NCT00599443已完成1 期
Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Tolerability of a Cell-Derived Influenza Vaccine in Healthy Adults Aged ≥18 Years and ≤ 49 Years.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Safety and tolerability of one dose of cell-derived influenza vaccine in healthy adults aged ≧18 years and ≦ 49 years after vaccination.
研究概览
简要总结
A controlled, double blinded study to determine the safety and reactogenicity in healthy adults of a single dose of a trivalent cell-derived influenza vaccine administered by intramuscular injection.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy female or male subjects aged ≧18 and ≦49 years
- •Willing and able to give informed consent
排除标准
- •Influenza vaccination of laboratory confirmed influenza infection within six months of informed consent,
- •presence of any significant medical condition,
- •a serious adverse reaction after a previous (influenza) vaccination,
- •underlying medical conditions for which annual influenza vaccine is recommended by the Advisory Committee on Immunization Practices (ACIP),
- •chronic diseases requiring long-term immunosuppressive therapy
结局指标
主要结局
Safety and tolerability of one dose of cell-derived influenza vaccine in healthy adults aged ≧18 years and ≦ 49 years after vaccination.
时间窗: 3 weeks
Long-term safety
时间窗: 6 months
次要结局
- HI antibody titers(3 weeks)
研究者
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