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

Influenza Clinical Trial

— MCSkipp  

Official title:

Monroe COunty School Kids Influenza Prevention Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224301
• Other study ID #: 00439262
• Status: Completed
• Phase: N/A
• First received: October 18, 2010
• Last updated: April 3, 2012
• Start date: September 2009
• Est. completion date: January 2011

Study information

• Verified date: April 2012
• Source: Monroe County Department of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

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

Related Conditions & MeSH terms

• Immunizations
• Influenza
• Influenza, Human
• School Health
• Vaccination

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Monroe County Department of Public Health	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
Monroe County Department of Public Health	University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

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