NCT00740155已完成2 期
Safety and Immunogenicity of Bivalent and Tetravalent Formulations of Dengue Vaccine Candidates in Healthy Flavivirus-Naïve Adults Aged 18 to 45 Years
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Safety: To provide information concerning the safety of ChimeriVax™ Dengue Vaccine
研究概览
简要总结
This is part of an ongoing effort to develop a satisfactory dengue vaccine:
Primary objective:
To describe the safety after each vaccination with bivalent and tetravalent formulations of dengue vaccine candidates.
To describe the immune response after each vaccination of dengue vaccine.
详细描述
Subjects will be randomized to five groups to receive assigned vaccines and followed up for 12 months.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy as determined by medical history, clinical examination, and biological safety parameters
- •Aged 18 to 45 years on the day of inclusion.
- •Informed consent form signed.
- •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 4 weeks prior to the first vaccination and at least 4 weeks after the last vaccination.
排除标准
- •History of thymic diseases or thymectomy.
- •For a woman of child-bearing potential, known or suspected pregnancy or positive pregnancy test
- •Breast-feeding
- •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.
- •Human Immunodeficiency Virus (HIV), Hepatitis B (HBs Ag) or Hepatitis C (HC) seropositivity in blood sample taken at screening.
- •Laboratory abnormalities considered clinically significant upon the Investigator's judgment or above the intensity thresholds (defined in the protocol) in blood sample taken at screening.
- •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 residence in or travel of more than 2 weeks to areas with high dengue infection endemicity.
- •Known 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 (i.e. egg, egg products, proteins of rodent or neural origin, gelatin, and thimerosal.
- •History of urticaria after hymenoptera envenomation.
- •History of flavivirus infection as reported by the subject.
- •Previous vaccination against flavivirus diseases (including Japanese encephalitis, tick-borne encephalitis, and yellow fever).
- •Planned travel during the present trial period to areas with high dengue infection endemicity.
- •Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term (at least 2 weeks within the previous 3 months) systemic corticosteroid therapy (at a dose of a t least 10 mg).
- •Chronic illness at a stage that could interfere with trial conduct or completion.
- •Blood or blood-derived products received in the past 3 months.
- •Any vaccination in the 4 weeks preceding the first trial vaccination.
- •Vaccination planned in the 4 weeks following any trial vaccination.
- •Flavivirus vaccination planned during the present trial period.
研究组 & 干预措施
Group 2
Experimental
干预措施: Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero) (Biological)
Group 3
Experimental
干预措施: Tetravalent blending VDV-2/CYD-1,3,4 Dengue (Vero) (Biological)
Group 4
Experimental
干预措施: Tetravalent CYD-1,2,3,4 Dengue (Vero) (Biological)
Group 5
Active Comparator
干预措施: JE-VAX®: Japanese encephalitis virus vaccine inactivated + Tetravalent CYD-1,2,3,4 Dengue (Vero) (Biological)
Group 1
Experimental
干预措施: Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero) (Biological)
结局指标
主要结局
Safety: To provide information concerning the safety of ChimeriVax™ Dengue Vaccine
时间窗: 12 months 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
2 期
Study of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Subjects in SingaporeDengue FeverDengue VirusDengue DiseasesDengue Hemorrhagic FeverNCT00880893Sanofi Pasteur, a Sanofi Company1,198
已完成
2 期
Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy SubjectsDengue DiseaseDengue FeverDengue VirusDengue Hemorrhagic FeverNCT00875524Sanofi Pasteur, a Sanofi Company180
已完成
3 期
Study of a Novel Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 14 Years in AsiaDengueDengue FeverDengue Hemorrhagic FeverNCT01373281Sanofi Pasteur, a Sanofi Company10,275
已完成
3 期
Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Gardasil®Dengue FeverHuman Papillomavirus DiseaseDengue Hemorrhagic FeverNCT02993757Sanofi Pasteur, a Sanofi Company528
终止
3 期
Study of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Adacel® in Healthy SubjectsDengue FeverDengue Hemorrhagic FeverNCT02992418Sanofi Pasteur, a Sanofi Company688