EUCTR2015-003203-30-Outside-EU/EEA进行中（未招募）不适用
Immunogenicity and Safety of the Purified Vero Rabies Vaccine- Serum Free (VRVg) in Comparison with the Human Diploid Cell Vaccine, IMOVAX® Rabies in a Pre-exposure Prophylaxis Regimen in Healthy Children and Adolescents Aged 2 to 17 Years
Sanofi Pasteur SA0 个研究点目标入组 342 人开始时间: 2016年4月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 342
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
- •- Aged 2 to 17 years on the day of inclusion
- •- Informed consent form has been signed and dated by the parent(s) (and subject, if applicable by local regulations), or another legally acceptable representative and by an independent witness, as applicable, and the assent form has been signed and dated by the subject (if applicable by the local Ethics Committee or country regulations)
- •- Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 342
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination)
- •- Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- •- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks following any trial vaccination
- •- Any previous vaccination against rabies (in pre- or post-exposure regimen) with either the trial vaccine or another vaccine
- •- Bite by a potentially rabid animal in the previous 6 months without post-exposure prophylaxis
- •- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- •- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- •- Self-reported seropositivity for Human Immunodeficiency Virus (HIV)
- •- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances
- •- Self-reported thrombocytopenia, contraindicating intramuscular vaccination
- •- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
- •- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- •- Current alcohol abuse or drug addiction
- •- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- •- Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature = 38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
- •- Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
- •- History of Guillain-Barré syndrome.
研究者
相似试验
进行中（未招募）
不适用
Study of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Reference Purified Vero Rabies VaccineProphylactic Immunization against RabiesEUCTR2015-005194-20-Outside-EU/EEASanofi Pasteur SA816
进行中（未招募）
1 期
Study of Purified Vero Rabies Vaccine Compared with Two Reference Rabies Vaccines, Given in a Pre-exposure Regimen to Children and Adults and as Single Booster Dose to a Subset of AdultsRabiesMedDRA version: 20.0Level: PTClassification code 10037742Term: RabiesSystem Organ Class: 10021881 - Infections and infestationsEUCTR2019-000973-22-Outside-EU/EEASanofi Pasteur SA
进行中（未招募）
1 期
Study of Purified Vero Rabies Vaccine Compared with Two Reference Rabies Vaccines in a Simulated Post-Exposure Regimen in AdultsMedDRA version: 20.0Level: PTClassification code 10037742Term: RabiesSystem Organ Class: 10021881 - Infections and infestationsEUCTR2018-004055-20-FRSanofi Pasteur SA640
进行中（未招募）
1 期
Immunogenicity of the Purified Vero Rabies Vaccine – Serum Free in Comparison with the Reference Purified Vero Rabies Vaccine in Pre-exposure Use in Healthy AdultsEUCTR2009-009877-85-FRSanofi Pasteur SA385
已完成
2 期
Study of Purified Vero Rabies Vaccine and Rabies Human Diploid Cell Vaccine in a Simulated Rabies Post-exposure RegimenRabiesNCT01877395Sanofi Pasteur, a Sanofi Company342