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

Last updated: June 5, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

4

Condition

Chest Pain

Dermatomyositis (Connective Tissue Disease)

Treatment

Cardiac Imaging

Clinical Study ID

NCT05295290
C4591036
  • Ages < 20
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Cohort 1/2:
  1. Age <21 years.

  2. Presentation to participating medical center with evaluation in Emergency Roomand/or hospitalization.

  3. Received either the 1st, 2nd, 3rd or booster dose(s) of COMIRNATY within 28days of symptom onset.

  4. Meets criteria of Centers for Disease Control and Prevention case definition ofprobable or confirmed myocarditis/pericarditis

  5. Capable of giving signed informed consent/assent (by parents/legal guardians ofminors and/or patients), which includes compliance with the requirements andrestrictions listed in the Informed Consent/Assent Document and in thisprotocol OR meets criteria for waiver of consent.

  • Cohort 3:
  1. Age <21 years.

  2. Presentation to participating medical center with evaluation in Emergency Roomand/or hospitalization.

  3. COVID-19-related disease

  4. Acute COVID-19 infection OR

  5. Multi-system Inflammatory Syndrome in Children Associated with COVID-19 (MIS-C) AND

  6. Probable or confirmed myocarditis/pericarditis* not temporally related tovaccination with COMINARTY

  7. 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 onechocardiogram
  • cMRI findings consistent with myocarditis OR
  1. Confirmed myocarditis/pericarditis as defined by:
  • Histopathologic confirmation of myocarditis OR
  • Elevated troponin above upper limit of normal AND cMRI findingsconsistent with myocarditis
  1. Capable of giving signed informed consent/assent (by parents/legal guardians ofminors and/or patients), which includes compliance with the requirements andrestrictions listed in the Informed Consent/Assent Document and in thisprotocol OR meets criteria for waiver of consent.

Exclusion

Exclusion Criteria:

  1. A plausible alternative etiology for myocarditis/pericarditis, as determined by thesite based upon their routine clinical practice for evaluation of potential causesfor myocarditis/pericarditis.

  2. Pre-existing cardiac conditions that could impact the primary endpoint, includingbut not limited to, documented history of left ventricular dysfunction (e.g.,cardiomyopathy or myocardial infarction), pacemaker, or congenital heart disease,with the exceptions of:

  3. Bicommissural aortic valve with < trivial stenosis and/or insufficiency

  4. Mitral valve prolapse with < trivial insufficiency

  5. Hemodynamically insignificant atrial septal or ventricular septal defects.

  6. Previous administration with an investigational drug or vaccine within 30 days ofenrollment (or as determined by the local requirement).

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Cardiac Imaging
Phase: 4
Study Start date:
November 21, 2022
Estimated Completion Date:
November 21, 2030

Study 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).

Connect with a study center

  • The Hospital for Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Active - Recruiting

  • Children's of Alabama

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • Phoenix Children's Hospital

    Phoenix, Arizona 85016
    United States

    Active - Recruiting

  • Childrens Hospital Los Angeles

    Los Angeles, California 90027
    United States

    Active - Recruiting

  • Valley Children's Hospital

    Madera, California 93636
    United States

    Active - Recruiting

  • Lucile Packard Children's Hospital Stanford

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • Childrens Hospital of Colorado

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Connecticut Children's Medical Center

    Hartford, Connecticut 06106
    United States

    Active - Recruiting

  • Nemours Children's Hospital, Delaware

    Wilmington, Delaware 19803
    United States

    Active - Recruiting

  • Childrens National Hospital

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • Memorial Healthcare System

    Hollywood, Florida 33021
    United States

    Active - Recruiting

  • Children's Healthcare of Atlanta - Egleston

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Lurie Children's Hospital

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Indiana University

    Indianapolis, Indiana 46202-5225
    United States

    Active - Recruiting

  • Indiana University School of Medicine

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Children's Hospital

    New Orleans, Louisiana 70118
    United States

    Active - Recruiting

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • University of Michigan Hospital-Mott Children's Hospital

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Children's Hospital of Michigan

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Children'S Hospitals & Clinics of Minn

    Minneapolis, Minnesota 55404
    United States

    Active - Recruiting

  • Children's Minnesota

    Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • Childrens Mercy Kansas City

    Kansas City, Missouri 64108
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Northwell Health-Cohen Children's Medical Center

    New Hyde Park, New York 11042
    United States

    Active - Recruiting

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • Duke University Hospital

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania 15224
    United States

    Active - Recruiting

  • Medical University of South Carolina (Musc) - Children's Hospital

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Medical University of South Carolina: Shawn Jenkins Women's and Children's Hospital

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Baylor College Of Medicine (Bcm) - Texas Children's Hospital (Tch)

    Houston, Texas 77030-2316
    United States

    Active - Recruiting

  • Texas Children's Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Primary Children's

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • Primary Children's Hospital

    Salt Lake City, Utah 84113
    United States

    Active - Recruiting

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Active - Recruiting

  • Seattle Children's Hospital & Research Institute

    Seattle, Washington 98101
    United States

    Active - Recruiting

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