Influenza Vaccination for Parents and Other Caregivers in the Pediatric Medical Home - Full Text View

Sponsored by:	Akron Children's Hospital
Information provided by:	Akron Children's Hospital
ClinicalTrials.gov Identifier:	NCT00812110

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 NICU environment.

Condition	Intervention	Phase
Influenza	Drug: Influenzae vaccine	Phase IV

MedlinePlus related topics: Caregivers Flu

Drug Information available for: Influenza Vaccines Fluvirin

U.S. FDA Resources

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

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

Primary Outcome Measures:

a) What is the background rate of influenza vaccination in the parents/caregivers of high risk pediatric patients in a low income population? [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

b) What is the acceptability of vaccination among the parents/caregivers of high risk pediatric patients in a low income population in the pediatric medical home, a nontraditional site for adult vaccination? [ Time Frame: 4 months ] [ Designated as safety issue: No ]
c) What factors are related to acceptance of influenza vaccination among the parents/caregivers of high risk pediatric patients in a low income population? [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	December 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Intervention Details:

0.5 mL Deltoid Intramuscular Injection X 1

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 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

More Information

Responsible Party:	Akron Children's Hospital ( P. Cooper White, M.D. )
Study ID Numbers:	081105
Study First Received:	December 18, 2008
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00812110
Health Authority:	United States: Institutional Review Board

Keywords provided by Akron Children's Hospital:

Influenza prevention

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 13, 2009