NCT01767896已完成3 期
Phase III Study of ASP7374 -Approved Egg-derived Vaccine Controlled, Double-blind, Parallel Group Study in Elderly Subjects
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,020
- 试验地点
- 3
- 主要终点
- seroconversion rate of hemoagglutination inhibition (HI) antibody titer
研究概览
简要总结
The purpose of this study is to compare immunogenicity and safety of ASP7374 (cell-culture derived influenza vaccine) with those of approved egg-derived trivalent inactivated vaccine (TIV) in elderly subjects.
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
- 65 Years 至 —（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: Interferon formulation, drugs which affect the immune system, corticosteroids, G-CSF, M-CSF, human immunoglobulin products, blood products
- •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
- •History of Guillain-Barre syndrome or acute disseminated encephalomyelitis (ADEM)
- •Confirmed diagnosis of influenza within 84 days prior to screening test
- •Body temperature of ≥37.5°C on Day 1 (before vaccination)
- •Immunological tests reveal positive HBs antigen, HCV antibody, and HIV antigen and/or antibody
研究组 & 干预措施
ASP7374 group
Experimental
cell-culture-derived vaccine group
干预措施: ASP7374 (Biological)
TIV group
Active Comparator
approved egg-derived TIV group
干预措施: approved egg-derived TIV (Biological)
结局指标
主要结局
seroconversion rate of hemoagglutination inhibition (HI) antibody titer
时间窗: Day 29
evaluated for A/H1N1, A/H3N2, and B
geometric mean titer (GMT) of HI antibody titer
时间窗: Day 29
evaluated for A/H1N1, A/H3N2, and B
次要结局
- seroprotection rate of HI antibody titer(Day 29)
- GMT ratio of HI antibody titer(Day 1 and Day 29)
- seroconversion rate of neutralizing antibody titer(Day 29)
- seroprotection rate of neutralizing antibody titer(Day 29)
- GMT of neutralizing antibody(Day 29)
- GMT ratio of neutralizing antibody(Day 1 and Day 29)
研究者
研究点 (3)
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