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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
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved
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.
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.
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 belowSelect...
I am younger than 21 years old.
Select...
I am younger than 21 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years following illness onset.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years following illness onset.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Composite findings of myocarditis
Functional Status by Behavior Assessment System for Children, Third Edition BASC-3 or PROMIS Short Forms
The Pediatric Quality of Life Inventory (PEDS QL)
+1 moreSecondary study objectives
For patients with isolated pericarditis, to determine time to recovery to normal.
Lower LVEF by composite results
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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
75 Previous Clinical Trials
219,705 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,919 Previous Clinical Trials
47,759,528 Total Patients Enrolled
1 Trials studying Myocarditis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I likely have or am confirmed to have heart inflammation.I have COVID-19 or MIS-C with heart inflammation not caused by the COMINARTY vaccine.I was evaluated in the ER or hospitalized at a participating medical center.I can sign the consent form myself or my guardian can, and I agree to follow the study rules.I received a COMIRNATY vaccine dose within 28 days before my symptoms started.I am younger than 21 years old.I do not have serious heart conditions that could affect the study.I am younger than 21 years old.The site will check if there could be another reason for heart inflammation based on their usual way of looking for causes of heart inflammation.You have been diagnosed with myocarditis or pericarditis according to the Centers for Disease Control and Prevention guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: myocarditis/pericarditis following COVID-19 or MIS-C
- Group 2: myocarditis/pericarditis following COMIRNATY
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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