A Study to Learn About The COVID-19 (Study) Vaccine (Called COMIRNATY) in People That Are Less Than 21 Years Old.
Status: Recruiting
Conditions: Myocarditis, Pericarditis
Location:
Boston Children's HospitalChildren's Healthcare of Atlanta - Egleston
Children's Hospital & Clinics of Minn
Children's Hospital - New Orleans
Children's Hospital Los Angeles
Children's Hospital of Colorado
Children's Hospital of Michigan
Children's Hospital of Philadelphia
Children's Mercy - Kansas City
Children's Minnesota
Children's National Hospital- Washington D.C.
Children's of Alabama - Birmingham
Cincinnati Children's Hospital Medical Center
Columbia University Medical Center
Connecticut Children's Medical Center
Duke University Medical Center
FL
Indiana University
Indiana University School of Medicine
Lucile Packard Children's Hospital Stanford
Lurie Children's Hospital
Medical University of South Carolina (Musc) - Childrens Hospital
Nemours Children's Hospital Delaware
Northwell Health- Cohen Children's Medical Center
Phoenix Children's Hospital
Portland
Primary Children's - Salt Lake City
Seattle Children's Hospital
Seattle Children's Hospital & Research Institute
Texas Children's Hospital
The Hospital for Sick Children Toronto
UPMC Children's Hospital of Pittsburgh
University of Michigan Hospital-Mott Children's Hospital
Valley Children's Hospital
Washington University School of Medicine
City/State:
Birmingham, Alabama
Phoenix, Arizona
Los Angeles, California
Madera, California
Palo Alto, California
Aurora, Colorado
Harford, Connecticut
Wilmington, Delaware
Washington, DC
Hollywood, Florida
Atlanta, Georgia
Chicago, Illinois
Indianapolis, Indiana
New Orleans, Louisiana
Boston, Massachusetts
Ann Arbor, Michigan
Detroit, Michigan
Minneapolis, Minnesota
Kansas City, Missouri
Saint Louis, Missouri
New Hyde Park, New York
New York, New York
Durham, North Carolina
Cincinatti, Ohio
Portland, Oregon
Philadelphia, Pennsylvania
Pittsburgh, Pennsylvania
Charleston, South Carolina
Houston, Texas
Salt Lake City, Utah
Seattle, Washington
Toronto, Ontario
Contact Information:
Pfizer CT.gov Call Center
(800) 718-1021
email: [email protected]
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:
-
-
- Are age <21 years.
- Have presentation to participating medical center with evaluation in Emergency Room and/or hospitalization.
- Received either the 1st, 2nd, 3rd or booster dose(s) of COMIRNATY within 7 days of symptom onset.
- Meet criteria of Centers for Disease Control and Prevention case definition of probable or confirmed myocarditis/pericarditis
- 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.
Detailed Description:
This is a low-interventional cohort study to determine cardiac and non-cardiac long-term outcomes of persons <21 years of age with myocarditis/pericarditis after the administration of COMIRNATY, compared with similarly aged persons with myocarditis/pericarditis associated with COVID-19, including MIS-C.
To be classified as having COMIRNATY-associated myocarditis/pericarditis, a person must 1) meet the CDC case definition for probable or confirmed myocarditis/pericarditis, 2) have received any dose of COMIRNATY ≤ 7 days of symptom onset, and 3) have no other plausible alternative etiology at the time of enrollment.
To be classified as having myocarditis/pericarditis associated with COVID-19, a person must have 1) either acute severe COVID-19 infection or MIS-C, as defined by the CDC, 2) findings of probable or confirmed myocarditis in the CDC definition, 3) no other plausible alternative etiology. A description of the three cohorts is as follows:
Cohort 1: Prospectively ascertained cases of probable or confirmed myocarditis/pericarditis associated with COMIRNATY , i.e., participants enrolled under protocol during hospitalization or </= 2 weeks of hospital discharge.
Cohort 2: Retrospectively ascertained cases of probable or confirmed myocarditis/pericarditis associated with COMIRNATY , i.e., participants enrolled > 2 weeks after hospital discharge. Participants can be retrospectively ascertained and enrolled at any time from their COMIRNATY-associated myocarditis/pericarditis.
Cohort 3: Comparator cohort of COVID-19- related myocarditis/pericarditis , including MIS-C, both retrospectively and prospectively ascertained, and enrolled at any time from their COVID-19 or MIS-C associated myocarditis/pericarditis diagnosis.
Participants in all cohorts will be those who present to participating medical centers for care. This study is a collaboration between the National Heart, Lung, and Blood Institute (NHLBI)’s Pediatric Heart Network (PHN) and Pfizer.
Enrollment will include approximately 300 prospectively and retrospectively ascertained cases of children, adolescents, and young adults <21 years of age who receive care for myocarditis/pericarditis associated with COMIRNATY (Cohort 1 and 2); and approximately 100 persons <21 years of age with COVID -19-associated myocarditis/pericarditis, including MIS-C (Cohort 3).
