Acceptability of Fluzone Intradermal Vaccine to Patients and Vaccine Administrators

NCT01716130 | Completed DMC

• 1 other identifier: M0611
• Study Type: observational
• Target: 249
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Response to Fluzone ID Vaccine

Keywords

Fluzone Intradermal vaccine

Outcome Measures

Primary Outcomes (1)

• Overall patient satisfaction with intradermal vaccine

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

  7 days

Secondary Outcomes (1)

• Overall satisfaction with the Fluzone ID vaccine by vaccine administrators

  seven days

Other Outcomes (1)

• Overall satisfaction with the Fluzone ID vaccine in two cohort groups

  7 days

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

community sample

You may not qualify if:

• 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.

Sponsors & Collaborators

• Touro University, California: lead
• Sanofi: collaborator

Study Sites (1)

Touro University California

Vallejo, California, 94592, United States

Location

Related Links

• Touro University California Web Site

Study Officials

• James E Foy, D.O.

  Touro University, California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics, Touro University College of Osteopathic Medicine

Study Record Dates

• First Submitted: October 24, 2012
• First Posted: October 29, 2012
• Study Start: October 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: October 29, 2012

Record last verified: 2012-10

Locations

US (1)