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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Antibody Levels
研究概览
简要总结
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.
详细描述
This study will follow subjects that participated in the NicVAX phase III studies for a second year. These predecessor studies, Nabi-4514 (NCT#00836199) and Nabi-4515 (NCT#01102114) evaluate the efficacy and safety of 6 vaccinations of NicVAX or placebo as an aid to smoking cessation. The two phase III studies are one year in duration, and subjects who complete these studies are eligible to enroll in Nabi-4522. As the phase III studies are ongoing, subject assignment to NicVAX or placebo will remain masked. No intervention will be administered in Nabi-4522. Subjects will be followed for immunogenicity (anti-nicotine antibody level)and for safety.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Antibody Levels
时间窗: 24 months after the initial injection
Analyze blood samples to determine nicotine antibody levels.
次要结局
- Safety as measured by serious adverse events(24 months after the initial injection)
- Antibody Levels(18 months after the initial injection)