NCT01961947已完成3 期
Phase 3 Study of ASP7374 -Approved Egg-derived Vaccine Controlled, Double-blind, Parallel Group Study in Adults ≥20 and <65 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
- 900
- 试验地点
- 2
- 主要终点
- seroconversion rate of hemagglutination 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 adults ≥20 and <65 years.
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 64 Years（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.
- •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 (including chicken, poultry, foodstuffs derived from chicken, et al.) 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
TIV group
Active Comparator
干预措施: approved egg-derived TIV (Biological)
ASP7374 group
Experimental
干预措施: ASP7374 (Biological)
结局指标
主要结局
seroconversion rate of hemagglutination 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 of neutralizing antibody titer(Day 29)
- GMT ratio of HI antibody titer (Day 29/Day 1)(Day1 and Day 29)
- seroconversion rate of neutralizing antibody titer(Day 29)
- seroprotection of neutralizing antibody titer(Day 29)
- GMT ratio of neutralizing antibody titer (Day 29/Day 1)(Day 1 and Day 29)
- Local and systemic reactions associated with the vaccination(Day 1 through Day 8)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Phase-3 Study of ASP7374, Cell-culture-derived Influenza VaccineInfluenzaNCT01767896UMN Pharma Inc.1,020
已完成
3 期
A Study to Evaluate Intramuscular ASP7374VaccineInfluenzaNCT01961960UMN Pharma Inc.55
已完成
3 期
Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Adult and Elderly SubjectsInfluenza, HumanNCT02344134SK Chemicals Co., Ltd.1,155
已完成
2 期
A Study to Evaluate the Immune Response to the ASP7373 and Its Safety in Healthy Adult VolunteersHealthyNCT01450579UMN Pharma Inc.180
已完成
3 期
Ross River Virus (RRV) Vaccine StudyProphylaxis of Ross River Virus InfectionNCT01242670Resilience Government Services, Inc.1,968