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NCT05295290 · ClinicalTrials.gov registry record · Phase 4

A Study to Learn About The COVID-19 (Study) Vaccine (Called COMIRNATY) in People That Are Less Than 21 Years Old.

A Phase 4 study of Myocarditis, sponsored by Pfizer.

Recruiting
Registry status
Phase 4
Development phase
300
Enrollment target
20
Study locations

NCT05295290 is a Phase 4 study of Myocarditis that is actively recruiting participants, run by Pfizer. The registered enrollment target is 300 participants, roughly in line with the 328-participant average among 5 other Myocarditis trials with a reported enrollment target. The trial reports 20 study locations across 16 states.

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The verdict

NCT05295290, a Phase 4 study of Myocarditis, is actively recruiting participants, sponsored by Pfizer.

RECRUITING
Registry status
Phase 4
Development phase
300 participants
Enrollment target
20
Study locations

Study Summary

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: 1. Are age \<21 years. 2. Have presentation to participating medical center with evaluation in Emergency Room and/or hospitalization. 3. Received either the 1st, 2nd, 3rd or booster dose(s) of COMIRNATY within 7 days of symptom onset. 4. Meet criteria of Centers for Disease Control and Prevention case definition of probable or confirmed myocarditis/pericarditis 5. 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.

Conditions Studied

Myocarditis

Interventions

  • DIAGNOSTIC_TEST Cardiac Imaging

Study Locations (20)

California

  • Childrens Hospital Los Angeles - Los Angeles
  • Valley Children's Hospital - Madera
  • Lucile Packard Children's Hospital Stanford - Palo Alto

Indiana

  • Indiana University School of Medicine - Indianapolis
  • Riley Hospital for Children at IU Health - Indianapolis

Michigan

  • University of Michigan Health Center - Ann Arbor
  • Children's Hospital of Michigan - Detroit

Alabama

  • Children's of Alabama - Birmingham

Arizona

  • Phoenix Children's Hospital - Phoenix

Colorado

  • Childrens Hospital of Colorado - Aurora

Connecticut

  • Connecticut Children's Medical Center - Hartford

Delaware

  • Nemours Children's Hospital, Delaware - Wilmington

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2022-11-21
Est. Completion 2030-11-21
Phase Phase 4

Sponsor

Pfizer

1,845 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05295290

The ClinicalTrials.gov registry entry for NCT05295290 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 328-participant average among 5 other Myocarditis trials with a reported enrollment target. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Myocarditis appearing as the primary indexed condition, and to 1 intervention - of which Cardiac Imaging is the first listed.

NCT05295290 reports 20 study locations spanning 16 distinct geographic areas - top geographies include California, Indiana, Michigan.

Frequently Asked Questions

What is clinical trial NCT05295290 about?

NCT05295290 is a clinical study titled "A Study to Learn About The COVID-19 (Study) Vaccine (Called COMIRNATY) in People That Are Less Than 21 Years Old.". 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: 1. Are age \<21 years. 2. Have presentation to participating medical center with evaluation in Emerge...

What is the current status of trial NCT05295290?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 300 participants. The study started on 2022-11-21. Estimated completion is 2030-11-21.

What conditions does trial NCT05295290 study?

This clinical trial studies the following conditions: Myocarditis.

What interventions are being tested in trial NCT05295290?

The interventions under investigation include: Cardiac Imaging (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT05295290?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05295290 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.