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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 used for the prevention of poliomyelitis in infants. It involves a sequential immunization regimen combining inactivated polio vaccine and bivalent oral polio vaccine, evaluated in a clinical trial to assess immunogenicity and safety.
The sIPV-sIPV-bOPV vaccination schedule is developed by Sinovac Biotech, Ltd, a biopharmaceutical company. The company is conducting clinical research on this vaccination regimen for poliomyelitis prevention.
The sIPV-sIPV-bOPV vaccination schedule is in Phase 3 clinical development. It is an investigational vaccination schedule, not yet approved, and is being studied for its immunogenicity and safety in infants.
The sIPV-sIPV-bOPV vaccination schedule was evaluated in a completed Phase 3 trial, NCT03822767, titled 'A Clinical Trial to Evaluate the Immunogenicity and Safety of sIPV in a "2+1" Sequential Schedule With bOPV in Infants'. The trial enrolled 240 participants in China.
The sIPV-sIPV-bOPV vaccination schedule is a sequential regimen that includes sIPV (inactivated polio vaccine) and bOPV (bivalent oral polio vaccine). It is not the same as sIPV alone, as it combines both vaccines in a specific schedule.