CTRI/2017/07/009034已完成1 期
A phase I, prospective, open label clinical study to assess the safety and tolerability of DTaP-IPV+Hib vaccine manufactured by Serum Institute of India Pvt. Ltd. in healthy adult volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
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 human subjects between 18 and 45 years of age (both
- •inclusive) .
- •2. Having a Body Mass Index (BMI) between 18.5 and 24.9 (both inclusive),
- •calculated as weight in kg/height in m2 with minimum of 50 kg weight.
- •3. Healthy subjects as established by personal medical history, physical
- •examination, laboratory investigation during screening and as per the
- •clinical judgment of the Investigator.
- •4. Sexually active participants to be using an effective method of
- •contraception (i.e. intrauterine device or hormonal contraception or
- •condom, diaphragm, cervical cap).
- •5. Subjectâ??s willingness and ability to comply with the requirements of the
- •6. Subject willing to sign a written informed consent.
排除标准
- •1. History of any allergic diseases or history of a serious reaction to any prior
- •vaccination or known hypersensitivity to any component of the study
- •2. History of anaphylactic shock.
- •3. History of previous vaccination against diphtheria, tetanus, pertussis, polio
- •or Hib with either the trial vaccine or another vaccine (except Tetanusprone
- •wound management for adults) in the past 5 years.
- •4. History of diphtheria, tetanus, pertussis, polio or Haemophilus influenzae
- •type B infection (confirmed either clinically, serologically or
- •microbiologically).
- •5. History of major congenital defects or illness that require medical therapy,
- •as determined by medical history or clinical assessment.
- •6. History of any cancer, leukemia, HIV infection, organ transplant or any
- •other immune system disease.
- •7. History or presence of any disease or condition which might compromise
- •the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous,
- •cardiovascular, immunological, dermatological, gastrointestinal or any
- •other body system.
- •8. Ingestion or Use of any medication (including herbal remedies) at any
- •time in 14 days or immune-modifying drugs in last 3 months prior to IP
- •administration or planned at any time during the study. In any such case
- •subject selection will be at the discretion of the Principal Investigator.
- •9. Any history or presence of asthma (including aspirin induced asthma) or
- •nasal polyp or NSAIDs induced urticaria.
- •10. Smokers, who smoke 10 or more than 10 cigarettes/beedis per day or
- •inability to abstain from smoking during the study.
- •11. History of significant alcoholism in the past one year.
- •12. The presence of clinically significant abnormal laboratory values during
- •13. Abnormal ECG and chest X-ray.
- •14. Use of any recreational drugs or history of drug addiction or testing
- •positive in pre study drug scans.
- •15. History or presence of psychiatric disorder
- •16. A positive hepatitis screen including hepatitis B surface antigen and/or
- •HCV antibodies.
- •17. A positive test result for HIV antibody.
- •18. Female participant who is pregnant or breast-feeding, or wanting to fall
- •pregnant during trial participation.
- •19. Investigator, site personnel directly affiliated with this study and their
- •immediate families. Immediate family is defined as a spouse, parent, child
- •or sibling, whether biological or legally adopted.
- •20. Acute illness (moderate or severe) and/or fever (oral temperature >=38°C)
- •at the time of vaccination or during the 7 days prior to the vaccination.
- •21. History of receipt a blood transfusion or other blood products in the year
- •prior to screening.
- •22. Use of any investigational or non-registered drug within 30 days preceding
- •the study vaccine administration, or planned use during the study period.
- •23. History of administration of any vaccine within 30 days prior to
- •administration of study vaccine or planned during the course of study
- •participation.
- •24. Participation in a drug research study within past 3 months or planned
- •participation during the study.
- 另有 2 项未显示
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