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Clinical Trials/NCT00844051
NCT00844051CompletedNot Applicable

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

Children's Hospital Los Angeles2 sites in 1 country4,455 target enrollmentStarted: January 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
4,455
Locations
2
Primary Endpoint
Rates of Confirmed Influenza Illness in Vaccinated and Non-vaccinated Children Attending Schools With and Without School-based Influenza Vaccination Programs

Study Overview

Brief 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.

Detailed Description

This prospective cohort study will evaluate rates of virologically confirmed influenza in children attending schools with and without school-based vaccination programs. Eight schools (4455 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
4 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Children enrolled in target schools

Exclusion Criteria

  • Not provided

Arms & Interventions

No Intervention

No Intervention

No school-based influenza vaccination program

Intervention

Active Comparator

School-based Influenza Vaccination Program

Intervention: School-based influenza vaccination program (Biological)

Outcomes

Primary Outcomes

Rates of Confirmed Influenza Illness in Vaccinated and Non-vaccinated Children Attending Schools With and Without School-based Influenza Vaccination Programs

Time Frame: 1 year

Secondary Outcomes

  • Rates of Absenteeism Among Children Attending Schools With and Without School-based Influenza Vaccination Programs(1 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Pia S. Pannaraj

Assistant Professor of Pediatrics

Children's Hospital Los Angeles

Study Sites (2)

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