NCT02366962已完成3 期
Phase III Study of ASP7374-Open-label Study of Subcutaneous Vaccination of Quadrivalent ASP7374 in Adult Subjects Aged 20 or Older
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
- Safety assessed by adverse events
研究概览
简要总结
The purpose of this study is to confirm the safety until Day 29 after injection of a single dose of quadrivalent vaccine ASP7374 in adult subjects aged 20 or older
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
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:
- •Within 28 days prior to vaccination with the study vaccine
- •Interferon formulation
- •Drugs which affect the immune system (e.g., immunosuppressants)
- •Systemic corticosteroids and inhaled corticosteroids
- •G-CSF and M-CSF
- •Within 84 days prior to vaccination with the study vaccine
- •Human immunoglobulin products
- •Blood products
- •Blood transfusion
- •Within 180 days prior to vaccination with the study vaccine
- •High-dose human immunoglobulin products (≥200 mg/kg)
- •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 (exclude a pyrexial attack in childhood)
- •History of Guillain-Barre syndrome or acute disseminated encephalomyelitis (ADEM)
- •Body temperature of ≥37.5°C on Day 1 (before vaccination)
- •Moderate to severe acute or febrile illness (≥37.5°C) within 7 days prior to vaccination
- •Concurrent hepatic disease (exclude fatty liver, hepatic cyst, biliary stone and gallbladder poly, which have laboratory findings only, no clinical symptoms, and not necessary to treat), or AST (GOT) and/or ALT (GPT) of >100 IU/L at screening on Day 1
- •Concurrent renal disease (exclude rental cyst and calculus kidney which have laboratory findings only, no clinical symptoms, and not necessary to treat), or creatinine of > 1.5 mg/dL at screening
- •Concurrent respiratory disease, hematologic disease, or developmental disorders
- •Concurrent or previous heart disease
- •Concurrent or previous cerebrovascular disorder
- •Concurrent malignancy or diagnosis or treatment of malignancy within 5 years before screening
- •Diagnosis of mental disorder including schizophrenia, bipolar disorder, or major depressive disorder or cognitive impairment, or received medications for cognitive impairment
- •Concurrent disease interfering with the evaluation of local and systemic reactions
研究组 & 干预措施
ASP7374 group
Experimental
干预措施: ASP7374 (Biological)
结局指标
主要结局
Safety assessed by adverse events
时间窗: Up to Day 29
次要结局
- Local and systemic reactions associated with the vaccination(Up to Day 8)
研究者
研究点 (1)
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