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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: Recruiting Phase 4 study of Myocarditis, sponsored by Pfizer.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This is a single composite primary outcome measure. This primary composite study endpoint is defined as the presence of 1 or more of the following 6 months after illness onset: left ventricular dysfunction (LVEF \< 55% by echocardiogram), findings of myocarditis by original or revised Lake Louise criteria on cardiac MRI, or the presence of high-grade arrhythmia or conduction system disturbance on ECG or ambulatory monitoring.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2022-11-21 |
| Est. Completion | 2030-11-21 |
| Phase | Phase 4 |
What NCT05295290 shows while recruiting
NCT05295290 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 328-participant average among 5 other Myocarditis trials with a reported enrollment target.
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 names 20 study sites across 16 states, led by 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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