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
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