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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Akron Children's Hospital
ClinicalTrials.gov Identifier:
NCT00812110
First received: December 18, 2008
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Influenza
 Drug: Influenzae vaccine
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Influenza Vaccination for Parents and Other Caregivers in the Pediatric Medical Home

Resource links provided by NLM:

MedlinePlus related topics: Caregivers Flu
U.S. FDA Resources

Further study details as provided by Akron Children's Hospital:

Primary Outcome Measures:
  • Number of Participants Who Received Influenza Vaccine. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    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? [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    Number of participants who received influenza vaccine the prior year.


Enrollment: 336
Study Start Date: December 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Influenzae vaccine
    0.5 mL Deltoid Intramuscular Injection X 1
    Other Name: Fluzone
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00812110

Locations
United States, Ohio
Akron Children's Hospital
Akron, Ohio, United States, 44308
Sponsors and Collaborators
Akron Children's Hospital
Investigators
Principal Investigator: Peter C White, MD Akron Children's Hospital
  More Information

No publications provided

Responsible Party: Akron Children's Hospital
ClinicalTrials.gov Identifier: NCT00812110     History of Changes
Other Study ID Numbers: 081105
Study First Received: December 18, 2008
Results First Received: October 31, 2011
Last Updated: December 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Akron Children's Hospital:
Influenza prevention

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 21, 2013