NCT00889889已完成2 期
Randomized, Double-Blind, Placebo-Controlled Study to Assess the Immunogenicity and Safety of a Cell-Derived Trivalent Subunit Influenza Vaccine in Subjects Aged >= 18 Years and <= 64 Years During Two Consecutive Years.
Abbott Biologicals15 个研究点 分布在 1 个国家目标入组 1,270 人开始时间: 2009年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,270
- 试验地点
- 15
- 主要终点
- To assess after the first vaccination the safety and tolerability of the cell-derived subunit vaccine compared to placebo.
研究概览
简要总结
Immunogenicity and safety of a cell-derived influenza vaccine in adults aged >= 18 and <= 64 years, plus revaccination
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to give informed consent and able to adhere to all protocol required study procedures.
- •Men and women aged >= 18 and <= 64 years.
- •Being in good health as judged by medical history, physical examination and clinical judgment of the investigator.
排除标准
- •Known to be allergic to constituents of the vaccine.
- •A serious adverse reaction after a previous (influenza) vaccination. Presence of any significant condition that may prohibit inclusion as determined by the investigator.
- •Having received vaccination against influenza or lab confirmed influenza within the previous six months before study vaccination.
研究组 & 干预措施
1
Experimental
干预措施: Cell-Derived Trivalent Subunit Influenza Vaccine (Biological)
2
Placebo Comparator
干预措施: Placebo (Biological)
结局指标
主要结局
To assess after the first vaccination the safety and tolerability of the cell-derived subunit vaccine compared to placebo.
时间窗: 6 months
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the FDA requirement for influenza vaccines.
时间窗: 3 weeks
次要结局
- To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine.(6 months)
- To assess after the second vaccination the safety and tolerability of the cell-derived subunit vaccine.(6 months)
- To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination.(3 weeks)
研究者
研究点 (15)
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