A Follow-up Study to Assess Long-term Immunogenicity and Safety of NicVAX/Placebo as an Aid to Smoking Cessation
A Phase 3, Multi-Center, Randomized, Double-Blinded, Placebo-Controlled Follow-up Study to Assess Long-term Immunogenicity and Safety of NicVAX™ as an Aid to Smoking Cessation
1 other identifier
observational
300
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2011
Shorter than P25 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 9, 2011
CompletedFirst Posted
Study publicly available on registry
February 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedMay 14, 2012
May 1, 2012
7 months
February 9, 2011
May 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Antibody Levels
Analyze blood samples to determine nicotine antibody levels.
24 months after the initial injection
Secondary Outcomes (3)
Safety as measured by serious adverse events
18 months after the initial injection
Safety as measured by serious adverse events
24 months after the initial injection
Antibody Levels
18 months after the initial injection
Study Arms (2)
NicVAX
NicVAX vaccine
Placebo vaccine
Placebo vaccine
Interventions
Prior treatment with NicVAX in Nabi-4514 or Nabi-4515. No intervention in Nabi-4522.
Prior treatment with Placebo in Nabi-4514 or Nabi-4515. No intervention in Nabi-4522.
Eligibility Criteria
Subjects will be invited into this study following their participation in Nabi-4514 or Nabi-4515.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
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
Biospecimen
serum samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Nabi Biopharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2011
First Posted
February 25, 2011
Study Start
January 1, 2011
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
May 14, 2012
Record last verified: 2012-05