RPCEC00000160尚未招募1 期
Parallel, controlled, randomized, double-blind phase I Clinical Trial to assess the safety and reactogenicity and to explore the immunogenicity of two doses of the Outer Membrane Vesicles (OMV) Bivalent AW135 Antimeningocóccal Vacccine Candidate in healthy adults of both gender
Finlay Institute, Center for Research, and Productions of Serum and Vaccines0 个研究点目标入组 50 人开始时间: 2013年6月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial. Masking: Double Blind. Control group: Active. Assignment: Parallel. Purpose: Prevention
入排标准
- 年龄范围
- 18 years 至 50 years（—）
- 性别
- All
入选标准
- •1.Woman or men from 18 to 50 years old with a body mass index (BMI) between 18 and 29,9. 2.Good physical and mental health state, established by mean of anamnesis and physical examination as a medical criteria, as well by mean of electrocardiogram and hematology, hemochemical and urine tests, within non clinically significant reference parameters, as well as negative results in the serology of VDRL, HIV and HBV surface Ag and HCV before the beginning of the study. 3.Willfulness expressed by mean of a written informed consent.
排除标准
- •1.Occurrence of acute illness (with or without fever) within 30 days prior to the moment the subject be included in the study. 2.Chronic diseases such cancers, diabetes, heart disease, liver disease, progressive neurological disease, autoimmune disease or blood dyscrasias, signs of heart or renal failure or severe malnutrition. 3.Any suspected or confirmed condition of immunodeficiency. 4.To have suffered meningococcal disease. 5.To have been immunized with meningococcal vaccine, 6 months prior to administration of the treatments included in the study. 6.History of immunoglobulin therapy during the 30 days prior to the administration of the treatments included in the clinical trial. 7.To be under immunosuppressive treatment (more than 14 days) or other medication which modify the immune status, excluding topical or inhaled steroids. 8.Administration of a vaccine not predicted in the protocol, 30 days before the beginning of the study. 9.Pregnancy or breastfeeding. 10.Alcoholism defined as set forth in the CENATOX algorithm 11.Allergy to Thiomersal.
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