NCT01375933已完成3 期
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
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 6
- 主要终点
- Immunogenicity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female smokers, age 18-55, who are currently smoking at least 10 cigarettes per day.
排除标准
- •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.
研究组 & 干预措施
NicVAX - Phase 3 Lot
Active Comparator
NicVAX - Phase 3 Lot
干预措施: NicVAX Vaccine (Biological)
NicVAX - Commercial Lot
Active Comparator
NicVAX - Commercial Lot
干预措施: NicVAX Vaccine (Biological)
结局指标
主要结局
Immunogenicity
时间窗: At Week 14
To compare imunogenicity of two lots by serum antibody concentration
次要结局
- Safety(Through Week 16)
研究者
研究点 (6)
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