Created at Source Raw Value Validated value
June 27, 2024, 4 p.m. usa

1. any vaccination/immunization within 30 days before the enrollment; 2. steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment 3. immunosuppressors therapy finished within 3 months before the enrollment 4. pregnancy or breast-feeding 5. acute coronary syndrome or stroke suffered less than one year before the enrollment 6. tuberculosis, chronic systemic infections 7. drug allergy (anaphylactic shock, quincke's edema, polymorphic exudative eczema, atopy, serum disease), hypersensitivity or allergic reaction to immunobiological products, known allergic reactions to study drug components, acute exacerbation of allergic diseases on the enrollment day 8. neoplasms in the past medical history (icd codes c00-d09) 9. donated blood or plasma (450+ ml) within 2 months before the enrollment 10. history of splenectomy; 11. neutropenia (absolute neutrophil count \<1,000/mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin \<80 g/l), immunodeficiency in the past medical history within 6 months before the enrollment 12. active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis b or c 13. anorexia, protein deficiency of any origin 14. big-size tattoos at the injection site (deltoid muscle area), which does not allow assessing the local response to the study drug/placebo administration 15. alcohol or drug addiction in the past medical history 16. participation in any other interventional clinical trial 17. any other condition that the study physician considers as a barrier to the trial completion as per the protocol 18. study center staff or other employees directly involved in the trial, or their families. if a subject has any contraindications to vaccination based on the guidelines on detection, investigation and prevention, of vaccination-induced side reactions (approved by the ministry of healthcare of russia on apr. 12, 2019, the vaccination may be postponed for a period of time specified in the document.

1. any vaccination/immunization within 30 days before the enrollment; 2. steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment 3. immunosuppressors therapy finished within 3 months before the enrollment 4. pregnancy or breast-feeding 5. acute coronary syndrome or stroke suffered less than one year before the enrollment 6. tuberculosis, chronic systemic infections 7. drug allergy (anaphylactic shock, quincke's edema, polymorphic exudative eczema, atopy, serum disease), hypersensitivity or allergic reaction to immunobiological products, known allergic reactions to study drug components, acute exacerbation of allergic diseases on the enrollment day 8. neoplasms in the past medical history (icd codes c00-d09) 9. donated blood or plasma (450+ ml) within 2 months before the enrollment 10. history of splenectomy; 11. neutropenia (absolute neutrophil count \<1,000/mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin \<80 g/l), immunodeficiency in the past medical history within 6 months before the enrollment 12. active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis b or c 13. anorexia, protein deficiency of any origin 14. big-size tattoos at the injection site (deltoid muscle area), which does not allow assessing the local response to the study drug/placebo administration 15. alcohol or drug addiction in the past medical history 16. participation in any other interventional clinical trial 17. any other condition that the study physician considers as a barrier to the trial completion as per the protocol 18. study center staff or other employees directly involved in the trial, or their families. if a subject has any contraindications to vaccination based on the guidelines on detection, investigation and prevention, of vaccination-induced side reactions (approved by the ministry of healthcare of russia on apr. 12, 2019, the vaccination may be postponed for a period of time specified in the document.

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

any vaccination/immunization within 30 days before the enrollment; steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment immunosuppressors therapy finished within 3 months before the enrollment pregnancy or breast-feeding acute coronary syndrome or stroke suffered less than one year before the enrollment tuberculosis, chronic systemic infections drug allergy (anaphylactic shock, quincke's edema, polymorphic exudative eczema, atopy, serum disease), hypersensitivity or allergic reaction to immunobiological products, known allergic reactions to study drug components, acute exacerbation of allergic diseases on the enrollment day neoplasms in the past medical history (icd codes c00-d09) donated blood or plasma (450+ ml) within 2 months before the enrollment history of splenectomy; neutropenia (absolute neutrophil count <1,000/mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin <80 g/l), immunodeficiency in the past medical history within 6 months before the enrollment active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis b or c anorexia, protein deficiency of any origin big-size tattoos at the injection site (deltoid muscle area), which does not allow assessing the local response to the study drug/placebo administration alcohol or drug addiction in the past medical history participation in any other interventional clinical trial any other condition that the study physician considers as a barrier to the trial completion as per the protocol study center staff or other employees directly involved in the trial, or their families. if a subject has any contraindications to vaccination based on the guidelines on detection, investigation and prevention, of vaccination-induced side reactions (approved by the ministry of healthcare of russia on apr. 12, 2019, the vaccination may be postponed for a period of time specified in the document.

any vaccination/immunization within 30 days before the enrollment; steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment immunosuppressors therapy finished within 3 months before the enrollment pregnancy or breast-feeding acute coronary syndrome or stroke suffered less than one year before the enrollment tuberculosis, chronic systemic infections drug allergy (anaphylactic shock, quincke's edema, polymorphic exudative eczema, atopy, serum disease), hypersensitivity or allergic reaction to immunobiological products, known allergic reactions to study drug components, acute exacerbation of allergic diseases on the enrollment day neoplasms in the past medical history (icd codes c00-d09) donated blood or plasma (450+ ml) within 2 months before the enrollment history of splenectomy; neutropenia (absolute neutrophil count <1,000/mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin <80 g/l), immunodeficiency in the past medical history within 6 months before the enrollment active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis b or c anorexia, protein deficiency of any origin big-size tattoos at the injection site (deltoid muscle area), which does not allow assessing the local response to the study drug/placebo administration alcohol or drug addiction in the past medical history participation in any other interventional clinical trial any other condition that the study physician considers as a barrier to the trial completion as per the protocol study center staff or other employees directly involved in the trial, or their families. if a subject has any contraindications to vaccination based on the guidelines on detection, investigation and prevention, of vaccination-induced side reactions (approved by the ministry of healthcare of russia on apr. 12, 2019, the vaccination may be postponed for a period of time specified in the document.

Oct. 26, 2020, 11:31 p.m. usa

1. any vaccination/immunization within 30 days before the enrollment; 2. steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment 3. immunosuppressors therapy finished within 3 months before the enrollment 4. pregnancy or breast-feeding 5. acute coronary syndrome or stroke suffered less than one year before the enrollment 6. tuberculosis, chronic systemic infections 7. drug allergy (anaphylactic shock, quincke's edema, polymorphic exudative eczema, atopy, serum disease), hypersensitivity or allergic reaction to immunobiological products, known allergic reactions to study drug components, acute exacerbation of allergic diseases on the enrollment day 8. neoplasms in the past medical history (icd codes c00-d09) 9. donated blood or plasma (450+ ml) within 2 months before the enrollment 10. history of splenectomy; 11. neutropenia (absolute neutrophil count <1,000/mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin <80 g/l), immunodeficiency in the past medical history within 6 months before the enrollment 12. active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis b or c 13. anorexia, protein deficiency of any origin 14. big-size tattoos at the injection site (deltoid muscle area), which does not allow assessing the local response to the study drug/placebo administration 15. alcohol or drug addiction in the past medical history 16. participation in any other interventional clinical trial 17. any other condition that the study physician considers as a barrier to the trial completion as per the protocol 18. study center staff or other employees directly involved in the trial, or their families. if a subject has any contraindications to vaccination based on the guidelines on detection, investigation and prevention, of vaccination-induced side reactions (approved by the ministry of healthcare of russia on apr. 12, 2019, the vaccination may be postponed for a period of time specified in the document.

1. any vaccination/immunization within 30 days before the enrollment; 2. steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment 3. immunosuppressors therapy finished within 3 months before the enrollment 4. pregnancy or breast-feeding 5. acute coronary syndrome or stroke suffered less than one year before the enrollment 6. tuberculosis, chronic systemic infections 7. drug allergy (anaphylactic shock, quincke's edema, polymorphic exudative eczema, atopy, serum disease), hypersensitivity or allergic reaction to immunobiological products, known allergic reactions to study drug components, acute exacerbation of allergic diseases on the enrollment day 8. neoplasms in the past medical history (icd codes c00-d09) 9. donated blood or plasma (450+ ml) within 2 months before the enrollment 10. history of splenectomy; 11. neutropenia (absolute neutrophil count <1,000/mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin <80 g/l), immunodeficiency in the past medical history within 6 months before the enrollment 12. active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis b or c 13. anorexia, protein deficiency of any origin 14. big-size tattoos at the injection site (deltoid muscle area), which does not allow assessing the local response to the study drug/placebo administration 15. alcohol or drug addiction in the past medical history 16. participation in any other interventional clinical trial 17. any other condition that the study physician considers as a barrier to the trial completion as per the protocol 18. study center staff or other employees directly involved in the trial, or their families. if a subject has any contraindications to vaccination based on the guidelines on detection, investigation and prevention, of vaccination-induced side reactions (approved by the ministry of healthcare of russia on apr. 12, 2019, the vaccination may be postponed for a period of time specified in the document.