CTRI/2017/03/008003已完成1 期
A phase-I, open label clinical trial to assess the safety of tetanus toxoid,reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccinemanufactured by Serum Institute of India Pvt. Ltd. in healthy Indianadults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
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. Healthy adult male or female aged between 18-45 years and normal
- •Body Mass Index (18.5 to 24.9 kg/m2) with minimum of 50 kg
- •2. Healthy subjects as established by personal medical history, physical
- •examination, laboratory investigation during screening and as per the
- •clinical judgment of the Investigator.
- •3. Sexually active participants to be using an effective method of
- •contraception (i.e. intrauterine device or hormonal contraception or
- •condom, diaphragm, cervical cap).
- •4. Subjectâ??s willingness and ability to comply with the requirements of
- •the protocol.
- •5. Subject willing to sign a written informed consent.
排除标准
- •1. History of previous vaccination against diphtheria, tetanus and pertussis with either the trial vaccine or another vaccine (except
- •Tetanus-prone wound management for adults) in the past 5 years.
- •2. History of Tetanus, diphtheria or pertussis infection.
- •3. Female participant who is pregnant or breast-feeding, or wanting to fall pregnant during study.
- •4. History of any major illness.
- •5. History of major congenital defects or illness.
- •6. Investigator, site personnel directly affiliated with this study and their immediate families.
- •7. Acute illness and/or fever at the time of vaccination or during the past 7 days.
- •8. Chronic administration high doses of
- •corticosteroids, cytotoxic agents or radiotherapy or immune-modifying drugs in last 3 months.
- •9. Receipt of any oral or injectable antibiotics and/or antiviral from 5 days before screening through to enrollment.
- •10. History of receipt a blood transfusion or other blood products in the past one year.
- •11. Use of any investigational or non-registered drug.
- •12. History of administration of any vaccine within past 30 days or during the study
- •13. History of any major illness.
- •14. Participant having any allergies to medication and food.
- •15. History of anaphylactic shock
- •16. History or presence of significant alcoholism or drug abuse in the past one year.
- •18. History or presence of significant smoking.
- •19. Reactive serology for HIV, hepatitis B and hepatitis C viruses
- •20. Abnormal ECG and chest X-ray
- •21. Participation in a drug research study within past 3 months or planned participation during the study.
- •22. Participant has any plans to relocate from the area prior to the completion of the study.
- •23. Any other condition which in the opinion of the investigator will
- •jeopardize the safety of the subject due to participation in the study.
研究者
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