NCT01178346已完成3 期
Health-Related Quality-of-Life and Health-Care Resource Utilization Assessment in Nabi-4514 and Nabi-4515 Phase 3 Studies
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 27
- 主要终点
- To evaluate the effect of NicVAX vs. placebo on HRQoL over the study period.
研究概览
简要总结
The purpose of this study is to look at pharmacoeconomic data for subjects that have received either NicVAX or placebo in the Nabi-4514 or Nabi-4515 studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 are eligible for randomization or have not reached Week 12 in Nabi-4514 or Nabi-4515 studies.
- •Subjects who agree to participate in health-related quality of life study.
排除标准
- •Subjects who are unable to complete a HRQoL questionnaire because of inability to understand the language or due to mental impairment.
研究组 & 干预措施
NicVAX
Experimental
Experimental vaccine
干预措施: NicVAX vaccine (Biological)
Placebo
Placebo Comparator
Placebo vaccine
干预措施: Placebo (Biological)
结局指标
主要结局
To evaluate the effect of NicVAX vs. placebo on HRQoL over the study period.
时间窗: one year
QoL and health utilization questionnaires will be used to measure this outcome.
次要结局
- To estimate utility scores for use in further health-economic models.(one year)
- To evaluate health care resource utilization.(one year)
研究者
研究点 (27)
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