A randomised, placebo-controlled, multi-centre study on the efficacy of Niccine, a vaccine for nicotine, in smoking relapse prevention, assessed in abstinent, adult smokers.

INTERVENTION: Product Name: Niccine Product Code: Niccine Pharmaceutical Form: Injection* Pharmaceutical form of the placebo: Injection* Route of administration of the placebo: Intramuscular use CONDITION: The intended indication for the drug under investigation is smoking relapse prevention. Tobacco smoking has been identified as the single largest preventable cause of morbidity and premature death in the developed world. The prevalence of smoking range from about 20 to 50 per cent in the developed countries and from a global perspective, tobacco smoking continues to increase. The study will be performed in smokers. ; MedDRA version: 9.1 Level: LLT Classification code 10056478 Term: Nicotine addiction PRIMARY OUTCOME: Main Objective: The main objective of the study is to evaluate the efficacy of Niccine compared to placebo, on relapse prevention at twelve months after the first vaccination with the study drug. The objective will be explored following six intramuscular injections of the study drug in subjects who have recently quit smoking with the smoking cessation aid Varenicline. Primary end point(s): The primary end point is to evaluate Niccines effect on preventing smoking relapses in Subjects that have recently quit smoking. Relapses will be assessed by smoking questionnaires. Secondary Objective: Safety ; Relapse prevention at six, nine and twelve months; Point prevalence ; Nicotine withdrawal; Exhaled carbon monoxide; Immunogenicity of Niccine; Time to first relapse; Smoking habits (including compensatory smoking); Continouse abstinence; Craving INCLUSION CRITERIA: 1. Cigarette smokers, smoking on average at least 10 cigarettes per day, has fewer than three months of abstinence in the past year and is motivated to quit. 2. Men or women, 25 to 50 years of age (inclusive). 3. Women of childbearing capacity must use a reliable contraceptive method, e.g. the double barrier method, an intra‐uterine device or oral contraceptive. 4. Positive for exhaled carbon monoxide (CO), >5 ppm. 5. Healthy and with normal findings in the pre‐study physical examination (as judged by the Investigator) 6. Has signed the Informed Consent Form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range