NCT00836199CompletedPhase 3
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess Efficacy, Immunogenicity and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) as an Aid to Smoking Cessation
Nabi Biopharmaceuticals22 sites in 1 country1,000 target enrollmentStarted: October 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Nabi Biopharmaceuticals
- Enrollment
- 1,000
- Locations
- 22
- Primary Endpoint
- Evaluate NicVAX as an aid to smoking cessation for long term abstinence.
Study Overview
Brief Summary
The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term abstinence.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Current smoker who smokes at least 10 cigarettes a day during the past year and wants to quit smoking.
- •Smokers who are in good general health.
Exclusion Criteria
- •Prior exposure to NicVAX or any other nicotine vaccine.
- •Use of systemic steroids.
- •Cancer or cancer treatment in last 5 years.
- •HIV infection.
- •History of drug or alcohol abuse or dependence within 12 months.
- •Significant cardiovascular, hepatic, renal, psychiatric and/or respiratory disease.
- •Inability to fulfill all visits for approximately 52 weeks.
Outcomes
Primary Outcomes
Evaluate NicVAX as an aid to smoking cessation for long term abstinence.
Time Frame: one year
Secondary Outcomes
- Evaluate abstinence rates at multiple intervals(multiple time points)
- Evaluate safety and immunogenicity(mulitple time points)
- Evaluate withdrawal symptoms, smoking satisfaction, cigarette consumption and nicotine dependence.(multiple time points)
Investigators
Study Sites (22)
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