Created at Source Raw Value Validated value
Jan. 15, 2021, 12:45 a.m. oms

1. Fever is suspected or diagnosed within 72 hours before enrollment (axillary temperature >=37.3 degree C/oral temperature >=37.5 degree C), or underarm body temperature >=37.3 degree C/oral temperature >=37.5 degree C on the day of enrollment, 2. Diastolic blood pressure >=100mmHg and/or systolic blood pressure .=150mmHg, 3. Those with a history of COVID-19, 4. One of the SARS-COV-2 nucleic acid and antibody tests is positive (In Indonesia, one of the SARS-COV-2 antigen and antibody tests), 5. People who currently suffer from the following diseases: (1) Having thrombocytopenia, any coagulation dysfunction or receiving anticoagulant treatment, etc., (2) History of congenital or acquired immunodeficiency or autoimmune disease, as well as no spleen, or history of splenic surgery, history of trauma or within 6 months Receive immunomodulator therapy, such as: immunosuppressant dose of glucocorticoid (dose reference: equivalent to prednisone 20mg/day, more than one week), or monoclonal antibody, or thymosin, or interferon, etc., but local medication is allowed ( Such as ointment, eye drops, inhalation or nasal spray), (3) related symptoms of acute respiratory infection (such as: sneezing, nasal congestion, runny nose, cough, sore throat, decreased taste, chills, shortness of breath, etc.), (4) cancer patients (Except for basal cell carcinoma), Past history of severe allergies to any vaccine, or history of severe allergies to any component of the test vaccine, including aluminum preparations, 6) For example: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis Reaction (Arthus reaction), dyspnea, angioedema, etc., 7. Inoculate subunit vaccine and inactivated vaccine within 14 days before the first dose of vaccine, and inoculate live attenuated vaccine within 30 days, 8. Have received blood or blood-related products, including immunoglobulins, within 3 months, or plan to use them from the beginning of the study to 6 months after the full vaccination, 9. Have participated in or are participating in other COVID-19 related clinical trials, 10. Lactating or pregnant women (including those who have a positive urine pregnancy test for women of childbearing age), 11. The investigator believes that any disease or condition in the subject may put the subject at an unacceptable risk, the subject cannot meet the requirements of the protocol, the situation that interferes with the assessment of the vaccine response.

1. Fever is suspected or diagnosed within 72 hours before enrollment (axillary temperature >=37.3 degree C/oral temperature >=37.5 degree C), or underarm body temperature >=37.3 degree C/oral temperature >=37.5 degree C on the day of enrollment, 2. Diastolic blood pressure >=100mmHg and/or systolic blood pressure .=150mmHg, 3. Those with a history of COVID-19, 4. One of the SARS-COV-2 nucleic acid and antibody tests is positive (In Indonesia, one of the SARS-COV-2 antigen and antibody tests), 5. People who currently suffer from the following diseases: (1) Having thrombocytopenia, any coagulation dysfunction or receiving anticoagulant treatment, etc., (2) History of congenital or acquired immunodeficiency or autoimmune disease, as well as no spleen, or history of splenic surgery, history of trauma or within 6 months Receive immunomodulator therapy, such as: immunosuppressant dose of glucocorticoid (dose reference: equivalent to prednisone 20mg/day, more than one week), or monoclonal antibody, or thymosin, or interferon, etc., but local medication is allowed ( Such as ointment, eye drops, inhalation or nasal spray), (3) related symptoms of acute respiratory infection (such as: sneezing, nasal congestion, runny nose, cough, sore throat, decreased taste, chills, shortness of breath, etc.), (4) cancer patients (Except for basal cell carcinoma), Past history of severe allergies to any vaccine, or history of severe allergies to any component of the test vaccine, including aluminum preparations, 6) For example: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis Reaction (Arthus reaction), dyspnea, angioedema, etc., 7. Inoculate subunit vaccine and inactivated vaccine within 14 days before the first dose of vaccine, and inoculate live attenuated vaccine within 30 days, 8. Have received blood or blood-related products, including immunoglobulins, within 3 months, or plan to use them from the beginning of the study to 6 months after the full vaccination, 9. Have participated in or are participating in other COVID-19 related clinical trials, 10. Lactating or pregnant women (including those who have a positive urine pregnancy test for women of childbearing age), 11. The investigator believes that any disease or condition in the subject may put the subject at an unacceptable risk, the subject cannot meet the requirements of the protocol, the situation that interferes with the assessment of the vaccine response.