NCT00948272已完成2 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 Adults
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 384
- 试验地点
- 6
- 主要终点
- To provide information concerning the immunogenicity of Purified Vero Rabies Vaccine.
研究概览
简要总结
The purpose of this study is to generate data in human on immunogenicity and safety of Purified Vero Rabies Vaccine (VRVg) in support of the vaccine registration.
Primary Objective:
- To demonstrate that VRVg is at least as immunogenic as the reference vaccine, Verorab, in terms of seroconversion rate at Day 42 of the primary vaccination series.
Secondary Objectives:
- To assess the clinical safety of VRVg after each vaccination when administered in a pre-exposure vaccination schedule with a booster at 12 months after the first vaccination in all subjects.
- To describe the immune response induced by VRVg 21 days after two vaccinations in a subset of randomized subjects and 14 days after the last vaccination of the primary vaccination series.
详细描述
All subjects will receive three vaccinations for primary series and a booster vaccination at 12 months after the first vaccination.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 60 years on the day of inclusion
- •Provision of a signed Informed Consent Form
- •Able to attend all scheduled visits and comply with all trial procedures
- •For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence for at least 4 weeks prior to each vaccination, until at least 4 weeks after each vaccination)
- •Entitlement to national social security
排除标准
- •For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test
- •Breast-feeding woman
- •Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
- •Planned participation in another clinical trial during the present trial period
- •Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
- •Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
- •Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
- •Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
- •Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
- •Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
- •Planned receipt of any vaccine in the 4 weeks following any trial vaccination
- •Known human immunodeficiency virus (HIV), Hepatitis B surface (HBs) antigen, or Hepatitis C seropositivity
- •Previous vaccination against rabies with any vaccine (in pre- or post-exposure regimen)
- •Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination
- •Subject at high risk for rabies exposure during the trial period
- •Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
- •Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.
- •Study site employee who is involved in the protocol and may have direct access to trial related data.
研究组 & 干预措施
VRVg Group
Experimental
干预措施: Purified Vero Rabies Vaccine - Serum Free (Biological)
Verorab Group
Active Comparator
干预措施: Purified inactivated rabies vaccine (Biological)
结局指标
主要结局
To provide information concerning the immunogenicity of Purified Vero Rabies Vaccine.
时间窗: 42 days post-primary series vaccination
次要结局
- To provide information concerning the safety after Purified Vero Rabies Vaccine.(0 to 7 days post-vaccination and entire study duration)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
2 期
Comparison of Purified Vero Rabies Vaccine, Serum Free With Human Diploid Cell Vaccine in Pre-exposure UseRabiesNCT01784874Sanofi Pasteur, a Sanofi Company408
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
已完成
3 期
Study of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Reference Purified Vero Rabies VaccineRabiesRabies VirusNCT01339312Sanofi Pasteur, a Sanofi Company816
已完成
3 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 AdultsHealthy VolunteersRabiesNCT04127786Sanofi Pasteur, a Sanofi Company1,708
已完成
3 期
Study of Purified Vero Rabies Vaccine Compared With Two Reference Rabies Vaccines in a Simulated Post-Exposure Regimen in AdultsRabies (Healthy Volunteers)NCT03965962Sanofi Pasteur, a Sanofi Company640