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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 (Responsible Party):
Pia S. Pannaraj, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier:
NCT00844051
First received: February 12, 2009
Last updated: August 1, 2016
Last verified: August 2016
  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
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:


Further study details as provided by Pia S. Pannaraj, 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 ]

Secondary Outcome Measures:
  • Rates of Absenteeism Among Children Attending Schools With and Without School-based Influenza Vaccination Programs [ Time Frame: 1 year ]

Enrollment: 4455
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. 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

Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children enrolled in target schools

Exclusion Criteria: none

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Los Angeles County Department of Public Health
Los Angeles, California, United States, 90012
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
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

Responsible Party: Pia S. Pannaraj, Assistant Professor of Pediatrics, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT00844051     History of Changes
Other Study ID Numbers: CHLA-08-00229
Study First Received: February 12, 2009
Results First Received: March 2, 2015
Last Updated: August 1, 2016

Keywords provided by Pia S. Pannaraj, 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
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 23, 2017