NCT00718146已完成2 期
Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 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
- Immunogenicity: To provide information concerning the immunogenicity of Influenza vaccine (split virion, inactivated).
研究概览
简要总结
This study is for a new marketing authorization application for the seasonal vaccine strains in compliance with the Note for Guidance (NfG) on harmonization requirements for influenza vaccine from the Committee for Human Medicinal Products (CHMP)
Objectives:
- To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine NH 2008-2009 formulation with the requirements of the CHMP NfG CPMP/BWP/214/96.
- To describe the safety of the inactivated, split-virion influenza vaccine, NH 2008-2009 formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 or 61 years and older 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 21 days after vaccination
排除标准
- •For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test at visit 01
- •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, chick proteins, neomycin, formaldehyde and octoxinol 9, 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
Group 1
Experimental
Age 16 to 60 years
干预措施: Split virion, inactivated Influenza vaccine (Biological)
Group 2
Experimental
Age over 60 years
干预措施: Split virion, inactivated Influenza vaccine (Biological)
结局指标
主要结局
Immunogenicity: To provide information concerning the immunogenicity of 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)
Loading locations...
相似试验
已完成
1 期
Safety and Immunogenicity Study of an Inactivated Vaccine Against Hand, Foot and Mouth Disease Caused by Enterovirus 71Hand, Foot and Mouth DiseaseNCT01376479Inviragen Inc.36
已完成
3 期
Adult Safety Study of 2009/2010 Seasonal Influenza VaccineInfluenzaNCT01063088Alachua Government Services, Inc.211
已完成
2 期
Trial to Describe the Safety and Immunogenicity of Fluzone®InfluenzaNCT00524940Sanofi Pasteur, a Sanofi Company124
已完成
3 期
Yearly Strain Variation Study, 2010/2011Seasonal InfluenzaInfluenzaNCT01157702Resilience Government Services, Inc.110
已完成
3 期
Yearly Strain Variation Study, 2009/2010Seasonal InfluenzaInfluenzaNCT00943657Alachua Government Services, Inc.110