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

1. positive history of allergy, drug intolerance, including increased sensibility to any of components of the test drug product, as well as the history of serious adverse events in the administration of vaccines (such as allergic reactions, respiratory disturbance, angioedema, stomach pain). 2. axillary body temperature ≥37.1 °c at the time of screening/randomization. 3. systolic blood pressure more than 139 mm hg or less than 100 mm hg and/or diastolic blood pressure more than 90 mm hg or less than 60 mm hg. 4. clinical significant abnormal laboratory and/or instrumental parameters at screening examination. 5. acute infectious diseases less than 4 weeks ahead of conduction of screening procedures. 6. acute and acute course of chronic diseases of git, liver, kidneys, cardiovascular, respiratory, nervous and endocrine systems. 7. history of blood and hematopoietic organ diseases. 8. history of diabetes mellitus. 9. history of epilepsy, epileptic syndrome, seizures. 10. history of congenital and acquired immunodeficiency, hiv-infection, lymphoma, leukaemia, systemic lupus erythematosus, juvenile rheumatoid arthritis or other autoimmune diseases. 11. history malignancies. 12. using immunotropic preparations (immunomodulators, immunostimulators, immunodepressants), antiallergic, cytotoxic preparations for more than 10 sequential days within the last 3 months (except for inhalant and local using glucocorticoids \[gcs\] or using specified preparations less than 4 weeks ahead of the screening. 13. using immunoglobulin preparations or blood transfusion less than 3 months ahead of the screening. 14. using antipyretics (including non-steroidal anti-inflammatory agents and anilides) within 24 hours ahead of randomization. 15. blood donation or loss (≥450 ml of blood or plasma) less than 3 months ahead of the screening. 16. vaccination within 6 mon. ahead of screening or reluctance to refuse from the administration of any other vaccine during the study. 17. anamnestic data/data on alcoholism, narcomania, drug abuse, mental illnesses. 18. major surgery planned within the nearest 6 months or underwent within the last 6 months ahead of the screening. 19. carrying out of body piercing procedures, an appendix of tattoo less than 1 month ahead of conduction of screening procedures and through all the study. 20. pregnancy or breast-feeding period. 21. participation in another clinical study within 3 months ahead of the screening. 22. psychic, physical and other reasons, not allowing a volunteer to adhere to conditions and procedures of study protocol. 23. volunteers, who are clinical site staff. 24. other reasons, not allowing the volunteer to take part in this study in view of the study physician.

1. positive history of allergy, drug intolerance, including increased sensibility to any of components of the test drug product, as well as the history of serious adverse events in the administration of vaccines (such as allergic reactions, respiratory disturbance, angioedema, stomach pain). 2. axillary body temperature ≥37.1 °c at the time of screening/randomization. 3. systolic blood pressure more than 139 mm hg or less than 100 mm hg and/or diastolic blood pressure more than 90 mm hg or less than 60 mm hg. 4. clinical significant abnormal laboratory and/or instrumental parameters at screening examination. 5. acute infectious diseases less than 4 weeks ahead of conduction of screening procedures. 6. acute and acute course of chronic diseases of git, liver, kidneys, cardiovascular, respiratory, nervous and endocrine systems. 7. history of blood and hematopoietic organ diseases. 8. history of diabetes mellitus. 9. history of epilepsy, epileptic syndrome, seizures. 10. history of congenital and acquired immunodeficiency, hiv-infection, lymphoma, leukaemia, systemic lupus erythematosus, juvenile rheumatoid arthritis or other autoimmune diseases. 11. history malignancies. 12. using immunotropic preparations (immunomodulators, immunostimulators, immunodepressants), antiallergic, cytotoxic preparations for more than 10 sequential days within the last 3 months (except for inhalant and local using glucocorticoids \[gcs\] or using specified preparations less than 4 weeks ahead of the screening. 13. using immunoglobulin preparations or blood transfusion less than 3 months ahead of the screening. 14. using antipyretics (including non-steroidal anti-inflammatory agents and anilides) within 24 hours ahead of randomization. 15. blood donation or loss (≥450 ml of blood or plasma) less than 3 months ahead of the screening. 16. vaccination within 6 mon. ahead of screening or reluctance to refuse from the administration of any other vaccine during the study. 17. anamnestic data/data on alcoholism, narcomania, drug abuse, mental illnesses. 18. major surgery planned within the nearest 6 months or underwent within the last 6 months ahead of the screening. 19. carrying out of body piercing procedures, an appendix of tattoo less than 1 month ahead of conduction of screening procedures and through all the study. 20. pregnancy or breast-feeding period. 21. participation in another clinical study within 3 months ahead of the screening. 22. psychic, physical and other reasons, not allowing a volunteer to adhere to conditions and procedures of study protocol. 23. volunteers, who are clinical site staff. 24. other reasons, not allowing the volunteer to take part in this study in view of the study physician.

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

positive history of allergy, drug intolerance, including increased sensibility to any of components of the test drug product, as well as the history of serious adverse events in the administration of vaccines (such as allergic reactions, respiratory disturbance, angioedema, stomach pain). axillary body temperature ≥37.1 °c at the time of screening/randomization. systolic blood pressure more than 139 mm hg or less than 100 mm hg and/or diastolic blood pressure more than 90 mm hg or less than 60 mm hg. clinical significant abnormal laboratory and/or instrumental parameters at screening examination. acute infectious diseases less than 4 weeks ahead of conduction of screening procedures. acute and acute course of chronic diseases of git, liver, kidneys, cardiovascular, respiratory, nervous and endocrine systems. history of blood and hematopoietic organ diseases. history of diabetes mellitus. history of epilepsy, epileptic syndrome, seizures. history of congenital and acquired immunodeficiency, hiv-infection, lymphoma, leukaemia, systemic lupus erythematosus, juvenile rheumatoid arthritis or other autoimmune diseases. history malignancies. using immunotropic preparations (immunomodulators, immunostimulators, immunodepressants), antiallergic, cytotoxic preparations for more than 10 sequential days within the last 3 months (except for inhalant and local using glucocorticoids [gcs] or using specified preparations less than 4 weeks ahead of the screening. using immunoglobulin preparations or blood transfusion less than 3 months ahead of the screening. using antipyretics (including non-steroidal anti-inflammatory agents and anilides) within 24 hours ahead of randomization. blood donation or loss (≥450 ml of blood or plasma) less than 3 months ahead of the screening. vaccination within 6 mon. ahead of screening or reluctance to refuse from the administration of any other vaccine during the study. anamnestic data/data on alcoholism, narcomania, drug abuse, mental illnesses. major surgery planned within the nearest 6 months or underwent within the last 6 months ahead of the screening. carrying out of body piercing procedures, an appendix of tattoo less than 1 month ahead of conduction of screening procedures and through all the study. pregnancy or breast-feeding period. participation in another clinical study within 3 months ahead of the screening. psychic, physical and other reasons, not allowing a volunteer to adhere to conditions and procedures of study protocol. volunteers, who are clinical site staff. other reasons, not allowing the volunteer to take part in this study in view of the study physician.

positive history of allergy, drug intolerance, including increased sensibility to any of components of the test drug product, as well as the history of serious adverse events in the administration of vaccines (such as allergic reactions, respiratory disturbance, angioedema, stomach pain). axillary body temperature ≥37.1 °c at the time of screening/randomization. systolic blood pressure more than 139 mm hg or less than 100 mm hg and/or diastolic blood pressure more than 90 mm hg or less than 60 mm hg. clinical significant abnormal laboratory and/or instrumental parameters at screening examination. acute infectious diseases less than 4 weeks ahead of conduction of screening procedures. acute and acute course of chronic diseases of git, liver, kidneys, cardiovascular, respiratory, nervous and endocrine systems. history of blood and hematopoietic organ diseases. history of diabetes mellitus. history of epilepsy, epileptic syndrome, seizures. history of congenital and acquired immunodeficiency, hiv-infection, lymphoma, leukaemia, systemic lupus erythematosus, juvenile rheumatoid arthritis or other autoimmune diseases. history malignancies. using immunotropic preparations (immunomodulators, immunostimulators, immunodepressants), antiallergic, cytotoxic preparations for more than 10 sequential days within the last 3 months (except for inhalant and local using glucocorticoids [gcs] or using specified preparations less than 4 weeks ahead of the screening. using immunoglobulin preparations or blood transfusion less than 3 months ahead of the screening. using antipyretics (including non-steroidal anti-inflammatory agents and anilides) within 24 hours ahead of randomization. blood donation or loss (≥450 ml of blood or plasma) less than 3 months ahead of the screening. vaccination within 6 mon. ahead of screening or reluctance to refuse from the administration of any other vaccine during the study. anamnestic data/data on alcoholism, narcomania, drug abuse, mental illnesses. major surgery planned within the nearest 6 months or underwent within the last 6 months ahead of the screening. carrying out of body piercing procedures, an appendix of tattoo less than 1 month ahead of conduction of screening procedures and through all the study. pregnancy or breast-feeding period. participation in another clinical study within 3 months ahead of the screening. psychic, physical and other reasons, not allowing a volunteer to adhere to conditions and procedures of study protocol. volunteers, who are clinical site staff. other reasons, not allowing the volunteer to take part in this study in view of the study physician.

Aug. 17, 2021, 6 p.m. usa

1. positive history of allergy, drug intolerance, including increased sensibility to any of components of the test drug product, as well as the history of serious adverse events in the administration of vaccines (such as allergic reactions, respiratory disturbance, angioedema, stomach pain). 2. axillary body temperature ≥37.1 °c at the time of screening/randomization. 3. systolic blood pressure more than 139 mm hg or less than 100 mm hg and/or diastolic blood pressure more than 90 mm hg or less than 60 mm hg. 4. clinical significant abnormal laboratory and/or instrumental parameters at screening examination. 5. acute infectious diseases less than 4 weeks ahead of conduction of screening procedures. 6. acute and acute course of chronic diseases of git, liver, kidneys, cardiovascular, respiratory, nervous and endocrine systems. 7. history of blood and hematopoietic organ diseases. 8. history of diabetes mellitus. 9. history of epilepsy, epileptic syndrome, seizures. 10. history of congenital and acquired immunodeficiency, hiv-infection, lymphoma, leukaemia, systemic lupus erythematosus, juvenile rheumatoid arthritis or other autoimmune diseases. 11. history malignancies. 12. using immunotropic preparations (immunomodulators, immunostimulators, immunodepressants), antiallergic, cytotoxic preparations for more than 10 sequential days within the last 3 months (except for inhalant and local using glucocorticoids [gcs] or using specified preparations less than 4 weeks ahead of the screening. 13. using immunoglobulin preparations or blood transfusion less than 3 months ahead of the screening. 14. using antipyretics (including non-steroidal anti-inflammatory agents and anilides) within 24 hours ahead of randomization. 15. blood donation or loss (≥450 ml of blood or plasma) less than 3 months ahead of the screening. 16. vaccination within 6 mon. ahead of screening or reluctance to refuse from the administration of any other vaccine during the study. 17. anamnestic data/data on alcoholism, narcomania, drug abuse, mental illnesses. 18. major surgery planned within the nearest 6 months or underwent within the last 6 months ahead of the screening. 19. carrying out of body piercing procedures, an appendix of tattoo less than 1 month ahead of conduction of screening procedures and through all the study. 20. pregnancy or breast-feeding period. 21. participation in another clinical study within 3 months ahead of the screening. 22. psychic, physical and other reasons, not allowing a volunteer to adhere to conditions and procedures of study protocol. 23. volunteers, who are clinical site staff. 24. other reasons, not allowing the volunteer to take part in this study in view of the study physician.

1. positive history of allergy, drug intolerance, including increased sensibility to any of components of the test drug product, as well as the history of serious adverse events in the administration of vaccines (such as allergic reactions, respiratory disturbance, angioedema, stomach pain). 2. axillary body temperature ≥37.1 °c at the time of screening/randomization. 3. systolic blood pressure more than 139 mm hg or less than 100 mm hg and/or diastolic blood pressure more than 90 mm hg or less than 60 mm hg. 4. clinical significant abnormal laboratory and/or instrumental parameters at screening examination. 5. acute infectious diseases less than 4 weeks ahead of conduction of screening procedures. 6. acute and acute course of chronic diseases of git, liver, kidneys, cardiovascular, respiratory, nervous and endocrine systems. 7. history of blood and hematopoietic organ diseases. 8. history of diabetes mellitus. 9. history of epilepsy, epileptic syndrome, seizures. 10. history of congenital and acquired immunodeficiency, hiv-infection, lymphoma, leukaemia, systemic lupus erythematosus, juvenile rheumatoid arthritis or other autoimmune diseases. 11. history malignancies. 12. using immunotropic preparations (immunomodulators, immunostimulators, immunodepressants), antiallergic, cytotoxic preparations for more than 10 sequential days within the last 3 months (except for inhalant and local using glucocorticoids [gcs] or using specified preparations less than 4 weeks ahead of the screening. 13. using immunoglobulin preparations or blood transfusion less than 3 months ahead of the screening. 14. using antipyretics (including non-steroidal anti-inflammatory agents and anilides) within 24 hours ahead of randomization. 15. blood donation or loss (≥450 ml of blood or plasma) less than 3 months ahead of the screening. 16. vaccination within 6 mon. ahead of screening or reluctance to refuse from the administration of any other vaccine during the study. 17. anamnestic data/data on alcoholism, narcomania, drug abuse, mental illnesses. 18. major surgery planned within the nearest 6 months or underwent within the last 6 months ahead of the screening. 19. carrying out of body piercing procedures, an appendix of tattoo less than 1 month ahead of conduction of screening procedures and through all the study. 20. pregnancy or breast-feeding period. 21. participation in another clinical study within 3 months ahead of the screening. 22. psychic, physical and other reasons, not allowing a volunteer to adhere to conditions and procedures of study protocol. 23. volunteers, who are clinical site staff. 24. other reasons, not allowing the volunteer to take part in this study in view of the study physician.

July 21, 2021, 4 p.m. usa

positive history of allergy, drug intolerance, including increased sensibility to any of components of the test drug product, as well as the history of serious adverse events in the administration of vaccines (such as allergic reactions, respiratory disturbance, angioedema, stomach pain). axillary body temperature ≥37.1 °c at the time of screening/randomization. systolic blood pressure more than 139 mm hg or less than 100 mm hg and/or diastolic blood pressure more than 90 mm hg or less than 60 mm hg. clinical significant abnormal laboratory and/or instrumental parameters at screening examination. acute infectious diseases less than 4 weeks ahead of conduction of screening procedures. acute and acute course of chronic diseases of git, liver, kidneys, cardiovascular, respiratory, nervous and endocrine systems. history of blood and hematopoietic organ diseases. history of diabetes mellitus. history of epilepsy, epileptic syndrome, seizures. history of congenital and acquired immunodeficiency, hiv-infection, lymphoma, leukaemia, systemic lupus erythematosus, juvenile rheumatoid arthritis or other autoimmune diseases. history malignancies. using immunotropic preparations (immunomodulators, immunostimulators, immunodepressants), antiallergic, cytotoxic preparations for more than 10 sequential days within the last 3 months (except for inhalant and local using glucocorticoids [gcs] or using specified preparations less than 4 weeks ahead of the screening. using immunoglobulin preparations or blood transfusion less than 3 months ahead of the screening. using antipyretics (including non-steroidal anti-inflammatory agents and anilides) within 24 hours ahead of randomization. blood donation or loss (≥450 ml of blood or plasma) less than 3 months ahead of the screening. vaccination within 6 mon. ahead of screening or reluctance to refuse from the administration of any other vaccine during the study. anamnestic data/data on alcoholism, narcomania, drug abuse, mental illnesses. major surgery planned within the nearest 6 months or underwent within the last 6 months ahead of the screening. carrying out of body piercing procedures, an appendix of tattoo less than 1 month ahead of conduction of screening procedures and through all the study. pregnancy or breast-feeding period. participation in another clinical study within 3 months ahead of the screening. psychic, physical and other reasons, not allowing a volunteer to adhere to conditions and procedures of study protocol. volunteers, who are clinical site staff. other reasons, not allowing the volunteer to take part in this study in view of the study physician.

positive history of allergy, drug intolerance, including increased sensibility to any of components of the test drug product, as well as the history of serious adverse events in the administration of vaccines (such as allergic reactions, respiratory disturbance, angioedema, stomach pain). axillary body temperature ≥37.1 °c at the time of screening/randomization. systolic blood pressure more than 139 mm hg or less than 100 mm hg and/or diastolic blood pressure more than 90 mm hg or less than 60 mm hg. clinical significant abnormal laboratory and/or instrumental parameters at screening examination. acute infectious diseases less than 4 weeks ahead of conduction of screening procedures. acute and acute course of chronic diseases of git, liver, kidneys, cardiovascular, respiratory, nervous and endocrine systems. history of blood and hematopoietic organ diseases. history of diabetes mellitus. history of epilepsy, epileptic syndrome, seizures. history of congenital and acquired immunodeficiency, hiv-infection, lymphoma, leukaemia, systemic lupus erythematosus, juvenile rheumatoid arthritis or other autoimmune diseases. history malignancies. using immunotropic preparations (immunomodulators, immunostimulators, immunodepressants), antiallergic, cytotoxic preparations for more than 10 sequential days within the last 3 months (except for inhalant and local using glucocorticoids [gcs] or using specified preparations less than 4 weeks ahead of the screening. using immunoglobulin preparations or blood transfusion less than 3 months ahead of the screening. using antipyretics (including non-steroidal anti-inflammatory agents and anilides) within 24 hours ahead of randomization. blood donation or loss (≥450 ml of blood or plasma) less than 3 months ahead of the screening. vaccination within 6 mon. ahead of screening or reluctance to refuse from the administration of any other vaccine during the study. anamnestic data/data on alcoholism, narcomania, drug abuse, mental illnesses. major surgery planned within the nearest 6 months or underwent within the last 6 months ahead of the screening. carrying out of body piercing procedures, an appendix of tattoo less than 1 month ahead of conduction of screening procedures and through all the study. pregnancy or breast-feeding period. participation in another clinical study within 3 months ahead of the screening. psychic, physical and other reasons, not allowing a volunteer to adhere to conditions and procedures of study protocol. volunteers, who are clinical site staff. other reasons, not allowing the volunteer to take part in this study in view of the study physician.

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

1. positive history of allergy, drug intolerance, including increased sensibility to any of components of the test drug product, as well as the history of serious adverse events in the administration of vaccines (such as allergic reactions, respiratory disturbance, angioedema, stomach pain). 2. axillary body temperature ≥37.1 °c at the time of screening/randomization. 3. systolic blood pressure more than 139 mm hg or less than 100 mm hg and/or diastolic blood pressure more than 90 mm hg or less than 60 mm hg. 4. clinical significant abnormal laboratory and/or instrumental parameters at screening examination. 5. acute infectious diseases less than 4 weeks ahead of conduction of screening procedures. 6. acute and acute course of chronic diseases of git, liver, kidneys, cardiovascular, respiratory, nervous and endocrine systems. 7. history of blood and hematopoietic organ diseases. 8. history of diabetes mellitus. 9. history of epilepsy, epileptic syndrome, seizures. 10. history of congenital and acquired immunodeficiency, hiv-infection, lymphoma, leukaemia, systemic lupus erythematosus, juvenile rheumatoid arthritis or other autoimmune diseases. 11. history malignancies. 12. using immunotropic preparations (immunomodulators, immunostimulators, immunodepressants), antiallergic, cytotoxic preparations for more than 10 sequential days within the last 3 months (except for inhalant and local using glucocorticoids [gcs] or using specified preparations less than 4 weeks ahead of the screening. 13. using immunoglobulin preparations or blood transfusion less than 3 months ahead of the screening. 14. using antipyretics (including non-steroidal anti-inflammatory agents and anilides) within 24 hours ahead of randomization. 15. blood donation or loss (≥450 ml of blood or plasma) less than 3 months ahead of the screening. 16. vaccination within 6 mon. ahead of screening or reluctance to refuse from the administration of any other vaccine during the study. 17. anamnestic data/data on alcoholism, narcomania, drug abuse, mental illnesses. 18. major surgery planned within the nearest 6 months or underwent within the last 6 months ahead of the screening. 19. carrying out of body piercing procedures, an appendix of tattoo less than 1 month ahead of conduction of screening procedures and through all the study. 20. pregnancy or breast-feeding period. 21. participation in another clinical study within 3 months ahead of the screening. 22. psychic, physical and other reasons, not allowing a volunteer to adhere to conditions and procedures of study protocol. 23. volunteers, who are clinical site staff. 24. other reasons, not allowing the volunteer to take part in this study in view of the study physician.

1. positive history of allergy, drug intolerance, including increased sensibility to any of components of the test drug product, as well as the history of serious adverse events in the administration of vaccines (such as allergic reactions, respiratory disturbance, angioedema, stomach pain). 2. axillary body temperature ≥37.1 °c at the time of screening/randomization. 3. systolic blood pressure more than 139 mm hg or less than 100 mm hg and/or diastolic blood pressure more than 90 mm hg or less than 60 mm hg. 4. clinical significant abnormal laboratory and/or instrumental parameters at screening examination. 5. acute infectious diseases less than 4 weeks ahead of conduction of screening procedures. 6. acute and acute course of chronic diseases of git, liver, kidneys, cardiovascular, respiratory, nervous and endocrine systems. 7. history of blood and hematopoietic organ diseases. 8. history of diabetes mellitus. 9. history of epilepsy, epileptic syndrome, seizures. 10. history of congenital and acquired immunodeficiency, hiv-infection, lymphoma, leukaemia, systemic lupus erythematosus, juvenile rheumatoid arthritis or other autoimmune diseases. 11. history malignancies. 12. using immunotropic preparations (immunomodulators, immunostimulators, immunodepressants), antiallergic, cytotoxic preparations for more than 10 sequential days within the last 3 months (except for inhalant and local using glucocorticoids [gcs] or using specified preparations less than 4 weeks ahead of the screening. 13. using immunoglobulin preparations or blood transfusion less than 3 months ahead of the screening. 14. using antipyretics (including non-steroidal anti-inflammatory agents and anilides) within 24 hours ahead of randomization. 15. blood donation or loss (≥450 ml of blood or plasma) less than 3 months ahead of the screening. 16. vaccination within 6 mon. ahead of screening or reluctance to refuse from the administration of any other vaccine during the study. 17. anamnestic data/data on alcoholism, narcomania, drug abuse, mental illnesses. 18. major surgery planned within the nearest 6 months or underwent within the last 6 months ahead of the screening. 19. carrying out of body piercing procedures, an appendix of tattoo less than 1 month ahead of conduction of screening procedures and through all the study. 20. pregnancy or breast-feeding period. 21. participation in another clinical study within 3 months ahead of the screening. 22. psychic, physical and other reasons, not allowing a volunteer to adhere to conditions and procedures of study protocol. 23. volunteers, who are clinical site staff. 24. other reasons, not allowing the volunteer to take part in this study in view of the study physician.