NCT00415129已完成2 期
Safety and Immunogenicity of an Intramuscular Pandemic Influenza Vaccine in Adults and the Elderly
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 4
- 主要终点
- To provide information concerning the safety of an A/H5N1 inactivated, split-virion influenza virus vaccine
研究概览
简要总结
Based on the results from a previous formulation/dosage ranging trial, this phase II multicenter, open trial was designed to determine the safety and immunogenicity of two vaccine formulation/dosages with and without adjuvant 21 days after each vaccination in adults (18 to 60 years and in the elderly (> 60 years) as required by the European Medicines Agency (EMEA) guideline. The antibody persistence until the booster vaccination at 6 or 12 months will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged over 18 years on the day of inclusion
- •Informed consent form signed
- •Able to attend all scheduled visits and to comply with all trial procedures
- •For a woman, inability to bear a child or negative urine pregnancy test
- •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.
排除标准
- •Systemic hypersensitivity to any component of the vaccine or a life-threatening reaction after previous administration of a vaccine containing the same substances
- •Febrile illness (oral temperature ≥ 37.5°C) on the day of inclusion
- •Breast-feeding
- •Previous vaccination with an avian flu vaccine
- •Participation in a clinical trial (drug, device, or medical procedure) within 4 weeks prior to the first vaccination
- •Planned participation in another clinical trial during the present trial period
- •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
- •Chronic illness that could interfere with trial conduct or completion (e.g. cardiac, renal, diabetes, or auto-immune disorders)
- •Current alcohol or drug abuse that may interfere with the subject's ability to comply with trial procedures
- •Receipt of blood or blood-derived products within the past 3 months
- •Any vaccination within 4 weeks prior to the first trial vaccination
- •Vaccination planned within 4 weeks after any trial vaccination
- •Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
- •Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
研究组 & 干预措施
Study Group 1
Experimental
Vaccine with adjuvant
干预措施: A/H5N1 inactivated, split-virion influenza virus (Biological)
Study Group 2
Experimental
Vaccine without adjuvant
干预措施: A/H5N1 inactivated, split-virion influenza virus (Biological)
结局指标
主要结局
To provide information concerning the safety of an A/H5N1 inactivated, split-virion influenza virus vaccine
时间窗: 21 Days post-vaccination
次要结局
未报告次要终点
研究者
研究点 (4)
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