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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01178346
First received: August 5, 2010
Last updated: May 8, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention Phase
Smoking Cessation
 Biological: NicVAX vaccine
Biological: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nabi Biopharmaceuticals:

Primary Outcome Measures:
  • To evaluate the effect of NicVAX vs. placebo on HRQoL over the study period. [ Time Frame: one year ] [ Designated as safety issue: No ]
    QoL and health utilization questionnaires will be used to measure this outcome.


Secondary Outcome Measures:
  • To estimate utility scores for use in further health-economic models. [ Time Frame: one year ] [ Designated as safety issue: No ]
    Scores will be computed from QoL questionnaires to measure this outcome.

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


Enrollment: 500
Study Start Date: July 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01178346

  Show 25 Study Locations
Sponsors and Collaborators
Nabi Biopharmaceuticals
GlaxoSmithKline
Investigators
Study Director: Medical Monitor Nabi Biopharmaceuticals
  More Information

No publications provided

Responsible Party: Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT01178346     History of Changes
Other Study ID Numbers: Nabi-4519
Study First Received: August 5, 2010
Last Updated: May 8, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on May 22, 2013