A Second Study of NicVAX/Placebo as an Aid for Smoking Cessation

A Second 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

The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term abstinence.

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 the 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.