NCT00498303已完成3 期
A Phase III, Multicenter, Uncontrolled, Open-Label Study to Evaluate Safety and Immunogenicity of Preservative Free, Inactivated Split Influenza Vaccine, Using the Strain Composition 2007/2008 When Administered to Adult and Elderly Subjects
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- evaluate the antibody response to each influenza vaccine antigen, as measured by haemagglutination inhibition (HI) test on Day 0 and on Day 21
研究概览
简要总结
Annual trial for registration of trivalent split influenza vaccine with the strain composition of the season 2007/2008 in healthy adult and elderly subjects
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
- •available for all the visits scheduled in the study and able to comply with all study requirements
- •in good health as determined by: medical history, physical examination, clinical judgment of the investigator
排除标准
- 未提供
结局指标
主要结局
evaluate the antibody response to each influenza vaccine antigen, as measured by haemagglutination inhibition (HI) test on Day 0 and on Day 21
evaluate safety of trivalent split influenza vaccine
次要结局
未报告次要终点
研究者
研究点 (2)
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