RPCEC00000056已完成1 期
Double-blind, randomized, controlled study to evaluate the safety, reactogenicity and immunogenicity of a single dose of vax-TyVi vaccine, given intramuscularly, compared to one intramuscular dose of control vaccines Typhim-Vi and vax-TET in young male and female adults between 18 and 20 years of age.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
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 20 years（—）
- 性别
- All
入选标准
- •1-A male or female between, and including, 18 and 20 years of age at the time of the vaccination. 2-Free from obvious health problems as established by medical history and clinical examination before entering into the study. 3-Written informed consent obtained from the parents or guardians.
排除标准
- •1-Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, metabolic or renal functional abnormality, as determined by physical examination. 2-History of typhoid fever. 3- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs prior to the vaccination. Inhaled and topical steroids are allowed. 4-Use of other typhoid vaccine within 2 years preceding the study. 5-Planned administration / administration of a vaccine not foreseen by the study protocol during the period starting one month before the application of the study vaccine and ending one month after that application. 6-Any hematological disease. 7-Administration of immunoglobulins and/or any blood products within the three months preceding the single dose of the candidate vaccine or planned administration during the study period. 8-Possibility of administration of any blood by-products during the study period. 9-Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. 10-A family history of congenital immunodeficiency. 11-History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. 12-History of any neurological disorders or seizures. 13-Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. 14-Axillary temperature of >= 37.5°C before vaccination. 15-History of chronic alcohol consumption. 16-Pregnancy (checked by rapid test). 17-breastfeeding mother. 18-Administration of radiotherapy or chemotherapy. 19-Neoplasic disease.
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