Influenza Vaccination in the Emergency Department

Influenza Clinical Trial

Official title:

Influenza Vaccination in the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00822627
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• First received: January 12, 2009
• Last updated: January 13, 2009
• Start date: November 2007
• Est. completion date: April 2008

Study information

• Verified date: January 2009
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Emergencies
• Influenza
• Influenza, Human

Intervention

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

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaccination status		4 months	No
Secondary	Influenza rate		4 months	No
Secondary	Influenza-like illness rate		4 months	No
Secondary	Visits to medical providers		4 months	No