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

Primary Purpose

Influenza

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Influenzae vaccine
Sponsored by
Akron Children's Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Akron Children's Hospital

Outcomes

Primary Outcome Measures

Number of Participants Who Received Influenza Vaccine.
Caregivers identified for participation were offered influenza vaccine. This describes the number who accepted vaccination

Secondary Outcome Measures

Background Rate of Influenza Vaccination in the Parents/Caregivers of High Risk Pediatric Patients in a Low Income Population?
Number of participants who received influenza vaccine the prior year.

Full Information

First Posted
December 18, 2008
Last Updated
December 13, 2012
Sponsor
Akron Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00812110
Brief Title
Influenza Vaccination for Parents and Other Caregivers in the Pediatric Medical Home
Official Title
Influenza Vaccination for Parents and Other Caregivers in the Pediatric Medical Home
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akron Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
336 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Influenzae vaccine
Other Intervention Name(s)
Fluzone
Intervention Description
0.5 mL Deltoid Intramuscular Injection X 1
Primary Outcome Measure Information:
Title
Number of Participants Who Received Influenza Vaccine.
Description
Caregivers identified for participation were offered influenza vaccine. This describes the number who accepted vaccination
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Background Rate of Influenza Vaccination in the Parents/Caregivers of High Risk Pediatric Patients in a Low Income Population?
Description
Number of participants who received influenza vaccine the prior year.
Time Frame
16 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter C White, MD
Organizational Affiliation
Akron Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States

12. IPD Sharing Statement

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

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