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NCT00844051 Clinical Trial

Study to Evaluate Impact of School-based Influenza Vaccination on School Populations

Influenza Clinical Trial

Official title:
Prospective Study of School-based Influenza Vaccination's Impact on School Populations

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00844051
Other study ID # CHLA-08-00229
Secondary ID
Status Completed
Phase N/A
First received February 12, 2009
Last updated January 27, 2014
Start date January 2009
Est. completion date June 2011

Study information
Verified date January 2014
Source Children's Hospital Los Angeles
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Rates of confirmed influenza illness in vaccinated and non-vaccinated children will be compared between schools with and without vaccination programs. The investigators hypothesize that in addition to lowering rates of influenza in vaccinated children, raising vaccination rates by 30-40% through school-based vaccination programs will decrease incidence of influenza in non-vaccinated children attending those schools compared to non-vaccinated children in schools with low vaccination rates.

Description:

This prospective cohort study will evaluate rates of virologically confirmed influenza in children attending schools with and without school-based vaccination programs. Twelve schools (8000 students) in two school districts matched for size, race/ethnicity, socioeconomic status, and location will serve as intervention and control schools. During influenza season defined by local surveillance data, nasal/throat swabs will be obtained for rapid influenza detection assays from all children with fever and respiratory symptoms identified by teachers for evaluation in the school nurse's office. Absent children will be offered testing at a central location within the schools' communities.Rates of confirmed influenza illness in vaccinated and non-vaccinated children will be compared between schools with and without vaccination programs. Rates of absenteeism also will be evaluated. The investigators hypothesize that in addition to lowering rates of influenza in vaccinated children, raising vaccination rates by 30-40% through school-based vaccination programs will decrease incidence of influenza in non-vaccinated children attending those schools compared to non-vaccinated children in schools with low vaccination rates.

Recruitment information / eligibility
Status Completed
Enrollment 4500
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 4 Years to 18 Years
Eligibility Inclusion Criteria:

- Children enrolled in target schools

Exclusion Criteria: none

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• School-based influenza vaccination program
School-based influenza vaccination program

Locations
Country Name City State
United States Childrens Hospital Los Angeles Los Angeles California
United States Los Angeles County Department of Public Health Los Angeles California

Sponsors (2)
Lead Sponsor Collaborator
Children's Hospital Los Angeles Los Angeles County Department of Public Health

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rates of confirmed influenza illness in vaccinated and non-vaccinated children attending schools with and without school-based influenza vaccination programs 1 year No
Secondary Rates of absenteeism among children attending schools with and without school-based influenza vaccination programs 1 year No
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