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Acceptability of Fluzone Intradermal Vaccine to Patients and Vaccine Administrators

NCT ID: NCT01716130

Last Updated: 2012-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

249 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2011-11-30

Brief Summary

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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

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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.

Conditions

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Patient Response to Fluzone ID Vaccine

Keywords

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Fluzone Intradermal vaccine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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 interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Exclusion Criteria

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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Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Touro University, California

OTHER

Sponsor Role lead

Responsible Party

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James E. Foy, D.O.

Professor of Pediatrics, Touro University College of Osteopathic Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James E Foy, D.O.

Role: PRINCIPAL_INVESTIGATOR

Touro University, California

Locations

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Touro University California

Vallejo, California, United States

Site Status

Countries

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United States

Related Links

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http://www.tu.edu

Touro University California Web Site

Other Identifiers

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M0611

Identifier Type: -

Identifier Source: org_study_id