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

Completed · Phase 3

Conditions studied: Smoking

In brief

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.

Key facts

Study ID

NCT01375933

Run by

Nabi Biopharmaceuticals

People needed

260

Starts

2011-05-01

Expected to finish

2011-10-01

Last updated by the study team

2012-05-14

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy male or female smokers, age 18-55, who are currently smoking at least 10 cigarettes per day.

You may not qualify if…

• Prior exposure to NicVAX or any other nicotine vaccine.
• History of clinically significant allergic reactions.
• Use of systemic steroids.
• Cancer or cancer treatment within 5 years.
• HIV infection.
• History of drug or alcohol abuse or dependence.
• Required treatment for depression within the past 12 months.
• Body mass index ≥ 30 [calculated as weight (kg)/height2 (m)].
• Significant cardiovascular, hepatic, renal, psychiatric and/or respiratory disease.
• Inability to fulfill all visits for approximately 30 weeks.

Where it is running

• NicVAX Investigator — Huntsville, Alabama, United States
• NicVAX Investigator — San Diego, California, United States
• NicVAX Investigator — Melbourne, Florida, United States
• NicVAX Investigator — Peoria, Illinois, United States
• NicVAX Investigator — South Bend, Indiana, United States
• NicVAX Investigator — Rockville, Maryland, United States

Full record on ClinicalTrials.gov

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