RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-11-21
Study Completion:2030-11-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05295290

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.

Ages Eligible for Study:0 Years to 20 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Cohort 1/2:
  2. 1. Age \<21 years.
  3. 2. Presentation to participating medical center with evaluation in Emergency Room and/or hospitalization.
  4. 3. Received either the 1st, 2nd, 3rd or booster dose(s) of COMIRNATY within 28 days of symptom onset.
  5. 4. Meets criteria of Centers for Disease Control and Prevention case definition of probable or confirmed myocarditis/pericarditis
  6. 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.
  7. * Cohort 3:
  8. 1. Age \<21 years.
  9. 2. Presentation to participating medical center with evaluation in Emergency Room and/or hospitalization.
  10. 3. COVID-19-related disease
  11. 1. Acute COVID-19 infection OR
  12. 2. Multi-system Inflammatory Syndrome in Children Associated with COVID-19 (MIS-C) AND
  13. 4. Probable or confirmed myocarditis/pericarditis\* not temporally related to vaccination with COMINARTY
  14. 1. Probable myocarditis/pericarditis as defined by ≥ 1 new finding of:
  15. * Elevated troponin above upper limit of normal
  16. * Abnormal ECG or rhythm monitoring finding consistent with myocarditis
  17. * Abnormal cardiac function or wall motion abnormalities on echocardiogram
  18. * cMRI findings consistent with myocarditis OR
  19. 2. Confirmed myocarditis/pericarditis as defined by:
  20. * Histopathologic confirmation of myocarditis OR
  21. * Elevated troponin above upper limit of normal AND cMRI findings consistent with myocarditis
  22. 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. 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. 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:
  3. 1. Bicommissural aortic valve with \< trivial stenosis and/or insufficiency
  4. 2. Mitral valve prolapse with \< trivial insufficiency
  5. 3. Hemodynamically insignificant atrial septal or ventricular septal defects.
  6. 3. Previous administration with an investigational drug or vaccine within 30 days of enrollment (or as determined by the local requirement).

Contacts and Locations

Study Contact

Pfizer CT.gov Call Center
CONTACT
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

Children's of Alabama
Birmingham, Alabama, 35233
United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016
United States
Childrens Hospital Los Angeles
Los Angeles, California, 90027
United States
Valley Children's Hospital
Madera, California, 93636
United States
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94304
United States
Childrens Hospital of Colorado
Aurora, Colorado, 80045
United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
United States
Nemours Children's Hospital, Delaware
Wilmington, Delaware, 19803
United States
Childrens National Hospital
Washington, District of Columbia, 20010
United States
Memorial Healthcare System
Hollywood, Florida, 33021
United States
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, 30322
United States
Lurie Children's Hospital
Chicago, Illinois, 60611
United States
Indiana University
Indianapolis, Indiana, 46202-5225
United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202
United States
Children's Hospital
New Orleans, Louisiana, 70118
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
University of Michigan Hospital-Mott Children's Hospital
Ann Arbor, Michigan, 48109
United States
Children's Hospital of Michigan
Detroit, Michigan, 48201
United States
Children'S Hospitals & Clinics of Minn
Minneapolis, Minnesota, 55404
United States
Children's Minnesota
Minneapolis, Minnesota, 55404
United States
Childrens Mercy Kansas City
Kansas City, Missouri, 64108
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Northwell Health-Cohen Children's Medical Center
New Hyde Park, New York, 11042
United States
Columbia University Medical Center
New York, New York, 10032
United States
Duke University Hospital
Durham, North Carolina, 27705
United States
Duke University Hospital
Durham, North Carolina, 27710
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
United States
Medical University of South Carolina (Musc) - Children's Hospital
Charleston, South Carolina, 29425
United States
Medical University of South Carolina: Shawn Jenkins Women's and Children's Hospital
Charleston, South Carolina, 29425
United States
Texas Children's Hospital
Houston, Texas, 77001
United States
Baylor College Of Medicine (Bcm) - Texas Children's Hospital (Tch)
Houston, Texas, 77030-2316
United States
Texas Children's Hospital
Houston, Texas, 77030
United States
Primary Children's
Salt Lake City, Utah, 84112
United States
Primary Children's Hospital
Salt Lake City, Utah, 84113
United States
Seattle Children's Hospital & Research Institute
Seattle, Washington, 98101
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-21
Study Completion Date2030-11-21

Study Record Updates

Study Start Date2022-11-21
Study Completion Date2030-11-21

Terms related to this study

Keywords Provided by Researchers

  • COMIRNATY
  • post-vaccine
  • COVID-19
  • MIS-C

Additional Relevant MeSH Terms

  • Myocarditis