Safety and Immunogenicity of H5N1 Adjuvanted, Inactivated, Split-Virion Pandemic Influenza Vaccine in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 251
- 试验地点
- 3
- 主要终点
- To provide information concerning the safety of A/H5N1 Inactivated split influenza virus vaccine
研究概览
简要总结
The purpose of this study is to test different adjuvanted vaccine formulations as a two-dose schedule in immunologically naïve adults against one vaccine formulation without adjuvant in terms of tolerance and immunogenicity
Primary Objective:
To describe the safety profile and immunogenicity following each injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 40 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.
排除标准
- •Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
- •Planned participation in another clinical trial during the present trial period.
- •Previous participation in a clinical trial involving an investigational flu pandemic vaccine.
- •Vaccination with an influenza vaccine during the past 6 months
- •Any vaccination in the 4 weeks preceding the first trial vaccination
- •Vaccination planned in the 4 weeks following any trial vaccination
- •Breast-feeding.
- •For a woman of child-bearing potential, the absence of an effective method of contraception or abstinence non observed for at least 4 weeks prior to the first vaccination and at least 4 weeks after the last vaccination.
- •Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy.
- •Known human immunodeficiency virus (HIV), hepatitis B (AgHBs) or hepatitis C seropositivity.
- •Known systemic hypersensitivity to egg proteins, chick proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
- •Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
- •Chronic illness at a stage that could interfere with trial conduct or completion.
- •Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
- •Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
- •Blood or blood-derived products received in the past 3 months.
- •Febrile illness (temperature ≥ 37.5°C) on the day of inclusion.
- •Laboratory abnormalities considered clinically significant upon the Investigator's judgment in blood sample taken at screening (for Step 1 only)
研究组 & 干预措施
Group 1
Dose 1 with Adjuvant
干预措施: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant (Biological)
Group 2
Dose 2 with adjuvant
干预措施: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant (Biological)
Group 3
Dose 3 with adjuvant
干预措施: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant (Biological)
Group 4
Dose 4 with adjuvant
干预措施: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant (Biological)
Group 5
Control
干预措施: A/H5N1 inactivated, split-virion influenza vaccine (Biological)
结局指标
主要结局
To provide information concerning the safety of A/H5N1 Inactivated split influenza virus vaccine
时间窗: Entire study period
次要结局
未报告次要终点