NCT02917304已完成3 期
A Multicenter, Open-label, Single Arm Study to Evaluate the Immunological Efficacy and Safety of GC3110A. Administered Intramuscularly in Healthy Subjects Aged 65 Years and Older
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 274
- 试验地点
- 10
- 主要终点
- Percentage of Participants Achieving Pre-defined Seroconversion Before and following vaccination
研究概览
简要总结
The purpose of this study is to evaluate immunological efficacy and safety of GC3110A among healthy adults over 65 years of age.
详细描述
Adults over 65 years of age will be once administered GC3110A(Quadrivalent influenza vaccine).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 65 years and older
- •Informed consent form has been signed and dated
- •Able to comply with the requirements of the study
排除标准
- •Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components
- •Personal history of Guillain-Barre syndrome(GBS)
- •Subjects with severe chronic disease who are considered by investigator to be ineligible for the study
- •Subjects who received a vaccination within 28 days before enrollment or who are scheduled for another vaccination during the study
- •Immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy
结局指标
主要结局
Percentage of Participants Achieving Pre-defined Seroconversion Before and following vaccination
时间窗: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
Percentage of Participants Achieving Pre-defined Seroconversion Before and following vaccination
Percentage of Participants Achieving Pre-defined Seroprotection Before and following vaccination
时间窗: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
Percentage of Participants Achieving Pre-defined Seroprotection Before and following vaccination
次要结局
- Geometric Mean Titer and Geometric Mean Titer Ratios of Antibodies to the GC3110A Before and Following Vaccination(Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination))
研究者
研究点 (10)
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