School Located Adolescent Vaccination Study

Examination of the Effectiveness of Adolescent Vaccines Given in Schools

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.

Study Overview

• Status: Completed
• Conditions: School Located Vaccine Program
• Intervention / Treatment: Behavioral: School Located Vaccine (SLV) Program

• Study Type: Interventional
• Enrollment (Actual): 2000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
    • Denver, Colorado, United States, 80231
      • Kaiser Permanente Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The likelihood of vaccination among eligible 6th grade students with one or more needed vaccines in intervention schools compared to control schools.	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.	end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
The likelihood of vaccination among eligible 6th grade students with Tdap vaccine in intervention schools compared to control schools.	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.	end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
The likelihood of vaccination among eligible 6th grade students with MCV4 vaccine in intervention schools compared to control schools.	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.	end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
The likelihood of vaccination among eligible 6th grade female students with HPV vaccine in intervention schools compared to control schools.	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.	end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The likelihood of vaccination with Tdap vaccine among eligible 7th and 8th grade students enrolled at intervention schools compared to control schools.	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.	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.	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.	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.	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.	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.	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.	end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Judy Shlay, MD, MSPH, Denver Public Health

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: October 30, 2012
• First Submitted That Met QC Criteria: October 30, 2012
• First Posted (Estimate): November 1, 2012

Study Record Updates

• Last Update Posted (Estimate): January 3, 2013
• Last Update Submitted That Met QC Criteria: December 31, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: school located vaccine program
• Other Study ID Numbers: 08-0204

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No