A Study to Learn About The COVID-19 (Study) Vaccine (Called COMIRNATY) in People That Are Less Than 21 Years Old.
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| ClinicalTrials.gov Identifier: NCT05295290 |
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Recruitment Status :
Recruiting
First Posted : March 25, 2022
Last Update Posted : April 11, 2024
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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:
- Are age <21 years.
- Have 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 7 days of symptom onset.
- Meet criteria of Centers for Disease Control and Prevention case definition of probable or confirmed myocarditis/pericarditis
- 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Myocarditis | Diagnostic Test: Cardiac Imaging | Phase 4 |
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).
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 300 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Masking Description: | 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. |
| Primary Purpose: | Other |
| Official Title: | Low Interventional Cohort Study of Myocarditis/Pericarditis Associated With COMIRNATY in Persons Less Than 21 Years of Age |
| Actual Study Start Date : | November 21, 2022 |
| Estimated Primary Completion Date : | November 21, 2030 |
| Estimated Study Completion Date : | November 21, 2030 |
| Arm | Intervention/treatment |
|---|---|
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myocarditis/pericarditis following COMIRNATY
myocarditis/pericarditis following COMIRNATY within 28 days of dose
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Diagnostic Test: Cardiac Imaging
ECG, echocardiogram, ambulatory monitor, exercise stress test |
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myocarditis/pericarditis following COVID-19 or MIS-C
myocarditis/pericarditis following COVID-19 or MIS-C without exposure to COMIRNATY
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Diagnostic Test: Cardiac Imaging
ECG, echocardiogram, ambulatory monitor, exercise stress test |
- Composite findings of myocarditis [ Time Frame: 6 months after illness onset ]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.
- Left ventricular ejection fraction (LVEF) < 55% by echocardiography [ Time Frame: Up to 5 years following illness onset. ]
- Myocarditis by original or revised Lake Louise criteria on cMRI [ Time Frame: Up to 5 years following illness onset. ]
- Arrhythmias on cardiac recording (ECG, ambulatory monitoring) [ Time Frame: Up to 5 years following illness onset. ]
- Complications, including non-cardiac morbidities by medical history [ Time Frame: Up to 5 years following illness onset. ]
- Functional Status by Behavior Assessment System for Children, Third Edition BASC-3 or PROMIS Short Forms [ Time Frame: Up to 5 years following illness onset. ]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)
- The Pediatric Quality of Life Inventory (PEDS QL) [ Time Frame: Up to 5 years following illness onset. ]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.
- The Quality of Life Scale (QOLS) [ Time Frame: Up to 5 years following illness onset. ]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.
- Conduction system disturbances on cardiac recording (ECG, ambulatory monitoring) [ Time Frame: Up to 5 years following illness onset. ]
- Left ventricular ejection fraction (LVEF) by echocardiogram as a measure of myocardial performance. [ Time Frame: 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 [ Time Frame: During hospitalization or within 2 weeks of hospital discharge, commonly less than 3 weeks from presentation ]
- Arrhythmias on cardiac recording (ECG, ambulatory monitoring) [ Time Frame: During hospitalization or within 2 weeks of hospital discharge, commonly less than 3 weeks from presentation ]
- Complications, including non-cardiac morbidities for myocarditis [ Time Frame: During hospitalization or within 2 weeks of hospital discharge, commonly less than 3 weeks from presentation ]
- Echocardiographic LVEF [ Time Frame: Up to 5 years following illness onset. ]
- Myocardial inflammation scarring (by cMRI) [ Time Frame: Up to 5 years following illness onset. ]
- Arrhythmias on cardiac recordings [ Time Frame: Up to 5 years following illness onset. ]
- Complications, including non-cardiac morbidities by medical history [ Time Frame: Up to 5 years following illness onset. ]
- Lower LVEF by composite results [ Time Frame: Up to 5 years following illness onset. ]Identification of possible sociodemographic and medical risk factors for greater frequency and severity of acute and longer-term cardiac sequelae in participants, measured by ECG, original or revised Lake Louise criteria on cMRI, and presence of high-grade arrhythmia or conduction system disturbance on ECG or ambulatory monitoring.
- For patients with isolated pericarditis, to determine time to recovery to normal. [ Time Frame: At each study visit, up to 5 years, until the endpoint event is met ]
Freedom from
- symptoms/signs of pericarditis;
- typical ECG findings of pericarditis;
- >small pericardial effusion;
- therapy with anti-inflammatory medications
- Conduction system disturbances on cardiac recording (ECG, ambulatory monitoring) [ Time Frame: During hospitalization or within 2 weeks of hospital discharge, commonly less than 3 weeks from presentation ]
- Conduction system disturbances on cardiac recordings [ Time Frame: Up to 5 years following illness onset. ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 0 Years to 20 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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.
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Cohort 3:
- Age <21 years.
- Presentation to participating medical center with evaluation in Emergency Room and/or hospitalization.
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COVID-19-related disease
- Acute COVID-19 infection OR
- Multi-system Inflammatory Syndrome in Children Associated with COVID-19 (MIS-C) AND
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Probable or confirmed myocarditis/pericarditis* not temporally related to vaccination with COMINARTY
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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
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Confirmed myocarditis/pericarditis as defined by:
- Histopathologic confirmation of myocarditis OR
- Elevated troponin above upper limit of normal AND cMRI findings consistent with myocarditis
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- 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.
Exclusion Criteria:
- 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.
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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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05295290
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Study Director: | Pfizer CT.gov Call Center | Pfizer |
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT05295290 |
| Other Study ID Numbers: |
C4591036 |
| First Posted: | March 25, 2022 Key Record Dates |
| Last Update Posted: | April 11, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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. |
| URL: | https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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COMIRNATY post-vaccine COVID-19 MIS-C |
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Myocarditis Cardiomyopathies Heart Diseases Cardiovascular Diseases |