Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Not applicable.

Reporting Groups

	Description
Arm A (Control)	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
Arm C (Choice Plus)	An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination

Participant Flow: Overall Study

	Arm A (Control)	Arm B (Choice)	Arm C (Choice Plus)
STARTED	4078^[1]	3757^[2]	4387^[3]
Vaccinated	1392^[4]	1489^[5]	2132^[6]
COMPLETED	1261^[7]	1320^[8]	1830^[9]
NOT COMPLETED	2817	2437	2557
Vaccinated; survey not completed	131	169	302
Employee was not vaccinated.	2686	2268	2255

[1]	Started includes all employees at participating sites.
[2]	Started includes all employees at participating sites
[3]	Started includes all employees at participating sites.
[4]	Vaccinated includes all employees who were vaccinated at the employee vaccination clinics.
[5]	Vaccinated includes all employees who were vaccinated at the employee vaccination clinics.
[6]	Vaccinated includes all employees who were vaccinated at the employee vaccination clinics.
[7]	Completed includes vaccinated employees who completed surveys.
[8]	Completed includes vaccinated employees who completed surveys.
[9]	Completed includes vaccinated employees who completed surveys.

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
Arm A (Control)	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
Arm C (Choice Plus)	An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination

Baseline Measures

	Arm A (Control)	Arm B (Choice)	Arm C (Choice Plus)	Total
Number of Participants [units: Participants]	1392	1489	2132	4411
Age, Customized [units: participants]
18 to 49 years	983	988	1398	65.6
≥ 50 years	409	501	734	34.4
Gender, Customized ^[1] [units: participants]
Male	748	814	808	47.2
Female	644	675	1324	52.8

Outcome Measures

1. Primary Outcome Measure: Overall vaccination rate, all ages [ Time Frame: 30Sep2008 through 23Dec2008 ]

Measure Type	Primary
Measure Name	Overall vaccination rate, all ages
Measure Description
Time Frame	30Sep2008 through 23Dec2008
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All employees at participating sites, including those who were vaccinated and those who were not

Reporting Groups

	Description
Arm A (Control)	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
Arm C (Choice Plus)	An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination

Measured Values

	Arm A (Control)	Arm B (Choice)	Arm C (Choice Plus)
Number of Participants Analyzed [units:participants]	4078	3757	4387
Overall vaccination rate, all ages [units: Percentage of participants]	41.6	45.1	51.0

No statistical analysis provided for Overall vaccination rate, all ages

2. Primary Outcome Measure: Overall vaccination rate, employees 18 to 49 years of age [ Time Frame: 30Sep2008 through 23Dec2008 ]

Measure Type	Primary
Measure Name	Overall vaccination rate, employees 18 to 49 years of age
Measure Description
Time Frame	30Sep2008 through 23Dec2008
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All vaccinated employees at participating sites, including those who completed surveys and those who did not

Reporting Groups

	Description
Arm A (Control)	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
Arm C (Choice Plus)	An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination

Measured Values

	Arm A (Control)	Arm B (Choice)	Arm C (Choice Plus)
Number of Participants Analyzed [units:participants]	983	988	1398
Overall vaccination rate, employees 18 to 49 years of age [units: Percentage of participants]	38.5	40.9	46.1

No statistical analysis provided for Overall vaccination rate, employees 18 to 49 years of age

3. Secondary Outcome Measure: Change in influenza vaccination rate from baseline season to intervention season in the total population [ Time Frame: 2007-2008 season through 2008-2009 season ]

Measure Type	Secondary
Measure Name	Change in influenza vaccination rate from baseline season to intervention season in the total population
Measure Description	Rate difference by arm from baseline to intervention season
Time Frame	2007-2008 season through 2008-2009 season
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All vaccinated employees at participating sites, including those who completed surveys and those who did not

Reporting Groups

	Description
Arm A (Control)	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
Arm C (Choice Plus)	An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination

Measured Values

	Arm A (Control)	Arm B (Choice)	Arm C (Choice Plus)
Number of Participants Analyzed [units:participants]	1392	1489	2132
Change in influenza vaccination rate from baseline season to intervention season in the total population [units: percentage points]	4.7	4.8	12.7

No statistical analysis provided for Change in influenza vaccination rate from baseline season to intervention season in the total population

4. Secondary Outcome Measure: 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 ]

Measure Type	Secondary
Measure Name	Change in influenza vaccination rate from baseline season to intervention season in employees 18-49 years of age
Measure Description	Rate difference by arm from baseline to intervention season
Time Frame	2007-2008 season through 2008-2009 season
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All vaccinated employees 18-49 years of age at participating sites, including those who completed surveys and those who did not

Reporting Groups

	Description
Arm A (Control)	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
Arm C (Choice Plus)	An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination

Measured Values

	Arm A (Control)	Arm B (Choice)	Arm C (Choice Plus)
Number of Participants Analyzed [units:participants]	983	988	1398
Change in influenza vaccination rate from baseline season to intervention season in employees 18-49 years of age [units: percentage points]	3.7	2.4	9.7

No statistical analysis provided for Change in influenza vaccination rate from baseline season to intervention season in employees 18-49 years of age

5. Secondary Outcome Measure: Percent of eligible participants 18-49 years of age choosing FluMist during intervention season [ Time Frame: 30Sep2008 through 23Dec2008 ]

Measure Type	Secondary
Measure Name	Percent of eligible participants 18-49 years of age choosing FluMist during intervention season
Measure Description
Time Frame	30Sep2008 through 23Dec2008
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All vaccinated employees 18-49 years of age at participating sites, including those who completed surveys and those who did not

Reporting Groups

	Description
Arm A (Control)	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
Arm C (Choice Plus)	An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination

Measured Values

	Arm A (Control)	Arm B (Choice)	Arm C (Choice Plus)
Number of Participants Analyzed [units:participants]	983	988	1398
Percent of eligible participants 18-49 years of age choosing FluMist during intervention season [units: percent]	0.8	19.1	26.8

No statistical analysis provided for Percent of eligible participants 18-49 years of age choosing FluMist during intervention season

6. Secondary Outcome Measure: Characteristics of participants 18-49 years of age choosing FluMist vs TIV: Race [ Time Frame: 30Sep2008 through 23Dec2008 ]

Measure Type	Secondary
Measure Name	Characteristics of participants 18-49 years of age choosing FluMist vs TIV: Race
Measure 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
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who completed surveys and were eligible to receive FluMist

Reporting Groups

	Description
Vaccinated with FluMist	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
Vaccinated with TIV	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.

Measured Values

	Vaccinated with FluMist	Vaccinated with TIV
Number of Participants Analyzed [units:participants]	399	1990
Characteristics of participants 18-49 years of age choosing FluMist vs TIV: Race [units: percent]	67.8	71.8

No statistical analysis provided for Characteristics of participants 18-49 years of age choosing FluMist vs TIV: Race

7. Secondary Outcome Measure: Characteristics of participants 18-49 years of age choosing FluMist vs TIV: Education [ Time Frame: 30Sep2008 through 23Dec2008 ]

Measure Type	Secondary
Measure Name	Characteristics of participants 18-49 years of age choosing FluMist vs TIV: Education
Measure 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
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who completed surveys and were eligible to receive FluMist

Reporting Groups

	Description
Vaccinated with FluMist	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.
Vaccinated with TIV	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.

Measured Values

	Vaccinated with FluMist	Vaccinated with TIV
Number of Participants Analyzed [units:participants]	399	1990
Characteristics of participants 18-49 years of age choosing FluMist vs TIV: Education [units: percent]	73.4	52.8

No statistical analysis provided for Characteristics of participants 18-49 years of age choosing FluMist vs TIV: Education

8. Secondary Outcome Measure: Characteristics of participants 18-49 years of age choosing FluMist vs TIV: Gender [ Time Frame: 30Sep2008 through 23Dec2008 ]

Measure Type	Secondary
Measure Name	Characteristics of participants 18-49 years of age choosing FluMist vs TIV: Gender
Measure 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
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who completed surveys and were eligible to receive FluMist

Reporting Groups

	Description
Vaccinated with FluMist	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.
Vaccinated with TIV	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.

Measured Values

	Vaccinated with FluMist	Vaccinated with TIV
Number of Participants Analyzed [units:participants]	399	1990
Characteristics of participants 18-49 years of age choosing FluMist vs TIV: Gender [units: percent]	49.9	49.7

No statistical analysis provided for Characteristics of participants 18-49 years of age choosing FluMist vs TIV: Gender

Serious Adverse Events

Time Frame	September 2008 - December 2008
Additional 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.

Reporting Groups

	Description
Arm A (Control)	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
Arm C (Choice Plus)	An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination

Serious Adverse Events

	Arm A (Control)	Arm B (Choice)	Arm C (Choice Plus)
Total, serious adverse events
# participants affected / at risk	0/0	0/0	0/0

Other Adverse Events

Time Frame	September 2008 - December 2008
Additional 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.

Frequency Threshold

Threshold above which other adverse events are reported	1%

Reporting Groups

	Description
Arm A (Control)	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
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 Adverse Events

	Arm A (Control)	Arm B (Choice)	Arm C (Choice Plus)
Total, other (not including serious) adverse events
# participants affected / at risk	0/0	0/0	0/0

Certain Agreements

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.

Results Point of Contact

Name/Title:	Seth Toback, MD
Organization:	MedImmune, LLC
Phone	301-398-0000
E-mail:	[email protected]