Study of COMIRNATY Vaccine in Young People with Myocarditis
This study aims to understand the long-term effects of the COMIRNATY vaccine in individuals under 21 years old who developed myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the sac around the heart). Researchers will compare these individuals to others who developed myocarditis/pericarditis due to COVID-19 infection. You might be able to join if you are under 21, were evaluated in an emergency room or hospitalized, received COMIRNATY within 21 days of your symptoms starting, and meet the CDC definition for probable or confirmed myocarditis/pericarditis. The study will look at heart health outcomes, including heart function, for up to 5 years after symptoms began. The current recruitment status is unclear.
- Study design
- This is a low-interventional cohort study planning to enroll 319 participants. It compares individuals who developed myocarditis/pericarditis after receiving COMIRNATY with those who developed it due to COVID-19.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 5 years after their illness onset to assess heart function and other outcomes.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Learn About The COVID-19 (Study) Vaccine (Called COMIRNATY) in People That Are Less Than 21 Years Old.
At a glance
Conditions
Where it's being run
18 sites across 14 statesStudy leadership
- Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Composite findings of myocarditis6 months after illness onset
This is a single composite primary outcome measure. This primary composite study endpoint is defined as the presence of 1 or more of the following 6 months after illness onset: left ventricular dysfunction (LVEF \< 55% by echocardiogram), findings of myocarditis by original or revised Lake Louise criteria on cardiac MRI, or the presence of high-grade arrhythmia or conduction system disturbance on ECG or ambulatory monitoring.
- Left ventricular ejection fraction (LVEF) < 55% by echocardiographyUp to 5 years following illness onset.
- Myocarditis by original or revised Lake Louise criteria on cMRIUp to 5 years following illness onset.
- Arrhythmias on cardiac recording (ECG, ambulatory monitoring)Up to 5 years following illness onset.
- Complications, including non-cardiac morbidities by medical historyUp to 5 years following illness onset.
- Functional Status by Behavior Assessment System for Children, Third Edition BASC-3 or PROMIS Short FormsUp to 5 years following illness onset.
Behavior Assessment System for Children, Third Edition (BASC-3), \<8 yr (T score \<30-\>70 with higher number meaning lower functioning) or PROMIS Short Forms ≥8 yr (scores from 3-15 with higher number meaning better functioning)
- The Pediatric Quality of Life Inventory (PEDS QL)Up to 5 years following illness onset.
The 27 question, age-appropriate and parent-proxy questionnaires, will be used in 2 to \<18-year-old participants to assess quality of life. Scores span 0-108 with higher number being better functioning.
- The Quality of Life Scale (QOLS)Up to 5 years following illness onset.
The QOLS, a 16-item self-report form that assesses overall quality of life on a scale of 16-112 (higher scores indicate better quality of life) will be administered for participants ≥18 years old.
- Conduction system disturbances on cardiac recording (ECG, ambulatory monitoring)Up to 5 years following illness onset.