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

Launched by PFIZER · Mar 23, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effects of the COVID-19 vaccine called COMIRNATY in young people under 21 years old who have experienced myocarditis or pericarditis, which are conditions that involve inflammation of the heart or surrounding tissue. Researchers want to understand if the vaccine has any long-term effects related to these conditions and how it compares to the effects of COVID-19 itself. To participate, individuals must have received one or more doses of the vaccine within 28 days of showing symptoms and must meet certain health criteria.

Participants in the study will undergo regular follow-up visits and complete heart imaging tests over a period of up to five years. This trial is currently recruiting participants who have been evaluated in an emergency room or hospitalized for their condition. It's important for parents or guardians to provide consent for younger participants, and the study aims to help ensure that the vaccine is safe and effective for this age group.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Cohort 1/2:
• • 1. Age \<21 years.
• • 2. Presentation to participating medical center with evaluation in Emergency Room and/or hospitalization.
• • 3. Received either the 1st, 2nd, 3rd or booster dose(s) of COMIRNATY within 28 days of symptom onset.
• • 4. Meets criteria of Centers for Disease Control and Prevention case definition of probable or confirmed myocarditis/pericarditis
• • 5. 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:
• • 1. Age \<21 years.
• • 2. Presentation to participating medical center with evaluation in Emergency Room and/or hospitalization.
• • 3. COVID-19-related disease
• • 1. Acute COVID-19 infection OR
• • 2. Multi-system Inflammatory Syndrome in Children Associated with COVID-19 (MIS-C) AND
• • 4. Probable or confirmed myocarditis/pericarditis\* not temporally related to vaccination with COMINARTY
• 1. 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
• 2. Confirmed myocarditis/pericarditis as defined by:
• • Histopathologic confirmation of myocarditis OR
• • Elevated troponin above upper limit of normal AND cMRI findings consistent with myocarditis
• • 5. 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 Criteria:
• • 1. 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.
• 2. 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:
• • 1. Bicommissural aortic valve with \< trivial stenosis and/or insufficiency
• • 2. Mitral valve prolapse with \< trivial insufficiency
• • 3. Hemodynamically insignificant atrial septal or ventricular septal defects.
• • 3. Previous administration with an investigational drug or vaccine within 30 days of enrollment (or as determined by the local requirement).