Population-based Incidence of Myopericarditis After Messenger Ribonucleic Acid (mRNA) COVID-19 Vaccination in Danish Children 5-11 Years Old
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myopericarditis
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 350000
- Locations
- 1
- Primary Endpoint
- Myopericarditis
- Last Updated
- 4 years ago
Overview
Brief Summary
Myopericarditis is a rare complication to messenger ribonucleic acid (mRNA) COVID-19 vaccines, especially in male adolescents and young adults. The risk in children 5-11 years old is unknown. In Denmark, the Pfizer-BioNTech mRNA COVID-19 vaccination was recommended from December 1, 2021 in individuals aged 5-11 years old. We aim to estimate the incidence of myopericarditis in children 5-11 years old after mRNA COVID-19 vaccination among vaccinated individuals based on a nationwide prospective population-based cohort study with detailed clinical phenotyping.
Detailed Description
AIM The project seeks to estimate the incidence of myopericarditis in children 5-11 years old after mRNA COVID-19 vaccination. HYPOTHESIS The incidence of myopericarditis after mRNA COVID-19 vaccination in children 5-11 years old is significantly lower than the incidence in adolescents. METHOD Prospective nationwide population-based cohort study of all individuals aged 5-11 years hospitalized due to myocarditis and pericarditis after COVID-19 mRNA vaccination in the period December 1, 2021 to February 1, 2022. The setting is a multicenter study including all 18 Danish Pediatric Departments, providing 24 hours emergency service, and in- and out-patient treatment for all Danish inhabitants aged ≤ 17 years. As part of a pediatric nationwide COVID-19 research set-up, all 18 departments have a principal investigator responsible for prospective real-time data collection of vaccine-associated disease. To calculate the incidence of myopericarditis among Danish individuals 5-11 years old, the number of individuals who have been mRNA COVID-19 vaccinated will be attained from the National COVID-19-vaccine Database at the Statens Serum Institut.
Investigators
Ulrikka Nygaard
Primary investigator
Rigshospitalet, Denmark
Eligibility Criteria
Inclusion Criteria
- •Children 5-11 years old hospitalized due to myocarditis and pericarditis following mRNA vaccination
Exclusion Criteria
- •Viral or bacterial cause of myopericarditis, or other known cause of myopericarditis
Outcomes
Primary Outcomes
Myopericarditis
Time Frame: Within 42 days after the first vaccine dose