Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule · 1 trial · 1 indication
Incidence of adverse reactions occured from Day 0 to Day 28 after each dose
The seroconversion rate of neutralizing antibodies 14 days (emergency schedule)/28 days (routine schedule) after the two-dose vaccination.
| Arm | Type | Description |
|---|---|---|
| Emergency schedule & Two doses of medium dosage vaccine | EXPERIMENTAL | 24 participants in phase Ⅰand 60 participants in phase Ⅱ will receive two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule,and 60 participants in phase Ⅱ will receive one dose of booster immunization with medium dosage vaccine 6 months after the emergency schedule |
| Emergency schedule & Two doses of high dosage vaccine | EXPERIMENTAL | 24 participants in phase Ⅰand 60 participants in phase Ⅱ will receive two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule,and 60 participants in phase Ⅱ will receive one dose of booster immunization with high dosage vaccine 6 months after the emergency schedule |
| Emergency schedule &Two doses of placebo | PLACEBO_COMPARATOR | 24 participants in phase Ⅰand 30 participants in phase Ⅱ will receive two doses of placebo at the emergency vaccination schedule,and 30 participants in phase Ⅱ will receive one dose of booster immunization with placebo 6 months after the emergency schedule |
| Routine schedule & Two doses of medium dosage vaccine | EXPERIMENTAL | 24 participants in phase Ⅰand 60 participants in phase Ⅱ will receive two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule,and 60 participants in phase Ⅱ will receive one dose of booster immunization with medium dosage vaccine 6 months after the routine schedule |
| Routine schedule &Two doses of high dosage vaccine | EXPERIMENTAL | 24 participants in phase Ⅰand 60 participants in phase Ⅱ will receive two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule,and 60 participants in phase Ⅱ will receive one dose of booster immunization with high dosage vaccine 6 months after the routine schedule |
| Routine schedule & Two doses of placebo | PLACEBO_COMPARATOR | 24 participants in phase Ⅰand 30 participants in phase Ⅱ will receive two doses of placebo at the routine vaccination schedule,and 30 participants in phase Ⅱ will receive one dose of booster immunization with placebo 6 months after the routine schedule |
| Emergency schedule & Three doses of medium dosage vaccine | EXPERIMENTAL | 60 participants in phase Ⅱ will receive three doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule |
| Emergency schedule & Three doses of high dosage vaccine | EXPERIMENTAL | 60 participants in phase Ⅱ will receive three doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule |
| Emergency schedule &Three doses of placebo | PLACEBO_COMPARATOR | 30 participants in phase Ⅱ will receive three doses of placebo at the emergency vaccination schedule |
| Routine schedule & Three doses of medium dosage vaccine | EXPERIMENTAL | 60 participants in phase Ⅱ will receive three doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule |
| Routine schedule &Three doses of high dosage vaccine | EXPERIMENTAL | 60 participants in phase Ⅱ will receive three doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule |
| Routine schedule &Three doses of placebo | PLACEBO_COMPARATOR | 30 participants in phase Ⅱ will receive three doses of placebo at the routine vaccination schedule |
| Name | Type | Description |
|---|---|---|
| Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule | BIOLOGICAL | Two doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,14,and one dose of booster immunization with medium dosage (600SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,14 in phaseⅡ. |
| Two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule | BIOLOGICAL | Two doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,14 and one dose of booster immunization with high dosage (1200SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,14 in phaseⅡ. |
| Two doses of placebo at the emergency vaccination schedule | BIOLOGICAL | Two doses of placebo at the schedule of day 0,14 and one dose of booster immunization with placebo 6 months after the schedule of day 0,14 in phaseⅡ. |
| Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule | BIOLOGICAL | Two doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,28 and one dose of booster immunization with medium dosage (600SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,28 in phaseⅡ. |
| Two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule | BIOLOGICAL | Two doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,28 and one dose of booster immunization with high dosage (1200SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,28 in phaseⅡ |
| Two doses of placebo at the routine vaccination schedule | BIOLOGICAL | Two doses of placebo at the schedule of day 0,28 and one dose of booster immunization with placebo 6 months after the schedule of day 0,28 in phaseⅡ. |
| Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule | BIOLOGICAL | Three doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,14,42 |
| Three doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule | BIOLOGICAL | Three doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,14,42 |
| Three doses of placebo at the emergency vaccination schedule | BIOLOGICAL | Three doses of placebo at the schedule of day 0,14,42 |
| Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule | BIOLOGICAL | Three doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,28,56 |
| Three doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule | BIOLOGICAL | Three doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,28,56 |
| Three doses of placebo at the routine vaccination schedule | BIOLOGICAL | Three doses of placebo at the schedule of day 0,28,56 |
Inclusion Criteria: * Healthy adults aged 18-59 years; * Proven legal identity; * Participants should be capable of understanding the informed consent form, and such form should be signed prior to enrolment ; Exclusion Criteria: * Travel history / residence history of Wuhan city and surrounding a...
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It is an inactivated SARS-CoV-2 vaccine candidate developed by Sinovac Biotech, Ltd for prevention of COVID-19. The described regimen uses two doses of a medium dosage strength given on an emergency vaccination schedule. It is a vaccine modality and is not a treatment for people who already have COVID-19.
It is used for prophylaxis of COVID-19, meaning it is intended to prevent SARS-CoV-2 infection rather than treat existing disease. The candidate is in development for COVID-19 in the infectious disease therapeutic area. Its only listed trial enrolled healthy adult volunteers aged 18 years and older in China.
Sinovac Biotech, Ltd is the developer of the two-dose medium dosage inactivated SARS-CoV-2 vaccine. The company trades under the ticker SVA. Sinovac is listed as the developer of the vaccine candidate studied in the completed Phase 1 trial of this regimen.
The two-dose medium dosage inactivated SARS-CoV-2 vaccine is in Phase 1 development. It is an investigational vaccine candidate and is not an approved product. The single listed trial for this regimen, NCT04352608, is a completed Phase 1 study, and no active trials of this regimen are listed.
One clinical trial is listed for this regimen: NCT04352608, titled Safety and Immunogenicity Study of Inactivated Vaccine for Prophylaxis of SARS CoV-2 Infection (COVID-19). It was a completed Phase 1 trial conducted in China with 744 enrolled participants. The study was randomized, double blind, placebo controlled, and enrolled healthy volunteers aged 18 years and older.
It is an inactivated vaccine, meaning it presents SARS-CoV-2 in a non-replicating form to stimulate an immune response against the virus. The regimen under study gives two doses of a medium dosage strength on an emergency vaccination schedule. The completed Phase 1 trial assessed safety and immunogenicity in healthy adult volunteers.