NCT02276625Unknown2 期
One-visit Multi-site Pre-exposure Intradermal Rabies Vaccination: Dose Finding in Healthy Adults.
Leiden University Medical Center2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年10月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Memory response in vaccinated subjects 1 year after primary vaccination (defined as seroprotection rate for all subjects within 7 days post-booster in a simulated post-exposure scenario)
研究概览
简要总结
To determine optimum dose level for a single visit multidose intradermal injection of rabies vaccine with the aim to induce immunological memory in all subjects.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Good health according to the investigator
- •Willingness and ability to adhere to the study regimen
- •Able to give informed consent
排除标准
- •Known or suspected previous vaccination against rabies
- •Known or suspected allergy against any of the vaccine components
- •History of unusual or severe reactions to any previous vaccination
- •Immunocompromized state due to illness or medication
- •Administration of plasma or blood products three months prior to inclusion in the study
- •(hydroxy)chloroquine or mefloquine use
- •History of any neurological disorder including epilepsy or febrile seizures
- •Pregnancy or breastfeeding
- •Any current infectious disease other than seasonal cold
- •Bleeding disorders or use of anticoagulants
结局指标
主要结局
Memory response in vaccinated subjects 1 year after primary vaccination (defined as seroprotection rate for all subjects within 7 days post-booster in a simulated post-exposure scenario)
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (2)
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