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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 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. Are age \<21 years. 2. Have 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 7 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
300
Start Date
2022-11-21
Completion Date
2030-11-21
Last Updated
2025-10-02
Healthy Volunteers
No
Conditions
Interventions
Cardiac Imaging
ECG, echocardiogram, ambulatory monitor, exercise stress test
Locations (34)
Children's of Alabama
Birmingham, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Childrens Hospital Los Angeles
Los Angeles, California, United States
Valley Children's Hospital
Madera, California, United States
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States
Childrens Hospital of Colorado
Aurora, Colorado, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Nemours Children's Hospital, Delaware
Wilmington, Delaware, 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
Lurie Children's Hospital
Chicago, Illinois, 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
Children'S Hospitals & Clinics of Minn
Minneapolis, Minnesota, United States
Childrens Mercy Kansas City
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, 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
Duke University Hospital
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina: Shawn Jenkins Women's and Children's Hospital
Charleston, South Carolina, United States
MUSC Summey Medical Pavilion
North Charleston, South Carolina, United States
Texas Children's Hospital
Houston, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
The Hospital for Sick Children
Toronto, Ontario, Canada