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Clinical Trials/NCT01719679
NCT01719679
Completed
Not Applicable

Examination of the Effectiveness of Adolescent Vaccines Given in Schools

University of Colorado, Denver2 sites in 1 country2,000 target enrollmentAugust 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
School Located Vaccine Program
Sponsor
University of Colorado, Denver
Enrollment
2000
Locations
2
Primary Endpoint
The likelihood of vaccination among eligible 6th grade students with one or more needed vaccines in intervention schools compared to control schools.
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
October 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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

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

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

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

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 Outcomes

  • The likelihood of vaccination with Tdap vaccine among eligible 7th and 8th grade students enrolled at intervention schools compared to control schools.(end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011)
  • 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.(end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011)
  • The likelihood of MCV4 vaccination among eligible 7th and 8th students enrolled in intervention schools compared to control schools.(end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011)
  • The likelihood of HPV vaccine series completion among female students in intervention schools compared to control schools.(end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011)

Study Sites (2)

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