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...