NCT00325260已完成3 期
A Randomized, Endpoint-Blind, Parallel Group Study to Demonstrate the Non-Inferiority of the Subunit Influenza Vaccine Influvac® to the Subunit Influenza Vaccine Agrippal® in Healthy Children, Adults and Elderly in China.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- HI titers 4 weeks after vaccination (efficacy) and safety and tolerability
研究概览
简要总结
In the study Influvac will be compared to Agrippal, another subunit influenza vaccine that is already on the market in China. The main objective of the study is to show that both vaccines are comparable with regard to efficacy. In addition, safety and efficacy data with Influvac will be assessed in the Chinese population.
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
- Double
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •signed and dated informed consent
- •being healthy
- •mental health enough to understand the study, the informed consent form and the questionnaire
排除标准
- •known to be allergic to constituents of the vaccine
- •having an autoimmune disorder, taking immunomodulating drugs or having immune disfunction secondary to HIV
- •having had a documented serious adverse reaction to previous influenza vaccination
- •having had documented influenza infection or vaccination in the six months prior to the start of the study
- •having received any other vaccines, immunoglobulins or investigational drugs in the month prior to the start of the study
结局指标
主要结局
HI titers 4 weeks after vaccination (efficacy) and safety and tolerability
次要结局
- HI derived parameters: seroprotection, seroconversion and mean fold increase 4 weeks after vaccination
研究者
研究点 (1)
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