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

* any vaccination/immunization carried out within 30 days prior to enrollment in the study; * treatment with steroids (except hormonal contraceptives) and/or with immunoglobulins or other blood products not completed 30 days before inclusion in the study; * immunosuppressive therapy completed less than three months before inclusion in the study; * female subjects during pregnancy or breastfeeding; * acute coronary syndrome or stroke suffered less than one year before inclusion into the study; * tuberculosis, chronic systemic infections; * aggravated allergy anamnesis (anamnesis of anaphylactic shock, quinque edema, polymorphic exudative eczema, atopia, serum disease), hypersensitivity or allergic reactions to immunobiological drugs, known allergic reactions to the components of the drug, aggravation of allergic diseases on the day of inclusion in the study; * the presence of neoplasms in the anamnesis (codes c00-d09); * donated blood or plasma (450 ml or more) less than 2 months before inclusion in the study; * splenectomy in anamnesis; * neutropenia (decrease in absolute number of neutrophils less than 1000/mm3), agraneulocytosis, significant haemorrhage, severe anaemia (hemoglobin less than 80 g/l), immunodeficiency in anamnesis for 6 months before inclusion in the study; * subjects with an active form of disease caused by human immunodeficiency virus, syphilis, hepatitis b and c; * anorexia, protein deficiency of any origin; * chronic autoimmune diseases or systemic collagenoses in anamnesis * extensive tattoos at the injection site (deltoid region) that do not allow for an assessment of the local response to imp/placebo administration; * alcoholism and drug addiction in anamnesis; * participation of the subject in any other interventional clinical trial; * any other condition of the subject which, in the opinion of the researcher's medical practitioner, may prevent completion of the investigation according to the protocol; * staff of research centers and other staff directly involved in the study and their families.

* any vaccination/immunization carried out within 30 days prior to enrollment in the study; * treatment with steroids (except hormonal contraceptives) and/or with immunoglobulins or other blood products not completed 30 days before inclusion in the study; * immunosuppressive therapy completed less than three months before inclusion in the study; * female subjects during pregnancy or breastfeeding; * acute coronary syndrome or stroke suffered less than one year before inclusion into the study; * tuberculosis, chronic systemic infections; * aggravated allergy anamnesis (anamnesis of anaphylactic shock, quinque edema, polymorphic exudative eczema, atopia, serum disease), hypersensitivity or allergic reactions to immunobiological drugs, known allergic reactions to the components of the drug, aggravation of allergic diseases on the day of inclusion in the study; * the presence of neoplasms in the anamnesis (codes c00-d09); * donated blood or plasma (450 ml or more) less than 2 months before inclusion in the study; * splenectomy in anamnesis; * neutropenia (decrease in absolute number of neutrophils less than 1000/mm3), agraneulocytosis, significant haemorrhage, severe anaemia (hemoglobin less than 80 g/l), immunodeficiency in anamnesis for 6 months before inclusion in the study; * subjects with an active form of disease caused by human immunodeficiency virus, syphilis, hepatitis b and c; * anorexia, protein deficiency of any origin; * chronic autoimmune diseases or systemic collagenoses in anamnesis * extensive tattoos at the injection site (deltoid region) that do not allow for an assessment of the local response to imp/placebo administration; * alcoholism and drug addiction in anamnesis; * participation of the subject in any other interventional clinical trial; * any other condition of the subject which, in the opinion of the researcher's medical practitioner, may prevent completion of the investigation according to the protocol; * staff of research centers and other staff directly involved in the study and their families.

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

- any vaccination/immunization carried out within 30 days prior to enrollment in the study; - treatment with steroids (except hormonal contraceptives) and/or with immunoglobulins or other blood products not completed 30 days before inclusion in the study; - immunosuppressive therapy completed less than three months before inclusion in the study; - female subjects during pregnancy or breastfeeding; - acute coronary syndrome or stroke suffered less than one year before inclusion into the study; - tuberculosis, chronic systemic infections; - aggravated allergy anamnesis (anamnesis of anaphylactic shock, quinque edema, polymorphic exudative eczema, atopia, serum disease), hypersensitivity or allergic reactions to immunobiological drugs, known allergic reactions to the components of the drug, aggravation of allergic diseases on the day of inclusion in the study; - the presence of neoplasms in the anamnesis (codes c00-d09); - donated blood or plasma (450 ml or more) less than 2 months before inclusion in the study; - splenectomy in anamnesis; - neutropenia (decrease in absolute number of neutrophils less than 1000/mm3), agraneulocytosis, significant haemorrhage, severe anaemia (hemoglobin less than 80 g/l), immunodeficiency in anamnesis for 6 months before inclusion in the study; - subjects with an active form of disease caused by human immunodeficiency virus, syphilis, hepatitis b and c; - anorexia, protein deficiency of any origin; - chronic autoimmune diseases or systemic collagenoses in anamnesis - extensive tattoos at the injection site (deltoid region) that do not allow for an assessment of the local response to imp/placebo administration; - alcoholism and drug addiction in anamnesis; - participation of the subject in any other interventional clinical trial; - any other condition of the subject which, in the opinion of the researcher's medical practitioner, may prevent completion of the investigation according to the protocol; - staff of research centers and other staff directly involved in the study and their families.

- any vaccination/immunization carried out within 30 days prior to enrollment in the study; - treatment with steroids (except hormonal contraceptives) and/or with immunoglobulins or other blood products not completed 30 days before inclusion in the study; - immunosuppressive therapy completed less than three months before inclusion in the study; - female subjects during pregnancy or breastfeeding; - acute coronary syndrome or stroke suffered less than one year before inclusion into the study; - tuberculosis, chronic systemic infections; - aggravated allergy anamnesis (anamnesis of anaphylactic shock, quinque edema, polymorphic exudative eczema, atopia, serum disease), hypersensitivity or allergic reactions to immunobiological drugs, known allergic reactions to the components of the drug, aggravation of allergic diseases on the day of inclusion in the study; - the presence of neoplasms in the anamnesis (codes c00-d09); - donated blood or plasma (450 ml or more) less than 2 months before inclusion in the study; - splenectomy in anamnesis; - neutropenia (decrease in absolute number of neutrophils less than 1000/mm3), agraneulocytosis, significant haemorrhage, severe anaemia (hemoglobin less than 80 g/l), immunodeficiency in anamnesis for 6 months before inclusion in the study; - subjects with an active form of disease caused by human immunodeficiency virus, syphilis, hepatitis b and c; - anorexia, protein deficiency of any origin; - chronic autoimmune diseases or systemic collagenoses in anamnesis - extensive tattoos at the injection site (deltoid region) that do not allow for an assessment of the local response to imp/placebo administration; - alcoholism and drug addiction in anamnesis; - participation of the subject in any other interventional clinical trial; - any other condition of the subject which, in the opinion of the researcher's medical practitioner, may prevent completion of the investigation according to the protocol; - staff of research centers and other staff directly involved in the study and their families.