NCT00995033View on ClinicalTrials.gov

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

PHASE2CompletedINTERVENTIONAL
Enrollment

558

Participants

Timeline

Start Date

October 31, 2009

Primary Completion Date

September 30, 2012

Study Completion Date

September 30, 2012

Conditions
Smoking BehaviorSmoking Lapse BehaviorSmoking Relapse Behavior
Interventions
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)

Trial Locations (2)

6200 MD

Maastricht University Medical Center, Maastricht

1006 BK

Slotervaart Hospital/ Smoking Cessation Clinic, Amsterdam

Sponsors

Collaborators (1)

Nabi Biopharmaceuticals
All Listed Sponsors
collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

collaborator

Nabi Biopharmaceuticals

INDUSTRY

lead

Maastricht University Medical Center

OTHER

NCT00995033 - Efficacy and Safety of NicVAX® Co-administered With Varenicline (Champix®) | Biotech Hunter | Biotech Hunter