NCT00730288已完成2 期
Safety of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects Previously Immunised With an Investigational Dengue or Yellow Fever Vaccine
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Safety: To provide information concerning the safety of ChimeriVax™
研究概览
简要总结
To evaluate effect of previous flavivirus exposure on the safety and immunogenicity of the ChimeriVax™ dengue tetravalent vaccine
Primary Objectives:
- To describe the safety of one injection of ChimeriVax™ dengue tetravalent vaccine.
- To describe the immune response against dengue before and after one injection of ChimeriVax™ dengue tetravalent vaccine
详细描述
This study will evaluate a dengue tetravalent vaccine formulation in subjects aged 18 to 40 years and previously immunised with a dengue or YF vaccine.
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
- None
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 the day of inclusion.
- •Informed consent form signed.
- •For a woman, inability to bear a child or negative serum pregnancy test.
- •Completed the one-year follow-up of Study DIV
- •Able to attend all scheduled visits and to comply with all trial procedures.
- •For a woman of child-bearing potential: use of an effective method of contraception or abstinence for at least four weeks prior to vaccination and at least four weeks after vaccination.
排除标准
- •History of thymic pathology (thymoma), thymectomy, or myasthenia gravis.
- •Breast-feeding.
- •Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
- •Previous flavivirus vaccination, e.g. Japanese encephalitis or yellow fever.
- •Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
- •Planned participation in another clinical trial during the present trial period.
- •History of flavivirus infection (confirmed either clinically, serologically or microbiologically).
- •Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months, or long-term systemic corticosteroids therapy.
- •Chronic illness at a stage that could interfere with trial conduct or completion.
- •Blood or blood-derived products received in the past three months.
- •Vaccination planned in the four weeks following the trial vaccination.
- •Flavivirus vaccination planned during the present trial period.
- •Planned travel during the present trial period to areas with high dengue endemicity.
- •Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalised without his/her consent.
- •Participation in another clinical trial in the four weeks preceding the trial vaccination.
- •Any vaccination in the four weeks preceding the trial vaccination.
- •Human Immunodeficiency Virus (HIV), Hepatitis B (Ag HBs) or Hepatitis C (HC) seropositivity in blood sample taken at screening.
- •Laboratory abnormalities considered clinically significant upon the Investigator's judgement in blood sample taken at screening.
- •Positive flavivirus serological test in blood sample taken at screening (for Controls only).
研究组 & 干预措施
1
Experimental
Received monovalent Vero dengue vaccine in Study DIV12
干预措施: Chimeric dengue serotype (1, 2, 3, 4) (Biological)
2
Experimental
Received Yellow fever vaccine in Study DIV12
干预措施: Chimeric dengue serotype (1, 2, 3, 4) (Biological)
3
Experimental
Flavivirus-naive subjects
干预措施: Chimeric dengue serotype (1, 2, 3, 4) (Biological)
结局指标
主要结局
Safety: To provide information concerning the safety of ChimeriVax™
时间窗: 28 days post-vaccination and entire study duration
Immunogenicity: To provide information concerning the immunogenicity of ChimeriVax™
时间窗: 28, 60 and 180 days post vaccination
次要结局
未报告次要终点
研究者
研究点 (1)
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