Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Two doses of commercial scale inactivated SARS-CoV-2 vaccine at the schedule of day 0, 14 · 1 trial · 1 indication
Neutralizing antibody assay will be performed using the micro-neutralization method
| Arm | Type | Description |
|---|---|---|
| Aged 26-45, Commercial Scale | EXPERIMENTAL | Commercial scale inactivated SARS-CoV-2 vaccine in adults aged 26-45 years. |
| Aged 18-59, Pilot Scale | EXPERIMENTAL | Pilot scale inactivated SARS-CoV-2 vaccine in adults aged 18-59 years. |
| Aged ≥60, Pilot Scale | EXPERIMENTAL | Pilot scale inactivated SARS-CoV-2 vaccine in elderly aged above 60 years. |
| Name | Type | Description |
|---|---|---|
| Two doses of commercial scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 | BIOLOGICAL | The antigen content of the commercial scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group 26-45. |
| Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 | BIOLOGICAL | The antigen content of the pilot scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group 18-59. |
| Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 in elderly | BIOLOGICAL | The antigen content of the pilot scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group above 60. |
Inclusion Criteria: 1. Healthy adults aged 18-59 or elderly aged ≥60 years; 2. Proven legal identity. Exclusion Criteria: 1. Travel/residence history of communities with reported cases within 14 days before trial; 2. History of exposure to Novel Coronavirus infection (nucleic acid positive) withi...