Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-01-01 @ 2:50 AM
Study NCT ID:
NCT00808808
Status:
COMPLETED
Last Update Posted:
2013-11-20
First Post:
2008-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessing Choice in the Employer Setting (ACES) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613429', 'term': 'FluMist'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tobacks@medimmune.com', 'phone': '301-398-0000', 'title': 'Seth Toback, MD', 'organization': 'MedImmune, LLC'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': '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.'}}, 'adverseEventsModule': {'timeFrame': 'September 2008 - December 2008', '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A (Control)', 'description': 'A control arm of usual care offering TIV with baseline advertisement', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm B (Choice)', 'description': 'An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Arm C (Choice Plus)', 'description': 'An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Vaccination Rate, All Ages', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4078', 'groupId': 'OG000'}, {'value': '3757', 'groupId': 'OG001'}, {'value': '4387', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Control)', 'description': 'A control arm of usual care offering TIV with baseline advertisement'}, {'id': 'OG001', 'title': 'Arm B (Choice)', 'description': 'An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist'}, {'id': 'OG002', 'title': 'Arm C (Choice Plus)', 'description': 'An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination'}], 'classes': [{'categories': [{'measurements': [{'value': '41.6', 'groupId': 'OG000'}, {'value': '45.1', 'groupId': 'OG001'}, {'value': '51.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30Sep2008 through 23Dec2008', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All employees at participating sites, including those who were vaccinated and those who were not'}, {'type': 'PRIMARY', 'title': 'Overall Vaccination Rate, Employees 18 to 49 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '983', 'groupId': 'OG000'}, {'value': '988', 'groupId': 'OG001'}, {'value': '1398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Control)', 'description': 'A control arm of usual care offering TIV with baseline advertisement'}, {'id': 'OG001', 'title': 'Arm B (Choice)', 'description': 'An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist'}, {'id': 'OG002', 'title': 'Arm C (Choice Plus)', 'description': 'An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination'}], 'classes': [{'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000'}, {'value': '40.9', 'groupId': 'OG001'}, {'value': '46.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30Sep2008 through 23Dec2008', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All vaccinated employees at participating sites, including those who completed surveys and those who did not'}, {'type': 'SECONDARY', 'title': 'Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in the Total Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1392', 'groupId': 'OG000'}, {'value': '1489', 'groupId': 'OG001'}, {'value': '2132', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Control)', 'description': 'A control arm of usual care offering TIV with baseline advertisement'}, {'id': 'OG001', 'title': 'Arm B (Choice)', 'description': 'An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist'}, {'id': 'OG002', 'title': 'Arm C (Choice Plus)', 'description': 'An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000'}, {'value': '4.8', 'groupId': 'OG001'}, {'value': '12.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2007-2008 season through 2008-2009 season', 'description': 'Rate difference by arm from baseline to intervention season', 'unitOfMeasure': 'percentage points', 'reportingStatus': 'POSTED', 'populationDescription': 'All vaccinated employees at participating sites, including those who completed surveys and those who did not'}, {'type': 'SECONDARY', 'title': 'Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in Employees 18-49 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '983', 'groupId': 'OG000'}, {'value': '988', 'groupId': 'OG001'}, {'value': '1398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Control)', 'description': 'A control arm of usual care offering TIV with baseline advertisement'}, {'id': 'OG001', 'title': 'Arm B (Choice)', 'description': 'An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist'}, {'id': 'OG002', 'title': 'Arm C (Choice Plus)', 'description': 'An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '2.4', 'groupId': 'OG001'}, {'value': '9.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2007-2008 season through 2008-2009 season', 'description': 'Rate difference by arm from baseline to intervention season', 'unitOfMeasure': 'percentage points', 'reportingStatus': 'POSTED', 'populationDescription': 'All vaccinated employees 18-49 years of age at participating sites, including those who completed surveys and those who did not'}, {'type': 'SECONDARY', 'title': 'Percent of Eligible Participants 18-49 Years of Age Choosing FluMist During Intervention Season', 'denoms': [{'units': 'Participants', 'counts': [{'value': '983', 'groupId': 'OG000'}, {'value': '988', 'groupId': 'OG001'}, {'value': '1398', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Control)', 'description': 'A control arm of usual care offering TIV with baseline advertisement'}, {'id': 'OG001', 'title': 'Arm B (Choice)', 'description': 'An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist'}, {'id': 'OG002', 'title': 'Arm C (Choice Plus)', 'description': 'An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '19.1', 'groupId': 'OG001'}, {'value': '26.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30Sep2008 through 23Dec2008', 'unitOfMeasure': 'percent', 'reportingStatus': 'POSTED', 'populationDescription': 'All vaccinated employees 18-49 years of age at participating sites, including those who completed surveys and those who did not'}, {'type': 'SECONDARY', 'title': 'Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '399', 'groupId': 'OG000'}, {'value': '1990', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccinated With FluMist', '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'}, {'id': 'OG001', 'title': 'Vaccinated With TIV', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.8', 'groupId': 'OG000'}, {'value': '71.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30Sep2008 through 23Dec2008', 'description': 'Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as white', 'unitOfMeasure': 'percent', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed surveys and were eligible to receive FluMist'}, {'type': 'SECONDARY', 'title': 'Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Education', 'denoms': [{'units': 'Participants', 'counts': [{'value': '399', 'groupId': 'OG000'}, {'value': '1990', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccinated With FluMist', '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.'}, {'id': 'OG001', 'title': 'Vaccinated With TIV', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.4', 'groupId': 'OG000'}, {'value': '52.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30Sep2008 through 23Dec2008', 'description': 'Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as college graduates.', 'unitOfMeasure': 'percent', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed surveys and were eligible to receive FluMist'}, {'type': 'SECONDARY', 'title': 'Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Gender', 'denoms': [{'units': 'Participants', 'counts': [{'value': '399', 'groupId': 'OG000'}, {'value': '1990', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccinated With FluMist', '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.'}, {'id': 'OG001', 'title': 'Vaccinated With TIV', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.9', 'groupId': 'OG000'}, {'value': '49.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30Sep2008 through 23Dec2008', 'description': 'Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as male.', 'unitOfMeasure': 'percent', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed surveys and were eligible to receive FluMist'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A (Control)', 'description': 'A control arm of usual care offering TIV with baseline advertisement'}, {'id': 'FG001', 'title': 'Arm B (Choice)', 'description': 'An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist'}, {'id': 'FG002', 'title': 'Arm C (Choice Plus)', 'description': 'An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Started includes all employees at participating sites.', 'groupId': 'FG000', 'numSubjects': '4078'}, {'comment': 'Started includes all employees at participating sites', 'groupId': 'FG001', 'numSubjects': '3757'}, {'comment': 'Started includes all employees at participating sites.', 'groupId': 'FG002', 'numSubjects': '4387'}]}, {'type': 'Vaccinated', 'achievements': [{'comment': 'Vaccinated includes all employees who were vaccinated at the employee vaccination clinics.', 'groupId': 'FG000', 'numSubjects': '1392'}, {'comment': 'Vaccinated includes all employees who were vaccinated at the employee vaccination clinics.', 'groupId': 'FG001', 'numSubjects': '1489'}, {'comment': 'Vaccinated includes all employees who were vaccinated at the employee vaccination clinics.', 'groupId': 'FG002', 'numSubjects': '2132'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed includes vaccinated employees who completed surveys.', 'groupId': 'FG000', 'numSubjects': '1261'}, {'comment': 'Completed includes vaccinated employees who completed surveys.', 'groupId': 'FG001', 'numSubjects': '1320'}, {'comment': 'Completed includes vaccinated employees who completed surveys.', 'groupId': 'FG002', 'numSubjects': '1830'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2817'}, {'groupId': 'FG001', 'numSubjects': '2437'}, {'groupId': 'FG002', 'numSubjects': '2557'}]}], 'dropWithdraws': [{'type': 'Vaccinated; survey not completed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '131'}, {'groupId': 'FG001', 'numSubjects': '169'}, {'groupId': 'FG002', 'numSubjects': '302'}]}, {'type': 'Employee was not vaccinated.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2686'}, {'groupId': 'FG001', 'numSubjects': '2268'}, {'groupId': 'FG002', 'numSubjects': '2255'}]}]}], 'recruitmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1392', 'groupId': 'BG000'}, {'value': '1489', 'groupId': 'BG001'}, {'value': '2132', 'groupId': 'BG002'}, {'value': '5013', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A (Control)', 'description': 'A control arm of usual care offering TIV with baseline advertisement'}, {'id': 'BG001', 'title': 'Arm B (Choice)', 'description': 'An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist'}, {'id': 'BG002', 'title': 'Arm C (Choice Plus)', 'description': 'An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18 to 49 years', 'categories': [{'measurements': [{'value': '983', 'groupId': 'BG000'}, {'value': '988', 'groupId': 'BG001'}, {'value': '1398', 'groupId': 'BG002'}, {'value': '3369', 'groupId': 'BG003'}]}]}, {'title': '≥ 50 years', 'categories': [{'measurements': [{'value': '409', 'groupId': 'BG000'}, {'value': '501', 'groupId': 'BG001'}, {'value': '734', 'groupId': 'BG002'}, {'value': '1644', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '748', 'groupId': 'BG000'}, {'value': '814', 'groupId': 'BG001'}, {'value': '808', 'groupId': 'BG002'}, {'value': '2370', 'groupId': 'BG003'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '644', 'groupId': 'BG000'}, {'value': '675', 'groupId': 'BG001'}, {'value': '1324', 'groupId': 'BG002'}, {'value': '2643', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Includes all vaccinated employees, not only participants who completed surveys.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4411}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-28', 'studyFirstSubmitDate': '2008-12-12', 'resultsFirstSubmitDate': '2012-07-30', 'studyFirstSubmitQcDate': '2008-12-15', 'lastUpdatePostDateStruct': {'date': '2013-11-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-08-10', 'studyFirstPostDateStruct': {'date': '2008-12-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Vaccination Rate, All Ages', 'timeFrame': '30Sep2008 through 23Dec2008'}, {'measure': 'Overall Vaccination Rate, Employees 18 to 49 Years of Age', 'timeFrame': '30Sep2008 through 23Dec2008'}], 'secondaryOutcomes': [{'measure': 'Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in the Total Population', 'timeFrame': '2007-2008 season through 2008-2009 season', 'description': 'Rate difference by arm from baseline to intervention season'}, {'measure': 'Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in Employees 18-49 Years of Age', 'timeFrame': '2007-2008 season through 2008-2009 season', 'description': 'Rate difference by arm from baseline to intervention season'}, {'measure': 'Percent of Eligible Participants 18-49 Years of Age Choosing FluMist During Intervention Season', 'timeFrame': '30Sep2008 through 23Dec2008'}, {'measure': 'Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Race', 'timeFrame': '30Sep2008 through 23Dec2008', 'description': 'Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as white'}, {'measure': 'Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Education', 'timeFrame': '30Sep2008 through 23Dec2008', 'description': 'Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as college graduates.'}, {'measure': 'Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Gender', 'timeFrame': '30Sep2008 through 23Dec2008', 'description': 'Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as male.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['FluMist, TIV, vaccination rates'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '20638452', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '20036102', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults at least 18 years of age who are current employees attending the influenza clinic sponsored by their employer', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for employer sites:\n\n* Located in the United States\n* 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\n* 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'}, 'identificationModule': {'nctId': 'NCT00808808', 'acronym': 'MA181', 'briefTitle': 'Assessing Choice in the Employer Setting (ACES) Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'MI-MA-181'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arm A (Control)', 'description': 'A control arm of usual care offering TIV with baseline advertisement', 'interventionNames': ['Biological: Control - Usual care offering TIV only with baseline advertisement']}, {'label': 'Arm B (Choice)', 'description': 'An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist', 'interventionNames': ['Biological: Choice of TIV or FluMist with baseline advertisement']}, {'label': 'Arm C (Choice Plus)', 'description': 'An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination', 'interventionNames': ['Other: Choice of TIV or FluMist with enhanced advertisement and incentives']}], 'interventions': [{'name': 'Choice of TIV or FluMist with baseline advertisement', 'type': 'BIOLOGICAL', 'description': 'An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist', 'armGroupLabels': ['Arm B (Choice)']}, {'name': 'Choice of TIV or FluMist with enhanced advertisement and incentives', 'type': 'OTHER', 'description': 'An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination', 'armGroupLabels': ['Arm C (Choice Plus)']}, {'name': 'Control - Usual care offering TIV only with baseline advertisement', 'type': 'BIOLOGICAL', 'description': 'A control arm of usual care offering TIV with baseline advertisement', 'armGroupLabels': ['Arm A (Control)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91311', 'city': 'Chatsworth', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.25723, 'lon': -118.6012}}, {'zip': '94945', 'city': 'Novato', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.10742, 'lon': -122.5697}}, {'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95833', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '96050', 'city': 'Santa Clara', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.35411, 'lon': -121.95524}}, {'zip': '90405', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '94089', 'city': 'Sunnyvale', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.36883, 'lon': -122.03635}}, {'zip': '91362', 'city': 'Thousand Oaks', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.17056, 'lon': -118.83759}}, {'zip': '80305', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '80246', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '20009', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33619', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '41048', 'city': 'Hebron', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 39.06589, 'lon': -84.70106}}, {'zip': '40031', 'city': 'La Grange', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 38.40757, 'lon': -85.37885}}, {'zip': '40342', 'city': 'Lawrenceburg', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 38.0373, 'lon': -84.89662}}, {'zip': '40203', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '40223', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '21401', 'city': 'Annapolis', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 38.97859, 'lon': -76.49184}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21202', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21209', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21220', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21244', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20705', 'city': 'Calverton', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.05761, 'lon': -76.93581}}, {'zip': '21030', 'city': 'Cockeysville', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.48122, 'lon': -76.64386}}, {'zip': '21045', 'city': 'Columbia', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.24038, 'lon': -76.83942}}, {'zip': '21046', 'city': 'Columbia', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.24038, 'lon': -76.83942}}, {'zip': '21114', 'city': 'Crofton', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.00178, 'lon': -76.68747}}, {'zip': '21076', 'city': 'Hanover', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.19289, 'lon': -76.72414}}, {'zip': '21031', 'city': 'Hunt Valley', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.49983, 'lon': -76.64108}}, {'zip': '20707', 'city': 'Laurel', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.09928, 'lon': -76.84831}}, {'zip': '21152', 'city': 'Sparks', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.53094, 'lon': -76.6458}}, {'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '8648', 'city': 'Larwenceville', 'state': 'New Jersey', 'country': 'United States'}, {'zip': '07962', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '87113', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '14586', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '14614', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '14625', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27260', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '45202', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45015', 'city': 'Hamilton', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.3995, 'lon': -84.56134}}, {'zip': '45036', 'city': 'Lebanon', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.43534, 'lon': -84.20299}}, {'zip': '45096', 'city': 'West Chester', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.33172, 'lon': -84.40716}}, {'zip': '22401', 'city': 'Fredericksburg', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.30318, 'lon': -77.46054}}], 'overallOfficials': [{'name': 'Seth Toback, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MedImmune LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedImmune LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Passport Health', 'class': 'INDUSTRY'}, {'name': 'University of Pittsburgh', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Seth Toback, MD', 'oldOrganization': 'Medimmune LLC'}}}}