HealthyMA181NCT00808808
Assessing Choice in the Employer Setting (ACES) Study
An observational study of Healthy, run by MedImmune LLC at 47 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Choice of TIV or FluMist with baseline advertisement and Choice of TIV or FluMist with enhanced advertisement and incentives
- Type of treatment
- Vaccines
- How many people
- 4,411 participants
- Where
- 47 sitesUnited States
- Study dates
- Sep 2008to Dec 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults at least 18 years of age who are current employees attending the influenza clinic sponsored by their employer
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
United States47 sites
Study site
Albuquerque, New Mexico, 87113
Study site
Annapolis, Maryland, 21401
Study site
Baltimore, Maryland, 21201
Study site
Baltimore, Maryland, 21202
Study site
Baltimore, Maryland, 21209
Study site
Baltimore, Maryland, 21220
Study site
Baltimore, Maryland, 21224
Study site
Baltimore, Maryland, 21244
Study site
Basking Ridge, New Jersey, 07920
Study site
Boulder, Colorado, 80305
Study site
Calverton, Maryland, 20705
Study site
Chatsworth, California, 91311
Study site
Cincinnati, Ohio, 45202
Study site
Cockeysville, Maryland, 21030
Study site
Columbia, Maryland, 21045
Study site
Columbia, Maryland, 21046
Study site
Crofton, Maryland, 21114
Study site
Denver, Colorado, 80246
Study site
Fredericksburg, Virginia, 22401
Study site
Hamilton, Ohio, 45015
Study site
Hanover, Maryland, 21076
Study site
Hebron, Kentucky, 41048
Study site
High Point, North Carolina, 27260
Study site
Hunt Valley, Maryland, 21031
Study site
La Grange, Kentucky, 40031
Study site
Larwenceville, New Jersey, 8648
Study site
Laurel, Maryland, 20707
Study site
Lawrenceburg, Kentucky, 40342
Study site
Lebanon, Ohio, 45036
Study site
Louisville, Kentucky, 40203
Study site
Louisville, Kentucky, 40223
Study site
Morristown, New Jersey, 07962
Study site
Novato, California, 94945
Study site
Rochester, New York, 14586
Study site
Rochester, New York, 14614
Study site
Rochester, New York, 14625
Study site
Sacramento, California, 95815
Study site
Sacramento, California, 95833
Study site
San Francisco, California, 94115
Study site
Santa Clara, California, 96050
Study site
Santa Monica, California, 90405
Study site
Sparks, Maryland, 21152
Study site
Sunnyvale, California, 94089
Study site
Tampa, Florida, 33619
Study site
Thousand Oaks, California, 91362
Study site
Washington D.C., District of Columbia, 20009
Study site
West Chester, Ohio, 45096
About this 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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Choice of TIV or FluMist with baseline advertisement, Choice of TIV or FluMist with enhanced advertisement and incentives, Control - Usual care offering TIV only with baseline advertisement
- Keywords
- FluMist, TIV, vaccination rates
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Choice of TIV or FluMist with baseline advertisementBiological
An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
Choice of TIV or FluMist with enhanced advertisement and incentivesOther
An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
Control - Usual care offering TIV only with baseline advertisementBiological
A control arm of usual care offering TIV with baseline advertisement
| Study group | Role | What they receive |
|---|---|---|
| Arm A (Control) | A control arm of usual care offering TIV with baseline advertisement Receives: Biological: Control - Usual care offering TIV only 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 Receives: Biological: Choice of TIV or FluMist with baseline advertisement | |
| Arm C (Choice Plus) | An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination Receives: Other: Choice of TIV or FluMist with enhanced advertisement and incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Vaccination Rate, All Ages
Measured: 30Sep2008 through 23Dec2008
Overall Vaccination Rate, Employees 18 to 49 Years of Age
Measured: 30Sep2008 through 23Dec2008
Secondary outcomes (6)
Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in the Total Population
Rate difference by arm from baseline to intervention season
Measured: 2007-2008 season through 2008-2009 season
Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in Employees 18-49 Years of Age
Rate difference by arm from baseline to intervention season
Measured: 2007-2008 season through 2008-2009 season
Percent of Eligible Participants 18-49 Years of Age Choosing FluMist During Intervention Season
Measured: 30Sep2008 through 23Dec2008
Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Race
Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as white
Measured: 30Sep2008 through 23Dec2008
Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Education
Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as college graduates.
Measured: 30Sep2008 through 23Dec2008
Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Gender
Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as male.
Measured: 30Sep2008 through 23Dec2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2008 (estimated)
- Study startSep 2008
- Primary completionNov 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 4,411 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Passport Health, University of Pittsburgh
- Investigators
- Seth Toback, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808808
- Sponsor's protocol ID
- MI-MA-181
- Acronym
- MA181
- Status last verified
- Oct 2013
- First submitted
- 12 Dec 2008
- Last updated
- 20 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20638452Nowalk 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.
PubMed 20036102
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00808808
- Acronym / sponsor ID
- MA181 / MI-MA-181
- Conditions
- Healthy
- Keywords
- FluMist, TIV, vaccination rates
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,411 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Collaborators
- Passport Health, University of Pittsburgh
- Study start
- Sep 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 16 Dec 2008 (estimated)
- Results
- Posted 13 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A (Control) | – | Biological: Control - Usual care offering TIV only with baseline advertisementA control arm of usual care offering TIV with baseline advertisement |
| Arm B (Choice) | – | Biological: Choice of TIV or FluMist with baseline advertisementAn intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist |
| Arm C (Choice Plus) | – | Other: Choice of TIV or FluMist with enhanced advertisement and incentivesAn intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults at least 18 years of age who are current employees attending the influenza clinic sponsored by their employer
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Choice of TIV or FluMist with baseline advertisementAn intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist | Biological | Arm B (Choice) |
| Choice of TIV or FluMist with enhanced advertisement and incentivesAn intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination | Other | Arm C (Choice Plus) |
| Control - Usual care offering TIV only with baseline advertisementA control arm of usual care offering TIV with baseline advertisement | Biological | Arm A (Control) |
Primary outcome
Overall Vaccination Rate, All Ages
Time frame: 30Sep2008 through 23Dec2008
Overall Vaccination Rate, Employees 18 to 49 Years of Age
Time frame: 30Sep2008 through 23Dec2008
6 secondary outcomes
Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in the Total Population
Time frame: 2007-2008 season through 2008-2009 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
Percent of Eligible Participants 18-49 Years of Age Choosing FluMist During Intervention Season
Time frame: 30Sep2008 through 23Dec2008
Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Race
Time frame: 30Sep2008 through 23Dec2008
Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Education
Time frame: 30Sep2008 through 23Dec2008
Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Gender
Time frame: 30Sep2008 through 23Dec2008
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20638452Lin 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.
- Results publication: PubMed 20036102Nowalk 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seth Toback, M.D. study director
MedImmune LLC
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by MedImmune LLC at 47 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Vaccination Rate, All Ages (time frame: 30Sep2008 through 23Dec2008). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00808808, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2013.