CTRI/2011/08/001957已完成3 期
A PHASE III, RANDOMIZED, MULTICENTERIC, CONTROLLED STUDY TO EVALUATE THE IMMUNOGENICITY AND SAFETY OF BBIL?s TYPHOID Vi CAPSULAR POLYSACCHARIDE-TETANUS TOXOID PROTEIN CONJUGATE VACCINE VS REFERENCE VACCINE IN HEALTHY SUBJECTS.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 981
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Provide voluntary written and signed informed consent from volunteer or if minor from parent/legal guardian.
- •2.Healthy subjects in two cohorts aged 6 to 24 months, and 2 - 45 years.
- •3.Are not participating in or plan to participate in another research during the next three months & be available throughout study period.
- •4.Family does not plan to move during the study period, and housed not further that 50 Km away from the study site.
排除标准
- •Fever of any origin or infections more than 3 days within one month prior
- •to screening or on the day of screening
- •2)Any confirmed or suspected immunosuppressive condition.
- •3)Any treatment with immunosuppressive or immunostimulant therapy
- •4)Use of any marketed or investigational or herbal medicine or non-registered drug or vaccine for typhoid.
- •5) Life threatening or serious cardiac (NYHA grade 3&4), respiratory, gastrointestinal, hepatic, renal, endocrine and systemic disorders.
- •6)Have been vaccinated against typhoid fever or had exposure to typhoid fever within the last three years.
研究者
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