Pharmacoeconomic Assessment in Nabi-4514 and Nabi-4515 Phase 3 Studies
Phase 3
Completed
- Conditions
- Smoking Cessation
- Interventions
- Biological: NicVAX vaccineBiological: Placebo
- Registration Number
- NCT01178346
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NicVAX NicVAX vaccine Experimental vaccine Placebo Placebo Placebo vaccine
- Primary Outcome Measures
Name Time Method To evaluate the effect of NicVAX vs. placebo on HRQoL over the study period. one year QoL and health utilization questionnaires will be used to measure this outcome.
- Secondary Outcome Measures
Name Time Method To evaluate health care resource utilization. one year Health care visits, medications, hospitalizations and medical procedures will be collected to measure this outcome.
To estimate utility scores for use in further health-economic models. one year Scores will be computed from QoL questionnaires to measure this outcome.
Trial Locations
- Locations (2)
NicVAX
🇺🇸Indianapolis, Indiana, United States
NicVAX Investigator
🇺🇸Madison, Wisconsin, United States