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...