Clinical trial NCT00844051: Study to Evaluate Impact of School-based Influenza Vaccination on School Populations
Official title: Prospective Study of School-based Influenza Vaccination's Impact on School Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Keywords: Influenza
influenza vaccination
school-based vaccination
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
Collaborators: name: Los Angeles County Department of Public Health
First posted: 2009-02-13
Enrollment: 4455
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Children enrolled in target schools

Exclusion Criteria: none

Primary outcomes:
measure: Rates of Confirmed Influenza Illness in Vaccinated and Non-vaccinated Children Attending Schools With and Without School-based Influenza Vaccination Programs
timeFrame: 1 year
Secondary outcomes:
measure: Rates of Absenteeism Among Children Attending Schools With and Without School-based Influenza Vaccination Programs
timeFrame: 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles County Department of Public Health
state: California
city: Los Angeles
country: United States
facility: Childrens Hospital Los Angeles
state: California
Study officials:
affiliation: Childrens Hospital Los Angeles, University of Southern California
name: Pia S Pannaraj, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: