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 650 人2006年3月30日

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注册库

who.int

开始日期

2006年3月30日

结束日期

待定

最后更新

14年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

Sanofi Pasteur SA

•1\) Aged over 18 years on the day of inclusion, and 18 to 60 years for the 50 additional subjects for A/Indonesia primary series.
•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 A/Indonesia booster.
•8\) Addendum 3 of the Informed Consent Form signed and dated by the subject (this inclusion criterion has to be checked only at V05 for subjects who are to receive a A/Indonesia booster).
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•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.