Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-25 @ 9:42 PM
Study NCT ID:
NCT00844051
Status:
COMPLETED
Last Update Posted:
2016-09-12
First Post:
2009-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Evaluate Impact of School-based Influenza Vaccination on School Populations
Sponsor:
Children's Hospital Los Angeles
Organization:
Study Overview
Official Title:
Prospective Study of School-based Influenza Vaccination's Impact on School Populations
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: