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NCT01304810 · ClinicalTrials.gov registry record
A Follow-up Study to Assess Long-term Immunogenicity and Safety of NicVAX/Placebo as an Aid to Smoking Cessation
A clinical trial of Smoking Cessation and Nicotine Dependence, sponsored by Nabi Biopharmaceuticals.
- Completed
- Registry status
- 300
- Enrollment target
- 12
- Study locations
NCT01304810: Completed study of Smoking Cessation and Nicotine Dependence, sponsored by Nabi Biopharmaceuticals.
NCT01304810 is a study of Smoking Cessation and Nicotine Dependence that has completed, run by Nabi Biopharmaceuticals. The registered enrollment target is 300 participants, below the 473-participant average among 188 other Smoking Cessation trials with a reported enrollment target (37% lower). The trial reports 12 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01304810, a study of Smoking Cessation and Nicotine Dependence, has completed, sponsored by Nabi Biopharmaceuticals.
- COMPLETED
- Registry status
- 300 participants
- Enrollment target
- 12
- Study locations
Study 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.
Primary Outcome
Analyze blood samples to determine nicotine antibody levels.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL NicVAX vaccine
Study Locations (12)
California
- NicVAX Investigator - Newport Beach
- NicVAX Investigator - San Diego
Florida
- NicVAX Investigator - Miami
Idaho
- NicVAX Investigator - Boise
Kentucky
- NicVAX Investigator - Lexington
Maryland
- NicVAX Investigator - College Park
Massachusetts
- NicVAX Investigator - Boston
New York
- NicVAX Investigator - Rochester
North Carolina
- NicVAX Investigator - Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2011-01 |
| Est. Completion | 2011-08 |
What the finished NCT01304810 record still lists
NCT01304810 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 473-participant average among 188 other Smoking Cessation trials with a reported enrollment target (37% lower).
The record links to 2 conditions, with Smoking Cessation appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01304810 lists 12 locations in 11 states (California, Florida, Idaho).
Frequently Asked Questions
What is clinical trial NCT01304810 about?
NCT01304810 is a clinical study titled "A Follow-up Study to Assess Long-term Immunogenicity and Safety of NicVAX/Placebo as an Aid to Smoking Cessation". 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.
What is the current status of trial NCT01304810?
This trial is currently completed. The enrollment target is 300 participants. The study started on 2011-01. Estimated completion is 2011-08.
What conditions does trial NCT01304810 study?
This clinical trial studies the following conditions: Smoking Cessation, Nicotine Dependence.
What interventions are being tested in trial NCT01304810?
The interventions under investigation include: Placebo (BIOLOGICAL), NicVAX vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01304810?
This trial is sponsored by Nabi Biopharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01304810 being conducted?
This trial has 12 study locations across California, Florida, Idaho, Kentucky, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Smoking Cessation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01304810's enrollment target sits among peer trials
300 80th of 188 higher than 107 of 188 other Smoking Cessation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Smoking Cessation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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