Status:
COMPLETED
Efficacy and Safety of NicVAX® Co-administered With Varenicline (Champix®)
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Nabi Biopharmaceuticals
Conditions:
Smoking Behavior
Smoking Lapse Behavior
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of NicVAX co-administered with varenicline as an aid in smoking cessation over a one-year period in smokers who want to quit smoking.
Eligibility Criteria
Inclusion
- Smokes at least 10 cigarettes per day
- Good general health
- Negative pregnancy test prior to study entry
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
558 Patients enrolled
Trial Details
Trial ID
NCT00995033
Start Date
October 1 2009
End Date
September 1 2012
Last Update
February 20 2013
Active Locations (2)
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1
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6200 MD
2
Slotervaart Hospital/ Smoking Cessation Clinic
Amsterdam, North Holland, Netherlands, 1006 BK