Pharmacoeconomic Assessment in Nabi-4514 and Nabi-4515 Phase 3 Studies

Health-Related Quality-of-Life and Health-Care Resource Utilization Assessment in Nabi-4514 and Nabi-4515 Phase 3 Studies

The purpose of this study is to look at pharmacoeconomic data for subjects that have received either NicVAX or placebo in the Nabi-4514 or Nabi-4515 studies.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Biological: NicVAX vaccine; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • NicVAX Investigator
  • California
    • Encino, California, United States, 91316
      • NicVAX Investigator
    • Los Alamitos, California, United States, 90720
      • NicVAX Investigator
    • Newport Beach, California, United States, 92660
      • NicVAX
    • San Diego, California, United States, 92108
      • NicVAX Investigator
  • Colorado
    • Denver, Colorado, United States, 80204
      • NicVAX Investigator
  • Florida
    • Brooksville, Florida, United States, 34601
      • NicVAX Investigator
    • Orlando, Florida, United States, 32806
      • NicVAX Investigator
    • St. Petersburg, Florida, United States, 33709
      • NicVAX Investigator
    • Tampa, Florida, United States, 33606
      • NicVAX Investigator
  • Idaho
    • Boise, Idaho, United States, 83704
      • NicVAX Investigator
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • NicVAX
  • Louisiana
    • Metarie, Louisiana, United States, 700006
      • NicVAX Investigator
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • NicVAX Investigator
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • NicVAX Investigator
    • Rochester, Minnesota, United States, 55905
      • NicVAX Investigator
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • NicVAX Investigator
  • New York
    • Buffalo, New York, United States, 14263
      • NicVAX Investigator
  • Ohio
    • Cincinnati, Ohio, United States, 45237
      • NicVAX Investigator
  • South Carolina
    • Mt Pleasant, South Carolina, United States, 29464
      • NicVAX Investigator
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • NicVAX Investigator
  • Utah
    • Salt Lake City, Utah, United States, 84020
      • NicVAX Investigator
    • Salt Lake City, Utah, United States, 84107
      • NicVAX Investigator
  • Washington
    • Seattle, Washington, United States, 98104
      • NicVAX Investigator
  • Wisconsin
    • Madison, Wisconsin, United States, 53711
      • NicVAX Investigator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects who are eligible for randomization or have not reached Week 12 in Nabi-4514 or Nabi-4515 studies.
• Subjects who agree to participate in health-related quality of life study.

Exclusion Criteria:

• Subjects who are unable to complete a HRQoL questionnaire because of inability to understand the language or due to mental impairment.

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NicVAX; Experimental vaccine	Biological: NicVAX vaccine; NicVAX vaccine given 6 times over 6 months
Placebo Comparator: Placebo; Placebo vaccine	Biological: Placebo; Placebo vaccine given 6 times over 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the effect of NicVAX vs. placebo on HRQoL over the study period.	QoL and health utilization questionnaires will be used to measure this outcome.	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To estimate utility scores for use in further health-economic models.	Scores will be computed from QoL questionnaires to measure this outcome.	one year
To evaluate health care resource utilization.	Health care visits, medications, hospitalizations and medical procedures will be collected to measure this outcome.	one year

Collaborators and Investigators

• Sponsor: Nabi Biopharmaceuticals
• Collaborators: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: August 5, 2010
• First Submitted That Met QC Criteria: August 6, 2010
• First Posted (Estimate): August 10, 2010

Study Record Updates

• Last Update Posted (Estimate): May 9, 2012
• Last Update Submitted That Met QC Criteria: May 8, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Quality of Life; Smoking; Smoking cessation; Health Outcomes; NicVAX; Smoking vaccine; Pharmacoeconomic
• Other Study ID Numbers: Nabi-4519