Please select the eligibility criteria that correspond to the clinical trial below.
Title: 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
Brief Summary: The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term abstinence.


Options:
A: 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.
B: Inclusion Criteria:

* Written informed consent
* Age 18 to 70 years
* Smokers: \> 10 and ≤ 40 cigarettes per day and smoking history of more than 3 years
* Fageström Test for Nicotine Dependence (FTND) score ≥ 5
* Female participant must meet one of the following criteria: a) no reproductive potential due to menopause, hysterectomy, bilateral oophorectomy, or tubal ligation; b) agrees to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 12 additional months after the last immunization

Exclusion Criteria:

* Pregnant or nursing
* History of severe allergy or immunological disorders
* Blood donation within previous 30 days
* Surgery within previous 30 days
* Use of investigational drugs within previous 60 days
* Significant cardiovascular disease:

  * angina pectoris
  * congestive heart failure
  * clinically significant murmurs
  * previous angioplasty or coronary artery bypass surgery
* Active infectious disease:

  * WBC \> 12 000 cells/µL
  * Seropositivity for Hepatitis B and C
  * History of risk behavior to acquire HIV
* Significant hepatic disease
* Significant renal disease
* Significant hematological disorder
* Significant pulmonary disease
* History of malignancy
* Autoimmune disease
* Organic neurological disorder or significant psychiatric disorder
* Use of psychoactive drug within one month before enrolment
* Abuse of drugs or alcohol
* Subjects using any concomitant medications due to chronic illness which bears a high risk of fluctuation in disease activity or exacerbations during a 12-months period such as coronary heart disease, asthma, severe COPD, chronic rheumatoid disease, diabetes, etc. should be excluded.
* Obesity: BMI \> 35 kg/m2
* Use of concomitant nicotine replacement treatment (NRT) at screening or visit 1
* Any planned surgical intervention during the study period
C: Inclusion Criteria:

* Smokes at least 15 cigarettes per day
* Wants to quit smoking
* Good general health
* Negative pregnancy test prior to study entry
* Carbon monoxide level greater than 10 ppm

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 steroids, immunosuppressive agents or other medication that might interfere with an immune response
D: Inclusion Criteria:

* Healthy smoker, ≥10 cigarettes per day for 6 months, exhaled carbon monoxide ≥10 ppm
* Written informed consent
* Negative urine pregnancy test, and willing to use birth control during the study, if applicable

Exclusion Criteria:

* Prior exposure to nicotine vaccine
* Clinically significant allergic reactions, especially to components of the vaccine
* Serious or unstable clinical disease within the past 6 months
* Use of any smoking cessation therapy within 30 days preceding 1st dose
* Immunosuppression, due to: steroids or other immunosuppressants in the last 30 days, history of cancer or cancer treatment in the last 60 months, known HIV infection, or congenital or acquired immunodeficiency
* Use of any vaccine other than influenza vaccine within 30 days prior to each study dose
* Use of another IND drug or device within 30 days preceding 1st dose
* Inability to follow the protocol, or illicit drug use in the past 12 months, or psychiatric disorder in the past 3 months

Answer: A