NCT00491257已完成2 期
Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2007-2008 Formulation (Intramuscular Route)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- To provide information concerning the immunogenicity of 2007-2008 Influenza vaccine (split virion, inactivated).
研究概览
简要总结
This study is designed to generate clinical data as outlined in the Note for Guidance on harmonization requirements for influenza vaccine marketing authorization by the European Medicines Agency.
The objectives of the trial are:
- To determine immunogenicity, of the inactivated, split-virion influenza vaccine Northern Hemisphere (NH) 2007-2008 formulation in terms of the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.
- To describe the safety of the inactivated, split-virion influenza vaccine, NH 2007-2008 formulation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 60 years (i.e. to the day before the 61st birthday) or 61 years or above (from the day of the 61st birthday) on the day of inclusion
- •Provision of a signed informed consent
- •Able to attend all scheduled visits and comply with all trial procedures
- •For a woman of child-bearing potential: avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination
排除标准
- •For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test at Visit 1
- •Febrile illness (temperature >= 37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
- •Breast-feeding woman
- •Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination
- •Planned participation in another clinical trial during the present trial period
- •Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
- •Known systemic hypersensitivity to egg proteins, chicken proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing any of the same substances
- •Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
- •Current alcohol abuse or drug addiction 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 trial vaccination
- •Planned receipt of any vaccine in the 3 weeks following the trial vaccination
- •Previous vaccination against influenza in the previous 6 months
- •Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination
- •Known Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen or Hepatitis C seropositivity
- •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
Participants aged 18 to 60 years at enrollment
干预措施: Inactivated influenza vaccine (split virion) NH 2007-2008 formulation (Biological)
Study Group 2
Experimental
Participants aged 61 years or older at enrollment.
干预措施: Inactivated influenza vaccine (split virion) NH 2007-2008 formulation (Biological)
结局指标
主要结局
To provide information concerning the immunogenicity of 2007-2008 Influenza vaccine (split virion, inactivated).
时间窗: 21 Days post-vaccination
次要结局
未报告次要终点
研究者
研究点 (2)
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