NCT00999206已完成3 期
Randomized, Double-Blind Study to Assess Safety, Immunogenicity, and Lot Consistency of Solvay's Cell-Derived Influenza Vaccine and Its Non-Inferiority Compared to Influvac®.
Abbott Biologicals37 个研究点 分布在 2 个国家目标入组 3,138 人开始时间: 2010年1月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,138
- 试验地点
- 37
- 主要终点
- Anti-HA antibody titers and derived parameters seroprotection, seroconversion and fold increase
研究概览
简要总结
A phase 3 study to obtain additional safety and immunogenicity data on Solvay's cell-derived seasonal trivalent subunit influenza vaccine in adult and elderly subjects without significant illnesses and to demonstrate consistency of the immunogenicity of the three lots of the same vaccine, comparison of cell-derived vaccine to Solvay's egg-derived vaccine including assessment of non-inferior immunogenicity
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female or male subjects >= 18 years of age (adults >= 18 to < =60 years of age or elderly >= 61 years of age).
- •Willing and able to give informed consent before any protocol procedures are performed.
- •Able to adhere to visit schedules and all protocol required study procedures.
- •Being in good health as determined by medical history, physical examination and clinical judgment of the investigator (subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease or hypothyroidism, as long as the disease is well controlled. If on medication for a condition, the medication dose must have been stable for at least 3 months preceding study vaccination).
排除标准
- •Influenza vaccination or laboratory confirmed influenza infection within six months preceding the date of study vaccination or planning an influenza vaccination during the three weeks after study vaccination (i.e. between study Day 1 and study Day 22).
- •Presence of any significant condition that may prohibit inclusion as determined by the Investigator.
- •A serious adverse reaction after a previous (influenza) vaccination.
- •A history of Guillain-Barré syndrome.
- •Known to be allergic to constituents of the study vaccines.
结局指标
主要结局
Anti-HA antibody titers and derived parameters seroprotection, seroconversion and fold increase
时间窗: 3 weeks
次要结局
未报告次要终点
研究者
研究点 (37)
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