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

October 28, 2013 updated by: MedImmune LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

4411

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • 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
    • Colorado
      • Boulder, Colorado, United States, 80305
      • Denver, Colorado, United States, 80246
    • District of Columbia
      • Washington, District of Columbia, United States, 20009
    • Florida
      • Tampa, Florida, United States, 33619
    • 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
    • Maryland
      • Annapolis, Maryland, United States, 21401
      • Baltimore, Maryland, United States, 21224
      • Baltimore, Maryland, United States, 21201
      • Baltimore, Maryland, United States, 21202
      • Baltimore, Maryland, United States, 21209
      • Baltimore, Maryland, United States, 21220
      • 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
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
      • Larwenceville, New Jersey, United States, 8648
      • Morristown, New Jersey, United States, 07962
    • New Mexico
      • Albuquerque, New Mexico, United States, 87113
    • New York
      • Rochester, New York, United States, 14586
      • Rochester, New York, United States, 14614
      • Rochester, New York, United States, 14625
    • North Carolina
      • High Point, North Carolina, United States, 27260
    • Ohio
      • Cincinnati, Ohio, United States, 45202
      • Hamilton, Ohio, United States, 45015
      • Lebanon, Ohio, United States, 45036
      • West Chester, Ohio, United States, 45096
    • Virginia
      • Fredericksburg, Virginia, United States, 22401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Vaccination Rate, All Ages
Time Frame: 30Sep2008 through 23Dec2008
30Sep2008 through 23Dec2008
Overall Vaccination Rate, Employees 18 to 49 Years of Age
Time Frame: 30Sep2008 through 23Dec2008
30Sep2008 through 23Dec2008

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2007-2008 season through 2008-2009 season
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
2007-2008 season through 2008-2009 season
Percent of Eligible Participants 18-49 Years of Age Choosing FluMist During Intervention Season
Time Frame: 30Sep2008 through 23Dec2008
30Sep2008 through 23Dec2008
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
30Sep2008 through 23Dec2008
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.
30Sep2008 through 23Dec2008
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.
30Sep2008 through 23Dec2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedImmune LLC

Collaborators

University of Pittsburgh
Passport Health

Investigators

  • Study Director: Seth Toback, M.D., MedImmune LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

December 12, 2008

First Submitted That Met QC Criteria

December 15, 2008

First Posted (Estimate)

December 16, 2008

Study Record Updates

Last Update Posted (Estimate)

November 20, 2013

Last Update Submitted That Met QC Criteria

October 28, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MI-MA-181

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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