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

Primary Purpose

Childhood Influenza Vaccination, School-located Influenza Vaccination

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
School-located Influenza Vaccination Clinic
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Childhood Influenza Vaccination focused on measuring Influenza vaccination rates

Eligibility Criteria

4 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Enrolled in participating, randomized school

Exclusion Criteria:

  • None

Sites / Locations

  • University of Rochester School of Medicine and Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control arm

School-located influenza vaccination clinics

Arm Description

No school-located influenza vaccination clinic

School-located influenza vaccination clinics

Outcomes

Primary Outcome Measures

Influenza vaccination status
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

Secondary Outcome Measures

Full Information

First Posted
August 25, 2014
Last Updated
April 28, 2017
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT02227186
Brief Title
Efficacy Study of School-located Influenza Vaccination Clinics to Increase Influenza Vaccination Rates in Monroe County, New York
Acronym
SKIPP RCT
Official Title
Study of Effectiveness of a School-located Influenza Vaccination Program in Raising Influenza Vaccination Rates
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 1, 2014 (Actual)
Primary Completion Date
July 31, 2015 (Actual)
Study Completion Date
July 31, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Children in schools in which influenza vaccination clinics are held during school hours will have higher rates of influenza vaccination than children in control schools (no school-located clinics offered)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Influenza Vaccination, School-located Influenza Vaccination
Keywords
Influenza vaccination rates

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20461 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control arm
Arm Type
No Intervention
Arm Description
No school-located influenza vaccination clinic
Arm Title
School-located influenza vaccination clinics
Arm Type
Experimental
Arm Description
School-located influenza vaccination clinics
Intervention Type
Other
Intervention Name(s)
School-located Influenza Vaccination Clinic
Intervention Description
Children in the intervention arm are enrolled in schools in Monroe County, NY that are offering school-located influenza vaccination clinics during school hours
Primary Outcome Measure Information:
Title
Influenza vaccination status
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Enrolled in participating, randomized school Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Szilagyi, MPH, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester School of Medicine and Dentistry
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31234842
Citation
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.
Results Reference
derived
PubMed Identifier
30878250
Citation
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.
Results Reference
derived
PubMed Identifier
30600690
Citation
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.
Results Reference
derived
PubMed Identifier
29248390
Citation
Szilagyi PG, Schaffer S, Rand CM, Goldstein NPN, Vincelli P, Hightower AD, Younge M, Eagan A, Blumkin A, Albertin CS, DiBitetto K, Yoo BK, Humiston SG. School-located Influenza Vaccinations for Adolescents: A Randomized Controlled Trial. J Adolesc Health. 2018 Feb;62(2):157-163. doi: 10.1016/j.jadohealth.2017.09.021. Epub 2017 Dec 13.
Results Reference
derived
PubMed Identifier
27940785
Citation
Szilagyi PG, Schaffer S, Rand CM, Vincelli P, Eagan A, Goldstein NP, Hightower AD, Younge M, Blumkin A, Albertin CS, Yoo BK, Humiston SG. School-Located Influenza Vaccinations: A Randomized Trial. Pediatrics. 2016 Nov;138(5):e20161746. doi: 10.1542/peds.2016-1746.
Results Reference
derived

Learn more about this trial

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

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