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2006年4月3日

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: Vaccination of adults (18-60 years) and elderly (>60 years) with pandemic flu H5N1 vaccine.
发起方: sanofi pasteur SA
入组人数: 600
状态: 进行中（未招募）
最后更新: 6年前

暂无简介。

注册库

who.int

开始日期

2006年4月3日

结束日期

2008年12月23日

最后更新

6年前

研究类型

Interventional clinical trial of medicinal product

发起方

sanofi pasteur SA

•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

•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.