A Follow-up Study to Assess Long-term Immunogenicity and Safety of NicVAX/Placebo as an Aid to Smoking Cessation

Completed · Has a placebo group

Conditions studied: Smoking Cessation, Nicotine Dependence

In brief

The purpose of the study is to obtain two year follow up data for subjects that received six vaccinations of NicVAX in prior phase III studies. No treatment will be administered. Anti-nicotine antibody levels and safety data will be collected.

Key facts

Study ID

NCT01304810

Run by

Nabi Biopharmaceuticals

People needed

300

Starts

2011-01-01

Expected to finish

2011-08-01

Last updated by the study team

2012-05-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who agree and sign consent to participate in this follow-up study.
• Subjects randomized and completed month 12 of the Nabi-4514 or Nabi-4515 study.
• Subjects who have received a total of 6 injections in Nabi-4514 or Nabi-4515.

You may not qualify if…

• Anticipated inability to follow the study protocol through-out the study period.
• Known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder compliance or failure to sign informed consent.
• Subjects who intend to receive, or who are receiving an Investigational New Drug/Device during the study.

Where it is running

• NicVAX Investigator — Newport Beach, California, United States
• NicVAX Investigator — San Diego, California, United States
• NicVAX Investigator — Miami, Florida, United States
• NicVAX Investigator — Boise, Idaho, United States
• NicVAX Investigator — Lexington, Kentucky, United States
• NicVAX Investigator — College Park, Maryland, United States
• NicVAX Investigator — Boston, Massachusetts, United States
• NicVAX Investigator — Rochester, New York, United States
• NicVAX Investigator — Raleigh, North Carolina, United States
• NicVAX Investigator — Portland, Oregon, United States
• NicVAX Investigator — Norfolk, Virginia, United States
• NicVAX Investigator — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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