NCT00735020已完成1 期
A Phase I, Observer-Blind, Randomized, Single-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Bedside Mixing Combination of Two Adjuvanted Influenza Vaccines in Healthy Adults Aged 18 to 39 Years.
Novartis Vaccines1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2008年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Safety as measured through local and systemic reactions and efficacy (immunogenicity) as measured by antibody titers.
研究概览
简要总结
This trial is designed to evaluate safety, tolerability and immunogenicity of a bedside mixing formulation of adjuvanted influenza vaccines.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy 18 to 39 year old males and females who are in good health and have provided informed consent prior to enrollment
排除标准
- •serious medical conditions
- •allergies to vaccine components, including but not limited to egg/chicken products
- •reduced immune function
- •recent use of immunosuppressive therapy
- •recent use of influenza vaccine
研究组 & 干预措施
1
Experimental
干预措施: Adjuvanted Influenza Vaccine (Biological)
2
Active Comparator
干预措施: Influenza Vaccine (Biological)
结局指标
主要结局
Safety as measured through local and systemic reactions and efficacy (immunogenicity) as measured by antibody titers.
时间窗: 36 Days
次要结局
- To evaluate immunogenicity of a single IM injection of adjuvanted Influenza vaccine(36 Days)
研究者
研究点 (1)
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