<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01716130</url>
  </required_header>
  <id_info>
    <org_study_id>M0611</org_study_id>
    <nct_id>NCT01716130</nct_id>
  </id_info>
  <brief_title>Acceptability of Fluzone Intradermal Vaccine to Patients and Vaccine Administrators</brief_title>
  <official_title>Acceptability of Fluzone Intradermal Vaccine to Patients and Vaccine Administrators</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Touro University, California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Touro University, California</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the acceptance of the Fluzone Intradermal (ID)vaccine in adults and vaccine&#xD;
      administrators in the United States. Patients completed 2 surveys, one immediately&#xD;
      post-vaccination and one seven days later, that documented demographics and assessed their&#xD;
      injection pain, injection anxiety, speed of injection, overall satisfaction, and preference&#xD;
      for next year's vaccine. Vaccine administrators completed one survey assessing ease of&#xD;
      vaccine preparation and administration, time required to administer, and safety/risk of&#xD;
      needle stick injury for patient and administrator.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients were divided into two groups: 1) those that reported receiving the intramuscular&#xD;
      (IM) influenza vaccine in the past 3 years; and 2) those that reported not receiving the IM&#xD;
      influenza vaccine in the past 3 years. The survey responses were compared between the two&#xD;
      groups. In addition, the subjects that reported receiving the IM vaccine in the past 3 years&#xD;
      were asked to compare their experience with the IM vaccine versus the ID vaccine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">November 2011</completion_date>
  <primary_completion_date type="Actual">November 2011</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overall patient satisfaction with intradermal vaccine</measure>
    <time_frame>7 days</time_frame>
    <description>Overall patient satisfaction was assessed immediately post-vaccination and seven days later by patient survey.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall satisfaction with the Fluzone ID vaccine by vaccine administrators</measure>
    <time_frame>seven days</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Overall satisfaction with the Fluzone ID vaccine in two cohort groups</measure>
    <time_frame>7 days</time_frame>
    <description>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.</description>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">249</enrollment>
  <condition>Patient Response to Fluzone ID Vaccine</condition>
  <arm_group>
    <arm_group_label>IM vaccine in the past 3 years</arm_group_label>
    <description>Those subjects that received the Fluzone ID influenza vaccine, and reported having received the IM influenza vaccine in the past three years.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no IM vaccine in the past 3 years</arm_group_label>
    <description>Patients that received the Fluzone ID vaccine and reported not receiving the IM influenza vaccine in the past 3 years.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>vaccine administrators</arm_group_label>
    <description>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.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        community sample&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:Age 18 -64 years of age Desire to receive the Fluzone Intradermal&#xD;
        vaccine to protect against influenza. -&#xD;
&#xD;
        Exclusion Criteria:Less than 18 years of age, or 65 years of age and older. Desire to&#xD;
        receive the Fluzone Intramuscular vaccine to protect against influenza.&#xD;
&#xD;
        problems of the immune system, current illness, severe allergy to eggs, severe (life&#xD;
        threatening) allergies, history of having Guillain-Barre Syndrome (a severe paralytic&#xD;
        illness) or having received a flu vaccine in the past three months.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James E Foy, D.O.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Touro University, California</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Touro University California</name>
      <address>
        <city>Vallejo</city>
        <state>California</state>
        <zip>94592</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.tu.edu</url>
    <description>Touro University California Web Site</description>
  </link>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>October 24, 2012</last_update_submitted>
  <last_update_submitted_qc>October 24, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 29, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Touro University, California</investigator_affiliation>
    <investigator_full_name>James E. Foy, D.O.</investigator_full_name>
    <investigator_title>Professor of Pediatrics, Touro University College of Osteopathic Medicine</investigator_title>
  </responsible_party>
  <keyword>Fluzone Intradermal vaccine</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01716130
org study id: M0611
nct id: NCT01716130
lead sponsor: 
collaborator: 
has dmc: Yes
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Overall patient satisfaction with intradermal vaccine
time frame: 7 days
description: Overall patient satisfaction was assessed immediately post-vaccination and seven days later by patient survey.
measure: Overall satisfaction with the Fluzone ID vaccine by vaccine administrators
time frame: seven days
description: 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.
measure: Overall satisfaction with the Fluzone ID vaccine in two cohort groups
time frame: 7 days
description: 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.
arm group label: IM vaccine in the past 3 years
description: Those subjects that received the Fluzone ID influenza vaccine, and reported having received the IM influenza vaccine in the past three years.
arm group label: no IM vaccine in the past 3 years
description: Patients that received the Fluzone ID vaccine and reported not receiving the IM influenza vaccine in the past 3 years.
arm group label: vaccine administrators
description: 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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: James E Foy, D.O.
role: Principal Investigator
affiliation: Touro University, California
facility: 
country: United States
url: http://www.tu.edu
description: Touro University California Web Site
responsible party type: Principal Investigator
investigator affiliation: Touro University, California
investigator full name: James E. Foy, D.O.
investigator title: Professor of Pediatrics, Touro University College of Osteopathic Medicine