EUCTR2007-000165-38-IT进行中（未招募）不适用
A Phase II, Open-label, Multi-Center Study to Evaluate Safety and Immunogenicity of a Booster Dose of FLUAD-H5N1 (Surface Antigen Adjuvanted with MF59C.1)Influenza Vaccine in Non-elderly Adult and Elderly Subjects - ND
OVARTIS VACCINES AND DIAGNOSTICS S.R.L.0 个研究点开始时间: 2007年7月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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. Male or female volunteers 18 years of age or older, mentally competent, willing and
- •able to give written informed consent prior to study entry
- •2. Previously participating in study V87P1, but did not receive the booster dose on
- •3. Able to comply with all the study requirements
- •4. In general good health as determined by:
- •a. Medical history
- •b. Physical examination
- •c. Clinical judgment of the investigator
- •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
- •1. Any serious disease such as:
- •a. Cancer (except for benign or localized skin cancer and non metastatic prostate
- •cancer not presently treated with chemotherapy)
- •b. Autoimmune disease (including rheumatoid arthritis)
- •c. Advanced atherosclerotic disease or complicated diabetes mellitus
- •d. Chronic obstructive pulmonary disease (COPD) that requires oxygen therapy
- •e. Acute or progressive hepatic disease
- •f. Acute or progressive renal disease
- •g. Congestive heart failure
- •2. Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein,
- •neomycin or polymyxin or any other component of the vaccine
- •3. History of neurological symptoms or signs, or anaphylactic shock following
- •administration of any vaccine
- •4. Known or suspected (or have a high risk of developing) impairment/ alteration of
- •immune function (excluding that normally associated with advanced age) resulting,
- •for example, from:
- •a. Receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or
- •cancer chemotherapy/radiotherapy) within the past 60 days and for the full length
- •of the study
- •b. Receipt of immunostimulants
- •c. Receipt of parenteral immunoglobulin preparation, blood products and/or plasma
- •derivates within the past 3 months
- •d. Suspected or known HIV infection or HIV-related disease
- •5. All females of childbearing potential who refuse to use an acceptable method of birth
- •control for 21 days after the booster vaccination and/or who refuse to perform a urine
- •pregnancy test prior to vaccination. 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
- •6. Pregnant or breastfeeding
- •7. Receipt of another vaccine or any investigational agent within the past 4 weeks
- •8. Experience of any acute disease or infections requiring systemic antibiotic or antiviral
- •therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) within
- •the past 7 days
- •9. Experience of fever (i.e., axillary temperature 38?C) within the past 3 days
- •10. Participation in another clinical study
- •11. Surgery planned during the study period
- •12. Any condition which, in the opinion of the investigator, might interfere with the
- •evaluation of the study objective
研究者
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