Efficacy and Safety of NicVAX® Co-administered With Varenicline (Champix®)

Inclusion Criteria: * Smokes at least 10 cigarettes per day * Good general health * Negative pregnancy test prior to study entry Exclusion Criteria: * Prior exposure to NicVAX or any other nicotine vaccine * Known allergic reaction to alum or any of the components of the vaccine * Use of systemic steroids, immunosuppressive agents or other medication that might interfere with an immune response * 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 * Previous intolerance to varenicline * Inability to fulfill all visits for approximately 54 weeks