NCT03657719已完成2 期
Open-labeled(Part 1), Single-group(Part 2), Randomized(Part 2), Double-blind(Part 2), Active-controlled(Part 2) Pharse II Clinical Trial to Evaluate Safety and Efficacy(Immunogenicity) of GC3114 in Elderly Healthy Subjects
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Adverse Event
研究概览
简要总结
Elderly healthy subjects will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj..
详细描述
Elderly healthy subjects will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj..
Safety and immunological efficacy will be evaluated.
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)
盲法说明
Part 1 : Open label, Part 2 : Double blind
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 over 65 years old
- •Informed consent form has been signed and dated
排除标准
- •Known systemic hypersensitive 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
研究组 & 干预措施
GC3114
Experimental
Pre-filled syringe inj., 0.5ml, Once, IM
干预措施: GC3114 (Biological)
Active Comparator: GCFLU Quadrivalent
Active Comparator
Pre-filled syringe inj., 0.5ml, Once, IM
干预措施: GCFLU Quadrivalent (Biological)
结局指标
主要结局
Adverse Event
时间窗: for 7 days from Day0/during study period
Solicited/Unsolicited Adverse Event
次要结局
- Percentage of participants achieving pre-defined Seroprotection Before and following vaccination(Day 0 and Day 28)
- Geometric Mean Ratio of Antibodies to the Investigational Product Before and Following vaccination(Day 0 and Day 28)
- Percentage of participants achieving pre-defined Seroconversion Before and following vaccination(Day 0 and Day 28)
- Geometric Mean Titer of Antibodies to the Investigational Product Before and Following vaccination(Day 0 and Day 28)
研究者
研究点 (1)
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