School Located Adolescent Vaccination Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01719679
First received: October 30, 2012
Last updated: December 31, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
School Located Vaccine Program
Behavioral: School Located Vaccine (SLV) Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Examination of the Effectiveness of Adolescent Vaccines Given in Schools

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 2000
Study Start Date: August 2010
Study Completion Date: October 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: School Located Vaccine (SLV) Program
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
Behavioral: School Located Vaccine (SLV) Program
A community vaccinator will administer vaccines to students whose parents consent for their child to participate
No Intervention: no School Located Vaccine (SLV) Program
Schools that are part of the non-intervention arm of the study will not have a school-located vaccine program.

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 2000 (1000 at intervention schools and 1000 in control schools) randomly selected students enrolled in 6th - 8th grade at randomly selected schools
  • students who appear to be in need of one or more immunizations of interest at the beginning of the school year
  • students enrolled in school by October 1st registration deadline will be included in the analysis

Exclusion Criteria:

  • students who appear to have had all immunizations of interest at the beginning of the school year
  • students enrolled after the October 1 school registration deadline will be excluded from the analysis
  • students enrolled in grades other than 6th, 7th, or 8th grade will not be eligible to participate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01719679

Locations
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Kaiser Permanente Colorado
Denver, Colorado, United States, 80231
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Judy Shlay, MD, MSPH Denver Public Health
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01719679     History of Changes
Other Study ID Numbers: 08-0204
Study First Received: October 30, 2012
Last Updated: December 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
school located vaccine program

ClinicalTrials.gov processed this record on July 24, 2014