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CompletedNCT01716130Updated Oct 29, 2012

Acceptability of Fluzone Intradermal Vaccine to Patients and Vaccine Administrators

An observational study in Patient Response to Fluzone ID Vaccine, sponsored by Touro University, California. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-29.

Sponsored by Touro University, California · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
249
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Patient Response to Fluzone ID Vaccine

Keywords

  • Fluzone Intradermal vaccine
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In context

Lead sponsor

Touro University, California is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

community sample

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.

-

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
249 participants (actual)

Groups and 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.

06

What researchers measure

Primary outcomes

  1. Overall patient satisfaction with intradermal vaccine

    Overall patient satisfaction was assessed immediately post-vaccination and seven days later by patient survey.

    Time frame: 7 days

Secondary outcomes

  1. 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.

    Time frame: seven days

Other outcomes

  1. Overall satisfaction with the Fluzone ID vaccine in two cohort groups

    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.

    Time frame: 7 days

07

Study locations

1 site
  • Touro University California
    Vallejo, California 94592, United States
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01716130
Lead sponsor
Touro University, California
Collaborators
Sanofi
Responsible party
James E. Foy, D.O. (Professor of Pediatrics, Touro University College of Osteopathic Medicine, Touro University, California) — Principal investigator
First posted
Oct 29, 2012
Start date
Oct 2011
Primary completion
Nov 2011
Completion
Nov 2011
Last update
Oct 29, 2012

Study contacts

James E Foy, D.O.
principal investigator · Touro University, California

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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