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A Study to Learn About The COVID-19 (Study) Vaccine (Called COMIRNATY) in People That Are Less Than 21 Years Old.
Sponsor: Pfizer
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.
Official title: LOW INTERVENTIONAL COHORT STUDY OF MYOCARDITIS/PERICARDITIS ASSOCIATED WITH COMIRNATY IN PERSONS LESS THAN 21 YEARS OF AGE
Key Details
Gender
All
Age Range
0 Years - 20 Years
Study Type
INTERVENTIONAL
Enrollment
319
Start Date
2022-11-21
Completion Date
2029-04-02
Last Updated
2026-05-07
Healthy Volunteers
No
Conditions
Interventions
Cardiac Imaging
ECG, echocardiogram, ambulatory monitor, exercise stress test
Locations (18)
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