Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2012-2013, in Non-Elderly Adult and Elderly Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Immunogenicity endpoint: Seroprotection rate
研究概览
简要总结
The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by hemagglutination inhibition (HAI) at three weeks post immunization in non-elderly and elderly subjects in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or non-pregnant females and aged ≥ 18 years;
- •Willing and able to adhere to visit schedules and all study requirements;
- •Subjects read and signed the study-specific informed consent.
排除标准
- 未提供
研究组 & 干预措施
AdimFlu-S
干预措施: AdimFlu-S (Biological)
AdimFlu-S
干预措施: Influenza vaccine (split virion, inactivated) (Biological)
结局指标
主要结局
Immunogenicity endpoint: Seroprotection rate
时间窗: At 3 weeks after vaccination
Seroprotection rate is defined as the proportion of subjects with HAI titer ≥ 1:40.
Immunogenicity endpoint: Seroconversion rate
时间窗: At 3 weeks after vaccination
The seroconversion is defined as the HAI titer of the post-vaccination serum is at least 1:40 for those who had a negative pre-vaccination HAI serum titer or a four-fold or greater increase in HAI titers in subjects who had a positive pre-vaccination HAI serum titer. The seropositive is defined as the HAI titer ≥ 1:10, and the seronegative is defined as HAI titer \< 1:10.
Immunogenicity endpoint: Geometric mean folds increase in HAI titer
时间窗: At 3 weeks after vaccination
次要结局
- Safety: Reactogenicity events(7 days after vaccination)
- Safety: Serious and non-serious adverse events(Through day 21 post vaccination)