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

Last updated: October 1, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

4

Condition

Dermatomyositis (Connective Tissue Disease)

Chest Pain

Covid-19

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

    Site Not Available

  • The Hospital for Sick Children

    Toronto 6167865, Ontario 6093943 M5G 1X8
    Canada

    Active - Recruiting

  • Children's of Alabama

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Children's of Alabama

    Birmingham 4049979, Alabama 4829764 35233
    United States

    Active - Recruiting

  • Phoenix Children's Hospital

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Phoenix Children's Hospital

    Phoenix 5308655, Arizona 5551752 85016
    United States

    Active - Recruiting

  • Childrens Hospital Los Angeles

    Los Angeles, California 90027
    United States

    Site Not Available

  • Valley Children's Hospital

    Madera, California 93636
    United States

    Site Not Available

  • Lucile Packard Children's Hospital Stanford

    Palo Alto, California 94304
    United States

    Site Not Available

  • Childrens Hospital Los Angeles

    Los Angeles 5368361, California 5332921 90027
    United States

    Active - Recruiting

  • Valley Children's Hospital

    Madera 5369568, California 5332921 93636
    United States

    Active - Recruiting

  • Lucile Packard Children's Hospital Stanford

    Palo Alto 5380748, California 5332921 94304
    United States

    Active - Recruiting

  • Childrens Hospital of Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Childrens Hospital of Colorado

    Aurora 5412347, Colorado 5417618 80045
    United States

    Active - Recruiting

  • Connecticut Children's Medical Center

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Connecticut Children's Medical Center

    Hartford 4835797, Connecticut 4831725 06106
    United States

    Active - Recruiting

  • Nemours Children's Hospital, Delaware

    Wilmington, Delaware 19803
    United States

    Site Not Available

  • Nemours Children's Hospital, Delaware

    Wilmington 4145381, Delaware 4142224 19803
    United States

    Active - Recruiting

  • Childrens National Hospital

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Childrens National Hospital

    Washington D.C. 4140963, District of Columbia 4138106 20010
    United States

    Active - Recruiting

  • Memorial Healthcare System

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Memorial Healthcare System

    Hollywood 4158928, Florida 4155751 33021
    United States

    Active - Recruiting

  • Children's Healthcare of Atlanta - Egleston

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Children's Healthcare of Atlanta - Arthur M. Blank Hospital

    Atlanta 4180439, Georgia 4197000 30329
    United States

    Active - Recruiting

  • Children's Healthcare of Atlanta - Egleston

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Active - Recruiting

  • Lurie Children's Hospital

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Lurie Children's Hospital

    Chicago 4887398, Illinois 4896861 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

    Site Not Available

  • Indiana University School of Medicine

    Indianapolis 4259418, Indiana 4921868 46202
    United States

    Active - Recruiting

  • Riley Hospital for Children at IU Health

    Indianapolis 4259418, Indiana 4921868 46202
    United States

    Active - Recruiting

  • Children's Hospital

    New Orleans, Louisiana 70118
    United States

    Site Not Available

  • Children's Hospital

    New Orleans 4335045, Louisiana 4331987 70118
    United States

    Active - Recruiting

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Active - Recruiting

  • University of Michigan Hospital-Mott Children's Hospital

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Children's Hospital of Michigan

    Detroit, Michigan 48201
    United States

    Site Not Available

  • University of Michigan Health Center

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Active - Recruiting

  • University of Michigan Hospital-Mott Children's Hospital

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Active - Recruiting

  • Children's Hospital of Michigan

    Detroit 4990729, Michigan 5001836 48201
    United States

    Active - Recruiting

  • Children'S Hospitals & Clinics of Minn

    Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • Children's Minnesota

    Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • Children'S Hospitals & Clinics of Minn

    Minneapolis 5037649, Minnesota 5037779 55404
    United States

    Active - Recruiting

  • Childrens Mercy Kansas City

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Childrens Mercy Kansas City

    Kansas City 4393217, Missouri 4398678 64108
    United States

    Active - Recruiting

  • Washington University School of Medicine

    St Louis 4407066, Missouri 4398678 63110
    United States

    Active - Recruiting

  • Northwell Health-Cohen Children's Medical Center

    New Hyde Park, New York 11042
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Northwell Health-Cohen Children's Medical Center

    New Hyde Park 5128514, New York 5128638 11042
    United States

    Active - Recruiting

  • Columbia University Medical Center

    New York 5128581, New York 5128638 10032
    United States

    Active - Recruiting

  • Duke University Hospital

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Duke University Hospital

    Durham 4464368, North Carolina 4482348 27710
    United States

    Active - Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati 4508722, Ohio 5165418 45229
    United States

    Active - Recruiting

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland 5746545, Oregon 5744337 97239
    United States

    Active - Recruiting

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • The Children's Hospital of Philadelphia

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Active - Recruiting

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh 5206379, Pennsylvania 6254927 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

    Site Not Available

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

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Active - Recruiting

  • MUSC Summey Medical Pavilion

    North Charleston 4589387, South Carolina 4597040 20406
    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

    Site Not Available

  • Texas Children's Hospital

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • Primary Children's

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Primary Children's Hospital

    Salt Lake City, Utah 84113
    United States

    Active - Recruiting

  • Primary Children's Hospital

    Salt Lake City 5780993, Utah 5549030 84113
    United States

    Active - Recruiting

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Site Not Available

  • Seattle Children's Hospital & Research Institute

    Seattle, Washington 98101
    United States

    Active - Recruiting

  • Seattle Children's Hospital

    Seattle 5809844, Washington 5815135 98105
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.