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

Information source: Children's Hospital Los Angeles
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza

Intervention: School-based influenza vaccination program (Biological)

Phase: N/A

Status: Completed

Sponsored by: Children's Hospital Los Angeles

Official(s) and/or principal investigator(s):
Pia S Pannaraj, MD, MPH, Principal Investigator, Affiliation: Childrens Hospital Los Angeles, University of Southern California

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.

Clinical Details

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

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

Primary outcome: Rates of confirmed influenza illness in vaccinated and non-vaccinated children attending schools with and without school-based influenza vaccination programs

Secondary outcome: Rates of absenteeism among children attending schools with and without school-based influenza vaccination programs

Detailed 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.

Eligibility

Minimum age: 4 Years. Maximum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Children enrolled in target schools

Exclusion Criteria: none

Locations and Contacts

Childrens Hospital Los Angeles, Los Angeles, California 90027, United States

Los Angeles County Department of Public Health, Los Angeles, California 90012, United States

Additional Information

Starting date: January 2009
Last updated: January 27, 2014

Page last updated: August 20, 2015

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