Acceptability of Fluzone Intradermal Vaccine to Patients and Vaccine Administrators

To assess the acceptance of the Fluzone Intradermal (ID)vaccine in adults and vaccine administrators in the United States. Patients completed 2 surveys, one immediately post-vaccination and one seven days later, that documented demographics and assessed their injection pain, injection anxiety, speed of injection, overall satisfaction, and preference for next year's vaccine. Vaccine administrators completed one survey assessing ease of vaccine preparation and administration, time required to administer, and safety/risk of needle stick injury for patient and administrator.

Study Overview

• Status: Completed
• Conditions: Patient Response to Fluzone ID Vaccine

Detailed Description

Patients were divided into two groups: 1) those that reported receiving the intramuscular (IM) influenza vaccine in the past 3 years; and 2) those that reported not receiving the IM influenza vaccine in the past 3 years. The survey responses were compared between the two groups. In addition, the subjects that reported receiving the IM vaccine in the past 3 years were asked to compare their experience with the IM vaccine versus the ID vaccine.

• Study Type: Observational
• Enrollment (Actual): 249

Contacts and Locations

Study Locations

• United States
  • California
    • Vallejo, California, United States, 94592
      • Touro University California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

community sample

Description

Inclusion Criteria:Age 18 -64 years of age Desire to receive the Fluzone Intradermal vaccine to protect against influenza. -

Exclusion Criteria:Less than 18 years of age, or 65 years of age and older. Desire to receive the Fluzone Intramuscular vaccine to protect against influenza.

problems of the immune system, current illness, severe allergy to eggs, severe (life threatening) allergies, history of having Guillain-Barre Syndrome (a severe paralytic illness) or having received a flu vaccine in the past three months.

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Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
IM vaccine in the past 3 years; Those subjects that received the Fluzone ID influenza vaccine, and reported having received the IM influenza vaccine in the past three years.
no IM vaccine in the past 3 years; Patients that received the Fluzone ID vaccine and reported not receiving the IM influenza vaccine in the past 3 years.
vaccine administrators; Those experienced vaccine administrators that administered the Fluzone ID vaccine, and were then surveyed concerning safety and overall satisfaction with the ID vaccine in comparison to the IM vaccine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall patient satisfaction with intradermal vaccine	Overall patient satisfaction was assessed immediately post-vaccination and seven days later by patient survey.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall satisfaction with the Fluzone ID vaccine by vaccine administrators	Vaccine administrators (#8)completed a survey rating the ID vaccine in comparison to the IM vaccine in terms of ease of vaccine preparation, time required to administer the vaccine, and safety/needle stick risk for patients and administrators.	seven days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall satisfaction with the Fluzone ID vaccine in two cohort groups	Using a survey tool, patients receiving the Fluzone ID vaccine were separated into 2 groups: 1) those that reported receiving the IM influenza vaccine in the past 3 years; and 2) those that reported not receiving the IM influenza vaccine in the past 3 years. All subject's satisfaction was assessed by survey immediately post-vaccination and 7 days later. Survey responses were compared between the 2 groups. The group that reported receiving the IM influenza vaccine in the past 3 years was asked to compare their experience with the ID vaccine in comparison to the IM vaccine.	7 days

Collaborators and Investigators

• Sponsor: Touro University, California
• Collaborators: Sanofi
• Investigators: Principal Investigator: James E Foy, D.O., Touro University, California

Publications and helpful links

Helpful Links

• Touro University California Web Site

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: October 24, 2012
• First Submitted That Met QC Criteria: October 24, 2012
• First Posted (Estimate): October 29, 2012

Study Record Updates

• Last Update Posted (Estimate): October 29, 2012
• Last Update Submitted That Met QC Criteria: October 24, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Fluzone Intradermal vaccine
• Other Study ID Numbers: M0611