EUCTR2014-001713-26-Outside-EU/EEA进行中（未招募）不适用
Immunogenicity and Large-Scale Safety of Tetravalent Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Singapore
Sanofi Pasteur SA0 个研究点目标入组 1,198 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
- 1,198
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 from 2 to 45 years on the day of inclusion.
- •2. Subject in good health, based on medical h istory and physical examination.
- •3. Provision of informed consent form (and assent form for subjects aged 6 to 12 years) signed by the subject and by the parent(s) or another legally acceptable representative for subjects aged less than 21 years.
- •4. Subject and parent(s)/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.
- •5. For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks before the first vaccination until 4 weeks after the last vaccination.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 503
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 695
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Febrile illness (temperature =37.5°C) or moderate or severe acute illness/infection on the day of the first vaccination, according to Investigator judgment.
- •2. For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test on the day of inclusion.
- •3. Breast-feeding woman.
- •4. Known systemic hypersensitivity to any of the components of the trial vaccines (especially egg proteins or neomycin) or h istory of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances.
- •5. Personal or family history of thymic pathology or myasthenia.
- •6. Previous hepatitis A vaccination (for children only).
- •7. 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 corticosteroid therapy.
- •8. Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
- •9. Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune response.
- •10. Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
- •11. Planned participation in another clinical trial during the 18 coming months.
- •12. Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
- •13. Planned receipt of any vaccine in the 4 weeks following the first trial vaccination.
- •14. Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
- •15. Current or past alcohol abuse or drug addiction that may interfere with the subject’s ability to comply with trial procedures.
- •16. Subject who plans to move to another country within the 18 coming months.
研究者
相似试验
进行中（未招募）
1 期
Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 2013/2014 SeasoEUCTR2013-000881-12-BEAbbott Biologicals B.V130
进行中（未招募）
不适用
Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 2012/2013 SeasoEUCTR2012-001032-57-DEAbbott Biologicals B.V.130
进行中（未招募）
不适用
Immunogenicity, Reactogenicity and Safety of the Trivalent Influenza Subunit Vaccine Influvac® for the Season 2008/2009. An Open-Label, Baseline-Controlled Multi-Center Study in Two Groups: Adult Subjects = 18 and = 60 Years and Elderly Subjects = 61 Years of Age - Influvac Annual Update 2008/2009EUCTR2008-001038-28-BESolvay Biologicals BV120
进行中（未招募）
不适用
Immunogenicity, Reactogenicity and Safety of the Trivalent Influenza Subunit Vaccine Influvac® for the Season 2008/2009. An Open-Label, Baseline-Controlled Multi-Center Study in Two Groups: Adult Subjects = 18 and = 60 Years and Elderly Subjects = 61 Years of Age - Influvac Annual Update 2008/2009EUCTR2008-001038-28-DESolvay Biologicals BV120
进行中（未招募）
不适用
Immunogenicity, Reactogenicity and Safety of the Trivalent Influenza Subunit Vaccine Influvac® for the Season 2010/2011. An Open-Label, Baseline-Controlled Multi-Center Study in Two Groups: Adult Subjects =18 and =60 Years and Elderly Subjects = 61 Years of Age. - Influvac Annual Update 2010/2011Prophylaxis of InfluenzaMedDRA version: 12.1Level: HLTClassification code 10022005Term: Influenza viral infectionsEUCTR2010-018350-13-BEAbbott Biologicals B.V.120