Acceptability of Fluzone Intradermal Vaccine to Patients and Vaccine Administrators

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Acceptability of Fluzone Intradermal Vaccine to Patients and Vaccine Administrators

Conditions
-----------------
Patient Response to Fluzone ID Vaccine

Participation Criteria
=================
Eligibility Criteria
-----------------
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. -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IM vaccine in the past 3 years<br>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<br>Patients that received the Fluzone ID vaccine and reported not receiving the IM influenza vaccine in the past 3 years. | |
| vaccine administrators<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fluzone Intradermal vaccine