Clinical trial NCT05186571: Myopericarditis After Messenger Ribonucleic Acid (mRNA) COVID-19 Vaccination in Children 5-11 Years Old
Official title: Population-based Incidence of Myopericarditis After Messenger Ribonucleic Acid (mRNA) COVID-19 Vaccination in Danish Children 5-11 Years Old
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myopericarditis
Myocarditis
Vaccination; Complications
COVID-19 Pandemic
SARS-CoV2 Infection
Keywords: myopericarditis
myocarditis
Vaccination
SARS-CoV2
mRNA vaccination
children
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Innovation Fund Denmark
name: Ministry of Education, Denmark
First posted: 2022-01-11
Enrollment: 350000
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children 5-11 years old in Denmark who have received mRNA vaccination

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.

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

Primary outcomes:
measure: Myopericarditis
timeFrame: Within 42 days after the first vaccine dose
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Rigshospitalet
Study officials:
References:
citation: Nygaard U, Holm M, Dungu KHS, Matthesen AT, Stensballe LG, Espenhain L, Hartling U. Risk of Myopericarditis After COVID-19 Vaccination in Danish Children Aged 5 to 11 Years. Pediatrics. 2022 Aug 1;150(2):e2022057508. doi: 10.1542/peds.2022-057508. No abstract available.