NCT00851266已完成1 期
A Dose-Escalation, Dose-Ranging Study of the Safety, Tolerability, and Immunogenicity of a Bivalent Influenza Peptide Conjugate Vaccine Formulated With Aluminum- and ISCOMATRIX(TM) Containing Adjuvants (BIPCV/IMX) Evaluated in Healthy Adults 18 to 35 Years of Age
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 187
- 主要终点
- Safety: Safety and tolerability of BIPCV/IMX as assessed by vaccine-related SAEs; Immunogenicity: 1) A/M2 specific immunogenicity; 2) B/HA0 specific immunogenicity
研究概览
简要总结
This is a first in man study evaluating the tolerability and immunogenicity of BIPCV/IMX (V512) at increasing concentrations of influenza viral peptides A/M2+B/HA0 peptides and IMX, a saponin-based adjuvant.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is in good physical health
- •Subject is not in the category of individuals recommended by the CDC to receive influenza vaccine for the upcoming 2 influenza seasons
- •Subject agrees not to seek vaccination with licensed influenza vaccines during the study
- •Female subjects agree to use acceptable birth control for 6 weeks prior to first dose of vaccine until 1 month post Dose 3
排除标准
- •Subject has a history of allergic reaction to the vaccine components
- •Subject has has a fever within 3 days of screening
- •Subject had a vaccination with an inactive virus within 14 days of Dose 1
- •Subject had a vaccination with a live virus within 30 days of Dose 1
结局指标
主要结局
Safety: Safety and tolerability of BIPCV/IMX as assessed by vaccine-related SAEs; Immunogenicity: 1) A/M2 specific immunogenicity; 2) B/HA0 specific immunogenicity
时间窗: Safety: 7 months; Immunogenicity: 1) 7 months; 2) 7 months
次要结局
- Persistence of A/M2 and B/HA0 immunogenicity(Months 12, 18, and 24)
研究者
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