Smoking Cessation
Conditions
Keywords
Pharmacoeconomic, Quality of Life, Health Outcomes, Smoking, NicVAX, Smoking vaccine, Smoking cessation
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.
Interventions
BIOLOGICALNicVAX vaccine
NicVAX vaccine given 6 times over 6 months
BIOLOGICALPlacebo
Placebo vaccine given 6 times over 6 months
Sponsors
GlaxoSmithKline
Nabi Biopharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| To estimate utility scores for use in further health-economic models. | one year | Scores will be computed from QoL questionnaires to measure this outcome. |
| To evaluate health care resource utilization. | one year | Health care visits, medications, hospitalizations and medical procedures will be collected to measure this outcome. |
Countries
United States
Outcome results
None listed