Phase III, open label, un-controlled, multicenter, bridging study to evaluate immunogenicity and safety of single dose of Sputnik Light in Indian adults and elderly for prevention of SARS-CoV-2 Infection

Dr Reddys Laboratories Limited0 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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•Subjects will be enrolled in the study if they meet all the following criteria.
•1.Ability to provide written informed consent and Willingness to participate in the study
•2.Participants of either gender of age of more than >=18 years to <99 years
•3.Negative COVID-19 RT-PCR test result at the screening visit (within 96 hours prior to Visit 1 [Day 1]). and negative IgM SARS specific antibodies at the screening visit
•4.No medical history of COVID-19 in last 90 days
•5.Consent for using effective methods of contraception during the entire trial and 3 months after its completion
•6.No history of any vaccine-induced reactions or complications after receiving immunobiological products
•7.No history of acute infection and/or respiratory diseases within at least 14 days before the enrollment

•Subjects will be entered into the study only if they meet none of the following criteria.
•1.Any vaccination/immunization within 30 days before the enrolment
•2.Any vaccination/immunization against COVID 19 before the enrolment
•3.Any ongoing systemic steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products in the last 30 days before the enrolment
•4.On Immunosuppressive therapy within 3 months of the enrolment
•5.Neutropenia (absolute neutrophil count <1,000 mm3),severe anemia (hemoglobin <80 g/L), in screening test
•6.Immunodeficiency or autoimmune disorders in the medical history within 6 months before the enrolment
•7.Pregnancy or breast-feeding
•8.Acute coronary syndrome or stroke in the last one year before the enrolment
•9.Active Tuberculosis or any other ongoing chronic systemic
•10.Anorexia, or protein deficiency of any origin
•11.Tattoos at the injection site (deltoid muscle area), which does not allow assessing the local response to the IMP administration
•12.Alcohol or drug addiction in the medical history
•13.Participation in any other interventional clinical trial within 90 days prior to the Screening
•14.Any other medical condition that would limit the participation of the subject as per Investigatorâ??s discretion
•15.HIV, hepatitis B or C infection
•16.Medical history of malignancy
•17.Splenectomy in the medical history
•18.Subjects contraindicated for vaccination

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