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School Influenza Vaccine vs Standard of Care With Nested Trial of 2 Parent Notification Intensities (MCSkipp)

This study has been completed.
Sponsor:
Collaborator:
University of Rochester
Information provided by (Responsible Party):
Sharon G. Humiston, M.D., M.P.H., University of Rochester
ClinicalTrials.gov Identifier:
NCT01224301
First received: October 18, 2010
Last updated: April 3, 2012
Last verified: April 2012

October 18, 2010
April 3, 2012
September 2009
October 2010   (final data collection date for primary outcome measure)
  • 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). [ Time Frame: Year 1 Influenza vaccine delivery season: August 15 2009 to January 15, 2010 ] [ Designated as safety issue: No ]
    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.
  • 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). [ Time Frame: Year 2: Influenza vaccine delivery season: August 1, 2010 to January 15, 2011 ] [ Designated as safety issue: No ]
    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.
  • School Influenza Vaccine vs Standard of Care With Nested [ Time Frame: August 15 2009 to January 15, 2010 ] [ Designated as safety issue: No ]
    Seasonal influenza vaccine rates for standard of care vs school-based influenza vaccine delivery School
  • Influenza Vaccine vs Standard of Care With Nested [ Time Frame: August 1, 2010 to january 15 2011 ] [ Designated as safety issue: No ]
    Seasonal influenza vaccine rates for standard of care vs school-based influenza vaccine delivery School
Complete list of historical versions of study NCT01224301 on ClinicalTrials.gov Archive Site
  • Number of seasonal influenza vaccines received by children enrolled in schools with high vs. low vs. no parental notification. [ Time Frame: Year 1 Influenza vaccine delivery season: August 15, 2009 to January 15, 2010 ] [ Designated as safety issue: No ]
    Vaccine rates among children offered seasonal influenza vaccine in school whose parents got high intensity notification of the program vs those who got low intensity notification. Notification included educational materials, program description, consent forms, phone messages, and varied by type and frequency for schools with High and Low levels of parental notification.
  • Number of seasonal influenza vaccines received by children enrolled in schools with high vs low vs no parental notification. [ Time Frame: Year 2: Influenza vaccine delivery season: August 1, 2010 to January 15, 2011 ] [ Designated as safety issue: No ]
    Vaccine rates among children offered seasonal influenza vaccine in school whose parents got high intensity notification of the program vs those who got low intensity notification. Notification included educational materials, program description, consent forms, phone messages, and varied by type and frequency for schools with High and Low levels of parental notification.
  • Costs and incremental cost effectiveness of seasonal influenza vaccines delivered in schools compared to cost of influenza vaccines delivered in private practice. [ Time Frame: Time Frame: (FDAAA) Year 1 Influenza vaccine delivery season: August 15 2009 to January 15, 2010 ] [ Designated as safety issue: No ]
    Economic analysis of costs and revenues associated with school-based seasonal influenza vaccine delivered by a mass vaccinator. The project is based on a business model for purchasing/acquiring vaccine from vendors and vaccines for children, and recovering payment from insurance. Costs associated with vaccines administered in school are derived from this clinical trial, School Influenza Vaccine vs Standard of Care, and private practice data are from the literature.
  • Title: School Influenza Vaccine vs Standard of Care With Nested... [ Time Frame: 8/15/2009 to 1/15/2010 ] [ Designated as safety issue: No ]
    Vaccine rates among children offered seasonal influenza vaccine in school whose parents got high intensity notification of the program vs those who got low intensity notification. Notification included educational materials, program description, consent forms, phone messages, and varied by type and frequency for schools with High and Low levels of parental notification.
  • School Influenza Vaccine vs Standard of Care With Nested... [ Time Frame: 8/15/2009 to 1/15/2010 ] [ Designated as safety issue: No ]
    Economic analysis of costs and revenues associated with school-based seasonal influenza vaccine delivered by a mass vaccinator. The project is based on a business model for purchasing/acquiring vaccine from vendors and vaccines for children, and recovering payment from insurance.
  • Title: School Influenza Vaccine vs Standard of Care With Nested... [ Time Frame: August 1 2010 to January 15, 2011 ] [ Designated as safety issue: No ]
    Economic analysis of costs and revenues associated with school-based seasonal influenza vaccine delivered by a mass vaccinator. The project is based on a business model for purchasing/acquiring vaccine from vendors and vaccines for children, and recovering payment from insurance.
  • Title: School Influenza Vaccine vs Standard of Care With Nested... [ Time Frame: August 1 2010 to January 15, 2011 ] [ Designated as safety issue: No ]
    Vaccine rates among children offered seasonal influenza vaccine in school whose parents got high intensity notification of the program vs those who got low intensity notification. Notification included educational materials, program description, consent forms, phone messages, and varied by type and frequency for schools with High and Low levels of parental notification.
Not Provided
Not Provided
 
School Influenza Vaccine vs Standard of Care With Nested Trial of 2 Parent Notification Intensities
Monroe COunty School Kids Influenza Prevention Project

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.

Background. The ACIP (American Committee on Immunization Practices) has now recommended influenza vaccination for all children 6 months to 18 years of age. While many school-aged children will be vaccinated in the medical home, the large number of children for whom the vaccine is now recommended exceeds the capacity of many primary care settings. Schools have been recommended as potential sites for influenza vaccination, yet little is known about the feasibility, implementation requirements, costs, or effectiveness of school-based influenza vaccination (SIV) programs. This project will implement and rigorously evaluate the feasibility, acceptability, billing and reimbursement components, costs, cost-effectiveness, and overall effectiveness of an SIV program that targets diverse populations and different intensity of interventions.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Immunizations
  • Vaccination
  • Influenza
  • School Health
  • Behavioral: School based flu vaccine: Low intensity
    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.
    Other Names:
    • Trivalent injectable influenza vaccine
    • Live Attenuated Influenza vaccine
    • School based vaccines
  • Behavioral: School based flu vaccine: High intensity
    Interventions: Parents in high intensity schools have 3 or more communications from schools about influenza illness, influenza vaccine, and school based clinics.
    Other Names:
    • Trivalent injectable influenza vaccine
    • Live Attenuated Influenza vaccine
    • School based vaccines
  • Experimental: School based flu vaccine: High intensity
    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.
    Intervention: Behavioral: School based flu vaccine: High intensity
  • Experimental: School based flu vaccine: Low intensity
    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.
    Intervention: Behavioral: School based flu vaccine: Low intensity
  • No Intervention: Standard of Care
    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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25366
January 2011
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

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

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Both
4 Years to 13 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01224301
00439262
No
Sharon G. Humiston, M.D., M.P.H., University of Rochester
Monroe County Department of Public Health
University of Rochester
Principal Investigator: Sharon G. Humiston, M.D., M.P.H. University of Rochester
Monroe County Department of Public Health
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP