NCT00518453已完成2 期
A Phase II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Ph.Eur, Formulation 2007-2008, When Administered to Non-Elderly Adult and Elderly Subjects
Novartis Vaccines1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2007年7月最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- evaluate the antibody response to each influenza vaccine antigen
研究概览
简要总结
Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO and CPMP recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly adults and elderly subjects (CPMP/BWP/214/96).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Subjects eligible for enrollment into this study are male and female adult volunteers
排除标准
- •Any serious disease
结局指标
主要结局
evaluate the antibody response to each influenza vaccine antigen
时间窗: 21 days post-immunization
次要结局
- Safety and tolerability of the study vaccine in the study population(Throughout the study)
研究者
研究点 (1)
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