Created at Source Raw Value Validated value
June 25, 2024, noon usa

1. any previous vaccination/immunization (within 30 days before the enrollment) and any planned vaccination within 30 days after enrollment 2. any previous or planning covid-19 vaccination with any other regulatory approved vaccine 3. positive sars-cov-2 screening result obtained by pcr (at screening) 4. administration of steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment 5. pregnancy or lactation 6. acute coronary syndrome or stroke suffered less than one year before study enrollment 7. tuberculosis, chronic systemic infections associated with immunocompromised subjects in medical history 8. history of severe allergic reaction to drug or vaccine (anaphylactic shock, quincke's edema, and other life-threatening allergic reactions), acute exacerbation of allergic diseases on screening and vaccination day 9. chronic autoimmune disease and system collagenases in medical history 10. organ transplantation and immunosuppressive therapy 11. immunosuppressive therapy and corticosteroid system therapy within 3 months before the enrollment 12. subjects with malignant neoplasms within 5 years before the enrollment 13. splenectomy in the past medical history 14. neutropenia (absolute neutrophil count \<1,000 mm3 agranulocytosis, significant blood loss, severe anemia (hemoglobin \<80 g/l), immunodeficient disease in the medical history within 6 months before the enrollment 15. the active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis b, or c 16. acute kidney injury or dialysis 17. anorexia or dysnutrition 18. tattoos at the injection site (deltoid muscle area), which in the medical opinion of the investigator does not allow assessing the local response to the vaccine/placebo 19. alcohol or drug abuse in medical history 20. participation in other interventional clinical trial within the previous 90 days prior to vaccination and over duration of the trial 21. any other condition that the investigator considers as a barrier to the trial completion as per the protocol

1. any previous vaccination/immunization (within 30 days before the enrollment) and any planned vaccination within 30 days after enrollment 2. any previous or planning covid-19 vaccination with any other regulatory approved vaccine 3. positive sars-cov-2 screening result obtained by pcr (at screening) 4. administration of steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment 5. pregnancy or lactation 6. acute coronary syndrome or stroke suffered less than one year before study enrollment 7. tuberculosis, chronic systemic infections associated with immunocompromised subjects in medical history 8. history of severe allergic reaction to drug or vaccine (anaphylactic shock, quincke's edema, and other life-threatening allergic reactions), acute exacerbation of allergic diseases on screening and vaccination day 9. chronic autoimmune disease and system collagenases in medical history 10. organ transplantation and immunosuppressive therapy 11. immunosuppressive therapy and corticosteroid system therapy within 3 months before the enrollment 12. subjects with malignant neoplasms within 5 years before the enrollment 13. splenectomy in the past medical history 14. neutropenia (absolute neutrophil count \<1,000 mm3 agranulocytosis, significant blood loss, severe anemia (hemoglobin \<80 g/l), immunodeficient disease in the medical history within 6 months before the enrollment 15. the active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis b, or c 16. acute kidney injury or dialysis 17. anorexia or dysnutrition 18. tattoos at the injection site (deltoid muscle area), which in the medical opinion of the investigator does not allow assessing the local response to the vaccine/placebo 19. alcohol or drug abuse in medical history 20. participation in other interventional clinical trial within the previous 90 days prior to vaccination and over duration of the trial 21. any other condition that the investigator considers as a barrier to the trial completion as per the protocol

Nov. 16, 2021, 6:30 p.m. usa

any previous vaccination/immunization (within 30 days before the enrollment) and any planned vaccination within 30 days after enrollment any previous or planning covid-19 vaccination with any other regulatory approved vaccine positive sars-cov-2 screening result obtained by pcr (at screening) administration of steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment pregnancy or lactation acute coronary syndrome or stroke suffered less than one year before study enrollment tuberculosis, chronic systemic infections associated with immunocompromised subjects in medical history history of severe allergic reaction to drug or vaccine (anaphylactic shock, quincke's edema, and other life-threatening allergic reactions), acute exacerbation of allergic diseases on screening and vaccination day chronic autoimmune disease and system collagenases in medical history organ transplantation and immunosuppressive therapy immunosuppressive therapy and corticosteroid system therapy within 3 months before the enrollment subjects with malignant neoplasms within 5 years before the enrollment splenectomy in the past medical history neutropenia (absolute neutrophil count <1,000 mm3 agranulocytosis, significant blood loss, severe anemia (hemoglobin <80 g/l), immunodeficient disease in the medical history within 6 months before the enrollment the active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis b, or c acute kidney injury or dialysis anorexia or dysnutrition tattoos at the injection site (deltoid muscle area), which in the medical opinion of the investigator does not allow assessing the local response to the vaccine/placebo alcohol or drug abuse in medical history participation in other interventional clinical trial within the previous 90 days prior to vaccination and over duration of the trial any other condition that the investigator considers as a barrier to the trial completion as per the protocol

any previous vaccination/immunization (within 30 days before the enrollment) and any planned vaccination within 30 days after enrollment any previous or planning covid-19 vaccination with any other regulatory approved vaccine positive sars-cov-2 screening result obtained by pcr (at screening) administration of steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment pregnancy or lactation acute coronary syndrome or stroke suffered less than one year before study enrollment tuberculosis, chronic systemic infections associated with immunocompromised subjects in medical history history of severe allergic reaction to drug or vaccine (anaphylactic shock, quincke's edema, and other life-threatening allergic reactions), acute exacerbation of allergic diseases on screening and vaccination day chronic autoimmune disease and system collagenases in medical history organ transplantation and immunosuppressive therapy immunosuppressive therapy and corticosteroid system therapy within 3 months before the enrollment subjects with malignant neoplasms within 5 years before the enrollment splenectomy in the past medical history neutropenia (absolute neutrophil count <1,000 mm3 agranulocytosis, significant blood loss, severe anemia (hemoglobin <80 g/l), immunodeficient disease in the medical history within 6 months before the enrollment the active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis b, or c acute kidney injury or dialysis anorexia or dysnutrition tattoos at the injection site (deltoid muscle area), which in the medical opinion of the investigator does not allow assessing the local response to the vaccine/placebo alcohol or drug abuse in medical history participation in other interventional clinical trial within the previous 90 days prior to vaccination and over duration of the trial any other condition that the investigator considers as a barrier to the trial completion as per the protocol

Feb. 8, 2021, 12:31 a.m. usa

1. any previous vaccination/immunization (within 30 days before the enrollment) and any planned vaccination within 30 days after enrollment 2. any previous or planning covid-19 vaccination with any other regulatory approved vaccine 3. positive sars-cov-2 screening result obtained by pcr (at screening) 4. administration of steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment 5. pregnancy or lactation 6. acute coronary syndrome or stroke suffered less than one year before study enrollment 7. tuberculosis, chronic systemic infections associated with immunocompromised subjects in medical history 8. history of severe allergic reaction to drug or vaccine (anaphylactic shock, quincke's edema, and other life-threatening allergic reactions), acute exacerbation of allergic diseases on screening and vaccination day 9. chronic autoimmune disease and system collagenases in medical history 10. organ transplantation and immunosuppressive therapy 11. immunosuppressive therapy and corticosteroid system therapy within 3 months before the enrollment 12. subjects with malignant neoplasms within 5 years before the enrollment 13. splenectomy in the past medical history 14. neutropenia (absolute neutrophil count <1,000 mm3 agranulocytosis, significant blood loss, severe anemia (hemoglobin <80 g/l), immunodeficient disease in the medical history within 6 months before the enrollment 15. the active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis b, or c 16. acute kidney injury or dialysis 17. anorexia or dysnutrition 18. tattoos at the injection site (deltoid muscle area), which in the medical opinion of the investigator does not allow assessing the local response to the vaccine/placebo 19. alcohol or drug abuse in medical history 20. participation in other interventional clinical trial within the previous 90 days prior to vaccination and over duration of the trial 21. any other condition that the investigator considers as a barrier to the trial completion as per the protocol

1. any previous vaccination/immunization (within 30 days before the enrollment) and any planned vaccination within 30 days after enrollment 2. any previous or planning covid-19 vaccination with any other regulatory approved vaccine 3. positive sars-cov-2 screening result obtained by pcr (at screening) 4. administration of steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment 5. pregnancy or lactation 6. acute coronary syndrome or stroke suffered less than one year before study enrollment 7. tuberculosis, chronic systemic infections associated with immunocompromised subjects in medical history 8. history of severe allergic reaction to drug or vaccine (anaphylactic shock, quincke's edema, and other life-threatening allergic reactions), acute exacerbation of allergic diseases on screening and vaccination day 9. chronic autoimmune disease and system collagenases in medical history 10. organ transplantation and immunosuppressive therapy 11. immunosuppressive therapy and corticosteroid system therapy within 3 months before the enrollment 12. subjects with malignant neoplasms within 5 years before the enrollment 13. splenectomy in the past medical history 14. neutropenia (absolute neutrophil count <1,000 mm3 agranulocytosis, significant blood loss, severe anemia (hemoglobin <80 g/l), immunodeficient disease in the medical history within 6 months before the enrollment 15. the active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis b, or c 16. acute kidney injury or dialysis 17. anorexia or dysnutrition 18. tattoos at the injection site (deltoid muscle area), which in the medical opinion of the investigator does not allow assessing the local response to the vaccine/placebo 19. alcohol or drug abuse in medical history 20. participation in other interventional clinical trial within the previous 90 days prior to vaccination and over duration of the trial 21. any other condition that the investigator considers as a barrier to the trial completion as per the protocol