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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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 Design
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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 Vaccines

Groups and Cohorts
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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


Outcome Measures
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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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
Contacts and Locations
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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


Locations
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United States, California
Chatsworth, California, United States, 91311
Novato, California, United States, 94945
Sacramento, California, United States, 95815
Sacramento, California, United States, 95833
San Francisco, California, United States, 94115
Santa Clara, California, United States, 96050
Santa Monica, California, United States, 90405
Sunnyvale, California, United States, 94089
Thousand Oaks, California, United States, 91362
United States, Colorado
Boulder, Colorado, United States, 80305
Denver, Colorado, United States, 80246
United States, District of Columbia
Washington, District of Columbia, United States, 20009
United States, Florida
Tampa, Florida, United States, 33619
United States, Kentucky
Hebron, Kentucky, United States, 41048
LaGrange, Kentucky, United States, 40031
Lawrenceburg, Kentucky, United States, 40342
Louisville, Kentucky, United States, 40203
Louisville, Kentucky, United States, 40223
United States, Maryland
Annapolis, Maryland, United States, 21401
Baltimore, Maryland, United States, 21201
Baltimore, Maryland, United States, 21202
Baltimore, Maryland, United States, 21209
Baltimore, Maryland, United States, 21220
Baltimore, Maryland, United States, 21224
Baltimore, Maryland, United States, 21244
Calverton, Maryland, United States, 20705
Cockeysville, Maryland, United States, 21030
Columbia, Maryland, United States, 21045
Columbia, Maryland, United States, 21046
Crofton, Maryland, United States, 21114
Hanover, Maryland, United States, 21076
Hunt Valley, Maryland, United States, 21031
Laurel, Maryland, United States, 20707
Sparks, Maryland, United States, 21152
United States, New Jersey
Basking Ridge, New Jersey, United States, 07920
Larwenceville, New Jersey, United States, 8648
Morristown, New Jersey, United States, 07962
United States, New Mexico
Albuquerque, New Mexico, United States, 87113
United States, New York
Rochester, New York, United States, 14586
Rochester, New York, United States, 14614
Rochester, New York, United States, 14625
United States, North Carolina
High Point, North Carolina, United States, 27260
United States, Ohio
Cincinnati, Ohio, United States, 45202
Hamilton, Ohio, United States, 45015
Lebanon, Ohio, United States, 45036
West Chester, Ohio, United States, 45096
United States, Virginia
Fredericksburg, Virginia, United States, 22401
Sponsors and Collaborators
MedImmune LLC
Passport Health
University of Pittsburgh
Investigators
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Study Director: Seth Toback, M.D. MedImmune LLC
More Information
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Publications of Results:

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Responsible Party: Seth Toback, MD, Medimmune LLC
ClinicalTrials.gov Identifier: NCT00808808    
Other Study ID Numbers: MI-MA-181
First Posted: December 16, 2008    Key Record Dates
Results First Posted: September 13, 2012
Last Update Posted: November 20, 2013
Last Verified: October 2013
Keywords provided by MedImmune LLC:
FluMist, TIV, vaccination rates