Created at Source Raw Value Validated value
Jan. 21, 2022, 2 a.m. oms

1. Aged <18 years of age 2. Any vaccination/immunization within 30 days before enrollment 3. Any treatment with steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products within 30 days before enrollment 4. Any treatment with immunosuppressive therapy within 3 months before enrollment 5. Any 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 enrollment day 6. Any neoplasms in the past medical history 7. Donated blood or plasma within 3 months before enrollment 8. Any history or evidence of splenectomy 9. Any immunodeficiency state 10. Any history or evidence of anorexia or protein deficiency of any origin 11. Alcohol or drug addiction in the past medical history 12. Participation in any other interventional clinical trial within 3 months 13. Any other condition that the study physician considers as a barrier to the trial completion as per the protocol 14. Pregnancy or breastfeeding 15. Subjects who test positive for Coronavirus disease through RT-PCR SARS CoV-2 Test and positive anti-COVID antibodies

1. Aged <18 years of age 2. Any vaccination/immunization within 30 days before enrollment 3. Any treatment with steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products within 30 days before enrollment 4. Any treatment with immunosuppressive therapy within 3 months before enrollment 5. Any 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 enrollment day 6. Any neoplasms in the past medical history 7. Donated blood or plasma within 3 months before enrollment 8. Any history or evidence of splenectomy 9. Any immunodeficiency state 10. Any history or evidence of anorexia or protein deficiency of any origin 11. Alcohol or drug addiction in the past medical history 12. Participation in any other interventional clinical trial within 3 months 13. Any other condition that the study physician considers as a barrier to the trial completion as per the protocol 14. Pregnancy or breastfeeding 15. Subjects who test positive for Coronavirus disease through RT-PCR SARS CoV-2 Test and positive anti-COVID antibodies