NCT00995033

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

A Phase 2B, Multi-Center, Randomized, Double-Blinded, Parallel-Arm , Study to Assess Efficacy and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®) or Placebo Co-Administered With Varenicline (Champix®) as an Aid in Smoking Cessation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 558 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Smoking Behavior
• Smoking Lapse Behavior
• Smoking Relapse Behavior

Interventions

Type	Name	Description
BIOLOGICAL	NicVAX vaccine	NicVAX vaccine given 6 times over 6 months
BIOLOGICAL	Placebo	Phosphate buffered saline and ALhydrogel of identical appearance to NicVAX; IM in 6 doses over 6 months
DRUG	Varenicline	Days 0-2: 0.5 mg once daily, Days 3-6: 0.5 mg twice daily (morning and evening), Day 7- 84: 1.0 mg twice daily (morning and evening)

Timeline

• Start date: 2009-10-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2009-10-14
• Last updated: 2013-02-20

Locations

2 sites across 1 country: Netherlands