NCT01668537已完成2 期
A Randomized, Double-blind, Multicenter Phase II Trial to Compare the Immunogenicity and Safety of a Liquid-frozen and a Freeze-dried Formulation of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in Vaccinia-naïve Healthy Subjects
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 651
- 试验地点
- 6
- 主要终点
- ELISA GMT
研究概览
简要总结
A randomized, double-blind, multicenter Phase II trial to compare the immunogenicity and safety of a liquid-frozen and a freeze-dried formulation of IMVAMUNE (MVA-BN®) smallpox vaccine in vaccinia-naïve healthy subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
ELISA GMT
时间窗: Week 6
Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'
次要结局
- ELISA GMTs(within 8 weeks)
- Number of Participants With Adverse Events of Special Interest (AESI)(up to 32 weeks)
- Number of Participants With Serious Adverse Events(up to 32 weeks)
- PRNT GMT(Week 6)
- PRNT GMTs(within 8 weeks)
- ELISPOT Magnitudes of Response(within 8 weeks)
- Percentage of Participants With Response by ELISPOT(within 8 weeks)
- Percentage of Responders by ELISPOT(within 8 weeks)
- Correlation ELISA vs PRNT Titers(within 8 weeks)
- Number of Participants With Related Grade >=3 Adverse Events(within 29 days after vaccination)
- Number of Participants With Solicited Local Averse Events(8 days after any vaccination)
- Percentage of Participants With Seroconversion by PRNT(within 8 weeks)
- Number of Participants With Solicited General Adverse Events(within 8 days after any vaccination)
- Percentage of Participants With Seroconversion by ELISA(within 8 weeks)
- Number of Participants With Unsolicited Adverse Events(within 29 days after vaccination)
研究者
研究点 (6)
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