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Completed

NCT Number: NCT00808808

Assessing Choice in the Employer Setting (ACES) Study

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.

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Key information

Conditions

Healthy Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chatsworth, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Control - Usual care offering TIV only with baseline advertisement

Biological

A control arm of usual care offering TIV with baseline advertisement

Primary outcomes

  1. Overall Vaccination Rate, All Ages

    Time frame: 30Sep2008 through 23Dec2008

  2. Overall Vaccination Rate, Employees 18 to 49 Years of Age

    Time frame: 30Sep2008 through 23Dec2008

Secondary outcomes

  1. Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in the Total Population

    Time frame: 2007-2008 season through 2008-2009 season

    Rate difference by arm from baseline to intervention season

  2. 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

    Rate difference by arm from baseline to intervention season

  3. Percent of Eligible Participants 18-49 Years of Age Choosing FluMist During Intervention Season

    Time frame: 30Sep2008 through 23Dec2008

  4. Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Race

    Time frame: 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

  5. Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Education

    Time frame: 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.

  6. Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Gender

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Collaborators

  • Passport Health
  • University of Pittsburgh

Registry information

Official study 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

Acronym: MA181

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Dec 16, 2008
Registry last updated
Nov 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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