EUCTR2005-004164-23-AT进行中（未招募）不适用
Single-blind, Randomized, Controlled Phase I/II Study to Compare the Safety and Immunogenicity of an Inactivated Influenza Vaccine (Whole Virion, Vero cell derived) with a Licensed Egg derived Influenza Vaccine - Phase 1/2 Modified Whole Virus Influenza Vaccine Trial
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Baxter AG
- 入组人数
- 423
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:
- •ØAre 18 to 45 years of age, inclusive, on the day of screening;
- •ØHave an understanding of the study, agree to its provisions, and give written informed consent prior to study entry;
- •ØAre 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);
- •ØAgree to keep a daily record of symptoms;
- •ØIf 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) no
- •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:
- •ØHave received any influenza vaccination for the 2005/2006 influenza season and/or the 2004/2005 influenza season;
- •ØHave received any vaccination within 2 weeks prior to vaccination in this study;
- •ØSuffer from any kind of immunodeficiency;
- •ØSuffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immune response;
- •ØHave a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis);
- •ØHave received a blood transfusion or immunoglobulins within 30 days of study entry;
- •ØHave donated blood or plasma within 30 days of study entry;
- •ØHave a history of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to eggs, allergy to components of the test or comparator vaccine);
- •ØHave a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating;
- •ØHave a known or suspected problem with alcohol or drug abuse;
- •ØAre unable to lead an independent life as a result of either physical or mental handicap;
- •ØWere administered an investigational drug within six weeks prior to study entry;
- •ØAre concurrently participating in a clinical study that includes the administration of an investigational product;
- •ØIf female, are pregnant or lactating;
- •ØAre 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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