CTRI/2017/02/007785已完成1 期
A phase-I, open label clinical trial to assess the safety and tolerability ofrecombinant quadrivalent Human Papilloma Virus (qHPV) vaccinemanufactured by Serum Institute of India Pvt.Ltd. in healthy adultvolunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
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 aged between 18-26 years and female subjects
- •aged between 18-45 years and normal Body Mass Index (18.5 to
- •24.9 kg/m2) with minimum of 50 kg weight.
- •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 HPV vaccination or HPV infection
- •2. Female participant who is pregnant or breast-feeding, or wanting to
- •fall pregnant during trial participation.
- •3. History of abnormal cervical cancer tests in females or history of
- •genital warts in females and males.
- •4. History of any surgical procedure for the removal of the uterus or
- •hysterectomy.
- •5. History of major congenital defects or illness.
- •6. Investigator site personnel directly affiliated with this study.
- •7. Acute illness and/or fever at the time of vaccination or during the past 7 days.
- •8. Administration of corticosteroids, cytotoxic agents or radiotherapy or other 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.
- •11. Use of any investigational or non-registered drug.
- •12. History of administration of any vaccine in past 30 days or during the study.
- •13. History of any major illness.
- •16. History of anaphylactic shock
- •17. Participant having any allergies to medications and food.
- •18. History or presence of significant alcoholism, drug abuse in the past one year.
- •19. History or presence of significant smoking.
- •20. Reactive serology for HIV, hepatitis B and hepatitis C viruses
- •21. Abnormal ECG and chest X-ray
- •22. Participation in a drug research study within past 3 months or planned participation during the study.
- •23. Participant has any plans to relocate from the area prior to the completion of the study.
- •24. 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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