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Acceptability of Fluzone Intradermal Vaccine to Patients and Vaccine Administrators

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
James E. Foy, D.O., Touro University, California
ClinicalTrials.gov Identifier:
NCT01716130
First received: October 24, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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.


Condition
Patient Response to Fluzone ID Vaccine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acceptability of Fluzone Intradermal Vaccine to Patients and Vaccine Administrators

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Touro University, California:

Primary Outcome Measures:
  • Overall patient satisfaction with intradermal vaccine [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Overall patient satisfaction was assessed immediately post-vaccination and seven days later by patient survey.


Secondary Outcome Measures:
  • Overall satisfaction with the Fluzone ID vaccine by vaccine administrators [ Time Frame: seven days ] [ Designated as safety issue: Yes ]
    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.


Other Outcome Measures:
  • Overall satisfaction with the Fluzone ID vaccine in two cohort groups [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 249
Study Start Date: October 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

community sample

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.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716130

Locations
United States, California
Touro University California
Vallejo, California, United States, 94592
Sponsors and Collaborators
Touro University, California
Sanofi
Investigators
Principal Investigator: James E Foy, D.O. Touro University, California
  More Information

Additional Information:
Touro University California Web Site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: James E. Foy, D.O., Professor of Pediatrics, Touro University College of Osteopathic Medicine, Touro University, California
ClinicalTrials.gov Identifier: NCT01716130     History of Changes
Other Study ID Numbers: M0611
Study First Received: October 24, 2012
Last Updated: October 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Touro University, California:
Fluzone Intradermal vaccine

ClinicalTrials.gov processed this record on May 22, 2013