Acceptability of Fluzone Intradermal Vaccine to Patients and Vaccine Administrators

Touro University, California

Status: Completed

Conditions: Patient Response to Fluzone ID Vaccine

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01716130

M0611

Details and patient eligibility

About

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.

Full 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.

Enrollment: 249 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

249 participants in 3 patient groups

IM vaccine in the past 3 years

Description:

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

Description:

Patients that received the Fluzone ID vaccine and reported not receiving the IM influenza vaccine in the past 3 years.

vaccine administrators

Description:

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.