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Assessing Choice in the Employer Setting (ACES) Study

NCT ID: NCT00808808

Last Updated: 2013-11-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4411 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Keywords

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FluMist, TIV, vaccination rates

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Arm A (Control)

A control arm of usual care offering TIV with baseline advertisement

Control - Usual care offering TIV only with baseline advertisement

Intervention Type BIOLOGICAL

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

Choice of TIV or FluMist with baseline advertisement

Intervention Type BIOLOGICAL

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

Choice of TIV or FluMist with enhanced advertisement and incentives

Intervention Type OTHER

An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination

Interventions

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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

Intervention Type BIOLOGICAL

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

Intervention Type OTHER

Control - Usual care offering TIV only with baseline advertisement

A control arm of usual care offering TIV with baseline advertisement

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Passport Health

INDUSTRY

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role collaborator

MedImmune LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Medimmune LLC

Principal Investigators

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Seth Toback, M.D.

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

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Chatsworth, California, United States

Site Status

Novato, California, United States

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Sacramento, California, United States

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Sacramento, California, United States

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San Francisco, California, United States

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Santa Clara, California, United States

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Santa Monica, California, United States

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Sunnyvale, California, United States

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Thousand Oaks, California, United States

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Boulder, Colorado, United States

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Denver, Colorado, United States

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Washington D.C., District of Columbia, United States

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Tampa, Florida, United States

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Hebron, Kentucky, United States

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La Grange, Kentucky, United States

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Lawrenceburg, Kentucky, United States

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Louisville, Kentucky, United States

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Louisville, Kentucky, United States

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Annapolis, Maryland, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Calverton, Maryland, United States

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Cockeysville, Maryland, United States

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Columbia, Maryland, United States

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Columbia, Maryland, United States

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Crofton, Maryland, United States

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Hanover, Maryland, United States

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Hunt Valley, Maryland, United States

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Laurel, Maryland, United States

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Sparks, Maryland, United States

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Basking Ridge, New Jersey, United States

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Larwenceville, New Jersey, United States

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Morristown, New Jersey, United States

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Albuquerque, New Mexico, United States

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Rochester, New York, United States

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Rochester, New York, United States

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Rochester, New York, United States

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High Point, North Carolina, United States

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Cincinnati, Ohio, United States

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Hamilton, Ohio, United States

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Lebanon, Ohio, United States

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West Chester, Ohio, United States

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Fredericksburg, Virginia, United States

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Countries

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United States

References

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Lin CJ, Nowalk MP, Toback SL, Rousculp MD, Raymund M, Ambrose CS, Zimmerman RK. Importance of vaccination habit and vaccine choice on influenza vaccination among healthy working adults. Vaccine. 2010 Nov 10;28(48):7706-12. doi: 10.1016/j.vaccine.2010.07.009. Epub 2010 Jul 16.

Reference Type RESULT
PMID: 20638452 (View on PubMed)

Nowalk MP, Lin CJ, Toback SL, Rousculp MD, Eby C, Raymund M, Zimmerman RK. Improving influenza vaccination rates in the workplace: a randomized trial. Am J Prev Med. 2010 Mar;38(3):237-46. doi: 10.1016/j.amepre.2009.11.011. Epub 2009 Dec 24.

Reference Type RESULT
PMID: 20036102 (View on PubMed)

Other Identifiers

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MI-MA-181

Identifier Type: -

Identifier Source: org_study_id