NCT01357265已完成2 期
A Phase II Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface, Antigen, Inactivated, Influenza Vaccine, Formulation 2011/2012, When Administered to Adult and Elderly Subjects
Novartis Vaccines11 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2011年5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
- 125
- 试验地点
- 11
- 主要终点
- To evaluate the antibody response to each influenza vaccine antigen at 21 days post-immunization in adult and elderly
研究概览
简要总结
This study will evaluate safety and immunogenicity of a sub-unit Influenza vaccine when administered to adult and elderly subjects.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, adult and elderly volunteers over 18 years
排除标准
- •Individuals with any serious chronic or acute disease or known or suspected impairment of the immune system.
结局指标
主要结局
To evaluate the antibody response to each influenza vaccine antigen at 21 days post-immunization in adult and elderly
时间窗: 22 days including follow-up period
To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) and/or HI at 21 days post-immunization in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines.
次要结局
未报告次要终点
研究者
研究点 (11)
Loading locations...
相似试验
已完成
2 期
Study to Evaluate Safety and Immunogenicity of Sub-unit Adjuvanted Influenza Vaccine Administered to Elderly Subjects, Formulation 2010-2011Seasonal InfluenzaNCT01152814Novartis Vaccines64
已完成
2 期
Study to Evaluate Safety and Immunogenicity of Sub-unit Adjuvanted Influenza Vaccine Administered to Elderly Subjects, Formulation 2011-2012Seasonal InfluenzaNCT01344057Novartis Vaccines63
已完成
2 期
Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2007/2008) When Administered to NON Elderly AND Elderly SubjectsInfluenzaNCT00518726Novartis Vaccines125
已完成
2 期
Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Subjects 18 Years of Age or OlderInfluenzaNCT00329966Novartis100
已完成
2 期
Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Elderly SubjectsInfluenzaNCT00329927Novartis60