Approval Probability
TA Base Rate
Adjusted LOA
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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...
It is a vaccine developed to prevent Covid-19. The regimen uses two doses of a commercial scale inactivated SARS-CoV-2 vaccine given on a day 0 and day 14 schedule. It is intended for adults, including elderly adults, and was studied in healthy volunteers in China.
Sinovac Biotech, Ltd is the developer of the two-dose commercial scale inactivated SARS-CoV-2 vaccine. The company trades under the ticker SVA. The vaccine is an inactivated SARS-CoV-2 vaccine candidate studied in a Phase 3 trial conducted in China.
The two-dose commercial scale inactivated SARS-CoV-2 vaccine is in Phase 3 development. Its single registered trial, NCT04617483, is listed as completed. The study was randomized, double blind, and controlled, and enrolled 1,040 participants aged 18 years and older in China.
The vaccine was studied in trial NCT04617483, titled a study of the commercial scale SARS-CoV-2 vaccine against the pilot scale among adults, and a bridging study of immunogenicity in elderly against that in adults. The Phase 3 trial enrolled 1,040 healthy volunteers in China and is completed.
The vaccine is given as two doses on a day 0 and day 14 schedule. This two-dose regimen was evaluated in the Phase 3 trial NCT04617483, which compared the commercial scale vaccine with the pilot scale vaccine in adults and assessed immunogenicity bridging in elderly adults.