Assessing Choice in the Employer Setting (ACES) Study

Completed

• Conditions: Healthy
• Interventions: Biological: Control - Usual care offering TIV only with baseline advertisement; Biological: Choice of TIV or FluMist with baseline advertisement; Other: Choice of TIV or FluMist with enhanced advertisement and incentives

• Registration Number: NCT00808808
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-09
• Primary Completion: 2008-11
• Study Completion: 2008-12
• Study First Submitted: 2008-12-12
• Study First Submitted QC: 2008-12-15
• Study First Posted: 2008-12-16
• Results First Submitted: 2012-07-30
• Results First Submitted QC: 2012-08-10
• Results First Posted: 2012-09-13
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-28
• Last Update Posted: 2013-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4411

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm A (Control)	Control - Usual care offering TIV only with baseline advertisement	A control arm of usual care offering TIV with baseline advertisement
Arm B (Choice)	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)	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

Name	Time	Method
Overall Vaccination Rate, All Ages	30Sep2008 through 23Dec2008
Overall Vaccination Rate, Employees 18 to 49 Years of Age	30Sep2008 through 23Dec2008

Secondary Outcome Measures

Name	Time	Method
Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in the Total Population	2007-2008 season through 2008-2009 season	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	2007-2008 season through 2008-2009 season	Rate difference by arm from baseline to intervention season
Percent of Eligible Participants 18-49 Years of Age Choosing FluMist During Intervention Season	30Sep2008 through 23Dec2008
Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Race	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
Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Education	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.
Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Gender	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.