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School-located Influenza Vaccination Clinics for Adolescents (SKIPP RCT2)

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ClinicalTrials.gov Identifier: NCT03137667
Recruitment Status : Completed
First Posted : May 3, 2017
Last Update Posted : May 4, 2017
Sponsor:
Collaborators:
University of Rochester
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Peter G Szilagyi, MD MPH, 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).

Condition or disease Intervention/treatment Phase
Childhood Influenza Vaccination School-located Influenza Vaccination Other: School-located Influenza Vaccination Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: The investigator is not aware of the allocation at the level of the patient. In addition, the investigator is not involved in vaccine verification (data collection involving patient-level vaccination status)
Primary Purpose: Health Services Research
Official Title: Efficacy Study of School-located Influenza Vaccination Clinics to Increase Influenza Vaccination Rates in Monroe County, New York
Actual Study Start Date : November 30, 2015
Actual Primary Completion Date : January 15, 2016
Actual Study Completion Date : July 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
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
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




Primary Outcome Measures :
  1. Influenza vaccination status as recorded in the NY state registry (NYSIIS) [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently enrolled students of a participating school

Exclusion Criteria:

  • Not a currently enrolled student of a participating school

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Peter G Szilagyi, MD MPH, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03137667     History of Changes
Other Study ID Numbers: 5R18HS021163-02 ( U.S. AHRQ Grant/Contract )
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peter G Szilagyi, MD MPH, University of California, Los Angeles:
Influenza Vaccination Rates
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs