A Phase II, Randomized, Controlled, Open Label, Single-Center Study to Evaluate the Immunogenicity, Safety and Tolerability of Fluad-H5N1 and Seasonal Influenza Vaccine in Adult Subjects. - V87P5

ovartis Vaccines and Diagnostics0 个研究点目标入组 400 人开始时间: 2014年10月21日最近更新: 2014年10月27日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 400

研究概览入排标准研究者记录与标识符相似试验

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

•1. Subjects aged 18 to 40 years of age who were mentally competent and who signed an informed consent form after having received a detailed explanation of the study protocol;
•2. Subjects who were in good health as determined by:
•? Medical history,
•? Physical examination,
•? Clinical judgment of the Investigator;
•3. Subjects who were able to understand and comply with all study procedures and to complete study diaries, can be contacted, and will be available for study visits;
•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 405
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•1. Who received another investigational agent within 4 weeks, or before completion of the safety follow-up period in another study, whichever was longer, prior to enrollment and were unwilling to refuse participation in another clinical study through the end of the study;
•2. Who received influenza vaccination for current season 2007;
•3. Who experienced any acute disease or infection requiring systemic antibiotic or antiviral therapy within the past 7 days;
•4. Who experienced fever (defined as axillary temperature =38.0°C) within 3 days prior to Visit 1;
•5. Who were Pregnant or breastfeeding;
•6. Females who refused to use an acceptable method of birth control for the duration of the study.
•7. Who had any serious disease, such as:
•b. Autoimmune disease (including rheumatoid arthritis),
•c. Diabetes mellitus,
•d. Chronic pulmonary disease,
•e. Acute or progressive hepatic disease,
•f. Acute or progressive renal disease;
•8. Who had surgery planned during the study period;
•9. Who had bleeding diathesis;
•10. Who had hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine;
•11. Who had history of any neurological symptoms or signs, or anaphylactic shock following administration of any vaccine;
•12. Who had known or suspected impairment/alteration of immune function, for
•example, resulting from:
•a. Receipt of immunosuppressive therapy (any corticosteroid therapy or cancer
•chemotherapy),
•b. Receipt of immunostimulants,
•c. High risk for developing an immunocompromising disease;
•13. Who had received another vaccine within 3 weeks prior and following each study vaccination;
•14. Who had history of (or current) drug or alcohol abuse that in the investigator’s opinion would interfere with safety of the subject or the evaluation of study objectives;
•15. Who had any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

研究者

发起方

ovartis Vaccines and Diagnostics

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