NCT00561184已完成2 期
A Phase II, Open-label, Multi-Center Study to Evaluate Safety and Immunogenicity of a Booster Dose of -H5N1 (Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccine in Non-elderly Adult and Elderly Subjects
Novartis Vaccines6 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2007年10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
- 47
- 试验地点
- 6
- 主要终点
- Number and percentage of subjects with at least one local reaction between 1 and 7 days after vaccination.
研究概览
简要总结
To assess persistence of antibody titers 17-18 months after primary immunization with two 0.5mL intramuscular (IM) doses of H5N1 influenza vaccine containing H5N1 influenza antigen, as measured by Hemagglutination Inhibition (HI), Single Radial Hemolysis (SRH), and Microneutralization (MN) test
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects who previously participated in study V87P1, but did not receive the booster dose on day 202
排除标准
- •Pregnant or breastfeeding
- •Receipt of another vaccine or any investigational agent within the past 4 weeks
- •Surgery planned during the study period
结局指标
主要结局
Number and percentage of subjects with at least one local reaction between 1 and 7 days after vaccination.
时间窗: 7 days
Number and percentage of subjects with at least one systemic reaction between 1 and 7 days after vaccination.
时间窗: 7 days
次要结局
- Number and percentage of subjects with at least one adverse event between day of vaccination and the study termination visit.Safety will be assessed in accordance with available safety data on influenza vaccines.(8 months)
研究者
研究点 (6)
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