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Assessing Choice in the Employer Setting (ACES) Study (MA181)

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ClinicalTrials.gov Identifier: NCT00808808
Recruitment Status : Completed
First Posted : December 16, 2008
Results First Posted : September 13, 2012
Last Update Posted : November 20, 2013
Sponsor:
Collaborators:
Passport Health
University of Pittsburgh
Information provided by:
MedImmune LLC

Brief Summary:
The purpose of this study is to determine, among adults and in the total population, the effects of offering a choice of FluMist or trivalent inactivated vaccine (TIV) in the employer setting when compared to a control group.

Condition or disease Intervention/treatment
Healthy Biological: Choice of TIV or FluMist with baseline advertisement Other: Choice of TIV or FluMist with enhanced advertisement and incentives Biological: Control - Usual care offering TIV only with baseline advertisement

Detailed Description:
The primary objective is to determine, among adults in the 18-49 year old population and in the total population, the effects of offering a choice of FluMist or TIV with and without enhanced advertisement/added incentive on the overall influenza vaccination rates in the employer setting when compared to a control group.

Study Type : Observational
Actual Enrollment : 4411 participants
Time Perspective: Prospective
Official Title: Assessing Choice in the Employer Setting (ACES Study): An Observational Study to Assess the Impact of Offering Intranasal Vaccine on Influenza Vaccination Rates in the Employer Setting
Study Start Date : September 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Shot
U.S. FDA Resources

Group/Cohort Intervention/treatment
Arm A (Control)
A control arm of usual care offering TIV with baseline advertisement
Biological: Control - Usual care offering TIV only with baseline advertisement
A control arm of usual care offering TIV with baseline advertisement
Arm B (Choice)
An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
Biological: Choice of TIV or FluMist with baseline advertisement
An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
Arm C (Choice Plus)
An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
Other: Choice of TIV or FluMist with enhanced advertisement and incentives
An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination



Primary Outcome Measures :
  1. Overall Vaccination Rate, All Ages [ Time Frame: 30Sep2008 through 23Dec2008 ]
  2. Overall Vaccination Rate, Employees 18 to 49 Years of Age [ Time Frame: 30Sep2008 through 23Dec2008 ]

Secondary Outcome Measures :
  1. Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in the Total Population [ Time Frame: 2007-2008 season through 2008-2009 season ]
    Rate difference by arm from baseline to intervention season

  2. Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in Employees 18-49 Years of Age [ Time Frame: 2007-2008 season through 2008-2009 season ]
    Rate difference by arm from baseline to intervention season

  3. Percent of Eligible Participants 18-49 Years of Age Choosing FluMist During Intervention Season [ Time Frame: 30Sep2008 through 23Dec2008 ]
  4. Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Race [ Time Frame: 30Sep2008 through 23Dec2008 ]
    Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as white

  5. Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Education [ Time Frame: 30Sep2008 through 23Dec2008 ]
    Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as college graduates.

  6. Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Gender [ Time Frame: 30Sep2008 through 23Dec2008 ]
    Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as male.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults at least 18 years of age who are current employees attending the influenza clinic sponsored by their employer
Criteria

Inclusion Criteria for employer sites:

  • Located in the United States
  • Has not previously offered FluMist in an employee vaccination program in the past or FluMist represented less than 5% of all vaccine received at past programs
  • Data are available that will allow for a reliable estimate of the employee (total and 18-49 year old populations) vaccination rate for the 2007-2008 influenza season

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00808808


  Show 47 Study Locations
Sponsors and Collaborators
MedImmune LLC
Passport Health
University of Pittsburgh
Investigators
Study Director: Seth Toback, M.D. MedImmune LLC