CTRI/2021/11/037996进行中（未招募）4 期
An active post-marketing surveillance study to evaluate the safety and immunogenicity of ZyVac TCV of M/s. Cadila Healthcare Limited in healthy subjects - NA
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1. Healthy subjects of either gender ââ?°Â¥6 months to ââ?°Â¤45 years of age at the time of enrollment
- •2. Subjects should be in a good health as determined by the medical history and physical examination based on clinical judgment of the investigator
- •3. No previous history of vaccination (oral or injectable) against typhoid fever
- •4. Informed consent from the adult subjects or from the parents of pediatric subjects. Additionally, assent from pediatric subjects aged 7 years or more
- •5. Adult subjects or parents of pediatric subjects literate enough to fill the diary card
- •6. Adult subjects or, pediatric subjects and their parents intend to be available
- •for follow-up for entire duration of the study
排除标准
- •1. History of hypersensitivity reaction to any component of the vaccine
- •2. History of laboratory confirmed or suspected typhoid fever in the past 3 years
- •3. Subject who have had household contact with/ and/or intimate exposure to an individual with laboratory confirmed S. typhi
- •4. Fever of any origin or infectious disorder of 3 days or more within the past month
- •5. Febrile illness (body temperature ââ?°Â¥ 37.5Ã?°C) at the time of enrollment
- •6. History of any vaccination within the past month
- •7. History of COVID-19 within the past 3 months
- •8. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder
- •9. Confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy
- •10. Known case of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy
- •11. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study
- •12. Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization)
- •13. Subject participated in another clinical study in the past 3 months or subject intend to participate in another clinical study within 3 months following
- •intended study vaccine administration
- •14. Subject with history of alcohol or drug abuse in the past one year
- •15. Any other reason for which the investigator feels that subject should not participate
研究者
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