Safety, Immunogenicity And Efficacy Of Vaccination In Military Personnel
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 262
- 试验地点
- 1
- 主要终点
- immunomediated disorders related to multiple vaccination
研究概览
简要总结
The purpose of this study is to determine if multiple vaccination in military personnel may be correlated with the appearance of poorly defined diseases as symptomatic multisyndrome, autoimmune or lymphoproliferative disorders. At the same time, considering possible interference between different vaccines, proteins and polysaccharides, living and inactivated, the study aims to assess the immunogenicity and efficacy also in relation to the specific Human Leucocyte Antigens (HLA) genetic structure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Military volunteers
- •No recently immunized
排除标准
- •Pregnancy
- •Documented immunodepression
- •Documented allergy or hypersensitivity to vaccines
研究组 & 干预措施
single arm :vaccinated
military personnel vaccinated with multiple vaccines and monitored about safety, immunogenicity and efficacy
干预措施: biological monitoring (Biological)
结局指标
主要结局
immunomediated disorders related to multiple vaccination
时间窗: three years
次要结局
- efficacy of multiple vaccination(Three years)
- immunogenicity of multiple vaccination(Three years)
研究者
Raffaele D'Amelio
Full Professor
University of Roma La Sapienza