MyopericarditisNCT05186571
Myopericarditis After Messenger Ribonucleic Acid (mRNA) COVID-19 Vaccination in Children 5-11 Years Old
An observational study of Myopericarditis and Myocarditis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Myopericarditis, Myocarditis, Vaccination; Complications
- What is being tested?
- Pfizer-BioNTech mRNA COVID-19 vaccination
- Type of treatment
- Vaccines
- How many people
- 350,000 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2021to 28 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Study population: All children 5-11 years old in Denmark who have received mRNA vaccination
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
Trial locations and contacts
1 site in 1 country.
Mette Holm, PhD MD contact
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital, Rigshospitalet
Copenhagen, 2100
Ulrikka Nygaard, PhD, 40794656, Ulrikka@dadlnet.dk
About this study
Official title: 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.
Read the 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.
- Conditions
- Myopericarditis, Myocarditis, Vaccination; Complications, COVID-19 Pandemic, SARS-CoV2 Infection
- Being tested
- Pfizer-BioNTech mRNA COVID-19 vaccination
- Keywords
- myopericarditis, myocarditis, Vaccination, SARS-CoV2, mRNA vaccination, children
- Medical subject headings
- Myocarditis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pfizer-BioNTech mRNA COVID-19 vaccinationBiological
Vaccination in children 5-11 years of age
What is being measured
The primary outcome is the main question the study is designed to answer.
Myopericarditis
Measured: Within 42 days after the first vaccine dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Dec 2021
- Primary completion1 Mar 2022 (estimated)
- Study completion28 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyopericarditisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Innovation Fund Denmark, Ministry of Education, Denmark
- Responsible party
- Principal investigator, Ulrikka Nygaard, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186571
- Sponsor's protocol ID
- H-20028631_mRNA
- Status last verified
- Jan 2022
- First submitted
- 9 Jan 2022
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35585684
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population-based Incidence of Myopericarditis After Messenger Ribonucleic Acid (mRNA) COVID-19 Vaccination in Danish Children 5-11 Years Old
- ClinicalTrials.gov ID
- NCT05186571
- Acronym / sponsor ID
- H-20028631_mRNA
- Conditions
- Myopericarditis, Myocarditis, Vaccination; Complications, COVID-19 Pandemic, SARS-CoV2 Infection
- Keywords
- myopericarditis, myocarditis, Vaccination, SARS-CoV2, mRNA vaccination, children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350,000 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Innovation Fund Denmark, Ministry of Education, Denmark
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 28 Apr 2022 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All children 5-11 years old in Denmark who have received mRNA vaccination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pfizer-BioNTech mRNA COVID-19 vaccinationVaccination in children 5-11 years of age | Biological | – |
Primary outcome
Myopericarditis
Time frame: Within 42 days after the first vaccine dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
- Derived from this study: PubMed 35585684Nygaard 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.
- Individual participant dataSharing planned: Undecided
Related trials for Myopericarditis
Not yet recruitingObservational study
Assessment of Myocarditis After Replication-Deficient Smallpox Immunization
Myopericarditis, Small Pox
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mette Holm, PhD MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopericarditis and Myocarditis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ulrikka Nygaard, PhD MD (+45 40794656, Ulrikka@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myopericarditis (time frame: Within 42 days after the first vaccine dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05186571, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2022.