Influenza Vaccination for Parents and Other Caregivers in the Pediatric Medical Home

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

336 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-09-30

Brief Summary

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We hypothesize that when offered influenza vaccine at little or no cost, in a setting where the value of the vaccine is connected to one's high risk child, vaccination rates for parents will approach 90-95%, similar to rates obtained in the Neonatal Intensive Care Unit environment.

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Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Influenzae vaccine

0.5 mL Deltoid Intramuscular Injection X 1

Intervention Type DRUG

Other Intervention Names

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Fluzone

Eligibility Criteria

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Inclusion Criteria

* Parents or caregiver adults who accompany at-risk children to a Pediatric Care outpatient clinic appointment. High risk children are defined as those 0 to 5 years of age, or who have any of the following diagnoses:

* Sickle cell disease
* Asthma
* Cystic fibrosis
* Chronic renal disease
* Congenital heart disease
* Cancer
* Any immunodeficiency

Exclusion Criteria

* Caregivers of children residing in group homes
* Persons whose children do not meet the Center for Disease Control (CDC) definition of high-risk
* Persons who have had allergic reactions to influenza vaccination or any other vaccination in the past
* Persons who are allergic to eggs or egg products
* Persons who are allergic to thimerosol
* Previous diagnosis of Guillain-Barré syndrome (GBS)
* Persons who are moderately to severely ill at the time the vaccination is to be given

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes