Clinical trial NCT01719679: School Located Adolescent Vaccination Study
Official title: Examination of the Effectiveness of Adolescent Vaccines Given in Schools
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: School Located Vaccine Program
Keywords: school located vaccine program
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2012-11-01
Enrollment: 2000
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: The likelihood of vaccination among eligible 6th grade students with one or more needed vaccines in intervention schools compared to control schools.
timeFrame: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
measure: The likelihood of vaccination among eligible 6th grade students with Tdap vaccine in intervention schools compared to control schools.
timeFrame: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
measure: The likelihood of vaccination among eligible 6th grade students with MCV4 vaccine in intervention schools compared to control schools.
timeFrame: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
measure: The likelihood of vaccination among eligible 6th grade female students with HPV vaccine in intervention schools compared to control schools.
timeFrame: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
Secondary outcomes:
measure: The likelihood of vaccination with Tdap vaccine among eligible 7th and 8th grade students enrolled at intervention schools compared to control schools.
timeFrame: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
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.
timeFrame: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
measure: The likelihood of MCV4 vaccination among eligible 7th and 8th students enrolled in intervention schools compared to control schools.
timeFrame: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
measure: The likelihood of HPV vaccine series completion among female students in intervention schools compared to control schools.
timeFrame: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Denver
country: United States
facility: Kaiser Permanente Colorado
state: Colorado
Study officials:
affiliation: Denver Public Health
name: Judy Shlay, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References: