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

NCT ID: NCT01224301

Last Updated: 2012-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25366 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-01-31

Brief 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

Immunizations; Vaccination; Influenza; School Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

School based flu vaccine: High intensity

Intervention Type: BEHAVIORAL

Interventions: Parents in high intensity schools have 3 or more communications from schools about influenza illness, influenza vaccine, and school based clinics.

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.

Group Type: EXPERIMENTAL

School based flu vaccine: Low intensity

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Trivalent injectable influenza vaccine; Live Attenuated Influenza vaccine; School based vaccines; Trivalent injectable influenza vaccine; Live Attenuated Influenza vaccine; School based vaccines

Eligibility 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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• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: collaborator

Monroe County Department of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Sharon G. Humiston, M.D., M.P.H.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sharon G. Humiston, M.D., M.P.H.

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

Monroe County Department of Public Health

Rochester, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24355665 (View on PubMed)

Other Identifiers

00439262

Identifier Type: -

Identifier Source: org_study_id