NCT02915809Unknown3 期
A Randomized, Double-Blind, Multicenter Study to Compare the Immunological Efficacy and Safety of GC3110B With GCFLU Quadrivalent Inj. Administered Intramuscularly in Healthy Adults
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 414
- 主要终点
- Geometric Mean Titer Ratios of Antibodies to the GC3110B or GCFLU Quadrivalent Inj.
研究概览
简要总结
The purpose of this study is to evaluate immunological efficacy and safety of GC3110B versus GCFLU Quadrivalent Inj. among healthy adults in 18 to 60 years of age.
详细描述
Adults 18 to 60 years of age will be randomly assigned in a 1:1 ratio to receive either GC3110B or GCFLU Quadrivalent Inj.
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
- Triple (Participant, Care Provider, 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 aged 18 to 60 years
- •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-Barré syndrome
- •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
Geometric Mean Titer Ratios of Antibodies to the GC3110B or GCFLU Quadrivalent Inj.
时间窗: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
Geometric mean titers of antibodies will be assessed using the hemagglutination inhibition (HI) assay.
次要结局
- Number and Percentage of Participants Reporting Solicited Adverse Events Following Vaccination(Day 0 to Day 6)
- Number and Percentage of Participants Reporting Unsolicited Adverse Events Following Vaccination(Day 0 to Day 21)
- Percentage of Participants Achieving Pre-Defined Seroprotection Before and Following Vaccination(Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination))
- Percentage of Participants Achieving Pre-Defined Seroconversion Before and Following Vaccination(Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination))
研究者
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