Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Three doses of experimental sIPV of lot 1 at the schedule of 2, 3, 4 months of age · 1 trial · 1 indication
Micro-neutralization method will be used in the neutralizing antibody assay
Micro-neutralization method will be used in the neutralizing antibody assay; Seropositive rates will be calculated based on the internationally accepted threshold value of ≥1:8. Seroconversion (1:8) is defined as a change from seronegative (\<1:8) to seropositive (≥1:8) or a 4-fold increase from baseline titers if seropositive.
| Arm | Type | Description |
|---|---|---|
| Experimental Vaccine-lot 1 | EXPERIMENTAL | sIPV manufactured by Sinovac Biotech Co., Ltd at commercial scale. |
| Experimental Vaccine-lot 2 | EXPERIMENTAL | sIPV manufactured by Sinovac Biotech Co., Ltd at commercial scale. |
| Experimental Vaccine-lot 3 | EXPERIMENTAL | sIPV manufactured by Sinovac Biotech Co., Ltd at commercial scale. |
| Control Vaccine | ACTIVE_COMPARATOR | Wild strain IPV (wIPV）manufactured by Sanofi Pasteur S.A. |
| Name | Type | Description |
|---|---|---|
| Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age | BIOLOGICAL | Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age |
| Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age | BIOLOGICAL | Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age |
| Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age | BIOLOGICAL | Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age |
| Three doses control wIPV at the schedule of 2,3,4 months of age | BIOLOGICAL | Three doses control wIPV at the schedule of 2,3,4 months of age |
Inclusion Criteria: * Healthy infants aged 60-89 days; * legal identity; * Informed consent form has been signed by guardians. Exclusion Criteria: * Vaccination history of polio vaccine; * Allergy history, history of asthma, including allergy history to vaccine or vaccine components, serious adve...