Back to resultsStudy to Evaluate Impact of School-based Influenza Vaccination on School Populations
Primary Purpose
Influenza
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
School-based influenza vaccination program
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza, influenza vaccination, school-based vaccination
Eligibility Criteria
Inclusion Criteria:
- Children enrolled in target schools
Exclusion Criteria: none
Sites / Locations
- Los Angeles County Department of Public Health
- Childrens Hospital Los Angeles
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
No Intervention
Intervention
Arm Description
No school-based influenza vaccination program
School-based Influenza Vaccination Program
Outcomes
Primary Outcome Measures
Rates of Confirmed Influenza Illness in Vaccinated and Non-vaccinated Children Attending Schools With and Without School-based Influenza Vaccination Programs
Secondary Outcome Measures
Rates of Absenteeism Among Children Attending Schools With and Without School-based Influenza Vaccination Programs
Full Information
NCT ID
NCT00844051
First Posted
February 12, 2009
Last Updated
August 1, 2016
Sponsor
Children's Hospital Los Angeles
Collaborators
Los Angeles County Department of Public Health
1. Study Identification
Unique Protocol Identification Number
NCT00844051
Brief Title
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
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital Los Angeles
Collaborators
Los Angeles County Department of Public Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, influenza vaccination, school-based vaccination
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
4455 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
No school-based influenza vaccination program
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
School-based Influenza Vaccination Program
Intervention Type
Biological
Intervention Name(s)
School-based influenza vaccination program
Intervention Description
School-based influenza vaccination program
Primary Outcome Measure Information:
Title
Rates of Confirmed Influenza Illness in Vaccinated and Non-vaccinated Children Attending Schools With and Without School-based Influenza Vaccination Programs
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Rates of Absenteeism Among Children Attending Schools With and Without School-based Influenza Vaccination Programs
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children enrolled in target schools
Exclusion Criteria: none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pia S Pannaraj, MD, MPH
Organizational Affiliation
Childrens Hospital Los Angeles, University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Los Angeles County Department of Public Health
City
Los Angeles
State/Province
California
ZIP/Postal Code
90012
Country
United States
Facility Name
Childrens Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate Impact of School-based Influenza Vaccination on School Populations
We'll reach out to this number within 24 hrs