Healthy
Conditions
Keywords
FluMist, TIV, vaccination rates
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.
Interventions
BIOLOGICALChoice 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
OTHERChoice 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
BIOLOGICALControl - Usual care offering TIV only with baseline advertisement
A control arm of usual care offering TIV with baseline advertisement
Sponsors
Passport Health
University of Pittsburgh
MedImmune LLC
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Vaccination Rate, All Ages | 30Sep2008 through 23Dec2008 |
| Overall Vaccination Rate, Employees 18 to 49 Years of Age | 30Sep2008 through 23Dec2008 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| 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 |
| 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. |
| 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. |
| 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 |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| Arm A (Control) A control arm of usual care offering TIV with baseline advertisement | 1,392 |
| Arm B (Choice) An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist | 1,489 |
| Arm C (Choice Plus) An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination | 2,132 |
| Total | 5,013 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Employee was not vaccinated. | 2,686 | 2,268 | 2,255 |
| Overall Study | Vaccinated; survey not completed | 131 | 169 | 302 |
Baseline characteristics
| Characteristic | Arm A (Control) | Arm B (Choice) | Arm C (Choice Plus) | Total |
|---|---|---|---|---|
| Age, Customized 18 to 49 years | 983 participants | 988 participants | 1398 participants | 3369 participants |
| Age, Customized ≥ 50 years | 409 participants | 501 participants | 734 participants | 1644 participants |
| Sex/Gender, Customized Female | 644 participants | 675 participants | 1324 participants | 2643 participants |
| Sex/Gender, Customized Male | 748 participants | 814 participants | 808 participants | 2370 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Overall Vaccination Rate, All Ages
Time frame: 30Sep2008 through 23Dec2008
Population: All employees at participating sites, including those who were vaccinated and those who were not
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A (Control) | Overall Vaccination Rate, All Ages | 41.6 Percentage of participants |
| Arm B (Choice) | Overall Vaccination Rate, All Ages | 45.1 Percentage of participants |
| Arm C (Choice Plus) | Overall Vaccination Rate, All Ages | 51.0 Percentage of participants |
Primary
Overall Vaccination Rate, Employees 18 to 49 Years of Age
Time frame: 30Sep2008 through 23Dec2008
Population: All vaccinated employees at participating sites, including those who completed surveys and those who did not
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A (Control) | Overall Vaccination Rate, Employees 18 to 49 Years of Age | 38.5 Percentage of participants |
| Arm B (Choice) | Overall Vaccination Rate, Employees 18 to 49 Years of Age | 40.9 Percentage of participants |
| Arm C (Choice Plus) | Overall Vaccination Rate, Employees 18 to 49 Years of Age | 46.1 Percentage of participants |
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
Time frame: 2007-2008 season through 2008-2009 season
Population: All vaccinated employees 18-49 years of age at participating sites, including those who completed surveys and those who did not
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A (Control) | Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in Employees 18-49 Years of Age | 3.7 percentage points |
| Arm B (Choice) | Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in Employees 18-49 Years of Age | 2.4 percentage points |
| Arm C (Choice Plus) | Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in Employees 18-49 Years of Age | 9.7 percentage points |
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
Time frame: 2007-2008 season through 2008-2009 season
Population: All vaccinated employees at participating sites, including those who completed surveys and those who did not
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A (Control) | Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in the Total Population | 4.7 percentage points |
| Arm B (Choice) | Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in the Total Population | 4.8 percentage points |
| Arm C (Choice Plus) | Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in the Total Population | 12.7 percentage points |
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.
Time frame: 30Sep2008 through 23Dec2008
Population: All participants who completed surveys and were eligible to receive FluMist
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A (Control) | Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Education | 73.4 percent |
| Arm B (Choice) | Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Education | 52.8 percent |
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.
Time frame: 30Sep2008 through 23Dec2008
Population: All participants who completed surveys and were eligible to receive FluMist
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A (Control) | Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Gender | 49.9 percent |
| Arm B (Choice) | Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Gender | 49.7 percent |
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
Time frame: 30Sep2008 through 23Dec2008
Population: All participants who completed surveys and were eligible to receive FluMist
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A (Control) | Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Race | 67.8 percent |
| Arm B (Choice) | Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Race | 71.8 percent |
Secondary
Percent of Eligible Participants 18-49 Years of Age Choosing FluMist During Intervention Season
Time frame: 30Sep2008 through 23Dec2008
Population: All vaccinated employees 18-49 years of age at participating sites, including those who completed surveys and those who did not
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A (Control) | Percent of Eligible Participants 18-49 Years of Age Choosing FluMist During Intervention Season | 0.8 percent |
| Arm B (Choice) | Percent of Eligible Participants 18-49 Years of Age Choosing FluMist During Intervention Season | 19.1 percent |
| Arm C (Choice Plus) | Percent of Eligible Participants 18-49 Years of Age Choosing FluMist During Intervention Season | 26.8 percent |