A Study to Learn About The COVID-19 (Study) Vaccine (Called COMIRNATY) in People That Are Less Th… (NCT05295290) | Clinical Trial Compass
Active — Not RecruitingPhase 4
A Study to Learn About The COVID-19 (Study) Vaccine (Called COMIRNATY) in People That Are Less Than 21 Years Old.
United States319 participantsStarted 2022-11-21
Plain-language 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.
Who can participate
Age range
0 Years – 20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age \<21 years.
. Presentation to participating medical center with evaluation in Emergency Room and/or hospitalization.
. Received any dose(s) of COMIRNATY within 21 days of symptom onset.
. Meets criteria of Centers for Disease Control and Prevention case definition of probable or confirmed myocarditis/pericarditis
. 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.
. Age \<21 years.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite findings of myocarditis
Timeframe: 6 months after illness onset
2
Left ventricular ejection fraction (LVEF) < 55% by echocardiography
Timeframe: Up to 5 years following illness onset.
3
Myocarditis by original or revised Lake Louise criteria on cMRI
Timeframe: Up to 5 years following illness onset.
4
Arrhythmias on cardiac recording (ECG, ambulatory monitoring)
Timeframe: Up to 5 years following illness onset.
5
Complications, including non-cardiac morbidities by medical history
Timeframe: Up to 5 years following illness onset.
6
Functional Status by Behavior Assessment System for Children, Third Edition BASC-3 or PROMIS Short Forms
. Presentation to participating medical center with evaluation in Emergency Room and/or hospitalization.
. COVID-19-related disease
Exclusion criteria
. A plausible alternative etiology for myocarditis/pericarditis, as determined by the site based upon their routine clinical practice for evaluation of potential causes for myocarditis/pericarditis.
. Pre-existing cardiac conditions that could impact the primary endpoint, including but not limited to, documented history of left ventricular dysfunction (e.g., cardiomyopathy or myocardial infarction), pacemaker, or congenital heart disease, with the exceptions of:
. Bicommissural aortic valve with \< trivial stenosis and/or insufficiency
. Mitral valve prolapse with \< trivial insufficiency
. Hemodynamically insignificant atrial septal or ventricular septal defects.
. Previous administration with an investigational drug or vaccine within 30 days of enrollment (or as determined by the local requirement).
8
The Quality of Life Scale (QOLS)
Timeframe: Up to 5 years following illness onset.
9
Conduction system disturbances on cardiac recording (ECG, ambulatory monitoring)