CTRI/2019/04/018656已完成1 期
An open label single centre phase-I study to evaluate safety, reactogenicity and immunogenicity of a single intramuscular dose of an inactivated poliomyelitis vaccine of Biological E Limited in 18-45 year old healthy adults. - None
Biological ELimited0 个研究点目标入组 24 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 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 male volunteers =18 to =45 years of age at the time of vaccination;
- •2. Must have received primary polio vaccination series according to the Indian National Immunization Programme based on vaccination card or verbal information given by subjects during interview with investigator.
- •3. Subject’s ability to understand information relevant to participation in the study and abide with the requirements of the subject diary and other study procedures;
- •4. Signed informed consent obtained prior to screening from subject;
- •5. Free of obvious health problems [with no significant pulmonary, cardiovascular, hepatobiliary, gastrointestinal, renal, neurological, mental or haematological functional abnormalities or illness that require medical therapy] as established by medical history, routine haematology and biochemistry parameters and clinical assessment;
排除标准
- •1. Received IPV or OPV booster dose after the age of 12 years;
- •2. Sero-positive for HIV, Hepatitis B or Hepatitis C infections;
- •3. Abnormal pre-treatment laboratory haematology and biochemistry parameters which are clinically significant according to the investigator;
- •4. Known or suspected allergy against any of the vaccine components;
- •5. History of unusual or severe reactions to any previous vaccination;
- •6. Known or suspected immune deficiency either congenital or hereditary;
- •7.Systemic treatment with corticosteroids within one month before screening;
- •8. Blood donation within one month before screening;
- •9. History of any neurological disorder including epilepsy or febrile seizures or a family history of mental illness;
- •10. Evidence of excessive alcohol use or drug abuse;
- •11. Any infectious disease or acute condition at the time of screening and/or inclusion;
- •12. Individuals with body temperature =100.4°F (=38.0°C) within 3 days prior of intended study immunization;
- •13. Participation in another clinical trial within three months before screening;
- •14. Bleeding disorders or the usage of anticoagulants in the past 3 weeks;
- •15. History of any blood disorder (e.g. thalassemia, thrombocytopenia, disorders of the lymphocytes, anaemias, etc.) in the past 3 weeks;
- •16. Subjects who have received any blood products, cytotoxic agents or radiotherapy within the last 3 months;
- •17. Any licensed or investigational drug or vaccine administered within 30 days prior to receipt of study vaccine or is scheduled to receive any other licensed vaccine within 30 days following receipt of study vaccine;
- •18. An employee (or first-degree relative of employee) of the Sponsor, the CRO, or any investigator or site personnel.
- •19. Inability or unwillingness to abide by the requirements of the study:
- •Participant is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study;
研究者
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