Status:
RECRUITING
A Study to Learn About The COVID-19 (Study) Vaccine (Called COMIRNATY) in People That Are Less Than 21 Years Old.
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Carelon Research
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Myocarditis
Eligibility:
All Genders
Up to 20 years
Phase:
PHASE4
Brief Summary
The purpose of this clinical trial is to learn about the safety and effects of the study vaccine (called COMIRNATY) for the potential prevention of COVID-19. This study is seeking participants who: 1...
Detailed Description
This is a low-interventional cohort study to determine cardiac and non-cardiac long-term outcomes of persons \<21 years of age with myocarditis/pericarditis after the administration of COMIRNATY, comp...
Eligibility Criteria
Inclusion
- Cohort 1/2:
- Age \<21 years.
- Presentation to participating medical center with evaluation in Emergency Room and/or hospitalization.
- Received either the 1st, 2nd, 3rd or booster dose(s) of COMIRNATY within 28 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.
- Cohort 3:
- Age \<21 years.
- Presentation to participating medical center with evaluation in Emergency Room and/or hospitalization.
- COVID-19-related disease
- Acute COVID-19 infection OR
- Multi-system Inflammatory Syndrome in Children Associated with COVID-19 (MIS-C) AND
- Probable or confirmed myocarditis/pericarditis\* not temporally related to vaccination with COMINARTY
- Probable myocarditis/pericarditis as defined by ≥ 1 new finding of:
- Elevated troponin above upper limit of normal
- Abnormal ECG or rhythm monitoring finding consistent with myocarditis
- Abnormal cardiac function or wall motion abnormalities on echocardiogram
- cMRI findings consistent with myocarditis OR
- Confirmed myocarditis/pericarditis as defined by:
- Histopathologic confirmation of myocarditis OR
- Elevated troponin above upper limit of normal AND cMRI findings consistent with myocarditis
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
November 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 21 2030
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05295290
Start Date
November 21 2022
End Date
November 21 2030
Last Update
October 2 2025
Active Locations (34)
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1
Children's of Alabama
Birmingham, Alabama, United States, 35233
2
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
3
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
4
Valley Children's Hospital
Madera, California, United States, 93636