Acceptability of Fluzone Intradermal Vaccine to Patients and Vaccine Administrators

Completed

• Conditions: Patient Response to Fluzone ID Vaccine

• Registration Number: NCT01716130
• Lead Sponsor: Touro University, California

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.

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-10
• Study First Submitted: 2012-10-24
• Study First Submitted QC: 2012-10-24
• Last Update Submitted: 2012-10-24
• Study First Posted: 2012-10-29
• Last Update Posted: 2012-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 249

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall patient satisfaction with intradermal vaccine	7 days	Overall patient satisfaction was assessed immediately post-vaccination and seven days later by patient survey.

Secondary Outcome Measures

Name	Time	Method
Overall satisfaction with the Fluzone ID vaccine by vaccine administrators	seven days	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.

Trial Locations

Locations (1)

Touro University California; 🇺🇸 Vallejo, California, United States