A Follow-up Study to Assess Long-term Immunogenicity and Safety of NicVAX/Placebo as an Aid to Smoking Cessation
NCT ID: NCT01304810
Last Updated: 2012-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
300 participants
OBSERVATIONAL
2011-01-31
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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NicVAX
NicVAX vaccine
NicVAX vaccine
Prior treatment with NicVAX in Nabi-4514 or Nabi-4515. No intervention in Nabi-4522.
Placebo vaccine
Placebo vaccine
Placebo
Prior treatment with Placebo in Nabi-4514 or Nabi-4515. No intervention in Nabi-4522.
Interventions
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NicVAX vaccine
Prior treatment with NicVAX in Nabi-4514 or Nabi-4515. No intervention in Nabi-4522.
Placebo
Prior treatment with Placebo in Nabi-4514 or Nabi-4515. No intervention in Nabi-4522.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Nabi Biopharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Nabi Biopharmaceuticals
Locations
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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
Countries
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Other Identifiers
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Nabi-4522
Identifier Type: -
Identifier Source: org_study_id
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