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New study tracks heart inflammation in teens after pfizer vaccine

NCT ID NCT05295290

Knowledge-focused Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 319 people under 21 who developed heart inflammation (myocarditis or pericarditis) within 21 days of receiving the Comirnaty (Pfizer) COVID-19 vaccine. Researchers will monitor their heart function with imaging tests for up to 5 years to see if there are lasting effects. The goal is to better understand the risks and recovery from this rare side effect.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could clarify the long-term heart health risks after COVID-19 vaccination in young people, helping guide future vaccine safety recommendations.
What could go wrong
This is an observational study, not a treatment trial, so it won't offer new therapies. The findings may be limited by the small number of participants (319) and the lack of a comparison group.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

319 people

The number who actually took part.

Started

Nov 2022

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 20 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Cohort 1/2: 1. Age \<21 years. 2. Presentation to participating medical center with evaluation in Emergency Room and/or hospitalization. 3. Received any dose(s) of COMIRNATY within 21 days of symptom onset. 4. Meets criteria of Centers for Disease Control and Prevention case definition of probable or confirmed myocarditis/pericarditis 5. 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: 1. Age \<21 years. 2. Presentation to participating medical center with evaluation in Emergency Room and/or hospitalization. 3. COVID-19-related disease 1. Acute COVID-19 infection OR 2. Multi-system Inflammatory Syndrome in Children Associated with COVID-19 (MIS-C) AND 4. Probable or confirmed myocarditis/pericarditis\* not temporally related to vaccination with COMINARTY 1. 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 2. Confirmed myocarditis/pericarditis as defined by: * Histopathologic confirmation of myocarditis OR * Elevated troponin above upper limit of normal AND cMRI findings consistent with myocarditis 5. 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: 1. 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. 2. 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: 1. Bicommissural aortic valve with \< trivial stenosis and/or insufficiency 2. Mitral valve prolapse with \< trivial insufficiency 3. Hemodynamically insignificant atrial septal or ventricular septal defects. 3. Previous administration with an investigational drug or vaccine within 30 days of enrollment (or as determined by the local requirement).

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Conditions

The condition(s) this trial relates to.

COVID-19 myocarditis pericarditis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myocarditis

Contacts and locations

Locations

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Children's Healthcare of Atlanta - Arthur M. Blank Hospital

    Atlanta, Georgia, 30329, United States

  • Children's Hospital

    New Orleans, Louisiana, 70118, United States

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201, United States

  • Childrens Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Childrens Mercy Kansas City

    Kansas City, Missouri, 64108, United States

  • Childrens National Hospital

    Washington D.C., District of Columbia, 20010, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106, United States

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202, United States

  • MUSC Summey Medical Pavilion

    North Charleston, South Carolina, 20406, United States

  • Memorial Healthcare System

    Hollywood, Florida, 33021, United States

  • Northwell Health-Cohen Children's Medical Center

    New Hyde Park, New York, 11042, United States

  • Riley Hospital for Children at IU Health

    Indianapolis, Indiana, 46202, United States

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • University of Michigan Health Center

    Ann Arbor, Michigan, 48109, United States

  • Valley Children's Hospital

    Madera, California, 93636, United States

More trials for these conditions

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