CClinicalTrials.gg
CompletedNCT03137667SKIPP RCT2Updated May 4, 2017

School-located Influenza Vaccination Clinics for Adolescents

An interventional study of School-located Influenza Vaccination in Childhood Influenza Vaccination and School-located Influenza Vaccination, sponsored by University of California, Los Angeles. Completed. Per ClinicalTrials.gov, last updated 2017-05-04.

Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Nov 2015, registered Apr 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
17,650
Allocation
Randomized
Sex
All
01

Study 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).

Read the 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).

02

Conditions studied

  • Childhood Influenza Vaccination
  • School-located Influenza Vaccination

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Keywords

  • Influenza Vaccination Rates
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 17,650 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Currently enrolled students of a participating school

Exclusion criteria

Exclusion Criteria:

  • Not a currently enrolled student of a participating school
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
17,650 participants (actual)

Study arms

  • No intervention
    Control

    No school-located influenza vaccination clinic

  • Experimental
    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

    Other: School-located Influenza Vaccination

Interventions

  • OtherSchool-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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Within one year

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Yoo BK, Schaffer SJ, Humiston SG, Rand CM, Goldstein NPN, Albertin CS, Concannon C, Szilagyi PG. Cost effectiveness of school-located influenza vaccination programs for elementary and secondary school children. BMC Health Serv Res. 2019 Jun 24;19(1):407. doi: 10.1186/s12913-019-4228-5. PubMed 31234842 ↗
  • Schaffer SJ, Rand CM, Humiston SG, Concannon C, Hightower AD, Albertin C, Szilagyi PG. Practical considerations in developing a successful school-located influenza vaccination (SLIV) program. Vaccine. 2019 Apr 10;37(16):2171-2173. doi: 10.1016/j.vaccine.2019.01.088. Epub 2019 Mar 13. No abstract available. PubMed 30878250 ↗
  • Szilagyi PG, Schaffer S, Rand CM, Goldstein NPN, Younge M, Mendoza M, Albertin CS, Concannon C, Graupman E, Hightower AD, Yoo BK, Humiston SG. Text Message Reminders for Child Influenza Vaccination in the Setting of School-Located Influenza Vaccination: A Randomized Clinical Trial. Clin Pediatr (Phila). 2019 Apr;58(4):428-436. doi: 10.1177/0009922818821878. Epub 2019 Jan 2. PubMed 30600690 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03137667
Lead sponsor
University of California, Los Angeles
Collaborators
University of Rochester, Agency for Healthcare Research and Quality (AHRQ)
Responsible party
Peter G Szilagyi, MD MPH (Principal Investigator, University of California, Los Angeles) — Principal investigator
First posted
May 3, 2017
Start date
Nov 30, 2015
Primary completion
Jan 15, 2016
Completion
Jul 31, 2016
Last update
May 4, 2017

Oversight

Data monitoring committee
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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