CTRI/2021/10/037137已完成3 期
A prospective, open-label, single arm, multicenter, phase III clinicalstudy to evaluate the immunogenicity and safety of 3mg (2 dose) regimen of NovelCorona Virus -2019-nCov vaccine candidate of M/s Cadila Healthcare Limited byintradermal route in healthy subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,000
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 subject of either gender >=12 years of age
- •2. Informed consent from the subjects / LAR and assent from subjects >=12 to <18 years of age
- •3. Adult subjects / LAR literate enough to fill the diary card
- •4. Females of childbearing potential, must agree to use one of the approved contraception methods (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization), from screening until completion of the followup visit and males who agree to use contraception
排除标准
- •1. Febrile illness (temperature >= 38°C or 100.4°F) or any acute illness or infection within 4 weeks of enrolment
- •2. History or laboratory evidence of confirmed SARS-CoV-2 positive in last 3 months
- •3. History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days
- •4. Subjects positive for antibodies against SARS-CoV-2 on antibody detection test (for immunogenicity cohort only) / RTPCR positive at the time of screening
- •5. History of SARS/ MERS infection
- •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 known history of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy
- •9. Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy
- •10. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, haematological, psychiatric or immunological disorder
- •11. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study
- •12. Any other vaccine administration within the last 30 days or planned to be administered during the study period
- •13. Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization)
- •14. Participation in another clinical trial in the past 3 months
- •15. History of drug / alcohol abuse
研究者
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