RPCEC00000203已完成1 期

Study Phase I-II, controlled, randomized, at double blind, to evaluate the safety, reactogenicity and the immune response, for bactericidal antibodies in serum, of the meningococcal polysaccharide vaccine ACW135, produced by the Institutes Finlay and Bio-Manguinhos/FIOCRUZ, using as control the vaccine MENCEVAX ACW, administered in unique dose in healthy young adults of both sexes.

Finlay Institute, Center for Research, and Productions of Serum and Vaccines.0 个研究点目标入组 352 人开始时间: 2015年12月4日最近更新: 2024年8月19日

研究概览

暂无简介。

研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Double Blind. Control group: Active. Assignment: Parallel. Purpose: Prevention

•1. Healthy adult of both sexes, with ages between 18-35 years old.
•2. Good state of physical and mental health established by medical opinion by means of anamnesis and physical exam, before beginning the study.
•3. Voluntary nature expressed by means of written informed consent.

•1. Presence of acute disease (with or without fever) previous to the moment of their incorporation to the study.
•2. Axilar temperature equal to or higher than 37.5 Celcius degrees immediately before the administration of the treatment.
•3. Any suspicious or confirmed condition of immunodeficiency including positive diagnostic of HIV.
•4. To have suffered meningococcal disease.
•5. Therapy history with immunoglobulin during the 30 previous days to the administration of the vaccines included in the study
•6. To be under immunosuppressive treatment (more than 14 days) or another type of medication that modifies the immunologic state, excluding the topical steroids or by inhalation.
•7. Administration of a vaccine not planned in the Protocol, 30 days before the beginning of the study.
•8. Pregnancy or lactation.

发起方

Finlay Institute, Center for Research, and Productions of Serum and Vaccines.