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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

350000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-04-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

myopericarditis myocarditis Vaccination SARS-CoV2 mRNA vaccination children

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pfizer-BioNTech mRNA COVID-19 vaccination

Vaccination in children 5-11 years of age

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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

Minimum Eligible Age

5 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ulrikka Nygaard

Primary investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Copenhagen University Hospital, Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ulrikka Nygaard, PhD MD

Role: CONTACT

Phone: +45 40794656

Email: [email protected]

Mette Holm, PhD MD

Role: CONTACT

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ulrikka Nygaard, PhD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED

PMID: 35585684 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H-20028631_mRNA

Identifier Type: -

Identifier Source: org_study_id