Touro University California
Vallejo, California, 94592, United States
Completed
NCT Number: NCT01716130
Acceptability of Fluzone Intradermal Vaccine to Patients and Vaccine Administrators
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.
Completed
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Conditions
Age range
18 year–64 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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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Treatment and study plan
Primary outcomes
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Overall patient satisfaction with intradermal vaccine
Time frame: 7 days
Overall patient satisfaction was assessed immediately post-vaccination and seven days later by patient survey.
Secondary outcomes
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Overall satisfaction with the Fluzone ID vaccine by vaccine administrators
Time frame: 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 outcomes
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Overall satisfaction with the Fluzone ID vaccine in two cohort groups
Time frame: 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.
Sponsors and collaborators
Lead sponsor
Touro University, California
Other
Collaborators
- Sanofi
Registry information
Important dates
- Study start
- 2011
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- Oct 29, 2012
- Registry last updated
- Oct 29, 2012
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.