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Vaccine

COMIRNATY Vaccine Long-Term Effects for Myocarditis

Phase 4
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cohort 3: 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
Cohort 3: 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 Confirmed myocarditis/pericarditis as defined by: Histopathologic confirmation of myocarditis OR Elevated troponin above upper limit of normal AND cMRI findings consistent with myocarditis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years following illness onset.
Awards & highlights

Study Summary

This trial will compare long-term effects of myocarditis/pericarditis following vaccination with COMIRNATY to those following infection with COVID-19 in people under 21, with follow-up for up to 5 years.

Who is the study for?
This study is for people under 21 who've had myocarditis/pericarditis symptoms within a week of getting the COMIRNATY COVID-19 vaccine. They must be able to consent or have a guardian who can, and should not have other heart conditions that could affect results.Check my eligibility
What is being tested?
The trial investigates the safety of the COMIRNATY vaccine in preventing COVID-19 and its potential link to heart inflammation (myocarditis/pericarditis). Participants will undergo cardiac imaging over up to five years to monitor long-term effects.See study design
What are the potential side effects?
While this study focuses on cardiac health, side effects may include typical vaccine reactions like sore arm, fever, fatigue; specifically looking at serious events such as heart inflammation following vaccination.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have COVID-19 or MIS-C with heart inflammation not caused by the COMINARTY vaccine.
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I likely have or am confirmed to have heart inflammation.
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I was evaluated in the ER or hospitalized at a participating medical center.
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I can sign the consent form myself or my guardian can, and I agree to follow the study rules.
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I received a COMIRNATY vaccine dose within 28 days before my symptoms started.
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I am younger than 21 years old.
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I am younger than 21 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years following illness onset.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years following illness onset. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite findings of myocarditis
Functional Status by Behavior Assessment System for Children, Third Edition BASC-3 or PROMIS Short Forms
Left ventricular ejection fraction (LVEF) < 55% by echocardiography
+3 more
Secondary outcome measures
Arrhythmias on cardiac recording (ECG, ambulatory monitoring)
Arrhythmias on cardiac recordings
Complications, including non-cardiac morbidities by medical history
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: myocarditis/pericarditis following COVID-19 or MIS-CExperimental Treatment1 Intervention
myocarditis/pericarditis following COVID-19 or MIS-C without exposure to COMIRNATY
Group II: myocarditis/pericarditis following COMIRNATYExperimental Treatment1 Intervention
myocarditis/pericarditis following COMIRNATY within 28 days of dose

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,819 Previous Clinical Trials
47,295,457 Total Patients Enrolled
1 Trials studying Myocarditis
Carelon ResearchOTHER
71 Previous Clinical Trials
206,433 Total Patients Enrolled
National Health Lung Blood InstituteUNKNOWN

Media Library

COMIRNATY (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05295290 — Phase 4
Myocarditis Research Study Groups: myocarditis/pericarditis following COVID-19 or MIS-C, myocarditis/pericarditis following COMIRNATY
Myocarditis Clinical Trial 2023: COMIRNATY Highlights & Side Effects. Trial Name: NCT05295290 — Phase 4
COMIRNATY (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05295290 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How would you appraise the risk of this intervention to participants?

"The safety of this medication has been confirmed by prior clinical data, thus receiving a score of 3. This is indicative of the treatment having achieved Phase 4 status and official approval."

Answered by AI

Does the trial accept participants under the age of 25?

"This medical trial is intended for patients between the ages of 0 and 20. There are 3 separate studies available to those under 18, while individuals over 65 may join 23 other clinical trials."

Answered by AI

Are there any available slots open for participants in this clinical trial?

"According to the information on clinicaltrials.gov, this particular medical experiment is not looking for participants at present. After being first published on October 1st 2022 and edited most recently in mid-October of that same year, recruiting has concluded. Nevertheless, 24 other trials are still actively seeking patients as we speak."

Answered by AI

For whom is this clinical experiment accepting participants?

"This clinical trial is accepting 300 participants aged 0 to 20 with carditis. The requirements are as follows: Age must be below 21, a COMIRNATY vaccine dose should have been received within 28 days of the onset of symptoms, meeting Centers for Disease Control and Prevention case definition criteria; granting consent (or waiver in some cases); COVID-19 diagnosis or MIS-C; elevated troponin levels above normal range; abnormal ECG/rhythm monitoring tests consistent with myocarditis."

Answered by AI
~200 spots leftby Nov 2029