EUCTR2006-000477-29-GB进行中（未招募）1 期
Safety and immunogenicity of an intramuscular, inactivated, split-virion, pandemic influenza A/H5N1 vaccine in adults and the elderly.
sanofi pasteur SA0 个研究点目标入组 600 人开始时间: 2006年4月3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
- 600
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
入选标准
- •1) Aged over 18 years on the day of inclusion.
- •2) Informed consent form signed.
- •3) Able to attend all scheduled visits and to comply with all trial procedures.
- •4) For a woman, inability to bear a child or negative urine pregnancy test.
- •5) For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior and at least 4 weeks after to each vaccination.
- •6) Addendum 1 of the informed consent form signed and dated by the subject (this inclusion criteria has to be checked only at V04 for subjects who are to receive a booster at M6 or later).
- •7) Addendum 2 of the informed consent form signed and dated by the subject (this inclusion criteria has to be checked only at V04_Add for subjects who are to receive a Clade 2 booster).
- •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) Systemic hypersensitivity to any component of the vaccine or a life-threatening reaction after previous administration of a vaccine containing the same substances (egg proteins, chick proteins, thimerosal, aluminum, neomycin, formaldehyde, and octoxinol 9).
- •2) Febrile illness (oral temperature =37.5°C) on the day of inclusion.
- •3) Breast-feeding.
- •4) Previous vaccination with an avian flu vaccine.
- •5) Participation in a clinical trial (drug, device, or medical procedure) within 4 weeks prior to the first vaccination.
- •6) Planned participation in another clinical trial during the present trial period.
- •7) Congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroid therapy.
- •8) Chronic illness that could interfere with trial conduct or completion (e.g. cardiac, renal, diabetes, or auto-immune disorders).
- •9) Current alcohol or drug abuse that may interfere with the subject’s ability to comply with trial procedures.
- •10) Receipt of blood or blood-derived products within the past 3 months.
- •11) Any vaccination within 4 weeks prior to the first trial vaccination.
- •12) Vaccination planned within 4 weeks after any trial vaccination.
- •13) Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
- •14) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
研究者
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