EUCTR2019-000973-22-Outside-EU/EEA进行中（未招募）1 期
Immunogenicity and Safety of a Purified Vero Rabies Vaccine – Serum Free in Comparison with Verorab® and Imovax® Rabies, in a Pre-exposure Regimen in Both Pediatric and Adult Populations and a Single Booster Dose of Purified Vero Rabies Vaccine – Serum Free Administered at 1 Year Post-3-dose Primary Series, and between 2 up to 3 years Post-One Week 2-Dose Primary Series in a Subset of Adults in Thailand
Sanofi Pasteur SA0 个研究点开始时间: 2020年11月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •- Aged =1 year on the day of inclusion
- •- Informed consent form has been signed and dated by the participant and /or and the parent(s) or Legally Acceptable Representative and by an independent witness (if required by local regulations), as necessary; and Assent form has been signed and dated by the participant, as required
- •- Participant (adult = 18 years) or participant and parent/LAR (1 year to <18 years) are able to attend all scheduled visits and to comply with all studyprocedures.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 505
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1162
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 33
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •- Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until 1 month after each vaccination. To be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, or surgically sterile.
- •- Participation at the time of study enrollment or, planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
- •- Receipt of any vaccine in the 4 weeks (28 days) preceding the first study vaccination or planned receipt of any vaccine prior to Visit 5 for pediatric participants and adult participants in Cohort 1, and prior to Visit 4 for adult participants in Cohort 2.
- •- Previous vaccination against rabies (in pre- or post-exposure regimen) with either the study vaccines or another vaccine.
- •- Bite by, or exposure to a potentially rabid animal in the previous 6 months with or 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).
- •- At high risk for rabies exposure during the study.
- •- Known systemic hypersensitivity to any of the study/control vaccine components, or history of a life-threatening reaction to the vaccines used in the study or 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 or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion.
- •- Chronic illness1 that, in the opinion of the Investigator, is at a stage where it might interfere with study 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 participant should not be included in the study until the condition has resolved or the febrile event has subsided.
- •- Personal history of Guillain-Barré syndrome.
- •- 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 (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
- •1 Chronic illness may include, but is not limited to, neurological, cardiopulmonary, gastrointestinal, renal, genitourinary, metabolic, hematologic, auto-immune, or psychiatric disorders or infection
研究者
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