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

This study has been completed.
Sponsor:
Collaborator:
Los Angeles County Department of Public Health
Information provided by:
Children's Hospital Los Angeles
ClinicalTrials.gov Identifier:
NCT00844051
First received: February 12, 2009
Last updated: August 31, 2011
Last verified: February 2010
History of Changes
  Purpose

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.


Condition Intervention
Influenza
 Biological: School-based influenza vaccination program

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prospective Study of School-based Influenza Vaccination's Impact on School Populations

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Children's Hospital Los Angeles:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rates of absenteeism among children attending schools with and without school-based influenza vaccination programs [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 4500
Study Start Date: January 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No Intervention
No school-based influenza vaccination program
Active Comparator: Intervention
School-based Influenza Vaccination Program
 Biological: School-based influenza vaccination program
School-based influenza vaccination program

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

Ages Eligible for Study:   4 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children enrolled in target schools

Exclusion Criteria: none

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00844051

Locations
United States, California
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
Los Angeles County Department of Public Health
Los Angeles, California, United States, 90012
Sponsors and Collaborators
Children's Hospital Los Angeles
Los Angeles County Department of Public Health
Investigators
Principal Investigator: Pia S Pannaraj, MD, MPH Childrens Hospital Los Angeles, University of Southern California
  More Information

No publications provided

Responsible Party: Pia S. Pannaraj, MD, MPH, Childrens Hospital Los Angeles, University of Southern California
ClinicalTrials.gov Identifier: NCT00844051     History of Changes
Other Study ID Numbers: CHLA-08-00229
Study First Received: February 12, 2009
Last Updated: August 31, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Los Angeles:
Influenza
influenza vaccination
school-based vaccination

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013