A Second Study of NicVAX/Placebo as an Aid for Smoking Cessation
NCT ID: NCT01102114
Last Updated: 2012-05-09
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
PHASE3
1000 participants
INTERVENTIONAL
2010-03-31
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo Vaccine
Placebo Vaccine
Placebo vaccine given 6 times over 6 months
NicVAX Vaccine
NicVAX Vaccine
NicVAX vaccine given 6 times over 6 months
Interventions
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NicVAX Vaccine
NicVAX vaccine given 6 times over 6 months
Placebo Vaccine
Placebo vaccine given 6 times over 6 months
Eligibility Criteria
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Inclusion Criteria
* Smokers who are in good general health.
Exclusion Criteria
* Use of systemic steroids.
* Cancer or cancer treatment in the last 5 years.
* HIV infection.
* History of drug or alcohol abuse or dependence within 12 months.
* Significant cardiovascular, hepatic, renal, psychiatric and/or respiratory disease.
* Inability to fulfill all visits for approximately 52 weeks.
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 Monitor
Role: STUDY_DIRECTOR
Nabi Biopharmaceuticals
Locations
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NicVAX Investigator
Encino, California, United States
NicVAX Investigator
Los Alamitos, California, United States
NicVAX Investigator
Denver, Colorado, United States
NicVAX Investigator
New Haven, Connecticut, United States
NicVAX Investigator
Brooksville, Florida, United States
NicVAX Investigator
Orlando, Florida, United States
NicVAX Investigator
Pembroke Pines, Florida, United States
NicVAX Investigator
Tampa, Florida, United States
NicVAX Investigator
Indianapolis, Indiana, United States
NicVAX Investigator
Wichita, Kansas, United States
NicVAX Investigator
Metairie, Louisiana, United States
NicVAX Investigator
Annapolis, Maryland, United States
NicVAX Investigator
Milford, Massachusetts, United States
NicVAX Investigator
East Lansing, Michigan, United States
NicVAX Investigator
Rochester, Minnesota, United States
NicVAX Investigator
Jackson, Mississippi, United States
NicVAX Investigator
Omaha, Nebraska, United States
NicVAX Investigator
Buffalo, New York, United States
NicVAX Investigator
Cincinnati, Ohio, United States
NicVAX Investigator
Mt. Pleasant, South Carolina, United States
NicVAX Investigator
Knoxville, Tennessee, United States
NicVAX Investigator
Nashville, Tennessee, United States
NicVAX Investigator
Houston, Texas, United States
NicVAX Investigator
Salt Lake City, Utah, United States
NicVAX Investigator
Charleston, West Virginia, United States
Countries
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Other Identifiers
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Nabi-4515
Identifier Type: -
Identifier Source: org_study_id
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