NCT00559975已完成1 期
A Phase 1, Randomized, Controlled, Observer-Blinded, Dose Escalation Study of the Safety, Tolerability and Immunogenicity of a Single Dose of Adjuvanted Influenza Vaccine Combined With CpG7909 in Healthy Adults
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Measures of humoral immunogenicity for each antigen
研究概览
简要总结
To evaluate the safety and tolerability of the an adjuvanted influenza vaccine combined with CpG7909 at three different doses of CpG 7909 as a single intramuscular (IM) administration in healthy adults. Safety will be assessed by observation of symptoms, physical examination findings and laboratory safety testing.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects aged 18 to ≤40 years
排除标准
- •Any serious disease, hypersensitivity to egg or vaccine components, neurological symptoms or positive antibody test against dsDNA, RF, ANA or thyroid.
- •Abnormal TSH from blood samples collected during the screening visit;
结局指标
主要结局
Measures of humoral immunogenicity for each antigen
时间窗: 22 days
次要结局
- Measures of vaccine-induced B and T cell immune responses(72 hours)
- Measure of alterated biomarkers and measure of safety(72 hours)
研究者
研究点 (2)
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