NCT00161837已完成2 期
Single-blind Randomized Controlled Phase II/III Study to Investigate the Immunogenicity and Safety of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell Derived) in Comparison to a Licensed Egg-derived Influenza Vaccine for Season 2003/2004
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
The objectives of the study are to assess the immunogenicity and safety of the inactivated influenza vaccine (whole virion, Vero cell-derived) at Day 21 and Day 180 after vaccination.
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
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects will be eligible for participation in this study if they:
- •are >= 18 and <= 60 years old (for Stratum A only);
- •are > 60 years old (for Stratum B only);
- •are in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical trial;
- •will reliably keep a daily record of symptoms;
- •understand the nature of the study, agree to its provisions, and give written informed consent;
- •if female and capable of bearing children - show a negative pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study.
排除标准
- •Male and female subjects will be excluded from participation in this study if they:
- •have received any influenza vaccine for the 2002/2003 season and/or for the 2003/2004 season;
- •suffer from any kind of immunodeficiency;
- •suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions;
- •have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis);
- •have received a blood transfusion or immunoglobulins within one month of study entry;
- •have a history of any vaccine-related contraindicating event (e.g. anaphylaxis);
- •have a rash or dermatological condition which may interfere with injection site reaction rating;
- •have a known or suspected problem with drug or alcohol abuse;
- •are unable to lead an independent life either physically or mentally;
- •had administration of an investigational drug within six weeks prior to the study start;
- •are concurrently participating in a clinical trial;
- •are pregnant or lactating.
研究者
研究点 (2)
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