NCT01195038已完成2 期
A Multicenter, Open-Label Study to Assess the Immunogenicity and Safety of a Booster Vaccination With a Recombinant H5N1 Influenza HA Vaccine in Healthy Young Adults Primed With a Two-Vaccination of a Recombinant H5N1 Influenza HA Vaccine
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Percentage of subjects achieving seroconversion 21 days after a booster vaccination, as measured by hemagglutination inhibition (HI) assay against H5N1 influenza viruses (A/Indonesia/05/2005 & A/Vietnam/1203/2004)
研究概览
简要总结
The study is designed to assess the immunogenicity and safety of one booster vaccination with 45 μg of a recombinant H5N1 influenza (A/Indonesia/05/2005) HA vaccine in healthy young adults, previously primed with a two-vaccination of 3 different doses of a recombinant H5N1 influenza (A/Vietnam/1203/2004) HA vaccine in a priming study (JPIP501-01a, NCT00980447).
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
- 21 Years 至 41 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who completed a priming study (JPIP501-01a, NCT00980447)
- •Male and female healthy adults
- •Written informed consent obtained from the subject before study entry
排除标准
- •History of H5N1 influenza or vaccination of other H5N1 influenza vaccines
- •Clinically diagnosed cardiovascular, hematological, psychological, neurological, hepatic, renal, pulmonary (including asthma), endocrinological or gastrointestinal disorder
- •Confirmed immune deficiency conditions, or diagnosed autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus
- •Severe allergic reactions or anaphylaxis to foods or drugs (including vaccines)
- •Treatment with disallowed drugs including other study drugs
- •Pregnant or nursing (lactating) women
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Percentage of subjects achieving seroconversion 21 days after a booster vaccination, as measured by hemagglutination inhibition (HI) assay against H5N1 influenza viruses (A/Indonesia/05/2005 & A/Vietnam/1203/2004)
时间窗: Day 21
次要结局
- Incidence of adverse events including solicited local or systemic reactions until 21 days after a booster vaccination(21 days)
- Percentage of subjects achieving seroprotection or significant increase in antibody titer on each blood sampling days after a booster vaccination, as measured by HI and microneutralization assays against the H5N1 influenza viruses(Days 7, 21)
研究者
研究点 (2)
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