A Study to Learn About The COVID-19 (Study) Vaccine (Called COMIRNATY) in People That Are Less Than 21 Years Old.

Condition(s) studied

Investigational drug(s) / intervention(s)

Cardiac Imaging: ECG, echocardiogram, ambulatory monitor, exercise stress test

Study summary

The purpose of this study is to learn about the safety and effects of the vaccine (called COMIRNATY) for the potential prevention of COVID-19. This study is seeking participants who:

1. Are age \<21 years.
2. Have presentation to participating medical center with evaluation in Emergency Room and/or hospitalization.
3. Received any dose(s) of COMIRNATY within 21 days of symptom onset.
4. Meet criteria of Centers for Disease Control and Prevention case definition of probable or confirmed myocarditis/pericarditis
5. Are capable of giving signed informed consent/assent (by parents/legal guardians of minors and/or patients), which includes compliance with the requirements and restrictions listed in the Informed Consent/Assent Document and in this protocol OR meets criteria for waiver of consent.

This study will examine the potential long-term effects associated with myocarditis/pericarditis following vaccination with COMIRNATY. The association of myocarditis/pericarditis in participants who received the study vaccine (COMIRNATY) compared with those associated with COVID-19 will also be examined. This will help us determine if COMIRNATY is safe and effective, and if there is a myocarditis/pericarditis association that should be noted. Participants will take part in this study for up to 5 years. During this time, they will receive complete cardiac imaging tests, and have follow up visits per guidance stated in the study protocol.

Eligibility

Primary outcome measure(s)

• Composite findings of myocarditis — 6 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 echocardiography — Up to 5 years following illness onset.
• Myocarditis by original or revised Lake Louise criteria on cMRI — Up 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 history — Up to 5 years following illness onset.
• Functional Status by Behavior Assessment System for Children, Third Edition BASC-3 or PROMIS Short Forms — Up 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.

Trial sites (18)

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