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...
It is an investigational Sabin strain inactivated polio vaccine (sIPV) regimen developed by Sinovac Biotech, Ltd. (SVA) for the prevention of poliomyelitis. The regimen consists of three doses of experimental sIPV from lot 1, given at 2, 3, and 4 months of age. It is intended for use in infants.
The three-dose experimental sIPV regimen is being developed by Sinovac Biotech, Ltd., which trades under the ticker SVA. Sinovac is a Chinese biopharmaceutical company focused on vaccines for infectious diseases.
The three-dose experimental sIPV regimen has completed a Phase 3 clinical trial. It is investigational and has not been approved by the FDA. The Phase 3 trial, NCT04386707, was a lot-consistency study of Sabin strain inactivated polio vaccine conducted in China.
The three-dose experimental sIPV regimen was evaluated in a single Phase 3 trial, NCT04386707, titled Lot-consistency Clinical Trial of Sabin Strain Inactivated Polio Vaccine. The trial enrolled 1,300 healthy infants in China, was randomized, double-blind, and active-controlled, and has been completed.
The three-dose experimental sIPV regimen is given at 2, 3, and 4 months of age. This schedule was used in the Phase 3 lot-consistency trial NCT04386707, which enrolled 1,300 healthy infants in China.