NCT00545701已完成2 期
Immunogenicity and Safety of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Adults
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- To provide information concerning the immunogenicity of A/H5N1 inactivated, split-virion influenza virus vaccine
研究概览
简要总结
The trial is a Phase II, open-label trial in healthy subjects aged 18 to 60 years to support the immunogenicity data from previous clinical studies.
Objectives:
- To describe the immune response 21 days after each vaccination.
- To describe the safety profiles following each vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 60 years on 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 to and at least 4 weeks after 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 (egg proteins, chick proteins, thimerosal, aluminum, neomycin, formaldehyde, and octoxinol 9).
- •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 in the past 3 months, that might interfere with the assessment of immune response.
- •Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
- •Planned receipt of any vaccine in the 4 weeks following 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.
结局指标
主要结局
To provide information concerning the immunogenicity of A/H5N1 inactivated, split-virion influenza virus vaccine
时间窗: Day 42 post-vaccination 1
次要结局
未报告次要终点
研究者
研究点 (2)
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