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

• Sponsor: MedImmune LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00808808
• Collaborator: Passport Health (Industry), University of Pittsburgh (Other)
• Enrollment: 4,411
• Locations: 47
• Duration (Months): 3
• Patients Per Site: 93.9
• Patients Per Site Per Month: 31.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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

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 Design

• Study Type: Observational
• Actual Enrollment: 4411 participants
• 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
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Overall Vaccination Rate, All Ages [30Sep2008 through 23Dec2008]

2. Overall Vaccination Rate, Employees 18 to 49 Years of Age [30Sep2008 through 23Dec2008]

Secondary Outcome Measures

1. 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

2. 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

3. Percent of Eligible Participants 18-49 Years of Age Choosing FluMist During Intervention Season [30Sep2008 through 23Dec2008]

4. 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

5. 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.

6. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1		Chatsworth	California	United States	91311
2		Novato	California	United States	94945
3		Sacramento	California	United States	95815
4		Sacramento	California	United States	95833
5		San Francisco	California	United States	94115
6		Santa Clara	California	United States	96050
7		Santa Monica	California	United States	90405
8		Sunnyvale	California	United States	94089
9		Thousand Oaks	California	United States	91362
10		Boulder	Colorado	United States	80305
11		Denver	Colorado	United States	80246
12		Washington	District of Columbia	United States	20009
13		Tampa	Florida	United States	33619
14		Hebron	Kentucky	United States	41048
15		LaGrange	Kentucky	United States	40031
16		Lawrenceburg	Kentucky	United States	40342
17		Louisville	Kentucky	United States	40203
18		Louisville	Kentucky	United States	40223
19		Annapolis	Maryland	United States	21401
20		Baltimore	Maryland	United States	21201
21		Baltimore	Maryland	United States	21202
22		Baltimore	Maryland	United States	21209
23		Baltimore	Maryland	United States	21220
24		Baltimore	Maryland	United States	21224
25		Baltimore	Maryland	United States	21244
26		Calverton	Maryland	United States	20705
27		Cockeysville	Maryland	United States	21030
28		Columbia	Maryland	United States	21045
29		Columbia	Maryland	United States	21046
30		Crofton	Maryland	United States	21114
31		Hanover	Maryland	United States	21076
32		Hunt Valley	Maryland	United States	21031
33		Laurel	Maryland	United States	20707
34		Sparks	Maryland	United States	21152
35		Basking Ridge	New Jersey	United States	07920
36		Larwenceville	New Jersey	United States	8648
37		Morristown	New Jersey	United States	07962
38		Albuquerque	New Mexico	United States	87113
39		Rochester	New York	United States	14586
40		Rochester	New York	United States	14614
41		Rochester	New York	United States	14625
42		High Point	North Carolina	United States	27260
43		Cincinnati	Ohio	United States	45202
44		Hamilton	Ohio	United States	45015
45		Lebanon	Ohio	United States	45036
46		West Chester	Ohio	United States	45096
47		Fredericksburg	Virginia	United States	22401

Sponsors and Collaborators

• MedImmune LLC
• Passport Health
• University of Pittsburgh

Investigators

• Study Director: Seth Toback, M.D., MedImmune LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00808808
• Other Study ID Numbers: MI-MA-181
• First Posted: Dec 16, 2008
• Last Update Posted: Nov 20, 2013
• Last Verified: Oct 1, 2013

• Keywords provided by , ,: FluMist, TIV, vaccination rates

Study Results

Participant Flow

Recruitment Details	Potential employers estimated to have at least 60 employees were contacted to determine their interest in participating in the study and were offered an influenza vaccine clinic on site at no cost. A screening questionnaire to determine eligibility was completed. Sites were excluded according to the study inclusion and exclusion criteria.

Arm/Group Title	Arm A (Control)	Arm B (Choice)	Arm C (Choice Plus)
Arm/Group Description	A control arm of usual care offering TIV with baseline advertisement	An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist	An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
Period Title: Overall Study
STARTED	4078	3757	4387
Vaccinated	1392	1489	2132
COMPLETED	1261	1320	1830
NOT COMPLETED	2817	2437	2557

Baseline Characteristics

Arm/Group Title	Arm A (Control)	Arm B (Choice)	Arm C (Choice Plus)	Total
Arm/Group Description	A control arm of usual care offering TIV with baseline advertisement	An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist	An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination	Total of all reporting groups
Overall Participants	1392	1489	2132	5013
Age, Customized (participants) [Number]
18 to 49 years	983 70.6%	988 66.4%	1398 65.6%	3369 67.2%
≥ 50 years	409 29.4%	501 33.6%	734 34.4%	1644 32.8%
Sex/Gender, Customized (participants) [Number]
Male	748 53.7%	814 54.7%	808 37.9%	2370 47.3%
Female	644 46.3%	675 45.3%	1324 62.1%	2643 52.7%

Outcome Measures

1. Primary Outcome

Title	Overall Vaccination Rate, All Ages
Time Frame	30Sep2008 through 23Dec2008

Outcome Measure Data

Analysis Population Description

All employees at participating sites, including those who were vaccinated and those who were not

Arm/Group Title	Arm A (Control)	Arm B (Choice)	Arm C (Choice Plus)
Arm/Group Description	A control arm of usual care offering TIV with baseline advertisement	An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist	An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
Measure Participants	4078	3757	4387
Number [Percentage of participants]	41.6 3%	45.1 3%	51.0 2.4%

2. Primary Outcome

Title	Overall Vaccination Rate, Employees 18 to 49 Years of Age
Time Frame	30Sep2008 through 23Dec2008

Outcome Measure Data

Analysis Population Description

All vaccinated employees at participating sites, including those who completed surveys and those who did not

Arm/Group Title	Arm A (Control)	Arm B (Choice)	Arm C (Choice Plus)
Arm/Group Description	A control arm of usual care offering TIV with baseline advertisement	An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist	An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
Measure Participants	983	988	1398
Number [Percentage of participants]	38.5 2.8%	40.9 2.7%	46.1 2.2%

3. Secondary Outcome

Title	Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in the Total Population
Description	Rate difference by arm from baseline to intervention season
Time Frame	2007-2008 season through 2008-2009 season

Outcome Measure Data

Analysis Population Description

All vaccinated employees at participating sites, including those who completed surveys and those who did not

Arm/Group Title	Arm A (Control)	Arm B (Choice)	Arm C (Choice Plus)
Arm/Group Description	A control arm of usual care offering TIV with baseline advertisement	An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist	An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
Measure Participants	1392	1489	2132
Number [percentage points]	4.7	4.8	12.7

4. Secondary Outcome

Title	Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in Employees 18-49 Years of Age
Description	Rate difference by arm from baseline to intervention season
Time Frame	2007-2008 season through 2008-2009 season

Outcome Measure Data

Analysis Population Description

All vaccinated employees 18-49 years of age at participating sites, including those who completed surveys and those who did not

Arm/Group Title	Arm A (Control)	Arm B (Choice)	Arm C (Choice Plus)
Arm/Group Description	A control arm of usual care offering TIV with baseline advertisement	An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist	An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
Measure Participants	983	988	1398
Number [percentage points]	3.7	2.4	9.7

5. Secondary Outcome

Title	Percent of Eligible Participants 18-49 Years of Age Choosing FluMist During Intervention Season
Time Frame	30Sep2008 through 23Dec2008

Outcome Measure Data

Analysis Population Description

All vaccinated employees 18-49 years of age at participating sites, including those who completed surveys and those who did not

Arm/Group Title	Arm A (Control)	Arm B (Choice)	Arm C (Choice Plus)
Arm/Group Description	A control arm of usual care offering TIV with baseline advertisement	An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist	An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
Measure Participants	983	988	1398
Number [percent]	0.8	19.1	26.8

6. Secondary Outcome

Title	Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Race
Description	Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as white
Time Frame	30Sep2008 through 23Dec2008

Outcome Measure Data

Analysis Population Description

All participants who completed surveys and were eligible to receive FluMist

Arm/Group Title	Vaccinated With FluMist	Vaccinated With TIV
Arm/Group Description	Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with FluMist, and who self-identified as white	Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with TIV, and who self-identified as white.
Measure Participants	399	1990
Number [percent]	67.8	71.8

7. Secondary Outcome

Title	Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Education
Description	Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as college graduates.
Time Frame	30Sep2008 through 23Dec2008

Outcome Measure Data

Analysis Population Description

All participants who completed surveys and were eligible to receive FluMist

Arm/Group Title	Vaccinated With FluMist	Vaccinated With TIV
Arm/Group Description	Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with FluMist, and who self-identified as college graduates.	Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with TIV, and who self-identified as college graduates.
Measure Participants	399	1990
Number [percent]	73.4	52.8

8. Secondary Outcome

Title	Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Gender
Description	Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as male.
Time Frame	30Sep2008 through 23Dec2008

Outcome Measure Data

Analysis Population Description

All participants who completed surveys and were eligible to receive FluMist

Arm/Group Title	Vaccinated With FluMist	Vaccinated With TIV
Arm/Group Description	Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with FluMist, and who self-identified as male.	Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with TIV, and who self-identified as male.
Measure Participants	399	1990
Number [percent]	49.9	49.7

Adverse Events

Time Frame	September 2008 - December 2008
Adverse Event Reporting Description	Participants received commercial vaccine per routine care at employer clinics; no investigational treatment was given. Safety data were not collected. Any participant who experienced an adverse event associated with a MedImmune commercial vaccine was to be advised to notify the MedImmune Patient Safety Department. No such events were reported.
Arm/Group Title	Arm A (Control)		Arm B (Choice)		Arm C (Choice Plus)
Arm/Group Description	A control arm of usual care offering TIV with baseline advertisement		An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist		An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
All Cause Mortality
	Arm A (Control)		Arm B (Choice)		Arm C (Choice Plus)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm A (Control)		Arm B (Choice)		Arm C (Choice Plus)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Arm A (Control)		Arm B (Choice)		Arm C (Choice Plus)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

The study was conducted during a single season, data to evaluate effects of the intervention by race were unavailable, baseline vaccination data were available at the company level only, and vaccines received outside the workplace were not assessed.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.The principal investigators (PIs) also agree for data to be presented first as a joint, multi-center publication.