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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00812110
• Other study ID #: 081105
• Status: Completed
• Phase: Phase 4
• First received: December 18, 2008
• Last updated: December 13, 2012
• Start date: December 2008
• Est. completion date: September 2009

Study information

• Verified date: December 2012
• Source: Akron Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Drug:
• Influenzae vaccine
0.5 mL Deltoid Intramuscular Injection X 1

Locations

Country	Name	City	State
United States	Akron Children's Hospital	Akron	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Akron Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Received Influenza Vaccine.	Caregivers identified for participation were offered influenza vaccine. This describes the number who accepted vaccination	1 hour	No
Secondary	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.	16 months	No