Randomized, Double-blind, Active -Controlled Trial to Assess Safety and Immunogenicity of Solvay's Cell-derived Influenza Vaccine, Including Revaccination, in Elderly Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 622
- 试验地点
- 24
- 主要终点
- To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the CHMP criteria for immunogenicity.
研究概览
简要总结
A controlled, double-blind study to determine the immunogenicity and safety of influenza cell derived vaccine in elderly subjects.
详细描述
This current phase II study is to pursue objectives similar to those of the ongoing adult phase II trial, but to expand into the elderly population who are more than 60 years of age. The results of this randomized, double blind, egg derived influenza vaccine (Influvac) - controlled, parallel-trial, in healthy elderly subjects are to be conducted over two consecutive years in multiple centers in Europe. At study initiation 600 subjects will be randomly allocated to receive the cell-derived or egg-derived influenza vaccine. At start of the second year subjects will be randomly re-allocated following stratification based upon the initial drug they were allocated and had received.
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
- 61 Years 至 —（Adult, Older 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 (elderly)
- •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.
结局指标
主要结局
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the CHMP criteria for immunogenicity.
时间窗: 3 weeks
To assess the safety and tolerability of the cell-derived vaccine and compare to an egg-derived influenza vaccine.
时间窗: 6 months
To assess the safety and tolerability of the cell-derived vaccine following revaccination.
时间窗: 6 months
次要结局
- To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination, by applying the CHMP criteria for immunogenicity.(3 weeks)
- To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine.(6 months)