A Study to Learn About The COVID-19 (Study) Vaccine (Called COMIRNATY) in People That Are Less Than 21 Years Old.
NCT ID: NCT05295290
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
300 participants
INTERVENTIONAL
2022-11-21
2030-11-21
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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myocarditis/pericarditis following COMIRNATY
myocarditis/pericarditis following COMIRNATY within 28 days of dose
Cardiac Imaging
ECG, echocardiogram, ambulatory monitor, exercise stress test
myocarditis/pericarditis following COVID-19 or MIS-C
myocarditis/pericarditis following COVID-19 or MIS-C without exposure to COMIRNATY
Cardiac Imaging
ECG, echocardiogram, ambulatory monitor, exercise stress test
Interventions
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Cardiac Imaging
ECG, echocardiogram, ambulatory monitor, exercise stress test
Eligibility Criteria
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Inclusion Criteria
1. Age \<21 years.
2. 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 28 days of symptom onset.
4. Meets criteria of Centers for Disease Control and Prevention case definition of probable or confirmed myocarditis/pericarditis
5. 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:
1. Age \<21 years.
2. Presentation to participating medical center with evaluation in Emergency Room and/or hospitalization.
3. COVID-19-related disease
1. Acute COVID-19 infection OR
2. Multi-system Inflammatory Syndrome in Children Associated with COVID-19 (MIS-C) AND
4. Probable or confirmed myocarditis/pericarditis\* not temporally related to vaccination with COMINARTY
1. 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
2. Confirmed myocarditis/pericarditis as defined by:
* Histopathologic confirmation of myocarditis OR
* Elevated troponin above upper limit of normal AND cMRI findings consistent with myocarditis
5. 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.
Exclusion Criteria
2. 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:
1. Bicommissural aortic valve with \< trivial stenosis and/or insufficiency
2. Mitral valve prolapse with \< trivial insufficiency
3. Hemodynamically insignificant atrial septal or ventricular septal defects.
3. Previous administration with an investigational drug or vaccine within 30 days of enrollment (or as determined by the local requirement).
0 Years
20 Years
ALL
No
Sponsors
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Carelon Research
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C4591036
Identifier Type: -
Identifier Source: org_study_id
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