NCT00708084已完成2 期
A Single-blind, Randomized, Monocentric Phase II Trial to Explore the Safety and Rabies-neutralizing Activity of Combined Administration of CL184 and Rabies Vaccine Versus Human Rabies Immune Globulin Plus Rabies Vaccine in Simulated Rabies Post-exposure Prophylaxis in Children and Adolescents
Crucell Holland BV1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2008年5月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
The aim of this study is to evaluate the safety of the monoclonal antibody cocktail CL184 in combination with rabies vaccine compared with human rabies immune globulin (HRIG) in combination with rabies vaccine in healthy children and adolescents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects free of obvious health-problems or with stable conditions
- •Male or female subject aged ≥5 to ≤18 years
- •Subject is living, studying, or working close to the study referral site
- •Parent or legal representative signed written informed consent; in addition for subjects ≥12 years: signed assent form
排除标准
- •Prior history of rabies exposure or immunization (rabies vaccine and/or immune globulin)
- •Acute infection or disease within the last 2 weeks
- •History and/or family history of clinically significant immunodeficiency or auto-immune disease
- •Any history of known or suspected anaphylaxis or hypersensitivity reaction
- •Planned immunization with live vaccines during the next 3 months
- •Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational medicinal product
结局指标
主要结局
Safety and tolerability
时间窗: 42 days
次要结局
- Rabies virus neutralizing activity(42 days)
研究者
研究点 (1)
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