Acceptability of Fluzone Intradermal Vaccine to Patients and Vaccine Administrators

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01716130

Enrollment

249

Registered

2012-10-29

Start date

2011-10-31

Completion date

2011-11-30

Last updated

2012-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Response to Fluzone ID Vaccine

Keywords

Fluzone Intradermal vaccine

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Yes

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. \-

Design outcomes

Primary

Measure	Time frame	Description
Overall patient satisfaction with intradermal vaccine	7 days	Overall patient satisfaction was assessed immediately post-vaccination and seven days later by patient survey.

Secondary

Measure	Time frame	Description
Overall satisfaction with the Fluzone ID vaccine by vaccine administrators	seven days	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

Measure	Time frame	Description
Overall satisfaction with the Fluzone ID vaccine in two cohort groups	7 days	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.

Countries

United States

Outcome results