EUCTR2008-003008-72-CZ进行中（未招募）不适用
A Phase III, Randomized, Open-label, Single-center Study to Evaluate the Safety and Immunogenicity of a FLUAD-H5N1 Influenza Vaccine in Adult Subjects Using Four Different Vaccination Schedules
ovartis Vaccines and Diagnostics S.r.l0 个研究点目标入组 240 人开始时间: 2008年8月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
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 60 years of age who are mentally competent and
- •who have signed an informed consent form after having received a
- •detailed explanation of the study protocol;
- •2.In good health as determined by:
- •a.Medical history,
- •b.Physical examination,
- •c.Clinical judgment of the Investigator;
- •3.Able to understand and comply with all study procedures and to complete
- •study diaries, can be contacted, and will be available for all study visits.
- •Informed consent must be obtained for all the subjects before enrollment
- •into 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
- •1.Previous receipt of any H5 vaccine;
- •2.Receipt of another investigational agent within 4 weeks, or before
- •completion of the safety follow-up period in another study, whichever is
- •longer, prior to enrollment and unwilling to refuse participation in another
- •clinical study through the end of the study;
- •3.Experienced any acute disease or infection requiring systemic antibiotic or
- •antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is
- •acceptable) within the past 7 days;
- •4.Experienced fever (defined as axillary temperature ?38.0°C) within 3 days
- •prior to Visit 1;
- •5.Pregnant or breastfeeding;
- •6.Females of childbearing potential who refuse to use an acceptable
- •method of birth control for the duration of the study. Adequate
- •contraception is defined as hormonal (e.g., oral, injection, transdermal
- •patch, implant, cervical ring), barrier (e.g., condom with spermicide or
- •diaphragm with spermicide), intrauterine device (e.g., IUD), or
- •monogamous relationship with vasectomized partner who has been
- •vasectomized for 6 months or more prior to the subject’s study entry;
- •7.Any serious disease, such as:
- •b.Autoimmune disease,
- •c.diabetes mellitus,
- •d.chronic pulmonary disease,
- •e.acute or progressive hepatic disease,
- •f.acute or progressive renal disease;
- •8.Surgery planned during the study period;
- •9.Bleeding diathesis;
- •10.Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral
- •protein, neomycin or polymyxin or any other component of the study
- •11.History of any neurological symptoms or signs following administration of
- •any vaccine, or anaphylactic shock following administration of any vaccine;
- •12.Known or suspected impairment/alteration of immune function, for
- •example, resulting from:
- •a.Receipt of immunosuppressive therapy (any corticosteroid therapy
- •b.Receipt of immunostimulants,
- •c.High risk for developing an immunocompromising disease;
- •13.Receipt of non study vaccine (with the exception of post-exposure
- •vaccination in a medical emergency, e.g. hepatitis, rabies, tetanus) within
- •3 weeks prior to Visit 1 or planned vaccination within 3 weeks following
- •the last study vaccination;
- •14.Body Mass Index above 35 kg/m2;
- •15.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;
- •16.Any condition, which, in the opinion of the Investigator, might interfere
- •with the evaluation of the study objectives;
- •17.Members of research staff and their relatives.
研究者
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