EUCTR2006-006307-37-AT进行中（未招募）不适用
AN OPEN LABEL PHASE III STUDY OF A VERO CELL-DERIVED WHOLE VIRUS H5N1 INFLUENZA VACCINE TO ASSESS THE IMMUNOGENICITY AND SAFETY AND TO INVESTIGATE THE NEED FOR AND TIMING OF A BOOSTER VACCINATION - Phase 3 H5N1 Influenza Vaccine Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 550
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male and female subjects will be eligible for participation in this study if they:·
- •Are 18 to 59 years of age on the day of screening (for Stratum A only); ·
- •Are 60 years of age and older on the day of screening (for Stratum B only);
- •Have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry;
- •Are clinically healthy (in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical study);·
- •Agree to keep a daily record of symptoms;·
- •If female and capable of bearing children – have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects will be excluded from participation in this study if they:·
- •Have a history of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza vaccine;·
- •Are at high risk of contracting H5N1 influenza infection (e.g. poultry workers);·
- •Suffer from or have a history of a significant cardiovascular, pulmonary, neurological, hepatic, rheumatic, autoimmune, hematological, metabolic or renal disorder;·
- •Are unable to lead an independent life as a result of either physical or mental handicap;
- •Suffer from any kind of immunodeficiency;
- •Suffer from a disease or were undergoing a treatment within 30 days prior to study entry or are currently undergoing a form of treatment that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (>800µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs;
- •Have a history of severe allergic reactions or anaphylaxis;
- •Have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating;
- •Have received a blood transfusion or immunoglobulins within 90 days of study entry;
- •Have donated blood or plasma within 30 days of study entry;
- •Have received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study;·
- •Have a functional or surgical asplenia;
- •Have a known or suspected problem with alcohol or drug abuse;
- •Were administered an investigational drug within six weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product;
- •Are a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator;
研究者
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