CTRI/2024/06/069638尚未招募3 期
A Phase III Open-label Study to Evaluate the Immunogenicity and Safety of Typhoid Tetanus Toxoid Conjugate Vaccine, Typbar TCV® in Adults (greater than 65 Years). - Typbar-TCV
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
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. Subjects of age =18 without significant medical history or abnormal
- •clinical findings
- •2. Subject who has been explained about all risks and benefits of the
- •Trail and is willing to provide written informed consent.
- •3. Agrees to be available for all Trail related visits and procedures
- •throughout the duration of the Trail.
- •4. Female subjects of child bearing potential must demonstrate a negative
- •urine pregnancy test at the time of screening.
- •5. Individuals who are in good health as determined by the outcome of
- •medical history, physical examination and based on clinical judgement of
- •the Principal Investigator.
排除标准
- •1. Subjects who are under the age of 18 years
- •2. Fever of any origin or duration for more than 3 days prior to intended Trail immunization
- •3. History of Typhoid vaccination in the last 5 years
- •4. History of Typhoid disease in the last 5 years
- •5. History of any illness or any laboratory abnormality that, in the opinion of the investigator, might
- •interfere with the results of the Trail or pose additional risk to the subjects due to participation
- •in the Trail
- •6. Individuals with any serious chronic or progressive diseases according to the judgment of
- •Investigator (eg: neurological, neoplasm, insulin dependent diabetes, hepatic, renal, cardiac
- •7. Any confirmed or suspected use of immunosuppressive drugs or immunodeficient condition.
- •8. Use of any marketed/investigational/herbal medicine or non-registered drug or vaccine for Typhoid.
- •9. Any criteria, which in the opinion of the investigator, suggests that the subject may not be
- •compliant with the Trail protocol.
- •10. History of allergy or allergic reactions to vaccine or any vaccine component
- •11. Women who are pregnant or breast-feeding.
- •12. Married or sexually active participants who are not willing to follow effective birth control
- •methods for at least 3 months after vaccine.
- •13. Individuals participating in any other clinical trial within one month prior to Trail participation
- •or intent to participate in any other clinical trial during the conduct of the Trail
研究者
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