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School Located Adolescent Vaccination Study

Examination of the Effectiveness of Adolescent Vaccines Given in Schools

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01719679
Enrollment
2000
Registered
2012-11-01
Start date
2010-08-31
Completion date
2011-10-31
Last updated
2013-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

School Located Vaccine Program

Keywords

school located vaccine program

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.

Interventions

BEHAVIORALSchool Located Vaccine (SLV) Program

A community vaccinator will administer vaccines to students whose parents consent for their child to participate

Sponsors

Centers for Disease Control and Prevention
CollaboratorFED
University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The likelihood of vaccination among eligible 6th grade female students with HPV vaccine in intervention schools compared to control schools.end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011The 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 vaccination among eligible 6th grade students with one or more needed vaccines in intervention schools compared to control schools.end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011The 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.end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011The 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.end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011The 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.

Secondary

MeasureTime frameDescription
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 - 2011The 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.end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011The 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.end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011The 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.end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011The 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026