Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
sIPV-bOPV-bOPV vaccination schedule · 1 trial · 1 indication
Subjects whose pre-immune antibody level \< 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted. Primary vaccination schedule: 3 doses with one month interval between doses (i.e., month 0, 1, 2).
| Arm | Type | Description |
|---|---|---|
| Experimental Group | EXPERIMENTAL | sIPV-bOPV-bOPV vaccination schedule |
| Control Group | ACTIVE_COMPARATOR | wIPV-bOPV-bOPV vaccination schedule |
| Name | Type | Description |
|---|---|---|
| sIPV-bOPV-bOPV vaccination schedule | BIOLOGICAL | Single intramuscular injection of the experimental sIPV (0.5 ml) on Day 0, following two doses of bOPV (0.1 ml) on Day 30 and Day 60 respectively. The investigational Sabin strain inactivated poliovirus vaccine (Vero cell)(sIPV) was manufactured by Sinovac Vaccine Technology Co., Ltd. The poliovirus (Live) vaccine type I \& type III (Human Dipoid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd. |
| wIPV-bOPV-bOPV vaccination schedule | BIOLOGICAL | Single intramuscular injection of the control wIPV (0.5 ml) on Day 0, following two doses of bOPV (0.1 ml) on Day 30 and Day 60 respectively.The control wild strain inactivated poliovirus vaccine (wIPV) was manufactured by SANOFI PASTEUR S.A. The poliovirus (Live) vaccine type I \& type III (Human Dipoid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd. |
Inclusion Criteria: * Healthy volunteer between 60-90 days old; * Healthy volunteers who fulfill all the required conditions for receiving the investigational vaccine as established by medical history and clinical examination and determined by investigators; * Proven legal identity; * Participants ...
The sIPV-bOPV-bOPV vaccination schedule is a sequential polio immunization regimen developed by Sinovac Biotech, Ltd. It combines one dose of Sabin strain inactivated poliovirus vaccine (sIPV) followed by two doses of bivalent oral poliovirus vaccine (bOPV). It is being studied for the prevention of poliomyelitis in infants.
The sIPV-bOPV-bOPV vaccination schedule is used for immunization against poliomyelitis in infants. It is designed to prevent polio infection by combining the injectable sIPV with oral bOPV in a sequential regimen. The schedule is intended for use in healthy infants starting at 60 days of age.
Sinovac Biotech, Ltd is developing the sIPV-bOPV-bOPV vaccination schedule. The company trades under the ticker SVA. Sinovac is the sponsor of the clinical trial evaluating this sequential polio vaccination regimen.
The sIPV-bOPV-bOPV vaccination schedule is in Phase 3 clinical development. The Phase 3 trial has been completed. It is an investigational regimen and is not approved for use.
The sIPV-bOPV-bOPV vaccination schedule has been evaluated in one Phase 3 clinical trial, NCT03822754. The trial was titled "A Clinical Trial to Evaluate the Immunogenicity and Safety of sIPV in a '1+2' Sequential Schedule With bOPV in Infants." It was a completed, randomized, double-blind, active-controlled study that enrolled 240 infants in China.