Assessing Choice in the Employer Setting (ACES) Study - Full Text View

Sponsors and Collaborators:	MedImmune LLC Passport Health University of Pittsburgh
Information provided by:	MedImmune LLC
ClinicalTrials.gov Identifier:	NCT00808808

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 TIV in the employer setting when compared to a control group.

Condition	Intervention
Healthy	Biological: FluMist

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Study Type:	Observational
Study Design:	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

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:

Demographic characteristics of the entire vaccinated population will be compared to the demographics of those who filled out the surveys to assess for any selection bias introduced by those who voluntarily chose not to complete a survey. [ Time Frame: February 28, 2009 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	5300
Study Start Date:	September 2008
Estimated Study Completion Date:	February 2009
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 TIV-only influenza injection	Biological: FluMist September-November 2008; 3 months continual
2 Choice of TIV or FluMist	Biological: FluMist September-November 2008; 3 months continual
3 Choice of TIV or FluMist	Biological: FluMist September-November 2008; 3 months continual

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 to 49 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Adults: 18 to 49 years of age

Criteria

Inclusion Criteria:

Located in the United States
Has offered an employee vaccination program for the previous 3 years
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 of 125 employees
Not in the healthcare field
Does not offer vaccines to dependents
Male or female at least 18 years of age
Current employee attending the influenza clinic sponsored by their employer

Exclusion Criteria:

In healthcare field
Has been previously offered FluMist in an employee vaccination program in the past or FluMist represented less than 5% of all vaccine received at past programs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808808

Show 54 Study Locations

Sponsors and Collaborators

MedImmune LLC

Passport Health

University of Pittsburgh

Investigators

Study Director:

Seth Toback, M.D.

MedImmune LLC

More Information

No publications provided

Responsible Party:	Medimmune LLC ( Seth Toback, MD )
Study ID Numbers:	MI-MA-181
Study First Received:	December 12, 2008
Last Updated:	February 4, 2009
ClinicalTrials.gov Identifier:	NCT00808808 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Influenza, Human
Healthy

ClinicalTrials.gov processed this record on May 07, 2009