School-located Influenza Vaccination Clinics for Adolescents

Childhood Influenza Vaccination Clinical Trial

— SKIPP RCT2  

Official title:

Efficacy Study of School-located Influenza Vaccination Clinics to Increase Influenza Vaccination Rates in Monroe County, New York

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03137667
• Other study ID #: 5R18HS021163-02
• Status: Completed
• Phase: N/A
• First received: April 28, 2017
• Last updated: May 2, 2017
• Start date: November 30, 2015
• Est. completion date: July 31, 2016

Study information

• Verified date: May 2017
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17650
• Est. completion date: July 31, 2016
• Est. primary completion date: January 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Currently enrolled students of a participating school

Exclusion Criteria:

• Not a currently enrolled student of a participating school

Related Conditions & MeSH terms

• Childhood Influenza Vaccination
• Influenza, Human
• School-located Influenza Vaccination

Intervention

Other:
• School-located Influenza Vaccination
Children in the intervention arm are enrolled in schools in Monroe County, New York that are offering school-located influenza vaccination clinics during school hours

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Los Angeles	Agency for Healthcare Research and Quality (AHRQ), University of Rochester

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Influenza vaccination status as recorded in the NY state registry (NYSIIS)	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	Within one year