NCT00316628已完成2 期
A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, (Adjuvanted With MF59C.1) Influenza Vaccine, Formulation 2005-2006, When Administered to Elderly Subjects.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.
研究概览
简要总结
The purpose of this study is to evaluate safety and immunogenicity of a single intramuscular (IM) injection of an adjuvanted influenza vaccine in elderly subjects.
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
- 否
入选标准
- •65 years of age or older and in good health
排除标准
- •Any serious disease such as: cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure.
- •any acute disease or infections requiring systemic antibiotic or antiviral therapy
- •hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin 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 within the past 7 days
结局指标
主要结局
CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.
次要结局
- Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection.
- Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection.
- Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24).
研究者
研究点 (3)
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