EUCTR2014-001709-41-Outside-EU/EEA进行中（未招募）不适用
Immunogenicity and Safety of Tetravalent Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Viet Nam
Sanofi Pasteur SA0 个研究点目标入组 180 人开始时间: 2014年5月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Aged 2 to 45 years on the day of inclusion. (Scr.)
- •2) Provision of Informed Consent/Assent Form signed by the subject (and/or by the parent or another legally acceptable representative for subjects <18 years). (Scr.)
- •3) Subject (and parent/guardian for subjects <18 years) able to attend all scheduled visits and to comply with all trial procedures. (Scr. + V01)
- •4) For a female subject of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to the first vaccination, until at least 4 weeks after the last vaccination. (Scr. + V01)
- •5) Subject in good health, based on medical history, physical examination and laboratory parameters. (Scr. + V01)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 150
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia. (Scr.)
- •2) For a female subject of child-bearing potential, known pregnancy or positive serum pregnancy test at Screening. (Scr.)
- •3) For a female subject of child-bearing potential, known pregnancy or positive urine pregnancy test on the day of the first injection. (V01)
- •4) Breast-feeding female subject. (Scr.)
- •5) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination. (Scr.)
- •6) Human immunodeficiency virus, hepatitis B, or hepatitis C seropositivity in the blood sample taken at screening. (V01)
- •7) Planned participation in another clinical trial during the first year of the study. (Scr.)
- •8) Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the past 6 months, or long-term systemic corticosteroids therapy. (Scr.)
- •9) Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances. (Scr.)
- •10) Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator. (Scr.)
- •11) Current alcohol abuse or drug addiction that may interfere with the subject’s ability to comply with trial procedures. (Scr.)
- •12) Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune response. (Scr.)
- •13) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent. (Scr.)
- •14) Laboratory abnormalities of at least moderate severity or clinically significant according to the Investigator in blood sample taken at screening. (V01)
- •15) Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination. (Scr. + V01)
- •16) Planned receipt of any vaccine in the 4 weeks following the first trial vaccination. (V01)
- •17) Familial atopy medical history (parents, brothers, or sisters). (Scr.)
- •18) Previous vaccination with meningococcal A + C or typhoid vaccines within 3 years prior to inclusion. (Scr.)
- •The exclusion criterion #18 was modified at the time of Amendment 1 (protocol Version 3.0 dated 08 April 2008) for accuracy.
- •19) History of meningococcal or typhoid infections (confirmed either clinically, serologically or microbiologically). (Scr.)
研究者
相似试验
进行中（未招募）
1 期
A phase IIIb, randomized, multicenter, open-label study in 688 subjects aged from 9 to 60 years in the PhilippinesDengue FeverDengue Hemorrhagic FeverEUCTR2019-003136-23-Outside-EU/EEASanofi Pasteur SA688
进行中（未招募）
1 期
Immunogenicity and Safety of a Tetravalent Dengue Vaccine Given as a Booster Injection in Adolescents and Adults Who Previously Completed the 3-dose Schedule in a Study Conducted in SingaporeDengue FeverDengue Hemorrhagic FeverEUCTR2019-000993-44-Outside-EU/EEASanofi Pasteur SA118
已完成
2 期
Study of a Tetravalent Dengue Vaccine in Healthy Adult Subjects Aged 18 to 45 Years in India.CTRI/2012/03/002518Sanofi Pasteur SA189
进行中（未招募）
不适用
Study of Sanofi Pasteur's dengue vaccine in healthy children aged 2 to 14 Years in Asia to evaluate its efficacyPrevention of symptomatic dengue diseaseEUCTR2014-001708-24-Outside-EU/EEASanofi Pasteur SA10,278
进行中（未招募）
不适用
Study of Sanofi Pasteur's dengue vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America to evaluate its efficacyPrevention of symptomatic dengue diseaseEUCTR2014-001716-19-Outside-EU/EEASanofi Pasteur SA20,875