NCT00320346已完成2 期
A Double-Blind, Randomised, Multi-Centre Study to Evaluate the Safety, Tolerability, Immunogenicity and Lot to Lot Consistency of Two Formulations of CSL Limited's Inactivated Prototype Pandemic Influenza Vaccine in a Healthy Adult Population (≤18 Years to ≥64 Years of Age).
Seqirus4 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2006年7月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Safety and Immunogenicity
研究概览
简要总结
The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza H5N1 virus strain is the leading candidate to cause the next influenza pandemic. This study will test the safety and immunogenicity of a H5N1 Pandemic Influenza Vaccine in healthy adults. The Study will also assess Lot to Lot consistency of the Pandemic Influenza Vaccine.
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
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Adults
排除标准
- •Previous vaccination with an influenza Vaccine containing the H5N1 strain
- •History of clinically significant medical conditions
- •History of Guillian-Barre Syndrome or active Neurological disease
结局指标
主要结局
Safety and Immunogenicity
次要结局
- Lot to Lot Consistency
研究者
研究点 (4)
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