NCT03700242已完成3 期
Imovax® Rabies and VERORAB® Immunogenicity and Safety After One Week 2-sites Intradermal or 1-site Intramuscular Pre-Exposure Prophylaxis Regimens, Followed by a Simulated Intradermal or Intramuscular Post-Exposure Prophylaxis Regimen at One Year
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 570
- 试验地点
- 4
- 主要终点
- Seroconversion of participant
研究概览
简要总结
The primary objective of the study is to demonstrate that a short intramuscular (IM) pre-exposure prophylaxis (PrEP) regimen is non-inferior to the reference IM PrEP regimen in terms of seroconversion rate.
The secondary objectives of the study are:
- To describe the immunogenicity of the PrEP regimen in each group
- To describe the antibody persistence in each group 6 months and 1 year after the last PrEP vaccination
- To describe the immunogenicity of the simulated post-exposure prophylaxis (PEP) regimen in each group
- To describe the safety profile of study vaccines administered as PrEP regimen and as a simulated PEP regimen in each group
详细描述
Study duration per participant is approximately 403 to 436 days
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
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Seroconversion of participant
时间窗: 14 days after the last PrEP vaccination
Rabies virus neutralizing antibodies (RVNA) titer ≥ 0.5 IU/mL
次要结局
- Participant RVNA titer ratios(14 days after last PrEP vaccination)
- Persistence of seropositivity(6 months and 1 year after the last PrEP vaccination)
- Seropositivity of participant after simulated PEP vaccination(7 and 14 days after the first simulated PEP vaccination)
- Persistence of RVNA titer(6 months and 1 year after the last PrEP vaccination)
- Seroconversion of participant after simulated PEP vaccination -(7 and 14 days after the first simulated PEPvaccination)
- Participant RVNA titer ratios (persistence assessment)(6 months and 1 year after the last PrEP vaccination)
- Solicited injection site and systemic reactions after simulated PEP vaccination(7 days after simulated PEP vaccination)
- Participant RVNA titer(Day 0 and 14 days after the last PrEP vaccination)
- Seropositivity of participant(Day 0 and 14 days after the last PrEP vaccination)
- Participant RVNA titer after simulated PEP vaccination(1 year after the last PrEP vaccination)
- Seroconversion of participant(Day 0 and 14 days after the last PrEP vaccination)
- Persistence of seroconversion(6 months and 1 year after the last PrEP vaccination)
- Solicited injection site and systemic reactions after PrEP vaccination(7 days after PrEP vaccination)
研究者
研究点 (4)
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