Randomized, Double Blind, Multicenter, Phase III Study to Evaluate the Immunogenicity and Safety of 'MG1109(Egg-based, Pre-pandemic Influenza(H5N1) Vaccine)' Administered Intramuscularly in Healthy Adult Volunteers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 420
- 试验地点
- 4
- 主要终点
- Percentage of subjects achieving post-vaccination seroconversion for Hemagglutination Inhibition(HI) antibody
研究概览
简要总结
The purpose of this study is to 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 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
Placebo
Placebo(for MG1109) 0.5 mL Intramuscularly injection, twice at an interval of 21 days
干预措施: Placebo (Biological)
MG1109
MG1109 0.5 mL Intramuscularly injection, twice at an interval of 21 days
干预措施: MG1109 (Biological)
结局指标
主要结局
Percentage of subjects achieving post-vaccination seroconversion for Hemagglutination Inhibition(HI) antibody
时间窗: 1st vaccination ~ 21 days after 2nd vaccination
GMR(Geometric Mean Ratio) of Hemagglutination Inhibition(HI) antibody titer at post-vaccination compared to pre-vaccination
时间窗: 1st vaccination ~ 21 days after 2nd vaccination
The percentage of subjects reporting unsolicited adverse events from the date of 1st vaccination until 24weeks after 2nd vaccination
时间窗: 1st vaccination ~ 24 weeks after 2nd vaccination
Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer ≥ 1:40
时间窗: 1st vaccination ~ 21 days after 2nd vaccination
The percentage of subjects reporting solicited adverse events from the date of vaccination until 7 days after each vaccination
时间窗: Each vaccination ~ 7 days after each vaccination
次要结局
- GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio) of neutralizing antibody titer pre-vaccination and post-vaccination(1st vaccination ~ 21 days after 2nd vaccination)
- Lab results(Hematology, Blood chemistry, Urinalysis)(1st vaccination ~ 21 days after 2nd vaccination)
- Vital signs(body temperature, pulse)(1st vaccination ~ 21 days after 2nd vaccination)
- The results of physical examinations(1st vaccination ~ 21 days after 2nd vaccination)
- GMT(Geometric Mean Titer) of Hemagglutination Inhibition(HI) antibody titer pre-vaccination and post-vaccination(1st vaccination ~ 21 days after 2nd vaccination)