<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/NCT01719679</url>
  </required_header>
  <id_info>
    <org_study_id>08-0204</org_study_id>
    <nct_id>NCT01719679</nct_id>
  </id_info>
  <brief_title>School Located Adolescent Vaccination Study</brief_title>
  <official_title>Examination of the Effectiveness of Adolescent Vaccines Given in Schools</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The provision of adolescent vaccination in a school setting will be feasible and acceptable&#xD;
      to parents as evidenced by the number and percentage of students immunized within each school&#xD;
      compared to those in schools without a program. The likelihood of vaccination for diphtheria,&#xD;
      tetanus, and pertussis (Tdap), human papillomavirus (HPV), and meningococcal conjugate&#xD;
      vaccine (MCV4) and all three combined) among eligible students enrolled in schools with a&#xD;
      comprehensive school-based immunization program will be significantly higher than that of&#xD;
      students enrolled in schools without a school-based immunization program.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2010</start_date>
  <completion_date type="Actual">October 2011</completion_date>
  <primary_completion_date type="Actual">August 2011</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The likelihood of vaccination among eligible 6th grade students with one or more needed vaccines in intervention schools compared to control schools.</measure>
    <time_frame>end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011</time_frame>
    <description>The vaccination status of eligible students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The likelihood of vaccination among eligible 6th grade students with Tdap vaccine in intervention schools compared to control schools.</measure>
    <time_frame>end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011</time_frame>
    <description>The Tdap vaccination status of eligible students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The likelihood of vaccination among eligible 6th grade students with MCV4 vaccine in intervention schools compared to control schools.</measure>
    <time_frame>end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011</time_frame>
    <description>The MCV4 vaccination status of eligible students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The likelihood of vaccination among eligible 6th grade female students with HPV vaccine in intervention schools compared to control schools.</measure>
    <time_frame>end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011</time_frame>
    <description>The HPV vaccination status of eligible female students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The likelihood of vaccination with Tdap vaccine among eligible 7th and 8th grade students enrolled at intervention schools compared to control schools.</measure>
    <time_frame>end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011</time_frame>
    <description>The Tdap vaccination status of students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The likelihood of vaccination with one or more HPV vaccines among eligible 7th and 8th grade female students enrolled in intervention schools compared to control schools.</measure>
    <time_frame>end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011</time_frame>
    <description>The HPV vaccination status of eligible female students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The likelihood of MCV4 vaccination among eligible 7th and 8th students enrolled in intervention schools compared to control schools.</measure>
    <time_frame>end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011</time_frame>
    <description>The MCV4 vaccination status of eligible 7th and 8th grade students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The likelihood of HPV vaccine series completion among female students in intervention schools compared to control schools.</measure>
    <time_frame>end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011</time_frame>
    <description>The HPV vaccine status of female students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2000</enrollment>
  <condition>School Located Vaccine Program</condition>
  <arm_group>
    <arm_group_label>School Located Vaccine (SLV) Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A vaccine program carried out by a community vaccinator will be conducted in a limited number of participating schools. The program will be open to the students enrolled at the participating schools</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no School Located Vaccine (SLV) Program</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Schools that are part of the non-intervention arm of the study will not have a school-located vaccine program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>School Located Vaccine (SLV) Program</intervention_name>
    <description>A community vaccinator will administer vaccines to students whose parents consent for their child to participate</description>
    <arm_group_label>School Located Vaccine (SLV) Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  2000 (1000 at intervention schools and 1000 in control schools) randomly selected&#xD;
             students enrolled in 6th - 8th grade at randomly selected schools&#xD;
&#xD;
          -  students who appear to be in need of one or more immunizations of interest at the&#xD;
             beginning of the school year&#xD;
&#xD;
          -  students enrolled in school by October 1st registration deadline will be included in&#xD;
             the analysis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  students who appear to have had all immunizations of interest at the beginning of the&#xD;
             school year&#xD;
&#xD;
          -  students enrolled after the October 1 school registration deadline will be excluded&#xD;
             from the analysis&#xD;
&#xD;
          -  students enrolled in grades other than 6th, 7th, or 8th grade will not be eligible to&#xD;
             participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Judy Shlay, MD, MSPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Denver Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Denver</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Colorado</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>December 31, 2012</last_update_submitted>
  <last_update_submitted_qc>December 31, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 3, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>school located vaccine program</keyword>
  <!-- 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/NCT01719679
org study id: 08-0204
nct id: NCT01719679
lead sponsor: 
collaborator: 
has dmc: No
The provision of adolescent vaccination in a school setting will be feasible and acceptable
      to parents as evidenced by the number and percentage of students immunized within each school
      compared to those in schools without a program. The likelihood of vaccination for diphtheria,
      tetanus, and pertussis (Tdap), human papillomavirus (HPV), and meningococcal conjugate
      vaccine (MCV4) and all three combined) among eligible students enrolled in schools with a
      comprehensive school-based immunization program will be significantly higher than that of
      students enrolled in schools without a school-based immunization program.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: The likelihood of vaccination among eligible 6th grade students with one or more needed vaccines in intervention schools compared to control schools.
time frame: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
description: The vaccination status of eligible students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.
measure: The likelihood of vaccination among eligible 6th grade students with Tdap vaccine in intervention schools compared to control schools.
time frame: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
description: The Tdap vaccination status of eligible students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.
measure: The likelihood of vaccination among eligible 6th grade students with MCV4 vaccine in intervention schools compared to control schools.
time frame: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
description: The MCV4 vaccination status of eligible students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.
measure: The likelihood of vaccination among eligible 6th grade female students with HPV vaccine in intervention schools compared to control schools.
time frame: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
description: The HPV vaccination status of eligible female students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.
measure: The likelihood of vaccination with Tdap vaccine among eligible 7th and 8th grade students enrolled at intervention schools compared to control schools.
time frame: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
description: The Tdap vaccination status of students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.
measure: The likelihood of vaccination with one or more HPV vaccines among eligible 7th and 8th grade female students enrolled in intervention schools compared to control schools.
time frame: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
description: The HPV vaccination status of eligible female students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.
measure: The likelihood of MCV4 vaccination among eligible 7th and 8th students enrolled in intervention schools compared to control schools.
time frame: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
description: The MCV4 vaccination status of eligible 7th and 8th grade students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.
measure: The likelihood of HPV vaccine series completion among female students in intervention schools compared to control schools.
time frame: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
description: The HPV vaccine status of female students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.
arm group label: School Located Vaccine (SLV) Program
arm group type: Experimental
description: A vaccine program carried out by a community vaccinator will be conducted in a limited number of participating schools. The program will be open to the students enrolled at the participating schools
arm group label: no School Located Vaccine (SLV) Program
arm group type: No Intervention
description: Schools that are part of the non-intervention arm of the study will not have a school-located vaccine program.
intervention type: Behavioral
intervention name: School Located Vaccine (SLV) Program
description: A community vaccinator will administer vaccines to students whose parents consent for their child to participate
arm group label: School Located Vaccine (SLV) Program
criteria: 
gender: All
minimum age: 10 Years
maximum age: 18 Years
healthy volunteers: No
last name: Judy Shlay, MD, MSPH
role: Principal Investigator
affiliation: Denver Public Health
facility: 
facility: 
country: United States
responsible party type: Sponsor