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RECRUITING
NCT05295290
PHASE4

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

Sponsor: Pfizer

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

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