EUCTR2007-005233-11-GB进行中（未招募）1 期
A Phase II, Randomized, Partially observer-blind, Single-centre study to Evaluate Safety and Immunogenicity of MF59-adjuvanted or Non-adjuvanted H5N1 Booster Influenza Vaccines in Adults Primed with MF59-adjuvanted A/Vietnam/1194/04 (H5N1) vaccine - Prime-boost vaccination using H5N1 vaccines
niversity Hospitals Of Leicester NHS Trust, Gwendolen Road0 个研究点目标入组 780 人开始时间: 2008年1月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 780
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
- •Inclusion criteria
- •1. Subjects 18 to 59 years of age, or 60 years of age and older, mentally
- •competent, who have signed an informed consent form after having received a
- •detailed explanation of the study protocol;
- •2. Are in good health or have one or more stable (See footnote) medical conditions,
- •as determined by:
- •a. Medical history,
- •b. Physical examination,
- •c. Clinical judgment of the medical investigator;
- •3. Are 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria
- •1. Receipt of another investigational agent within 3 months, 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;
- •2. Subjects who experienced any acute disease or infection requiring systemic
- •antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract
- •prophylaxis is acceptable) during the 7 days preceding vaccination;
- •3. Subjects who experienced fever (defined as axillary temperature >=38C) within 3
- •days prior to Visit 1;
- •4. Subjects who are pregnant or breastfeeding;
- •5. Females of childbearing potential who refuse to use an acceptable method of
- •birth control for a period of 56 days before and after each 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), monogamous relationship with
- •vasectomised partner who has been vasectomised for 6 months or more prior to
- •the subject’s study entry, or abstain from heterosexual intercourse (e.g., through
- •sexual orientation or religious or other beliefs about premarital intercourse);
- •6. Subjects with any serious disease, including:
- •b. acute or progressive hepatic disease,
- •c. acute or progressive renal disease,
- •d. chronic pulmonary disease requiring home oxygen therapy,
- •e. active neurological disorder,
- •f. autoimmune disease (including rheumatoid arthritis);
- •7. Subjects for whom surgery is planned during the study period;
- •8. Subjects with a bleeding diathesis;
- •9. Subjects with hypersensitivity to eggs, chicken protein, chicken feathers,
- •influenza viral protein, neomycin or polymixin, or any other component of the
- •study vaccine;
- •10.Subjects with a history of any neurological symptoms and signs, or anaphylactic
- •shock following administration of any vaccine;
- •11. Subjects with known or suspected impairment/alteration of immune function, for
- •example, resulting from:
- •a. receipt of oral immunosuppressive therapy (e.g., corticosteroid therapy or
- •cancer chemotherapy) (long-term, inhaled steroids for asthma management is
- •acceptable),
- •b. receipt of immunostimulants or interferon,
- •c. receipt of parenteral immunoglobulin preparation, blood products, and/or
- •plasma derivatives within 3 months prior to Visits 1 (Day 1), 2 (Day 22), or 5
- •(Day 382), or planned during the full length of the study,
- •d. high risk from developing an immunocompromising disease;
- •12. Actual or planned receipt of another vaccine during the period 3 weeks before
- •to 3 weeks after vaccination on Days 1, 22, and 382;
- •13. Subjects with a history of (or current) drug or alcohol abuse (20g/day for
- •females; 30g/day for males) that in the investigator’s opinion would interfere
- •with safety of the subject or the evaluation of the study objectives;
- •14. Subjects who are unable to lead an independent life either physically or
- •15. Have participated in a previous study of H5 avian influenza vaccine;
- •16. Have been previously vaccinated with a vaccine containing MF59 or similar
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研究者
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