Evaluation of Immunogenicity, Efficacy and Safety of single dose of COVID-19 vaccines (Covishield, Covaxin and Sputnik V) in previously SARS-CoV2 infected individuals - A Randomized controlled clinical trial

Indian Council of Medical research ICMR0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Males and females >=18 years and willing to give informed consent
•2.Group I and II: Subjects with positive history of RT-PCR proven COVID-19, 3 months or more, prior to their enrolment
•3.Group III: Subjects with no history of COVID-19 infection in the past
•4.Females should be non-pregnant and willing to adopt contraception for minimum three months (group 1 - 3 months after the 1st dose; group 2 & 3 - during the period between 1st & 2nd doses and 3 months after 2nd dose)
•4.Subjects with co morbidities including Diabetes and Hypertension with stable medical condition

•1.Subjects with significant co-morbid conditions with unacceptable clinical and / or laboratory profile in view of the investigator
•2.Those who are on long term steroid therapy (>=3 months) and immunosuppressive treatment including anticancer treatment within past 6 months
•3.Those who are in immunosuppressed or immunodeficient state
•4.Subjects with active malignancy of any organ or system
•5.Those who have received blood / blood products / immunoglobulins in the past 3 months
•6.Subjects on regular anticoagulant therapy
•7.History of bleeding disorders
•8.H/O hypersensitivity to any of the vaccines and / or the constituents in the vaccine

发起方

Indian Council of Medical research ICMR