Study to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of 100µg NIC002 Vaccine in Cigarette Smokers Who Are Motivated to Quit Smoking.

A Double Blind, Placebo-controlled, Multi-centre Study to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of Repeated s.c Administrations of 100µg NIC002 Vaccine in Cigarette Smokers Who Are Motivated to Quit Smoking.

This study is designed to determine the efficacy of high nicotine-specific antibody titers in smoking cessation.

Inclusion Criteria:

• Healthy male and female smoking subjects age 18 to 65 years of age
• Subjects must be smoking 10 or more cigarettes per day during the past 12 months
• The exhaled breath carbon monoxide (CO) concentration must be 10 ppm or more at screening. Urine cotinine at screening must be positive.
• The Fagerström Test for Nicotine Dependence (FTND) score of 5 or above at screening.

Exclusion Criteria:

• Attempted to quit smoking in the three (3) months.
• Prior use of smoking cessation aid.

Other protocol-defined inclusion/exclusion criteria may apply