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

NCT05186571 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 350000

Last updated 2022-01-31

No results posted yet for this study

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.

Conditions

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

Interventions

BIOLOGICAL

Pfizer-BioNTech mRNA COVID-19 vaccination

Vaccination in children 5-11 years of age

Sponsors & Collaborators

  • Innovation Fund Denmark

    collaborator INDIV

  • Ministry of Education, Denmark

    collaborator OTHER_GOV

  • Rigshospitalet, Denmark

    lead OTHER

Eligibility

Min Age
5 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-03-01
Completion
2022-04-28

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05186571 on ClinicalTrials.gov