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OpenTrials
Completed

NCT Number: NCT00812110

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Akron Children's Hospital

Akron, Ohio, 44308, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Influenzae vaccine

Drug

0.5 mL Deltoid Intramuscular Injection X 1

Other names: Fluzone

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Akron Children's Hospital

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 19, 2008
Registry last updated
Jan 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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