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Influenza Vaccination in the Emergency Department

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.
ClinicalTrials.gov Identifier: NCT00822627
Recruitment Status : Completed
First Posted : January 14, 2009
Last Update Posted : January 14, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
Randomized controlled trial of influenza vaccination versus referral for vaccination in the Emergency department. Is the Emergency Department an effective venue for vaccination for influenza? Does vaccination for influenza in the Emergency Department change the rates of influenza, influenza-like-illness or medical provider visits when compared with patient referred for vaccination in the community?

Condition or disease Intervention/treatment
Influenza Drug: Influenza Vaccination Behavioral: Education and referral

Detailed Description:
This study is a prospective randomized, controlled trial of influenza vaccination vs referral for influenza vaccination in the Emergency Department. Subjects are either offered vaccination or education regarding vaccination and a list of community providers. At a four-month follow up, rates of influenza, influenza-like illness and number of medical provider visits are determined.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Influenza Vaccination in the Emergency Department
Study Start Date : November 2007
Primary Completion Date : April 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Experimental: Vaccination group
Vaccination group
Drug: Influenza Vaccination
0.5 mL Sanofi-Pasteur intramuscular influenza vaccination
Experimental: Education/referral
Education/referral
Behavioral: Education and referral
Patients are given information regarding the inactivated influenza vaccination and a list of community providers who provide influenza vaccination


Outcome Measures

Primary Outcome Measures :
  1. Vaccination status [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Influenza rate [ Time Frame: 4 months ]
  2. Influenza-like illness rate [ Time Frame: 4 months ]
  3. Visits to medical providers [ Time Frame: 4 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Unvaccinated patients presenting to the Emergency Department aged 6 months or more who have at least one high risk attribute:
  • Age 6-59 months or >50 years
  • Pregnant
  • Health care worker
  • Aged 6 months-18 years on chronic aspirin therapy
  • Comorbidity (cardiovascular disease, pulmonary disease, metabolic disease, renal disease, hepatic disease, seizures, neuromuscular disease, cognitive dysfunction, or any reason to have had regular medical follow up or hospitalization in the preceding year)
  • Household contact or caregiver of someone with at least one high risk attribute

Exclusion Criteria:

  • Prior vaccination
  • History of Guillan-Barre syndrome within 6 weeks of prior influenza vaccination
  • Allergy to influenza vaccination or eggs
  • Age < 6 months old
  • Fever with more than minor illness
  • Hospitalization
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00822627


Locations
United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
Investigators
Principal Investigator: Katherine M Hiller, MD University of Arizona Department of Emergency Medicine
More Information

Responsible Party: Katherine M Hiller, MD, Department of Emergency Medicine
ClinicalTrials.gov Identifier: NCT00822627     History of Changes
Other Study ID Numbers: 1
First Posted: January 14, 2009    Key Record Dates
Last Update Posted: January 14, 2009
Last Verified: January 2009

Keywords provided by University of Arizona:
Influenza
vaccination
Emergency Department

Additional relevant MeSH terms:
Vaccines
Influenza, Human
Emergencies
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Immunologic Factors
Physiological Effects of Drugs