A Study to Learn About The COVID-19 (Study) Vaccine (Called COMIRNATY) in People That Are Less Than 21 Years Old.
Public ClinicalTrials.gov record NCT05295290. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
LOW INTERVENTIONAL COHORT STUDY OF MYOCARDITIS/PERICARDITIS ASSOCIATED WITH COMIRNATY IN PERSONS LESS THAN 21 YEARS OF AGE
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to learn about the safety and effects of the 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 any dose(s) of COMIRNATY within 21 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.
Study identification
- NCT ID
- NCT05295290
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 319 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 0 Years to 20 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 20, 2022
- Primary completion
- Apr 1, 2029
- Completion
- Apr 1, 2029
- Last update posted
- May 6, 2026
2022 – 2029
United States locations
- U.S. sites
- 18
- U.S. states
- 14
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Childrens Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Valley Children's Hospital | Madera | California | 93636 | — |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | — |
| Childrens National Hospital | Washington D.C. | District of Columbia | 20010 | — |
| Memorial Healthcare System | Hollywood | Florida | 33021 | — |
| Children's Healthcare of Atlanta - Arthur M. Blank Hospital | Atlanta | Georgia | 30329 | — |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | — |
| Riley Hospital for Children at IU Health | Indianapolis | Indiana | 46202 | — |
| Children's Hospital | New Orleans | Louisiana | 70118 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| University of Michigan Health Center | Ann Arbor | Michigan | 48109 | — |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | — |
| Childrens Mercy Kansas City | Kansas City | Missouri | 64108 | — |
| Northwell Health-Cohen Children's Medical Center | New Hyde Park | New York | 11042 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| MUSC Summey Medical Pavilion | North Charleston | South Carolina | 20406 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05295290, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 6, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05295290 live on ClinicalTrials.gov.