A Comparability Study of the Phase 3 Lot and a Single Commercial Lot of NicVAX in Healthy Adult Smokers
A Phase 3, Multicenter, Double-Blinded, Randomized, Study to Assess Comparability of a Single Phase 3 Lot and a Single Commercial Lot of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) in Healthy Adult Smokers
1 other identifier
interventional
260
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2011
Shorter than P25 for phase_3
6 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
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 15, 2011
CompletedFirst Posted
Study publicly available on registry
June 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedMay 14, 2012
May 1, 2012
5 months
June 15, 2011
May 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Immunogenicity
To compare imunogenicity of two lots by serum antibody concentration
At Week 14
Secondary Outcomes (1)
Safety
Through Week 16
Study Arms (2)
NicVAX - Phase 3 Lot
ACTIVE COMPARATORNicVAX - Phase 3 Lot
NicVAX - Commercial Lot
ACTIVE COMPARATORNicVAX - Commercial Lot
Interventions
NicVAX Vaccine given 6 times over 6 months
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
NicVAX Investigator
Huntsville, Alabama, 35802, United States
NicVAX Investigator
San Diego, California, 92018, United States
NicVAX Investigator
Melbourne, Florida, 32935, United States
NicVAX Investigator
Peoria, Illinois, 61602, United States
NicVAX Investigator
South Bend, Indiana, 46601, United States
NicVAX Investigator
Rockville, Maryland, 20850, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Nabi Biopharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- 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
June 15, 2011
First Posted
June 20, 2011
Study Start
May 1, 2011
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
May 14, 2012
Record last verified: 2012-05