Influenza Clinical Trial
— MCSkippOfficial title:
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.
Status | Completed |
Enrollment | 25366 |
Est. completion date | January 2011 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 4 Years to 13 Years |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
United States | Monroe County Department of Public Health | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
Monroe County Department of Public Health | University of Rochester |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
Secondary | Number of seasonal influenza vaccines received by children enrolled in schools with high vs. low vs. no parental notification. | 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. | Year 1 Influenza vaccine delivery season: August 15, 2009 to January 15, 2010 | No |
Secondary | Number of seasonal influenza vaccines received by children enrolled in schools with high vs low vs no parental notification. | 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. | Year 2: Influenza vaccine delivery season: August 1, 2010 to January 15, 2011 | No |
Secondary | Costs and incremental cost effectiveness of seasonal influenza vaccines delivered in schools compared to cost of influenza vaccines delivered in private practice. | 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. | Time Frame: (FDAAA) Year 1 Influenza vaccine delivery season: August 15 2009 to January 15, 2010 | No |
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