Study to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of 100µg NIC002 Vaccine in Cigarette Smokers Who Are Motivated to Quit Smoking.
A Double Blind, Placebo-controlled, Multi-centre Study to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of Repeated s.c Administrations of 100µg NIC002 Vaccine in Cigarette Smokers Who Are Motivated to Quit Smoking.
1 other identifier
interventional
200
1 country
2
Brief Summary
This study is designed to determine the efficacy of high nicotine-specific antibody titers in smoking cessation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2008
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 14, 2008
CompletedFirst Posted
Study publicly available on registry
August 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedMarch 21, 2017
March 1, 2017
1.2 years
August 14, 2008
March 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Smoking status
12 weeks
Exhaled carbon monoxide
12 weeks
Secondary Outcomes (3)
Smoking status at various time intervals from target quit date to the end of the study
52 weeks
Safety and tolerability
52 weeks
Immunogenicity (specific anti-nicotine antibodies in serum)
52 weeks
Study Arms (2)
1
ACTIVE COMPARATOR2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Healthy male and female smoking subjects age 18 to 65 years of age
- Subjects must be smoking 10 or more cigarettes per day during the past 12 months
- The exhaled breath carbon monoxide (CO) concentration must be 10 ppm or more at screening. Urine cotinine at screening must be positive.
- The Fagerström Test for Nicotine Dependence (FTND) score of 5 or above at screening.
You may not qualify if:
- Attempted to quit smoking in the three (3) months.
- Prior use of smoking cessation aid.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (2)
Novartis Investigative Site
Mainz, Germany
Novartis Investigator Site
Neuss, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Novartis
Novartis Investigator Site
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2008
First Posted
August 15, 2008
Study Start
August 1, 2008
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
March 21, 2017
Record last verified: 2017-03