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

COVID-19 Pandemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05186571
• Other study ID #: H-20028631_mRNA
• Status: Recruiting
• Start date: December 1, 2021
• Est. completion date: April 28, 2022

Study information

• Verified date: January 2022
• Source: Rigshospitalet, Denmark
• Contact: Ulrikka Nygaard, PhD MD
• Phone: +45 40794656
• Email: Ulrikka[@]dadlnet.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350000
• Est. completion date: April 28, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Biological:
• Pfizer-BioNTech mRNA COVID-19 vaccination
Vaccination in children 5-11 years of age

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital, Rigshospitalet	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Innovation Fund Denmark, Ministry of Education, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myopericarditis		Within 42 days after the first vaccine dose