CTRI/2021/01/030416已完成3 期
A phase III, randomized, multi-centre, double blind, placebocontrolled, study to evaluate efficacy, safety and immunogenicityof Novel Corona Virus -2019-nCov vaccine candidate of M/sCadila Healthcare Limited.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 28,216
- 试验地点
- 59
- 主要终点
- To demonstrate the efficacy of ZyCoV-D in the prevention of virologically confirmed symptomatic COVID-19 cases as compared to placebo.
研究概览
简要总结
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was first reported in January, 2020.The virus is highly transmissible between humans and has spread rapidly, causing the COVID-19 pandemic. Patients infected with SARS-CoV-2, especially older patients and those with pre-existing respiratory or cardiovascular conditions are at greater risk for severe complications, including severe pneumonia, acute respiratory distress syndrome, multiple organ failure, and in some cases, death. In the absence of effective prevention measures, current management to control the epidemic is the enforcement of quarantine, isolation, and physical distancing. Effective vaccines against COVID-19 are urgently needed to reduce the enormous burden of mortality and morbidity associated with SARS-CoV-2 infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy subject of either gender ≥12 years of age.
- •Agrees not to take any COVID-19 licensed vaccination for the entire duration of the study.
- •Ability to provide 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).
- •Adult subjects or parents of paediatric subjects literate enough to fill the diary card.
- •Subjects with good health or with stable medical condition for chronic disease.
- •(Stable condition is defined as there is no change in the medication or dose of medication or severity of disease from last 3 months before enrolment.)
- •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 follow-up visit and males will agree to use contraception.
- •Willing to allow storage and future use of biological samples for future research.
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.
- •Laboratory confirmed SARS-CoV-2 positive.
- •History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days.
- •History of SARS/ MERS infection.
- •Previous participation in any clinical trial of a SARS-CoV-2 candidate vaccine.
- •Past history of hypersensitivity reaction or any serious adverse event after any vaccination.
- •Past history of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy.
- •Subjects with confirmed immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy.
- •Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, haematological, psychiatric or immunological disorder.
- •Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study.
- •Any other vaccine administration within the last 30 days or planned to be administered during the study period.
- •Pregnant and lactating women.
- •Participation in another clinical trial in the past 3 months.
- •History of drug / alcohol abuse.
结局指标
主要结局
To demonstrate the efficacy of ZyCoV-D in the prevention of virologically confirmed symptomatic COVID-19 cases as compared to placebo.
时间窗: Day 84 to Day 364
次要结局
- To demonstrate the efficacy of a ZyCoV-D in the prevention of virologically confirmed(COVID-19 death as compared to placebo.)
- To demonstrate the efficacy of a ZyCoV-D in the prevention of virologically confirmed mild(COVID-19 cases as compared to placebo.)
- To evaluate the immunogenicity by neutralizing antibody (nAb) assay in subset of(population.)
- To evaluate persistence of immunogenicity after first dose(of ZyCoV-D.)
- To evaluate the Lot-to-Lot consistency based on the IgG titer of the three consecutive lots used in the study.(At Day 84)
- To evaluate safety and tolerability of ZyCoV-D.(Day 0 to Day 364)
研究者
研究点 (59)
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