- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04485624
Vaccination Coverage Amongst Children/Young People Attending the PED
Do Children and Young People Attending the Paediatric Emergency Department Have Lower Levels of Vaccination Coverage Than Their Peers in the Local General Population?
In the United Kingdom (UK), most childhood vaccinations are given in the community, although uptake has decreased in recent years. A Paediatric Emergency Department (PED) attendance offers an opportunity to check the vaccination status of children and young people (CYP) and all parents/carers should be asked about this routinely. Those not up-to-date with vaccinations could then be signposted to existing services or perhaps offered a vaccine in the PED.
CYP attending the PED may also have lower vaccination coverage than their peers, so may benefit even more from interventions to increase uptake. However, recall by parents/carers is not always sufficiently accurate to identify those who have not yet received all their age-appropriate vaccinations. The most complete record of an individual's vaccination history is held within their primary care records. However, these records are often in a separate computer system that is inaccessible from the hospital's main computer system, although some information (including vaccination) may be accessed from within the hospital via a third system.
This study aims to see if CYP attending the PED are under-vaccinated compared to their peers and assess the accuracy of parent/carer recall. The results of this study will then be used to inform recommendations for developing better ways to access accurate vaccination data during a PED consultation. If such a system existed, under-vaccinated children could be identified routinely during an attendance, and an intervention offered if appropriate. This would be particularly useful if there was an outbreak of a vaccine-preventable disease such measles.
All CYP (< 16 years old) attending a PED in a district general hospital in Manchester will be invited to participate. CYP/their parent/carer will be asked to provide consent for their vaccination records to be accessed as well as being asked if the child/young person is up-to-date with all their vaccinations. Approximately 1000 participants will be enrolled.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Greater Manchester
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Manchester, Greater Manchester, United Kingdom, M8 5RB
- Paediatric Emergency Department, North Manchester General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- attending the study site PED; under the age of 16 at the time of attendance; able to give consent or accompanied by someone able to give consent
Exclusion Criteria:
- life threatening illness or injury
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Attendees at Paediatric Emergency Department 1 (PED1)
These participants will be recruited from the children and young people (under the age of 16) attending the PED of a large district general hospital. There was going to be a second group recruited but COVID meant that the site was not able to support non-COVID studies by the time the necessary approvals were in place. |
Observational study
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percentage of children/young people attending the PED who have received all of their age-appropriate vaccinations.
Time Frame: Through study completion (estimated one year)
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The % of children and young people attending the PED who have received all of their age-appropriate vaccinations will be compared to their peers in the local general population.
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Through study completion (estimated one year)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy of parent/carer recall of the vaccination status of children/young people attending the PED.
Time Frame: Through study completion (estimated one year)
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The accuracy of parent/carer recall of the vaccination status of children/young people attending the PED will be made by comparing their responses to electronic community records.
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Through study completion (estimated one year)
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Percentage of children attending the PED who have received two doses of MMR by the age of 5 years.
Time Frame: Through study completion (estimated one year)
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The % of children attending the PED who have received two doses of the Measles, Mumps, and Rubella vaccine (MMR) by the age of 5 years will be compared to their peers in the local general population.
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Through study completion (estimated one year)
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Percentage of children attending the PED who have received at least one dose of MMR by the age of 2 years.
Time Frame: Through study completion (estimated one year)
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The % of children attending the PED who have received at least one dose of MMR by the age of 2 years will be compared to their peers in the local general population.
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Through study completion (estimated one year)
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRAS278815
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
Results of study intended to be published in an open access journal within a year of completion of analysis of data.
Anonymised data will be shared under certain circumstances; no patient-identifiable data will be available to other researchers.
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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