School-located Influenza Vaccination Clinics for Adolescents

Not Applicable

Completed

• Conditions: School-located Influenza Vaccination; Childhood Influenza Vaccination
• Interventions: Other: School-located Influenza Vaccination

• Registration Number: NCT03137667
• Lead Sponsor: University of California, Los Angeles

Brief Summary

A cluster-randomized trial (clustering by school) was conducted in Monroe County, NY. Twenty middle and high schools were paired based on several characteristics and randomized within pairs to receiving a school-based influenza vaccination clinic or not (control).

Detailed Description

The overarching goal of the study was to evaluate the effectiveness and cost-effectiveness of offering school-based influenza vaccination clinics during school hours on influenza vaccination rates. A cluster-randomized trial (clustering by school) was conducted in Monroe County, NY. Twenty middle and high schools were paired based on several characteristics including urban/suburban,school grade-span (6-8th, 9-12th), school size, percent of students eligible for free or reduced school lunch, and influenza vaccination rates in the previous season among students in the school. School were randomized within pairs, with one school offering a school-based influenza vaccination clinic or and one school not offering the clinic (control).

Study Timeline

• Study Start: 2015-11-30
• Primary Completion: 2016-01-15
• Study Completion: 2016-07-31
• Study First Submitted: 2017-04-28
• Study First Submitted QC: 2017-04-28
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Study First Posted: 2017-05-03
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17650

Inclusion Criteria

• Currently enrolled students of a participating school

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Exclusion Criteria

• Not a currently enrolled student of a participating school

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
School-located Influenza Vaccination	School-located Influenza Vaccination	Children in intervention schools were offered a chance to receive influenza vaccination at a school-located influenza vaccination clinic, if their parent or legal guardian provided permission

Primary Outcome Measures

Name	Time	Method
Influenza vaccination status as recorded in the NY state registry (NYSIIS)	Within one year	Vaccination status for the 2014/2015 influenza season will be assessed. The vaccination date will be recorded, as well as the provider name, to determine whether vaccine was received at the school-located influenza clinic