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

StatusActive, Not Recruiting
PhasePhase 4
SponsorPfizer
Started2022-11-21
View on ClinicalTrials.gov ↗
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.

Amendment record

Amended 37 times since 2022-03-23; most recent filed 2026-05-05. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-29.

2026-05-05
Amendment RecruitingActive, Not Recruiting Study Identification, Study Status, Oversight, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v37
2025-10-01
Amendment Study Status, Contacts/Locations v36
2025-09-02
Amendment Study Status v35
2025-08-04
Amendment Study Status v34
2025-07-08
Amendment Study Status v33
2025-06-05
Amendment Study Status v32
2025-05-29
Amendment Study Status, Contacts/Locations v31
2025-05-12
Amendment Study Status, Contacts/Locations v30
2025-04-10
Amendment Study Status, Contacts/Locations v29
2025-02-07
Amendment Study Status, Contacts/Locations v28
2024-11-12
Amendment Study Status, Contacts/Locations v27
2024-09-26
Amendment Study Status, Contacts/Locations v26
2024-08-06
Amendment Study Status, Contacts/Locations v25
2024-06-17
Amendment Study Status, Contacts/Locations v24
2024-05-10
Amendment Study Status, Contacts/Locations v23
2024-05-08
Amendment Study Status, Contacts/Locations v22
2024-04-10
Amendment Study Status, Contacts/Locations v21
2024-03-11
Amendment Study Status, Contacts/Locations v20
2024-03-01
Amendment Study Status, Study Design, Contacts/Locations v19
2023-12-14
Amendment Study Status, Sponsor/Collaborators, Study Description, Study Design, Contacts/Locations v18
2023-11-02
Amendment Study Status, Contacts/Locations v17
2023-10-04
Amendment Study Status, Contacts/Locations v16
2023-09-13
Amendment Study Status, Contacts/Locations v15
2023-09-11
Amendment Study Status, Contacts/Locations v14
2023-08-29
Amendment Study Status, Contacts/Locations v13
2023-08-04
Amendment Study Status, Contacts/Locations v12
2023-08-01
Amendment Study Status, Contacts/Locations v11
2023-07-10
Amendment Study Status, Contacts/Locations v10
2023-06-02
Amendment Study Status v9
2023-03-22
Amendment Study Status, Contacts/Locations v8
2023-03-17
Amendment Study Status, Contacts/Locations v7
2023-03-02
Amendment Study Status, Contacts/Locations v6
2023-02-17
Amendment Study Status, Contacts/Locations v5
2023-01-20
Amendment Study Status, Contacts/Locations v4
2022-12-19
Amendment Not Yet RecruitingRecruiting Study Identification, Study Status, Sponsor/Collaborators, Study Description, Study Design, Contacts/Locations v3
2022-10-18
Amendment Study Status v2
2022-07-15
Amendment Study Status v1
2022-03-23
Original filing
Trial Details
NCT Number NCT05295290
Lead Sponsor Pfizer
Collaborators: Carelon Research, National Heart, Lung, and Blood Institute (NHLBI)
Conditions Myocarditis
Enrollment 319 participants
Start Date 2022-11-21
Primary Completion 2029-04-02 (estimated)
Study Completion 2029-04-02 (estimated)
Updated on ClinicalTrials.gov 2026-05-07