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

Description

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.

Conditions

Myocarditis

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

Low Interventional Cohort Study of Myocarditis/Pericarditis Associated With COMIRNATY in Persons Less Than 21 Years of Age

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

Condition
Myocarditis
Intervention / Treatment

-

Contacts and Locations

Birmingham

Children's of Alabama, Birmingham, Alabama, United States, 35233

Phoenix

Phoenix Children's Hospital, Phoenix, Arizona, United States, 85016

Los Angeles

Childrens Hospital Los Angeles, Los Angeles, California, United States, 90027

Madera

Valley Children's Hospital, Madera, California, United States, 93636

Palo Alto

Lucile Packard Children's Hospital Stanford, Palo Alto, California, United States, 94304

Aurora

Childrens Hospital of Colorado, Aurora, Colorado, United States, 80045

Hartford

Connecticut Children's Medical Center, Hartford, Connecticut, United States, 06106

Wilmington

Nemours Children's Hospital, Delaware, Wilmington, Delaware, United States, 19803

Washington

Childrens National Hospital, Washington, District of Columbia, United States, 20010

Hollywood

Memorial Healthcare System, Hollywood, Florida, United States, 33021

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Cohort 1/2:
  • 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.
  • 1. A plausible alternative etiology for myocarditis/pericarditis, as determined by the site based upon their routine clinical practice for evaluation of potential causes for myocarditis/pericarditis.
  • 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).

Ages Eligible for Study

0 Years to 20 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pfizer,

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

2030-11-21