Clinical trial NCT00808808: Assessing Choice in the Employer Setting (ACES) Study
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: FluMist, TIV, vaccination rates
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
Collaborators: name: Passport Health
name: University of Pittsburgh
First posted: 2008-12-16
Enrollment: 4411
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
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

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.

Eligibility 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

Primary outcomes:
measure: Overall Vaccination Rate, All Ages
timeFrame: 30Sep2008 through 23Dec2008
measure: Overall Vaccination Rate, Employees 18 to 49 Years of Age
timeFrame: 30Sep2008 through 23Dec2008
Secondary outcomes:
measure: Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in the Total Population
timeFrame: 2007-2008 season through 2008-2009 season
measure: Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in Employees 18-49 Years of Age
timeFrame: 2007-2008 season through 2008-2009 season
measure: Percent of Eligible Participants 18-49 Years of Age Choosing FluMist During Intervention Season
timeFrame: 30Sep2008 through 23Dec2008
measure: Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Race
timeFrame: 30Sep2008 through 23Dec2008
measure: Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Education
timeFrame: 30Sep2008 through 23Dec2008
measure: Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Gender
timeFrame: 30Sep2008 through 23Dec2008
Other outcomes:
Locations:
city: Chatsworth
country: United States
state: California
city: Novato
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Santa Clara
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Sunnyvale
country: United States
state: California
city: Thousand Oaks
country: United States
state: California
city: Boulder
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Tampa
country: United States
state: Florida
city: Hebron
country: United States
state: Kentucky
city: LaGrange
country: United States
state: Kentucky
city: Lawrenceburg
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Annapolis
country: United States
state: Maryland
city: Baltimore
country: United States
state: Maryland
city: Baltimore
country: United States
state: Maryland
city: Baltimore
country: United States
state: Maryland
city: Baltimore
country: United States
state: Maryland
city: Baltimore
country: United States
state: Maryland
city: Baltimore
country: United States
state: Maryland
city: Calverton
country: United States
state: Maryland
city: Cockeysville
country: United States
state: Maryland
city: Columbia
country: United States
state: Maryland
city: Columbia
country: United States
state: Maryland
city: Crofton
country: United States
state: Maryland
city: Hanover
country: United States
state: Maryland
city: Hunt Valley
country: United States
state: Maryland
city: Laurel
country: United States
state: Maryland
city: Sparks
country: United States
state: Maryland
city: Basking Ridge
country: United States
state: New Jersey
city: Larwenceville
country: United States
state: New Jersey
city: Morristown
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Rochester
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: High Point
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Hamilton
country: United States
state: Ohio
city: Lebanon
country: United States
state: Ohio
city: West Chester
country: United States
state: Ohio
city: Fredericksburg
country: United States
state: Virginia
Study officials:
affiliation: MedImmune LLC
name: Seth Toback, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.