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. Identifier: NCT00822627
Recruitment Status : Completed
First Posted : January 14, 2009
Last Update Posted : January 14, 2009
Information provided by:
University of Arizona

January 12, 2009
January 14, 2009
January 14, 2009
November 2007
April 2008   (Final data collection date for primary outcome measure)
Vaccination status [ Time Frame: 4 months ]
Same as current
No Changes Posted
  • Influenza rate [ Time Frame: 4 months ]
  • Influenza-like illness rate [ Time Frame: 4 months ]
  • Visits to medical providers [ Time Frame: 4 months ]
Same as current
Not Provided
Not Provided
Influenza Vaccination in the Emergency Department
Influenza Vaccination in the Emergency Department
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?
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.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
  • Drug: Influenza Vaccination
    0.5 mL Sanofi-Pasteur intramuscular influenza vaccination
  • Behavioral: Education and referral
    Patients are given information regarding the inactivated influenza vaccination and a list of community providers who provide influenza vaccination
  • Experimental: Vaccination group
    Vaccination group
    Intervention: Drug: Influenza Vaccination
  • Experimental: Education/referral
    Intervention: Behavioral: Education and referral
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
April 2008
April 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Months and older   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Katherine M Hiller, MD, Department of Emergency Medicine
University of Arizona
Not Provided
Principal Investigator: Katherine M Hiller, MD University of Arizona Department of Emergency Medicine
University of Arizona
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP