Created at Source Raw Value Validated value
Aug. 3, 2021, 3:30 p.m. irct

Subjects with active infection with SARS-COV-2 signs at the screening visit Subjects with body temperature equal or more than 38 degrees centigrade, during 72 hours before screening visit or during the visit Subjects with any progressive or severe neurological disorder, including dementia, stroke, seizures, or a history of Guillain-Barre syndrome High-risk subjects who are prioritized for the national vaccination program, those are treated with immunosuppressive drugs or cytotoxic drugs, or systemic corticosteroids at doses ≥ 10 mg daily of prednisolone or equivalent doses of other corticosteroids more than 14 days Pregnant women, or breastfeeding mothers, or women who plan to become pregnant during the study Subjects who have a history of severe allergic reactions (e.g. anaphylaxis) to the study vaccine or any components of the vaccine or any other drugs Subjects who have received any other investigational product within 30 days prior to the screening visit or intend to participate in other clinical studies during this trial Subjects who have been vaccinated with other vaccines against the SARS-CoV-2 virus Subjects who received other authorized vaccines within 28 days prior to the screening visit in this study or intend to receive any vaccines up to 14 days after the second vaccination Subjects who have any known bleeding disorder or may have problems with the intramuscular injection according to the researcher's opinion Subjects who have received or intend to receive any blood / plasma or immunoglobulin products 90 days prior to the screening visit Subjects with special circumstances who, may increase the risk of participating in the study or interfering with the evaluation of the primary endpoints of the study according to researcher's opinion Subjects who have donated ≥450 ml of blood or blood products 28 days prior to the screening visit Subjects who are given the priority of vaccination within 2 months after participating in the study, according to the national immunization program Subjects with ESRD Subjects with dawn syndrome Subjects with BMI ≥ 40 Subjects with cystic fibrosis, COPD, PAH Subjects with uncontrolled asthma Subjects with uncontrolled hypertension Subjects with uncontrolled diabetes Mellitus

Subjects with active infection with SARS-COV-2 signs at the screening visit Subjects with body temperature equal or more than 38 degrees centigrade, during 72 hours before screening visit or during the visit Subjects with any progressive or severe neurological disorder, including dementia, stroke, seizures, or a history of Guillain-Barre syndrome High-risk subjects who are prioritized for the national vaccination program, those are treated with immunosuppressive drugs or cytotoxic drugs, or systemic corticosteroids at doses ≥ 10 mg daily of prednisolone or equivalent doses of other corticosteroids more than 14 days Pregnant women, or breastfeeding mothers, or women who plan to become pregnant during the study Subjects who have a history of severe allergic reactions (e.g. anaphylaxis) to the study vaccine or any components of the vaccine or any other drugs Subjects who have received any other investigational product within 30 days prior to the screening visit or intend to participate in other clinical studies during this trial Subjects who have been vaccinated with other vaccines against the SARS-CoV-2 virus Subjects who received other authorized vaccines within 28 days prior to the screening visit in this study or intend to receive any vaccines up to 14 days after the second vaccination Subjects who have any known bleeding disorder or may have problems with the intramuscular injection according to the researcher's opinion Subjects who have received or intend to receive any blood / plasma or immunoglobulin products 90 days prior to the screening visit Subjects with special circumstances who, may increase the risk of participating in the study or interfering with the evaluation of the primary endpoints of the study according to researcher's opinion Subjects who have donated ≥450 ml of blood or blood products 28 days prior to the screening visit Subjects who are given the priority of vaccination within 2 months after participating in the study, according to the national immunization program Subjects with ESRD Subjects with dawn syndrome Subjects with BMI ≥ 40 Subjects with cystic fibrosis, COPD, PAH Subjects with uncontrolled asthma Subjects with uncontrolled hypertension Subjects with uncontrolled diabetes Mellitus