School Located Adolescent Vaccination Study

NCT ID: NCT01719679

Last Updated: 2013-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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School Located Vaccine Program

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

School Located Vaccine (SLV) Program

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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School Located Vaccine (SLV) Program

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Judy Shlay, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

Denver Public Health

Locations

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University of Colorado Denver

Aurora, Colorado, United States

Site Status

Kaiser Permanente Colorado

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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08-0204

Identifier Type: -

Identifier Source: org_study_id

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