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

Last updated: January 16, 2022
Sponsor: Rigshospitalet, Denmark
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dermatomyositis (Connective Tissue Disease)

Chest Pain

Covid-19

Treatment

N/A

Clinical Study ID

NCT05186571
H-20028631_mRNA
  • Ages 5-11
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Children 5-11 years old hospitalized due to myocarditis andpericarditis following mRNA vaccination

Exclusion

Exclusion Criteria: Viral or bacterial cause of myopericarditis, or other known cause ofmyopericarditis

Study Design

Total Participants: 350000
Study Start date:
December 01, 2021
Estimated Completion Date:
April 28, 2022

Study 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.

Connect with a study center

  • Copenhagen University Hospital, Rigshospitalet

    Copenhagen, 2100
    Denmark

    Active - Recruiting

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