Clinical Trials Directory

Trials / Completed

CompletedNCT01224301

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

Monroe COunty School Kids Influenza Prevention Project

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
25,366 (actual)
Sponsor
Monroe County Department of Public Health · Academic / Other
Sex
All
Age
4 Years – 13 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSchool based flu vaccine: Low intensityInterventions: 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.
BEHAVIORALSchool based flu vaccine: High intensityInterventions: Parents in high intensity schools have 3 or more communications from schools about influenza illness, influenza vaccine, and school based clinics.

Timeline

Start date
2009-09-01
Primary completion
2010-10-01
Completion
2011-01-01
First posted
2010-10-20
Last updated
2012-04-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01224301. Inclusion in this directory is not an endorsement.