<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/NCT02227186</url>
  </required_header>
  <id_info>
    <org_study_id>5R18HS021163</org_study_id>
    <secondary_id>5R18HS021163</secondary_id>
    <nct_id>NCT02227186</nct_id>
  </id_info>
  <brief_title>Efficacy Study of School-located Influenza Vaccination Clinics to Increase Influenza Vaccination Rates in Monroe County, New York</brief_title>
  <acronym>SKIPP RCT</acronym>
  <official_title>Study of Effectiveness of a School-located Influenza Vaccination Program in Raising Influenza Vaccination Rates</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Children in schools in which influenza vaccination clinics are held during school hours will&#xD;
      have higher rates of influenza vaccination than children in control schools (no&#xD;
      school-located clinics offered)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2014</start_date>
  <completion_date type="Actual">July 31, 2015</completion_date>
  <primary_completion_date type="Actual">July 31, 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Influenza vaccination status</measure>
    <time_frame>Within one year</time_frame>
    <description>Vaccination status for the 2014/2015 influenza season will be assessed. The vaccination date will be recorded, as well as the provider name, to determine whether vaccine was received at the school-located influenza clinic</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20461</enrollment>
  <condition>Childhood Influenza Vaccination</condition>
  <condition>School-located Influenza Vaccination</condition>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No school-located influenza vaccination clinic</description>
  </arm_group>
  <arm_group>
    <arm_group_label>School-located influenza vaccination clinics</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>School-located influenza vaccination clinics</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>School-located Influenza Vaccination Clinic</intervention_name>
    <description>Children in the intervention arm are enrolled in schools in Monroe County, NY that are offering school-located influenza vaccination clinics during school hours</description>
    <arm_group_label>School-located influenza vaccination clinics</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrolled in participating, randomized school&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Szilagyi, MPH, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rochester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Rochester School of Medicine and Dentistry</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>April 28, 2017</last_update_submitted>
  <last_update_submitted_qc>April 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Peter G Szilagyi, MD MPH</investigator_full_name>
    <investigator_title>Professor and Vice-Chair for Clinical Research</investigator_title>
  </responsible_party>
  <keyword>Influenza vaccination rates</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <!-- 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/NCT02227186
org study id: 5R18HS021163
secondary id: 5R18HS021163
nct id: NCT02227186
lead sponsor: 
has dmc: No
Children in schools in which influenza vaccination clinics are held during school hours will
      have higher rates of influenza vaccination than children in control schools (no
      school-located clinics offered)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Investigator, Outcomes Assessor)
measure: Influenza vaccination status
time frame: Within one year
description: Vaccination status for the 2014/2015 influenza season will be assessed. The vaccination date will be recorded, as well as the provider name, to determine whether vaccine was received at the school-located influenza clinic
arm group label: Control arm
arm group type: No Intervention
description: No school-located influenza vaccination clinic
arm group label: School-located influenza vaccination clinics
arm group type: Experimental
description: School-located influenza vaccination clinics
intervention type: Other
intervention name: School-located Influenza Vaccination Clinic
description: Children in the intervention arm are enrolled in schools in Monroe County, NY that are offering school-located influenza vaccination clinics during school hours
arm group label: School-located influenza vaccination clinics
criteria: 
gender: All
minimum age: 4 Years
maximum age: 19 Years
healthy volunteers: No
last name: Peter Szilagyi, MPH, MD
role: Principal Investigator
affiliation: University of Rochester
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Peter G Szilagyi, MD MPH
investigator title: Professor and Vice-Chair for Clinical Research
mesh term: Influenza, Human