Acceptability of Fluzone Intradermal Vaccine to Patients and Vaccine Administrators
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 249
- Locations
- 1
- Primary Endpoint
- Overall patient satisfaction with intradermal vaccine
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Overall patient satisfaction with intradermal vaccine
Time Frame: 7 days
Overall patient satisfaction was assessed immediately post-vaccination and seven days later by patient survey.
Secondary Outcomes
- Overall satisfaction with the Fluzone ID vaccine by vaccine administrators(seven days)
Investigators
James E. Foy, D.O.
Professor of Pediatrics, Touro University College of Osteopathic Medicine
Touro University, California