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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00812110
Recruitment Status : Completed
First Posted : December 19, 2008
Results First Posted : January 23, 2013
Last Update Posted : January 23, 2013
Information provided by (Responsible Party):
Akron Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Influenza Drug: Influenzae vaccine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 336 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Influenza Vaccination for Parents and Other Caregivers in the Pediatric Medical Home
Study Start Date : December 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: Influenzae vaccine
    0.5 mL Deltoid Intramuscular Injection X 1
    Other Name: Fluzone

Primary Outcome Measures :
  1. Number of Participants Who Received Influenza Vaccine. [ Time Frame: 1 hour ]
    Caregivers identified for participation were offered influenza vaccine. This describes the number who accepted vaccination

Secondary Outcome Measures :
  1. Background Rate of Influenza Vaccination in the Parents/Caregivers of High Risk Pediatric Patients in a Low Income Population? [ Time Frame: 16 months ]
    Number of participants who received influenza vaccine the prior year.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00812110

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

Responsible Party: Akron Children's Hospital Identifier: NCT00812110     History of Changes
Other Study ID Numbers: 081105
First Posted: December 19, 2008    Key Record Dates
Results First Posted: January 23, 2013
Last Update Posted: January 23, 2013
Last Verified: December 2012

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