A Study to Learn About The COVID-19 (Study) Vaccine (Called COMIRNATY) in People That Are Less Than 21 Years Old.
Low Interventional Cohort Study of Myocarditis/Pericarditis Associated With COMIRNATY in Persons Less Than 21 Years of Age
1 other identifier
interventional
300
2 countries
34
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2022
Longer than P75 for phase_4
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2022
CompletedFirst Posted
Study publicly available on registry
March 25, 2022
CompletedStudy Start
First participant enrolled
November 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 21, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 21, 2030
October 2, 2025
October 1, 2025
8 years
January 10, 2022
October 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Composite findings of myocarditis
This is a single composite primary outcome measure. This primary composite study endpoint is defined as the presence of 1 or more of the following 6 months after illness onset: left ventricular dysfunction (LVEF \< 55% by echocardiogram), findings of myocarditis by original or revised Lake Louise criteria on cardiac MRI, or the presence of high-grade arrhythmia or conduction system disturbance on ECG or ambulatory monitoring.
6 months after illness onset
Left ventricular ejection fraction (LVEF) < 55% by echocardiography
Up to 5 years following illness onset.
Myocarditis by original or revised Lake Louise criteria on cMRI
Up to 5 years following illness onset.
Arrhythmias on cardiac recording (ECG, ambulatory monitoring)
Up to 5 years following illness onset.
Complications, including non-cardiac morbidities by medical history
Up to 5 years following illness onset.
Functional Status by Behavior Assessment System for Children, Third Edition BASC-3 or PROMIS Short Forms
Behavior Assessment System for Children, Third Edition (BASC-3), \<8 yr (T score \<30-\>70 with higher number meaning lower functioning) or PROMIS Short Forms ≥8 yr (scores from 3-15 with higher number meaning better functioning)
Up to 5 years following illness onset.
The Pediatric Quality of Life Inventory (PEDS QL)
The 27 question, age-appropriate and parent-proxy questionnaires, will be used in 2 to \<18-year-old participants to assess quality of life. Scores span 0-108 with higher number being better functioning.
Up to 5 years following illness onset.
The Quality of Life Scale (QOLS)
The QOLS, a 16-item self-report form that assesses overall quality of life on a scale of 16-112 (higher scores indicate better quality of life) will be administered for participants ≥18 years old.
Up to 5 years following illness onset.
Conduction system disturbances on cardiac recording (ECG, ambulatory monitoring)
Up to 5 years following illness onset.
Secondary Outcomes (12)
Left ventricular ejection fraction (LVEF) by echocardiogram as a measure of myocardial performance.
During the hospitalization or within 2 weeks of hospital discharge, generally obtained less than 3 weeks from presentation.
Time to recovery of myocardial inflammation and injury by Lake Louise (the original or revised) criteria
During hospitalization or within 2 weeks of hospital discharge, commonly less than 3 weeks from presentation
Arrhythmias on cardiac recording (ECG, ambulatory monitoring)
During hospitalization or within 2 weeks of hospital discharge, commonly less than 3 weeks from presentation
Complications, including non-cardiac morbidities for myocarditis
During hospitalization or within 2 weeks of hospital discharge, commonly less than 3 weeks from presentation
Echocardiographic LVEF
Up to 5 years following illness onset.
- +7 more secondary outcomes
Study Arms (2)
myocarditis/pericarditis following COMIRNATY
OTHERmyocarditis/pericarditis following COMIRNATY within 28 days of dose
myocarditis/pericarditis following COVID-19 or MIS-C
OTHERmyocarditis/pericarditis following COVID-19 or MIS-C without exposure to COMIRNATY
Interventions
ECG, echocardiogram, ambulatory monitor, exercise stress test
Eligibility Criteria
You may qualify if:
- Cohort 1/2:
- Age \<21 years.
- Presentation to participating medical center with evaluation in Emergency Room and/or hospitalization.
- Received either the 1st, 2nd, 3rd or booster dose(s) of COMIRNATY within 28 days of symptom onset.
- Meets criteria of Centers for Disease Control and Prevention case definition of probable or confirmed myocarditis/pericarditis
- 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:
- Age \<21 years.
- Presentation to participating medical center with evaluation in Emergency Room and/or hospitalization.
- COVID-19-related disease
- Acute COVID-19 infection OR
- Multi-system Inflammatory Syndrome in Children Associated with COVID-19 (MIS-C) AND
- Probable or confirmed myocarditis/pericarditis\* not temporally related to vaccination with COMINARTY
- Probable myocarditis/pericarditis as defined by ≥ 1 new finding of:
- Elevated troponin above upper limit of normal
- +7 more criteria
You may not qualify if:
- 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.
- 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:
- Bicommissural aortic valve with \< trivial stenosis and/or insufficiency
- Mitral valve prolapse with \< trivial insufficiency
- Hemodynamically insignificant atrial septal or ventricular septal defects.
- Previous administration with an investigational drug or vaccine within 30 days of enrollment (or as determined by the local requirement).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Carelon Researchcollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (34)
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 D.C., District of Columbia, 20010, United States
Memorial Healthcare System
Hollywood, Florida, 33021, United States
Children's Healthcare of Atlanta - Arthur M. Blank Hospital
Atlanta, Georgia, 30329, United States
Lurie Children's Hospital
Chicago, Illinois, 60611, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Riley Hospital for Children at IU Health
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 Health Center
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
Childrens Mercy Kansas City
Kansas City, Missouri, 64108, United States
Washington University School of Medicine
St 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, 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: Shawn Jenkins Women's and Children's Hospital
Charleston, South Carolina, 29425, United States
MUSC Summey Medical Pavilion
North Charleston, South Carolina, 20406, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Primary Children's Hospital
Salt Lake City, Utah, 84113, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- This is a low-interventional cohort study to determine cardiac and non-cardiac long-term outcomes of persons less than 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, without exposure to COMIRNATY.
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2022
First Posted
March 25, 2022
Study Start
November 21, 2022
Primary Completion (Estimated)
November 21, 2030
Study Completion (Estimated)
November 21, 2030
Last Updated
October 2, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.