A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008, When Administered to Elderly Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 3
- 主要终点
- Antibody response to each influenza vaccine antigen as measured by Single Radial Hemolysis in elderly subjects (≥65y) in compliance with the requirements of the current EU recommendations for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96)
研究概览
简要总结
To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 65 years and over
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •65 years of age or older
排除标准
- •any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or insulin-dependent diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure and bleeding diathesis or conditions associated with prolonged bleeding time
- •hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or kanamycin or any other component of the vaccine
- •history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
- •known or suspected (or high risk of developing) impairment/alteration of immune function
- •any acute disease or infections requiring systemic antibiotic or antiviral therapy within the past 7 days
- •fever within the past 3 days
结局指标
主要结局
Antibody response to each influenza vaccine antigen as measured by Single Radial Hemolysis in elderly subjects (≥65y) in compliance with the requirements of the current EU recommendations for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96)
时间窗: 21 days post-vaccination
The measures of immunogenicity for each antigen are: * the geometric mean area (GMA) on Day 0 and Day 21 * the Day 21/Day 0 geometric mean area ratio (GMR) * the percentage of subjects achieving seroconversion1 or significant increase in antibody titer2 * the percentage of subjects achieving an SRH area ≥ 25 mm2 on Day 0 and Day 21 1. Seroconversion is defined as negative prevaccination serum/postvaccination serum area ≥ 25 mm2. 2. Significant increase in antibody titer is defined as at least a 50% increase in area.
次要结局
- To evaluate the safety of the administration of a single intramuscular (IM) injection of FLUAD® vaccine (formulation 2007/2008) in elderly subjects (≥ 65 years).(3 days, respectively 21 days post-vaccination)