<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04485624</url>
  </required_header>
  <id_info>
    <org_study_id>IRAS278815</org_study_id>
    <nct_id>NCT04485624</nct_id>
  </id_info>
  <brief_title>Vaccination Coverage Amongst Children/Young People Attending the PED</brief_title>
  <official_title>Do Children and Young People Attending the Paediatric Emergency Department Have Lower Levels of Vaccination Coverage Than Their Peers in the Local General Population?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lancaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pennine Acute Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Lancaster University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the United Kingdom (UK), most childhood vaccinations are given in the community, although&#xD;
      uptake has decreased in recent years. A Paediatric Emergency Department (PED) attendance&#xD;
      offers an opportunity to check the vaccination status of children and young people (CYP) and&#xD;
      all parents/carers should be asked about this routinely. Those not up-to-date with&#xD;
      vaccinations could then be signposted to existing services or perhaps offered a vaccine in&#xD;
      the PED.&#xD;
&#xD;
      CYP attending the PED may also have lower vaccination coverage than their peers, so may&#xD;
      benefit even more from interventions to increase uptake. However, recall by parents/carers is&#xD;
      not always sufficiently accurate to identify those who have not yet received all their&#xD;
      age-appropriate vaccinations. The most complete record of an individual's vaccination history&#xD;
      is held within their primary care records. However, these records are often in a separate&#xD;
      computer system that is inaccessible from the hospital's main computer system, although some&#xD;
      information (including vaccination) may be accessed from within the hospital via a third&#xD;
      system.&#xD;
&#xD;
      This study aims to see if CYP attending the PED are under-vaccinated compared to their peers&#xD;
      and assess the accuracy of parent/carer recall. The results of this study will then be used&#xD;
      to inform recommendations for developing better ways to access accurate vaccination data&#xD;
      during a PED consultation. If such a system existed, under-vaccinated children could be&#xD;
      identified routinely during an attendance, and an intervention offered if appropriate. This&#xD;
      would be particularly useful if there was an outbreak of a vaccine-preventable disease such&#xD;
      measles.&#xD;
&#xD;
      All CYP (&lt; 16 years old) attending a PED in a district general hospital in Manchester will be&#xD;
      invited to participate. CYP/their parent/carer will be asked to provide consent for their&#xD;
      vaccination records to be accessed as well as being asked if the child/young person is&#xD;
      up-to-date with all their vaccinations. Approximately 1000 participants will be enrolled.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 24, 2021</start_date>
  <completion_date type="Actual">November 30, 2021</completion_date>
  <primary_completion_date type="Actual">November 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of children/young people attending the PED who have received all of their age-appropriate vaccinations.</measure>
    <time_frame>Through study completion (estimated one year)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Accuracy of parent/carer recall of the vaccination status of children/young people attending the PED.</measure>
    <time_frame>Through study completion (estimated one year)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of children attending the PED who have received two doses of MMR by the age of 5 years.</measure>
    <time_frame>Through study completion (estimated one year)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of children attending the PED who have received at least one dose of MMR by the age of 2 years.</measure>
    <time_frame>Through study completion (estimated one year)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2693</enrollment>
  <condition>Vaccination/Immunisation Status</condition>
  <arm_group>
    <arm_group_label>Attendees at Paediatric Emergency Department 1 (PED1)</arm_group_label>
    <description>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.&#xD;
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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>Observational study</description>
    <arm_group_label>Attendees at Paediatric Emergency Department 1 (PED1)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children and young people accessing PED&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  attending the study site PED; under the age of 16 at the time of attendance; able to&#xD;
             give consent or accompanied by someone able to give consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  life threatening illness or injury&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Paediatric Emergency Department, North Manchester General Hospital</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M8 5RB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>December 10, 2021</last_update_submitted>
  <last_update_submitted_qc>December 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lancaster University</investigator_affiliation>
    <investigator_full_name>Rachel Isba</investigator_full_name>
    <investigator_title>Professor of Medicine and Consultant in Paediatric Public Health Medicine</investigator_title>
  </responsible_party>
  <keyword>Vaccination</keyword>
  <keyword>Immunisation</keyword>
  <keyword>Opportunistic</keyword>
  <keyword>Child</keyword>
  <keyword>Young person</keyword>
  <keyword>Paediatric Emergency Department</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Results of study intended to be published in an open access journal within a year of completion of analysis of data.&#xD;
Anonymised data will be shared under certain circumstances; no patient-identifiable data will be available to other researchers.</ipd_time_frame>
    <ipd_access_criteria>Anonymised data will be made available following reasonable request.</ipd_access_criteria>
  </patient_data>
  <pending_results>
    <submitted>March 13, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04485624
org study id: IRAS278815
nct id: NCT04485624
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Case-Only
time perspective: Cross-Sectional
measure: 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)
description: 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.
measure: Accuracy of parent/carer recall of the vaccination status of children/young people attending the PED.
time frame: Through study completion (estimated one year)
description: 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.
measure: 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)
description: 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.
measure: 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)
description: 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.
arm group label: Attendees at Paediatric Emergency Department 1 (PED1)
description: 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.
intervention type: Other
intervention name: No intervention
description: Observational study
arm group label: Attendees at Paediatric Emergency Department 1 (PED1)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 0 Years
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Lancaster University
investigator full name: Rachel Isba
investigator title: Professor of Medicine and Consultant in Paediatric Public Health Medicine
sharing ipd: Yes
ipd info type: Clinical Study Report (CSR)
ipd 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 access criteria: Anonymised data will be made available following reasonable request.
submitted: March 13, 2023