Created at Source Raw Value Validated value
Dec. 5, 2020, 12:45 a.m. oms

1. Male or female volunteers, age: 18-59 years old (including threshold). 2. Body weight: male >= 50 kg, female >= 45 kg, body mass index (BMI) in the range of 18-30 kg / m2 (including critical value). 3. From signing the informed consent form to 12 months after the last vaccine injection, the fertile female subjects or partners with fertile male subjects agreed and could take effective contraceptive measures, such as avoiding sexual life or using oral contraceptives, condoms, intrauterine devices and other reliable contraceptive measures. 4. Subjects with normal or abnormal physical examination without clinical significance. 5. Subjects with normal vital signs (body temperature, blood pressure, pulse, respiratory rate) or abnormal, but the researchers think it has no clinical significance. The results of ECG were consistent with any of the following 12 leads (1) The 12 lead ECG and clinical laboratory results were within the normal reference range, (2) The 12 lead ECG and clinical laboratory results were beyond the normal reference range, but they were < 1 level defined in the guidelines for classification of adverse events in clinical trials of preventive vaccines, (3) Other 12 lead ECG and clinical laboratory results were within or beyond the normal reference value range, but the researchers did not consider them to be clinically significant (indicators not covered in the guidelines for the classification of adverse events in clinical trials of preventive vaccines). 7. The subjects who voluntarily participate in the clinical trial can correctly understand and sign the written informed consent. 8. Be able to cooperate with the research objects, comply with the requirements of the research protocol, and complete the inspection according to the relevant procedures of the program, agree to abide by the lifestyle specified in the research program (restrictions on going abroad, business trip, travel, etc.) during the study period.

1. Male or female volunteers, age: 18-59 years old (including threshold). 2. Body weight: male >= 50 kg, female >= 45 kg, body mass index (BMI) in the range of 18-30 kg / m2 (including critical value). 3. From signing the informed consent form to 12 months after the last vaccine injection, the fertile female subjects or partners with fertile male subjects agreed and could take effective contraceptive measures, such as avoiding sexual life or using oral contraceptives, condoms, intrauterine devices and other reliable contraceptive measures. 4. Subjects with normal or abnormal physical examination without clinical significance. 5. Subjects with normal vital signs (body temperature, blood pressure, pulse, respiratory rate) or abnormal, but the researchers think it has no clinical significance. The results of ECG were consistent with any of the following 12 leads (1) The 12 lead ECG and clinical laboratory results were within the normal reference range, (2) The 12 lead ECG and clinical laboratory results were beyond the normal reference range, but they were < 1 level defined in the guidelines for classification of adverse events in clinical trials of preventive vaccines, (3) Other 12 lead ECG and clinical laboratory results were within or beyond the normal reference value range, but the researchers did not consider them to be clinically significant (indicators not covered in the guidelines for the classification of adverse events in clinical trials of preventive vaccines). 7. The subjects who voluntarily participate in the clinical trial can correctly understand and sign the written informed consent. 8. Be able to cooperate with the research objects, comply with the requirements of the research protocol, and complete the inspection according to the relevant procedures of the program, agree to abide by the lifestyle specified in the research program (restrictions on going abroad, business trip, travel, etc.) during the study period.