NCT01450579已完成2 期
Phase II Study of ASP7373 Evaluation of Immunogenicity and Safety of ASP7373 in Healthy Adults
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Immunogenicity (HI antibody titer)- second vaccine
研究概览
简要总结
This trial is to investigate the clinically recommended dosage for ASP7373 based on the comparison of the immunogenicity and safety among the three doses of ASP7373 in healthy adults.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body weight: Female: ≥40.0 kg, <70.0 kg, Male: ≥50.0 kg, <80.0 kg
- •BMI: ≥17.6, <26.4
- •Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations (subjective symptoms and objective findings) and all tests obtained
排除标准
- •Scheduled to receive another vaccine during study period
- •History of H5 influenza infection or received H5 influenza vaccine
- •Past history of anaphylactic shock or an allergic reaction such as generalized eruption due to food or drug (including vaccines) allergies, fever ≥ 39.0°C within 2 days after the previous vaccination (influenza vaccine and others)
- •Diagnosis of immune deficit in the past, has a family member (within the third degree of kinship) with a diagnosis of congenital immunodeficiency syndrome
- •Received or scheduled to receive a live vaccine within 28 days prior to vaccination of the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination of the study vaccine
- •History of seizures
- •Female subjects who are breastfeeding, pregnant, possibly pregnant, and planning to become pregnant during the study period
研究组 & 干预措施
Dose -2
Experimental
ASP7373
干预措施: ASP7373 (Biological)
Dose -1
Experimental
ASP7373
干预措施: ASP7373 (Biological)
Placebo
Placebo Comparator
Saline
干预措施: Placebo (Biological)
Dose -3
Experimental
ASP7373
干预措施: ASP7373 (Biological)
结局指标
主要结局
Immunogenicity (HI antibody titer)- second vaccine
时间窗: on Day 43
second vaccination on Day 22
Immunogenicity (HI antibody titer)- first vaccine
时间窗: on Day 21
Safety assessed by the incidence of adverse events, vital signs, laboratory tests and 12-lead ECGs
时间窗: up to 43 days
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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