NCT05186571

Myopericarditis After Messenger Ribonucleic Acid (mRNA) COVID-19 Vaccination in Children 5-11 Years Old

Population-based Incidence of Myopericarditis After Messenger Ribonucleic Acid (mRNA) COVID-19 Vaccination in Danish Children 5-11 Years Old

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 350,000 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 5 Years – 11 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myopericarditis
• Myocarditis
• Vaccination; Complications
• COVID-19 Pandemic
• SARS-CoV2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	Pfizer-BioNTech mRNA COVID-19 vaccination	Vaccination in children 5-11 years of age

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-03-01
• Completion: 2022-04-28
• First posted: 2022-01-11
• Last updated: 2022-01-31

Locations

1 site across 1 country: Denmark