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
Started

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Record History

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  1. Primary and study completion dates: Nov 21, 2030 to Apr 2, 2029v38 Show 6 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 300 to confirmed 319
    • Study sites: 34 to 18
    • Eligibility criteria shortened, about 6 words
    • Secondary endpoints: 12 to 14
    • Study description expanded, about 23 words
  2. Study sites: 32 to 34v37
  3. 4 versions Re-verified since Jun 5, 2025, no change to tracked fieldsv33-v36
  4. Site details revised at 1 of 32 sitesv32
  5. Site details revised at 1 of 32 sitesv31
Show 29 earlier versionsHide 29 earlier versions
  1. Site details revised at 1 of 32 sitesv30
  2. Study sites: 40 to 32v29
  3. Site details revised at 1 of 40 sitesv28
  4. Study sites: 38 to 40v27
  5. Study sites: 36 to 38v26
  6. Site details revised at 1 of 36 sitesv25
  7. Site details revised at 1 of 36 sitesv24
  8. Study sites: 34 to 36v23
  9. Primary and study completion dates: Nov 21, 2029 to Nov 21, 2030
    • Study sites: 33 to 34
    v22
  10. Study sites: 32 to 33v21
  11. Enrollment target: 400 to 300
    • Study sites: 30 to 32
    v20
  12. Enrollment target: 300 to 400
    • Study sites: 28 to 30
    • Study description shortened, about 31 words
    • Collaborators revised (2)
    v19
  13. Site details revised at 2 of 28 sitesv18
  14. Site details revised at 1 of 28 sitesv17
  15. Site details revised at 1 of 28 sitesv16
  16. Study sites: 27 to 28v15
  17. Primary and study completion dates: Nov 19, 2028 to Nov 21, 2029
    • Site details revised at 1 of 27 sites
    v14
  18. Study sites: 26 to 27v13
  19. Study sites: 23 to 26v12
  20. Study sites: 16 to 23v11
  21. Re-verified, no change to tracked fieldsv10
  22. Site details revised at 1 of 16 sitesv9
  23. Study sites: 9 to 16v8
  24. Study sites: 8 to 9v7
  25. Study sites: 4 to 8v6
  26. Study sites: 1 to 4v5
  27. Trial status: Not Yet Recruiting to Recruitingv4 Show 6 more changesShow less
    • Study sites: 2 to 1
    • Primary and study completion dates: Oct 15, 2028 to Nov 19, 2028
    • Start date changed from estimate of Oct 2022 to Nov 21, 2022
    • Study description expanded, about 345 words
    • Collaborators: 1 to 2
    • Study title expanded, about 4 words
  28. Start date: Jul 18, 2022 to Oct 2022
    • Primary and study completion dates: Jul 16, 2028 to Oct 15, 2028
    v3
  29. Start date: Jun 15, 2022 to Jul 18, 2022
    • Primary and study completion dates: Jun 13, 2028 to Jul 16, 2028
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Pfizer
441 trials monitored
See 30 trials at risk
Heart Disease
8,862 trials monitored
See 438 trials at risk
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.
Trial Details
NCT Number NCT05295290
Lead Sponsor Pfizer
Collaborators: Carelon Research, National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Myocarditis
Related terms COVID-19, Myocarditis
Enrollment 319 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov