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

Condition(s) targeted: Immunizations; Vaccination; Influenza; School Health

Intervention: School based flu vaccine: Low intensity (Behavioral); School based flu vaccine: High intensity (Behavioral)

Phase: N/A

Status: Completed

Sponsored by: Monroe County Department of Public Health

Official(s) and/or principal investigator(s):
Sharon G. Humiston, M.D., M.P.H., Principal Investigator, Affiliation: University of Rochester

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.

Official title: Monroe COunty School Kids Influenza Prevention Project

Study design: Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Primary outcome:

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).

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).

Secondary outcome:

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

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

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

Detailed description: 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.

Minimum age: 4 Years. Maximum age: 13 Years. Gender(s): Both.

Criteria:

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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Monroe County Department of Public Health, Rochester, New York 14692, United States

Starting date: September 2009
Last updated: April 3, 2012