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

NCT ID: NCT00844051

Last Updated: 2016-09-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4455 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-06-30

Brief Summary

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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

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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.

Conditions

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Influenza

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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No Intervention

No school-based influenza vaccination program

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

School-based Influenza Vaccination Program

Group Type ACTIVE_COMPARATOR

School-based influenza vaccination program

Intervention Type BIOLOGICAL

School-based influenza vaccination program

Interventions

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School-based influenza vaccination program

School-based influenza vaccination program

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Children enrolled in target schools
Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Los Angeles County Department of Public Health

OTHER_GOV

Sponsor Role collaborator

Children's Hospital Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Pia S. Pannaraj

Assistant Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pia S Pannaraj, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Childrens Hospital Los Angeles, University of Southern California

Locations

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Los Angeles County Department of Public Health

Los Angeles, California, United States

Site Status

Childrens Hospital Los Angeles

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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CHLA-08-00229

Identifier Type: -

Identifier Source: org_study_id

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