NCT01961960已完成3 期
Phase 3 Study of ASP7374 -Open-label Study of Intramuscular ASP7374 in Adults ≥61 Years of Age-
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- hemagglutination inhibition (HI) antibody titer
研究概览
简要总结
The purpose of this study is to evaluate safety and immunogenicity of intramuscular ASP7374 in adults ≥61 years of age.
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
- 61 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy or medically stable, as judged on the basis of history and concurrent diseases.
- •Subject understands procedure of the protocol and is willing to comply with the protocol.
- •Written informed consent has been obtained.
排除标准
- •Scheduled to receive another vaccine during the study.
- •Received influenza HA vaccine within 180 days prior to screening.
- •Received or scheduled to receive a live vaccine within 28 days prior to vaccination with the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination with the study vaccine.
- •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 one of the following medications or treatment prior to vaccination with the study vaccine: Interferon formulation, Drugs which affect the immune system, corticosteroids, G-CSF, M-CSF, Human immunoglobulin products, Blood products, Blood transfusion
- •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)
- •History of seizures, except for febrile seizures in childhood
研究组 & 干预措施
ASP7374 group
Experimental
干预措施: ASP7374 (Biological)
结局指标
主要结局
hemagglutination inhibition (HI) antibody titer
时间窗: Day 1 and Day 29
evaluated for A/H1N1, A/H3N2, and B
次要结局
- neutralizing antibody titer(Day 1 and Day 29)
- Local and systemic reactions associated with the vaccination(Day 1 through Day 8)
研究者
研究点 (1)
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