Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sinovac PCV13 lot 1 · 1 trial · 1 indication
Equivalence Criterion: The 95% confidence intervals (CIs) for the ratios of serotype-specific IgG geometric mean concentrations (GMCs) between any two lots shall lie entirely within the range of 0.5 to 2.0,as measured by enzyme-linked immunosorbent assay (ELISA) method
| Arm | Type | Description |
|---|---|---|
| PCV13 Lot 1 | EXPERIMENTAL | 375 participants aged 2-5 years will be randomized to receive Sinovac PCV13 Lot 1\. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose |
| PCV13 Lot 2 | EXPERIMENTAL | 375 participants aged 2-5 years will be randomized to receive Sinovac PCV13 Lot 2. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose |
| PCV13 Lot 3 | EXPERIMENTAL | 375 participants aged 2-5 years will be randomized to receive Sinovac PCV13 Lot 3. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose |
| Name | Type | Description |
|---|---|---|
| Sinovac PCV13 lot 1 | BIOLOGICAL | One dose of Sinovac PCV13 lot 1 (0.5ml) was administered |
| Sinovac PCV13 lot 2 | BIOLOGICAL | One dose of Sinovac PCV13 lot 2 (0.5ml) was administered |
| Sinovac PCV13 lot 3 | BIOLOGICAL | One dose of Sinovac PCV13 lot 3(0.5ml) was administered |
Inclusion Criteria: 1. Healthy children aged 2 to 5 years with stable health status 2. Participants and their legal representative provide legal proof of identity, as well as vaccination record 3. Participants' legal representative understand and voluntarily sign the informed consent form 4. Willin...