Approval Probability
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sIPV-sIPV-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-sIPV-bOPV vaccination schedule |
| Control Group | ACTIVE_COMPARATOR | wIPV-wIPV-bOPV vaccination schedule |
| Name | Type | Description |
|---|---|---|
| sIPV-sIPV-bOPV vaccination schedule | BIOLOGICAL | Two intramuscular injections of the investigational vaccine (0.5 ml) on Day 0 and Day 30 respectively; Single dose of bOPV (0.1 ml) on Day 60. The investigational Sabin strain inactivated poliovirus vaccine (Vero cell)(sIPV) was manufactured by Sinovac Biotech Co., Ltd . The poliovirus (Live) vaccine type I \& type III (Human Diploid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd. |
| wIPV-wIPV-bOPV vaccination schedule | BIOLOGICAL | Two intramuscular injections of the control vaccine(0.5 ml) on Day 0 and Day 30 respectively; Single dose of bOPV (0.1 ml) on Day 60. The investigational Sabin strain inactivated poliovirus vaccine (Vero cell)(sIPV) was manufactured by SANOFI PASTEUR S.A. The poliovirus (Live) vaccine type I \& type III (Human Diploid 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-sIPV-bOPV vaccination schedule is a sequential polio immunization regimen that uses two doses of Sabin strain inactivated poliovirus vaccine (sIPV) followed by one dose of bivalent oral poliovirus vaccine (bOPV). It is being developed by Sinovac Biotech, Ltd. as a "2+1" schedule for preventing poliomyelitis in infants.
The sIPV-sIPV-bOPV vaccination schedule 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 sIPV-sIPV-bOPV vaccination schedule has completed a Phase 3 clinical trial. It is an investigational regimen and is not approved for use. The Phase 3 trial, NCT03822767, has been completed.
The sIPV-sIPV-bOPV vaccination schedule has been evaluated in one clinical trial: NCT03822767, a Phase 3 study titled "A Clinical Trial to Evaluate the Immunogenicity and Safety of sIPV in a '2+1' Sequential Schedule With bOPV in Infants." The trial was completed and enrolled 240 infants in China.
The sIPV-sIPV-bOPV vaccination schedule is intended for the prevention of poliomyelitis in infants. It is a sequential immunization regimen that combines inactivated and oral poliovirus vaccines to protect against polio.