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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 used for poliomyelitis, a viral infectious disease. It is a sequential immunization regimen being studied in infants to evaluate the immunogenicity and safety of the schedule.
The sIPV-bOPV-bOPV vaccination schedule is developed by Sinovac Biotech, Ltd, a biopharmaceutical company. The company is listed on the stock exchange under the ticker SVA.
The sIPV-bOPV-bOPV vaccination schedule is in Phase 3 clinical development. It is an investigational vaccination schedule, not yet approved, and is being evaluated in a completed Phase 3 trial.
The sIPV-bOPV-bOPV vaccination schedule was studied in a Phase 3 clinical trial with the identifier NCT03822754. This trial, titled 'A Clinical Trial to Evaluate the Immunogenicity and Safety of sIPV in a 1+2 Sequential Schedule With bOPV in Infants,' was completed in China and enrolled 240 participants.
The sIPV-bOPV-bOPV vaccination schedule is a specific sequential regimen combining inactivated polio vaccine (sIPV) and bivalent oral polio vaccine (bOPV). It is not a standard single vaccine but a schedule being evaluated for its immunogenicity and safety in infants.