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

Running, not enrolling · Phase 4

Conditions studied: Myocarditis

In brief

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.

Key facts

Study ID

NCT05295290

Run by

Pfizer

People needed

319

Starts

2022-11-21

Expected to finish

2029-04-02

Last updated by the study team

2026-05-07

Who can join

Age: any, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cohort 1/2:
• 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.
• 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.

You may not qualify if…

• 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).

Where it is running

• Childrens Hospital Los Angeles — Los Angeles, California, United States
• Valley Children's Hospital — Madera, California, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Childrens National Hospital — Washington D.C., District of Columbia, United States
• Memorial Healthcare System — Hollywood, Florida, United States
• Children's Healthcare of Atlanta - Arthur M. Blank Hospital — Atlanta, Georgia, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• Riley Hospital for Children at IU Health — Indianapolis, Indiana, United States
• Children's Hospital — New Orleans, Louisiana, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• University of Michigan Health Center — Ann Arbor, Michigan, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• Childrens Mercy Kansas City — Kansas City, Missouri, United States
• Northwell Health-Cohen Children's Medical Center — New Hyde Park, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• MUSC Summey Medical Pavilion — North Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.