CTRI/2020/07/026352已完成1 期
A prospective, randomized, adaptive, phase I/II clinical study to evaluate the safety and immunogenicity of Novel Corona Virus -2019-nCov vaccine candidate of M/s Cadila Healthcare Limited by intradermal route in healthy subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 1,048
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 male and non-pregnant, non-lactating female subjects between 18-55 years of age (both inclusive)
- •2.Body weight > 50 kg for male and > 45 kg for female and BMI within the range 18.5 - 29.9 kg/m2 (Both inclusive)
- •3.Able and willing to complete informed consent process with understanding of the purpose and procedures of the study
- •4.Subjects who, in the opinion of the Investigator, are healthy as determined by their pre study medical history, clinical examination, 12-lead ECG and clinical laboratory tests within the institutional normal range or judged as not clinically significant by the Investigator, including the following parameters: haematology, serum biochemistry, urinalysis, and serology
- •5.Subjects who can comply with trial procedures and who are available for the duration of follow up
- •6.Male subjects and female subjects of childbearing potential must practice highly effective contraception during the study and be willing and able to continue contraception for 90 days after administration of last study vaccine.
- •For Phase II:-
- •1.Healthy subject of either gender =12 years of age
- •2.Informed consent from the adult subjects or from the parents of paediatric subjects. Additionally, assent from paediatric subjects (Audio video recording in case of vulnerable subject)
- •3.Adult subjects or parents of paediatric subjects literate enough to fill the diary card
- •4.Females of childbearing potential, must agree to use one of the approved contraception methods, from screening until completion of the follow-up visit and males will agree to use contraception.
排除标准
- •For Phase I
- •1.Febrile illness (temperature = 38°C or 100.4°F) or any acute illness or infection within 4 weeks of enrolment
- •2.History of confirmed SARS-CoV-2 positive
- •3.History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days
- •4.History of SARS/ MERS infection
- •5.Subjects positive for antibody and antigen against SARS-CoV-2.
- •6.Previous participation in any clinical trial of a SARS-CoV-2 candidate vaccine
- •7.Any clinically significant laboratory or ECG findings during screening or check-in
- •8.History or presence of significant smoking (?10 cigarettes per day)
- •9.Systolic blood pressure more than 140 mmHg and less than 100 mmHg and diastolic blood pressure more than 90 mmHg and less than 60 mmHg.
- •10.History of, or positive screening test for, hepatitis C infection (defined as positive for hepatitis C virus antibody), hepatitis B infection (defined as positive for hepatitis B surface antigen), or human immunodeficiency virus I or II
- •For Phase II
- •1.Febrile illness (temperature = 38°C or 100.4°F) or any acute illness or infection within 4 weeks of enrolment
- •2.History of confirmed SARS-CoV-2 positive
- •3.History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days
- •4.History of SARS/ MERS infection
- •5.Subjects positive for antibodies against SARS-CoV-2 on antibody detection test at the time of screening
- •6.Previous participation in any clinical trial of a SARS-CoV-2 candidate vaccine
- •7.Past history of hypersensitivity reaction or any serious adverse event after any vaccination
- •8.Subjects with thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy
研究者
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