Created at Source Raw Value Validated value
May 5, 2022, 11:30 p.m. oms

Subjects will be entered into the study only if they meet none of the following criteria. <br/ >1. Prior receipt of any COVID-19 vaccine in less than 6 months of duration <br/ >2. Currently receiving or have received (in last 4 weeks) medication intended to prevent COVID-19 except for multi-vitamin supplements <br/ >3. Receipt of steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products within 30 days prior to enrollment <br/ >4. Pregnancy or breast-feeding <br/ >5. Tuberculosis, chronic systemic infections associated with immunocompromised subjects in medical history <br/ >6. History of severe allergic reaction to drug or vaccine (anaphylactic shock, or other life-threatening allergic reactions), acute exacerbation of allergic diseases on screening and randomization day <br/ >7. Chronic immune disease or systemic collagenosis in medical history <br/ >8. Subjects who received transplantation and on immunosuppressive therapy <br/ >9. Other immunosuppressive therapy (other than steroids) that completed less than three months prior to randomization into the study <br/ >10. Splenectomy in the past medical history <br/ >11. Subjects with oncological disease within 5 years prior to inclusion into the study <br/ >12. Neutropenia (absolute number of neutrophils less than <1000/mm2), agranulocytosis, severe anemia (hemoglobin < 8 g/l) <br/ >13. Significant loss of blood, Immunodeficiency in the medical history within 6 months before the enrolment <br/ >14. Active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis B, or C <br/ >15. Acute Kidney injury or dialysis <br/ >16. Anorexia or Malnutrition <br/ >17. Tattoos or scars at the injection site (deltoid muscle area), which in the medical opinion of the investigator does not allow assessing the local response to the study vaccine administration <br/ >18. Alcohol or Drug addiction in medical history <br/ >19. Participation in other interventional clinical trial within the previous 90 days prior to enrolment and over duration of the trial <br/ >20. Any other condition that the study physician considers as a barrier to the trial completion as per the protocol

Subjects will be entered into the study only if they meet none of the following criteria. <br/ >1. Prior receipt of any COVID-19 vaccine in less than 6 months of duration <br/ >2. Currently receiving or have received (in last 4 weeks) medication intended to prevent COVID-19 except for multi-vitamin supplements <br/ >3. Receipt of steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products within 30 days prior to enrollment <br/ >4. Pregnancy or breast-feeding <br/ >5. Tuberculosis, chronic systemic infections associated with immunocompromised subjects in medical history <br/ >6. History of severe allergic reaction to drug or vaccine (anaphylactic shock, or other life-threatening allergic reactions), acute exacerbation of allergic diseases on screening and randomization day <br/ >7. Chronic immune disease or systemic collagenosis in medical history <br/ >8. Subjects who received transplantation and on immunosuppressive therapy <br/ >9. Other immunosuppressive therapy (other than steroids) that completed less than three months prior to randomization into the study <br/ >10. Splenectomy in the past medical history <br/ >11. Subjects with oncological disease within 5 years prior to inclusion into the study <br/ >12. Neutropenia (absolute number of neutrophils less than <1000/mm2), agranulocytosis, severe anemia (hemoglobin < 8 g/l) <br/ >13. Significant loss of blood, Immunodeficiency in the medical history within 6 months before the enrolment <br/ >14. Active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis B, or C <br/ >15. Acute Kidney injury or dialysis <br/ >16. Anorexia or Malnutrition <br/ >17. Tattoos or scars at the injection site (deltoid muscle area), which in the medical opinion of the investigator does not allow assessing the local response to the study vaccine administration <br/ >18. Alcohol or Drug addiction in medical history <br/ >19. Participation in other interventional clinical trial within the previous 90 days prior to enrolment and over duration of the trial <br/ >20. Any other condition that the study physician considers as a barrier to the trial completion as per the protocol