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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01178346
Recruitment Status : Completed
First Posted : August 10, 2010
Last Update Posted : May 9, 2012
Information provided by (Responsible Party):
Nabi Biopharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Biological: NicVAX vaccine Biological: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Health-Related Quality-of-Life and Health-Care Resource Utilization Assessment in Nabi-4514 and Nabi-4515 Phase 3 Studies
Study Start Date : July 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

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

Primary Outcome Measures :
  1. To evaluate the effect of NicVAX vs. placebo on HRQoL over the study period. [ Time Frame: one year ]
    QoL and health utilization questionnaires will be used to measure this outcome.

Secondary Outcome Measures :
  1. To estimate utility scores for use in further health-economic models. [ Time Frame: one year ]
    Scores will be computed from QoL questionnaires to measure this outcome.

  2. To evaluate health care resource utilization. [ Time Frame: one year ]
    Health care visits, medications, hospitalizations and medical procedures will be collected to measure this outcome.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01178346

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Sponsors and Collaborators
Nabi Biopharmaceuticals
Study Director: Medical Monitor Nabi Biopharmaceuticals

Responsible Party: Nabi Biopharmaceuticals Identifier: NCT01178346     History of Changes
Other Study ID Numbers: Nabi-4519
First Posted: August 10, 2010    Key Record Dates
Last Update Posted: May 9, 2012
Last Verified: May 2012

Keywords provided by Nabi Biopharmaceuticals:
Quality of Life
Health Outcomes
Smoking vaccine
Smoking cessation

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs