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

January 16, 2022 updated by: Ulrikka Nygaard, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

350000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Copenhagen University Hospital, Rigshospitalet
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All children 5-11 years old in Denmark who have received mRNA vaccination

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Myopericarditis
Time Frame: Within 42 days after the first vaccine dose
Within 42 days after the first vaccine dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Innovation Fund Denmark
Ministry of Education, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

April 28, 2022

Study Registration Dates

First Submitted

January 9, 2022

First Submitted That Met QC Criteria

January 9, 2022

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Actual)

January 31, 2022

Last Update Submitted That Met QC Criteria

January 16, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-20028631_mRNA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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