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| Name | Class |
|---|---|
| Passport Health | INDUSTRY |
| University of Pittsburgh | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (Control) | A control arm of usual care offering TIV with baseline advertisement |
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| Arm B (Choice) | An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist |
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| Arm C (Choice Plus) | An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Choice of TIV or FluMist with baseline advertisement | Biological | An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Vaccination Rate, All Ages | 30Sep2008 through 23Dec2008 | |
| Overall Vaccination Rate, Employees 18 to 49 Years of Age | 30Sep2008 through 23Dec2008 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in the Total Population | Rate difference by arm from baseline to intervention season | 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 |
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Inclusion Criteria for employer sites:
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Adults at least 18 years of age who are current employees attending the influenza clinic sponsored by their employer
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| Name | Affiliation | Role |
|---|---|---|
| Seth Toback, M.D. | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chatsworth | California | 91311 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20638452 | Result | 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. | |
| 20036102 | Result | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A (Control) | A control arm of usual care offering TIV with baseline advertisement |
| FG001 | Arm B (Choice) | An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Choice of TIV or FluMist with enhanced advertisement and incentives | Other | An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination |
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| Control - Usual care offering TIV only with baseline advertisement | Biological | A control arm of usual care offering TIV with baseline advertisement |
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Rate difference by arm from baseline to intervention season |
| 2007-2008 season through 2008-2009 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 | Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as white | 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. | 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. | 30Sep2008 through 23Dec2008 |
| Novato |
| California |
| 94945 |
| United States |
| Sacramento | California | 95815 | United States |
| Sacramento | California | 95833 | United States |
| San Francisco | California | 94115 | United States |
| Santa Clara | California | 96050 | United States |
| Santa Monica | California | 90405 | United States |
| Sunnyvale | California | 94089 | United States |
| Thousand Oaks | California | 91362 | United States |
| Boulder | Colorado | 80305 | United States |
| Denver | Colorado | 80246 | United States |
| Washington D.C. | District of Columbia | 20009 | United States |
| Tampa | Florida | 33619 | United States |
| Hebron | Kentucky | 41048 | United States |
| La Grange | Kentucky | 40031 | United States |
| Lawrenceburg | Kentucky | 40342 | United States |
| Louisville | Kentucky | 40203 | United States |
| Louisville | Kentucky | 40223 | United States |
| Annapolis | Maryland | 21401 | United States |
| Baltimore | Maryland | 21201 | United States |
| Baltimore | Maryland | 21202 | United States |
| Baltimore | Maryland | 21209 | United States |
| Baltimore | Maryland | 21220 | United States |
| Baltimore | Maryland | 21224 | United States |
| Baltimore | Maryland | 21244 | United States |
| Calverton | Maryland | 20705 | United States |
| Cockeysville | Maryland | 21030 | United States |
| Columbia | Maryland | 21045 | United States |
| Columbia | Maryland | 21046 | United States |
| Crofton | Maryland | 21114 | United States |
| Hanover | Maryland | 21076 | United States |
| Hunt Valley | Maryland | 21031 | United States |
| Laurel | Maryland | 20707 | United States |
| Sparks | Maryland | 21152 | United States |
| Basking Ridge | New Jersey | 07920 | United States |
| Larwenceville | New Jersey | 8648 | United States |
| Morristown | New Jersey | 07962 | United States |
| Albuquerque | New Mexico | 87113 | United States |
| Rochester | New York | 14586 | United States |
| Rochester | New York | 14614 | United States |
| Rochester | New York | 14625 | United States |
| High Point | North Carolina | 27260 | United States |
| Cincinnati | Ohio | 45202 | United States |
| Hamilton | Ohio | 45015 | United States |
| Lebanon | Ohio | 45036 | United States |
| West Chester | Ohio | 45096 | United States |
| Fredericksburg | Virginia | 22401 | United States |
| FG002 | Arm C (Choice Plus) | An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination |
| Vaccinated |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A (Control) | A control arm of usual care offering TIV with baseline advertisement |
| BG001 | Arm B (Choice) | An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist |
| BG002 | Arm C (Choice Plus) | An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex/Gender, Customized | Includes all vaccinated employees, not only participants who completed surveys. | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Vaccination Rate, All Ages | All employees at participating sites, including those who were vaccinated and those who were not | Posted | Number | Percentage of participants | 30Sep2008 through 23Dec2008 |
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| Primary | Overall Vaccination Rate, Employees 18 to 49 Years of Age | All vaccinated employees at participating sites, including those who completed surveys and those who did not | Posted | Number | Percentage of participants | 30Sep2008 through 23Dec2008 |
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| Secondary | Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in the Total Population | Rate difference by arm from baseline to intervention season | All vaccinated employees at participating sites, including those who completed surveys and those who did not | Posted | Number | percentage points | 2007-2008 season through 2008-2009 season |
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| Secondary | 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 | All vaccinated employees 18-49 years of age at participating sites, including those who completed surveys and those who did not | Posted | Number | percentage points | 2007-2008 season through 2008-2009 season |
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| Secondary | Percent of Eligible Participants 18-49 Years of Age Choosing FluMist During Intervention Season | All vaccinated employees 18-49 years of age at participating sites, including those who completed surveys and those who did not | Posted | Number | percent | 30Sep2008 through 23Dec2008 |
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| Secondary | 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 | All participants who completed surveys and were eligible to receive FluMist | Posted | Number | percent | 30Sep2008 through 23Dec2008 |
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| Secondary | 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. | All participants who completed surveys and were eligible to receive FluMist | Posted | Number | percent | 30Sep2008 through 23Dec2008 |
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| Secondary | 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. | All participants who completed surveys and were eligible to receive FluMist | Posted | Number | percent | 30Sep2008 through 23Dec2008 |
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September 2008 - December 2008
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A (Control) | A control arm of usual care offering TIV with baseline advertisement | 0 | 0 | 0 | 0 | ||
| EG001 | Arm B (Choice) | An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist | 0 | 0 | 0 | 0 | ||
| EG002 | Arm C (Choice Plus) | An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination | 0 | 0 | 0 | 0 |
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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.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Seth Toback, MD | MedImmune, LLC | 301-398-0000 | tobacks@medimmune.com |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000613429 | FluMist |
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| ≥ 50 years |
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| Female |
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