DK (1); NO (1)