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
1 other identifier
observational
350,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2021
CompletedFirst Submitted
Initial submission to the registry
January 9, 2022
CompletedFirst Posted
Study publicly available on registry
January 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2022
CompletedJanuary 31, 2022
January 1, 2022
3 months
January 9, 2022
January 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Myopericarditis
Within 42 days after the first vaccine dose
Interventions
Vaccination in children 5-11 years of age
Eligibility Criteria
All children 5-11 years old in Denmark who have received mRNA vaccination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rigshospitalet, Denmarklead
- Innovation Fund Denmarkcollaborator
- Ministry of Education, Denmarkcollaborator
Study Sites (1)
Copenhagen University Hospital, Rigshospitalet
Copenhagen, 2100, Denmark
Related Publications (1)
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.
PMID: 35585684DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Primary investigator
Study Record Dates
First Submitted
January 9, 2022
First Posted
January 11, 2022
Study Start
December 1, 2021
Primary Completion
March 1, 2022
Study Completion
April 28, 2022
Last Updated
January 31, 2022
Record last verified: 2022-01