Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Single-dose regimen of high dosage investigational sIPV · 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.
GMT of each group of the phase II trial 30 days after three-dose regimen which lasts 60 days.
The GMI is the increase of post-immune GMT from pre-immune GMT.
| Arm | Type | Description |
|---|---|---|
| Phase I Adult Group - High dosage | EXPERIMENTAL | * Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0; * Intervention: Single-dose regimen of high dosage investigational sIPV |
| Phase I Adult Group - Medium dosage | EXPERIMENTAL | * Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0; * Intervention: Single-dose regimen of medium dosage investigational sIPV |
| Phase I Child Group - High dosage | EXPERIMENTAL | * Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0; * Intervention: Single-dose regimen of high dosage investigational sIPV |
| Phase I Child Group - Medium dosage | EXPERIMENTAL | * Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0; * Intervention: Single-dose regimen of medium dosage investigational sIPV |
| Phase I Infant Group - High dosage | EXPERIMENTAL | * Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention: Three-dose regimen of high dosage investigational sIPV |
| Phase I Infant Group - Medium dosage | EXPERIMENTAL | * Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention: Three-dose regimen of medium dosage investigational sIPV |
| Phase I Infant Group - Low dosage | EXPERIMENTAL | * Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention: Three-dose regimen of low dosage investigational sIPV |
| PhaseⅡExperimental Group - High dosage | EXPERIMENTAL | * Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention: Three-dose regimen of high dosage investigational sIPV |
| PhaseⅡExperimental Group - Medium dosage | EXPERIMENTAL | * Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention: Three-dose regimen of medium dosage investigational sIPV |
| PhaseⅡExperimental Group - Low dosage | EXPERIMENTAL | * Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention: Three-dose regimen of low dosage investigational sIPV |
| PhaseⅡControl Group -commercialized sIPV | ACTIVE_COMPARATOR | * Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention:Three-dose regimen of commercialized sIPV |
| PhaseⅡ Control Group -commercialized IPV | ACTIVE_COMPARATOR | * Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention: Three-dose regimen of commercialized IPV |
| Name | Type | Description |
|---|---|---|
| Single-dose regimen of high dosage investigational sIPV | BIOLOGICAL | The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd.. |
| Single-dose regimen of medium dosage investigational sIPV | BIOLOGICAL | The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd.. |
| Three-dose regimen of high dosage investigational sIPV | BIOLOGICAL | The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd.. |
| Three-dose regimen of medium dosage investigational sIPV | BIOLOGICAL | The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd.. |
| Three-dose regimen of low dosage investigational sIPV | BIOLOGICAL | The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd.. |
| Three-dose regimen of commercialized sIPV | BIOLOGICAL | The control vaccine was manufactured by Chinese Academy of Medical Sciences. |
| Three-dose regimen of commercialized IPV | BIOLOGICAL | The control vaccine was manufactured by Sanofi Pasteur S.A (IMOVAX POLIO). |
Inclusion Criteria: * Healthy volunteer between 60-90 days old, 6-12 years old, or 18-49 years 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; * Pr...
It is an investigational Sabin inactivated poliovirus vaccine developed by Sinovac Biotech, Ltd. It is being studied as a single-dose, high dosage regimen for the prevention of poliomyelitis. It is not an approved product and remains in clinical development.
It is being studied for poliomyelitis, the infectious disease caused by poliovirus. The vaccine is intended to induce immune protection against poliovirus infection. Its use is currently limited to clinical research and it is not approved for general use.
Sinovac Biotech, Ltd is developing the single-dose regimen of high dosage investigational sIPV. The company trades under the ticker SVA. The vaccine is part of Sinovac's poliovirus vaccine research program.
The single-dose regimen of high dosage investigational sIPV is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA or any other regulatory agency. One Phase 1 trial has been completed.
The single-dose regimen of high dosage investigational sIPV has been studied in one completed Phase 1 trial, NCT02985320, titled Studies of the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine. The trial enrolled 708 participants in China, including healthy volunteers aged 2 months and older.
NCT02985320 was a randomized, active-controlled Phase 1 trial of the Sabin inactivated poliovirus vaccine. It enrolled 708 participants of all sexes in China, with a minimum age of 2 months, and included healthy volunteers. The trial has been completed.