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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 1/2: Age <21 years
Cohort 3: Age <21 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years following illness onset.
Awards & highlights

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 am younger than 21 years old.
Select...
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 Health Lung Blood InstituteUNKNOWN
Carelon ResearchOTHER
74 Previous Clinical Trials
218,484 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,854 Previous Clinical Trials
47,817,572 Total Patients Enrolled
1 Trials studying Myocarditis

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
~200 spots leftby Nov 2030