NCT00844051

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,455

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

August 1, 2016

Completed
Last Updated

September 12, 2016

Status Verified

August 1, 2016

Enrollment Period

2.4 years

First QC Date

February 12, 2009

Results QC Date

March 2, 2015

Last Update Submit

August 1, 2016

Conditions

Keywords

Influenzainfluenza vaccinationschool-based vaccination

Outcome Measures

Primary Outcomes (1)

  • Rates of Confirmed Influenza Illness in Vaccinated and Non-vaccinated Children Attending Schools With and Without School-based Influenza Vaccination Programs

    1 year

Secondary Outcomes (1)

  • Rates of Absenteeism Among Children Attending Schools With and Without School-based Influenza Vaccination Programs

    1 year

Study Arms (2)

No Intervention

NO INTERVENTION

No school-based influenza vaccination program

Intervention

ACTIVE COMPARATOR

School-based Influenza Vaccination Program

Biological: School-based influenza vaccination program

Interventions

School-based influenza vaccination program

Intervention

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children enrolled in target schools

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Los Angeles County Department of Public Health

Los Angeles, California, 90012, United States

Location

Childrens Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Pia Pannaraj, MD, MPH
Organization
Children's Hospital Los Angeles

Study Officials

  • Pia S Pannaraj, MD, MPH

    Childrens Hospital Los Angeles, University of Southern California

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

February 12, 2009

First Posted

February 13, 2009

Study Start

January 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

September 12, 2016

Results First Posted

August 1, 2016

Record last verified: 2016-08

Locations