NCT01224301

Brief Summary

Purpose of the study. The purpose of the project is to evaluate the feasibility, acceptability, and cost effectiveness of providing influenza vaccine in schools to children in grades Kindergarten through 6th grade. Hypothesis 1: School based influenza vaccination (SIV) will increase the overall rate of influenza vaccination in school children. Hypothesis 2: Higher intensity parent notification about school based influenza vaccination does not increase immunization rates compared to low intensity. Hypothesis 3: School based vaccination from the perspective of mass vaccinators is cost neutral.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25,366

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 20, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

April 4, 2012

Status Verified

April 1, 2012

Enrollment Period

1.1 years

First QC Date

October 18, 2010

Last Update Submit

April 3, 2012

Conditions

ImmunizationsVaccinationInfluenzaSchool Health

Keywords

seasonal influenza vaccineschool-based clinicseconomic analysis of school based influenza vaccine deliverypediatric influenza vaccine ratesInfluenza vaccine information for parents

Outcome Measures

Primary Outcomes (2)

  • Seasonal influenza vaccine rates for children attending schools with and without school-based influenza vaccine delivery as reported in the New York State Immunization Information System (NYSIIS).

    Number of children with at least one seasonal influenza vaccine given in school compared to number of children with influenza vaccine given elsewhere and number of children with no record of influenza vaccine.

    Year 1 Influenza vaccine delivery season: August 15 2009 to January 15, 2010

  • Seasonal influenza vaccine rates for children attending schools with and without school-based influenza vaccine delivery as reported in the New York State Immunization Information System (NYSIIS).

    Number of children with at least one seasonal influenza vaccine given in school compared to number of children with influenza vaccine given elsewhere and number of children with no record of influenza vaccine.

    Year 2: Influenza vaccine delivery season: August 1, 2010 to January 15, 2011

Secondary Outcomes (3)

  • Number of seasonal influenza vaccines received by children enrolled in schools with high vs. low vs. no parental notification.

    Year 1 Influenza vaccine delivery season: August 15, 2009 to January 15, 2010

  • Number of seasonal influenza vaccines received by children enrolled in schools with high vs low vs no parental notification.

    Year 2: Influenza vaccine delivery season: August 1, 2010 to January 15, 2011

  • Costs and incremental cost effectiveness of seasonal influenza vaccines delivered in schools compared to cost of influenza vaccines delivered in private practice.

    Time Frame: (FDAAA) Year 1 Influenza vaccine delivery season: August 15 2009 to January 15, 2010

Study Arms (3)

School based flu vaccine: High intensity

EXPERIMENTAL

Interventions: Parents in high intensity schools have access to school-based flu vaccine clinics and 3 or more communications from schools about influenza illness, influenza vaccine, and school based clinics.

Behavioral: School based flu vaccine: High intensity

School based flu vaccine: Low intensity

EXPERIMENTAL

Interventions: Parents in low intensity schools have access to school-based flu vaccine clinics and less than 3 communications from schools about influenza illness, influenza vaccine, and school based clinics.

Behavioral: School based flu vaccine: Low intensity

Standard of Care

NO INTERVENTION

Control Schools did not have any in school seasonal influenza vaccine clinics. Parents of children in control schools got no notification from the schools and sought seasonal influenza vaccines for their children as they normally would.

Interventions

School based flu vaccine: Low intensityBEHAVIORAL

Interventions: Parents of children in Low Intensity Notification schools got less than 3 communications from schools describing influenza vaccine and the clinics, and consent forms sent home one.

Also known as: Trivalent injectable influenza vaccine, Live Attenuated Influenza vaccine, School based vaccines
School based flu vaccine: Low intensity
School based flu vaccine: High intensityBEHAVIORAL

Interventions: Parents in high intensity schools have 3 or more communications from schools about influenza illness, influenza vaccine, and school based clinics.

Also known as: Trivalent injectable influenza vaccine, Live Attenuated Influenza vaccine, School based vaccines
School based flu vaccine: High intensity

Eligibility Criteria

Age4 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children in grades K through 5 enrolled in schools that agreed to participate in the randomized trial of school based influenza vaccine

You may not qualify if:

  • Children and schools not enrolled in school based influenza vaccine program Children in participating schools in grades other than Kindergarten through 5th grade.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monroe County Department of Public Health

Rochester, New York, 14692, United States

Location

Related Publications (1)

  • Humiston SG, Schaffer SJ, Szilagyi PG, Long CE, Chappel TR, Blumkin AK, Szydlowski J, Kolasa MS. Seasonal influenza vaccination at school: a randomized controlled trial. Am J Prev Med. 2014 Jan;46(1):1-9. doi: 10.1016/j.amepre.2013.08.021.

    PMID: 24355665DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Sharon G. Humiston, M.D., M.P.H.

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 18, 2010

First Posted

October 20, 2010

Study Start

September 1, 2009

Primary Completion

October 1, 2010

Study Completion

January 1, 2011

Last Updated

April 4, 2012

Record last verified: 2012-04

Locations

US(1)