NCT00996138已完成2 期
A Multi-center, Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Doses of Adjuvanted Cell-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Japanese Adult Subjects
Novartis Vaccines1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2009年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Seroprotection, GMRs and Seroconversion rate at Weeks 0, 3 and 6
研究概览
简要总结
This study is to identify the preferred vaccine dosage (of antigen and adjuvant) and schedule (one or two administrations) of the cell-derived H1N1sw monovalent vaccine in healthy adults based on EMEA/CHMP criteria, and safety & tolerability.
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
- 29 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese adults aged 20 to 60 years
排除标准
- •History of anaphylaxis, serious vaccine reactions, hypersensitivity to vaccine viral proteins or excipients
- •Administration of adjuvanted influenza vaccine or suspected influenza disease within 3 month prior to study start
- •Administration of any other vaccines within 4 weeks prior to enrollment expect for seasonal influenza vaccines within 1 week
- •History of progressive or severe neurological disorders
研究组 & 干预措施
Arm 1
Other
Dose ranging
干预措施: Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine (Biological)
Arm 2
Other
Dose ranging
干预措施: Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine (Biological)
结局指标
主要结局
Seroprotection, GMRs and Seroconversion rate at Weeks 0, 3 and 6
时间窗: 6 weeks
次要结局
- AEs, vital signs, laboratory tests(6 weeks)
研究者
研究点 (1)
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