Interim Analysis of Myocarditis and Pericarditis Associated with COMIRNATY in Persons Less Than 21 Years of Age

Study identification

• EU PAS number:
  EUPAS1000000600
• Study ID:
  1000000600
• Official title and acronym:
  Interim Analysis of Myocarditis and Pericarditis Associated with COMIRNATY in Persons Less Than 21 Years of Age
• DARWIN EU® study:
  No
• Study countries:
  Canada

  United States
• Study description:
  This protocol (C4591079) is an interim analysis based on data from the ongoing C4591036 study titled "Low-interventional Study of Myocarditis and Pericarditis Associated with COMIRNATY in Persons Less Than 21 Years of Age" This is a non-interventional study designated as a PASS. ; The research objective of this study (C4591079) is as follows: ; What are the acute and long term sequalae associated with myocarditis and pericarditis ; following vaccination with COMIRNATY?
• Study status:
  Planned

Research institutions and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Planned:30/06/2025

Study start date

Planned:01/09/2025

Data analysis start date

Planned:01/09/2025

Date of final study report

Planned:31/03/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer 100%

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

C4591079