Clinical trial

Clinical Course, Outcomes and Risk Factors of Myocarditis and Pericarditis Following Administration of mRNA- 1273 (ELASOMERAN)

Name

mRNA-1273-P910

Description

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.

Trial arms

Trial start

2023-03-31

Estimated PCD

2024-08-31

Trial end

2025-06-30

Status

Active (not recruiting)

Treatment

mRNA-1273

intramuscular injection

Arms:

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

Other names:

Elasomeran, Imelasomeran, Davesomeran, Spikevax, Spikevax bivalent

Size

1500

Primary endpoint

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

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

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 1500, 'type': 'ESTIMATED'}}

Updated at

2023-11-02

1 organization

1 product

2 indications

Organization

Product

Indication

Indication