NCT01389466已完成1 期
Randomized Phase I/II Study to Evaluate the Safety and Immunogenicity of 'MG1109(Egg-based, Pre-pandemic Influenza(H5N1) Vaccine)' Administered Intramuscularly in Healthy Adult Volunteers
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 346
- 试验地点
- 4
- 主要终点
- Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer ≥ 1:40 in each dose group
研究概览
简要总结
This study was designed in two steps with Step 1, a single-center, double-blind, randomized clinical Pilot study and Step 2, a multi-center, single-blind, randomized clinical Pivotal study. The investigator evaluate the immunogenicity and safety of the investigational vaccine in the subjects during their participation in the study.
详细描述
MG1109 is purified, inactivated influenza viral antigen.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 58 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults who are available for follow-up during the study
排除标准
- •Subjects with history of exposure to the H5N1 subtype or H5N1 subtype vaccine
- •Subjects with immune system disorder including immune deficiency disease
研究组 & 干预措施
MG1109 - Step 1
Experimental
干预措施: Step 1 (Biological)
Normal Saline - Step 1
Placebo Comparator
干预措施: Step 1 (Biological)
MG1109 - Step 2
Experimental
干预措施: Step 2 (Biological)
结局指标
主要结局
Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer ≥ 1:40 in each dose group
时间窗: 42 days after vaccination
Number of subjects with Solicited / Unsolicited adverse events
时间窗: With in 24 weeks after vaccination
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
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