EUCTR2009-013858-32-FI进行中（未招募）不适用
Immunogenicity and Safety of Multiple Formulations of an Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With and Without Adjuvant in Healthy European Subjects Aged 6 to 35 Months - Immunogenicity and safety of different formulations of intramuscular swine-origin influenza vaccine
Sanofi Pasteur SA0 个研究点开始时间: 2009年7月13日最近更新:
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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
- •All subjects
- •1) Aged 6 to 35 months on the day of inclusion
- •2) Informed consent form has been signed and dated by the parent(s) or other legally
- •acceptable representative
- •3) Subject and parent/legal representative are able to attend all scheduled visits and
- •to comply with all trial procedures
- •4) Completion of vaccination according to the national immunization schedule
- •Subjects =6 to <24 months of age
- •5) Born at full term of pregnancy (=37 weeks) and with a birth weight =2.5 kg
- •At V05 (M8) for antibody persistence assessment (amendment 2)
- •6) Having received two half doses of the 15 µg HA vaccine or of the
- •3.8 µg HA + AF03 vaccine
- •7) Addendum 1 to Informed Consent Form has been signed and dated by the
- •parent(s) or other legally acceptable representative
- •At V06, for subjects eligible for the Ab persistence evaluation who will receive the TIV (amendment 3):
- •8)Addendum 2 to Informed Consent Form has been signed by the subject’s parents/legal representative.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •All subjects
- •1) Participation in another clinical trial investigating a vaccine, drug, medical device,
- •or medical procedure in the 4 weeks preceding the first trial vaccination
- •2) Planned participation in another clinical trial during the present trial period
- •3) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
- •4) Planned receipt of any vaccine prior to the Day 42 blood sample
- •5) Receipt of blood or blood-derived products in the past 3 months, which might
- •interfere with assessment of the immune response
- •6) Known or suspected 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 (prednisone or equivalent for more than 2 consecutive weeks within the
- •past 3 months)
- •7) Seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B antigen, or
- •Hepatitis C as reported by parents/legal representative
- •8) Known systemic hypersensitivity to any of the vaccine components, or history of
- •a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine
- •containing any of the same substances
- •9) Thrombocytopenia, contraindicating IM vaccination as reported by parents/legal
- •representative
- •10) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
- •contraindicating IM vaccination
- •11) Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
- •12) Family members of the Investigator or of the employees of the study center
- •13) Previous participation in a trial investigating a vaccine with the swine-origin
- •A/H1N1 influenza strain
- •14) Confirmed infection with the swine-origin A/H1N1 influenza strain (different
- •from the seasonal strain) in 2009
- •15) Febrile illness (temperature =38.0°C) or moderate or severe acute illness/infection
- •on the day of vaccination, according to Investigator judgment
- •16) Receipt of any allergy shots and/or seasonal allergy medication in the 7-day
- •period prior to enrollment (vaccination), or scheduled to receive any allergy shots
- •and/or seasonal allergy medication in the 7-day period after enrollment
- •(vaccination)
- •Subjects =6 to <24 months of age
- •17) History of seizures
- •At V05 (M8), for antibody persistence assessment (amendment 2)
- •18) Subjects who received, in the context of a pandemic immunization program,
- •another A/H1N1 pandemic influenza vaccine than the Investigational Medicinal
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