NCT00848848已完成1 期
A Phase Ib, Multi-Center, Randomized, Observer-Blind, Proof of Concept, Dose- and Formulation-Ranging Study to Evaluate Safety, Tolerability, and Immunogenicity of One Dose of Trivalent Inactivated Influenza Vaccine in Different Presentations (Intramuscular and Intradermal Delivery), Dosages (Regular or Higher A/H3N2 Content) and Doses of Adjuvant Administered to Healthy Elderly Aged ≥ 65 Years
Seqirus2 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2008年10月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment.
研究概览
简要总结
The study will evaluate the safety, tolerability and immunogenicity of different doses and types of Influenza Vaccine in healthy elderly subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects 65 years or older generally in good health as determined by medical history, physical assessment and clinical judgment of the investigator.
排除标准
- •Subjects who have received influenza vaccine within the past 6 month and who have received adjuvanted vaccine in the past two years.
- •Subjects with hypersensitivity to vaccine components. Subjects who are on or were recently on immunosuppressive therapy.
结局指标
主要结局
Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment.
时间窗: 21 days
次要结局
- Strain-specific influenza antibody titers will be used to assess Immunogenicity(21 days)
研究者
研究点 (2)
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