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

This study has been completed.
Sponsor:
Collaborators:
Passport Health
University of Pittsburgh
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00808808
First received: December 12, 2008
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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 Intervention
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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Overall Vaccination Rate, All Ages [ Time Frame: 30Sep2008 through 23Dec2008 ] [ Designated as safety issue: No ]
  • Overall Vaccination Rate, Employees 18 to 49 Years of Age [ Time Frame: 30Sep2008 through 23Dec2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in the Total Population [ Time Frame: 2007-2008 season through 2008-2009 season ] [ Designated as safety issue: No ]
    Rate difference by arm from baseline to intervention 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 ] [ Designated as safety issue: No ]
    Rate difference by arm from baseline to intervention season

  • Percent of Eligible Participants 18-49 Years of Age Choosing FluMist During Intervention Season [ Time Frame: 30Sep2008 through 23Dec2008 ] [ Designated as safety issue: No ]
  • Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Race [ Time Frame: 30Sep2008 through 23Dec2008 ] [ Designated as safety issue: No ]
    Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as white

  • Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Education [ Time Frame: 30Sep2008 through 23Dec2008 ] [ Designated as safety issue: No ]
    Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as college graduates.

  • Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Gender [ Time Frame: 30Sep2008 through 23Dec2008 ] [ Designated as safety issue: No ]
    Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as male.


Enrollment: 4411
Study Start Date: September 2008
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00808808

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