NCT01375933

A Comparability Study of the Phase 3 Lot and a Single Commercial Lot of NicVAX in Healthy Adult Smokers

A Phase 3, Multicenter, Double-Blinded, Randomized, Study to Assess Comparability of a Single Phase 3 Lot and a Single Commercial Lot of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) in Healthy Adult Smokers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Nabi Biopharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the comparability of the phase 3 lot and a single commercial lot of NicVAX in healthy smokers.

Conditions

• Smoking

Interventions

Type	Name	Description
BIOLOGICAL	NicVAX Vaccine	NicVAX Vaccine given 6 times over 6 months

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2011-06-20
• Last updated: 2012-05-14

Locations

6 sites across 1 country: United States