Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0, 28 · 2 trials · 1 indication
Incidence of adverse reactions after each dose vaccination.
Neutralizing antibody assay will be performed using the micro-neutralization method. Seroconversion will be defined as a change from seronegative (\<1:8) to seropositive (≥1:8), or ≥4 fold increase from baseline.
| Arm | Type | Description |
|---|---|---|
| Experimental Vaccine-low dosage | EXPERIMENTAL | low dosage inactivated SARS-CoV-2 vaccine |
| Experimental Vaccine-medium dosage | EXPERIMENTAL | medium dosage inactivated SARS-CoV-2 vaccine |
| Placebo | PLACEBO_COMPARATOR | No active ingredient in the placebo |
| Experimental Vaccine-high dosage | EXPERIMENTAL | 24 participants in high-dosage group in phase Ⅰ will receive two doses of primary immunization according to the immunization schedule of day 0, 28 and will receive 1 dose of booster immunization 1 year after primary immunization; 100 participants in high-dosage group in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 ,1 dose of booster immunization 6 months after primary immunization(the third dose) and the second booster dose (fourth dose) 1 year after the second dose . |
| Name | Type | Description |
|---|---|---|
| Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 | BIOLOGICAL | The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd., with a antigen content of 300SU/0.5ml |
| Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 | BIOLOGICAL | The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd., with a antigen content of 600SU/0.5ml |
| Two doses of placebo at the schedule of day 0,28 | OTHER | The placebo contains no active ingredient and manufactured by Sinovac Research \& Development Co., Ltd. |
| Two doses of high dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 | BIOLOGICAL | The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd..Two doses of high dosage (1200SU/0.5ml) experimental vaccine at the schedule of day 0,28,and one dose of booster immunization(the third dose) with medium dosage (1200SU/0.5ml) experimental vaccine 1 year after primary immunization at the schedule of day 0,28 in phaseⅠand 6 months after primary immunization at the schedule of day 0,28 in phase Ⅱ.And the second booster dose (the fourth dose) 1 year after the second dose. |
Inclusion Criteria: * Healthy children and adolescents aged 3-17 years; * The subject and/or guardian can understand and voluntarily sign the informed consent form (double sign required for 8-17 years old); * Proven legal identity. Exclusion Criteria: * Travel history / residence history of commu...