School Influenza Vaccine vs Standard of Care With Nested Trial of 2 Parent Notification Intensities
MCSkipp
Monroe COunty School Kids Influenza Prevention Project
MCSkipp
Monroe COunty School Kids Influenza Prevention Project
Sponsor study identifier
interventional
25,366
1 country
1
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2010
Actual (reported)Study Completion
January 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
October 2010
Actual (reported)October 18, 2010
Actual (reported)October 20, 2010
Actual (reported)January 2011
Actual (reported)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
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.
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.
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.
Monroe County Department of Public Health
Rochester, New York, 14692, United States
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.
Sharon G. Humiston, M.D., M.P.H.
University of Rochester
25,366 participants (actual enrollment reported by the registry).
First Submitted
October 18, 2010
First Posted
October 20, 2010
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
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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
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: Parents in high intensity schools have 3 or more communications from schools about influenza illness, influenza vaccine, and school based clinics.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
October 2010
Actual (reported)Study Completion
January 2011
Actual (reported)Last Updated
April 4, 2012
Record last verified: 2012-04
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Source: ClinicalTrials.gov.
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