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...
Sinovac PCV13 lot 1 is an investigational pneumococcal vaccine candidate developed by Sinovac Biotech, Ltd. It is being studied for the prevention of pneumococcal infectious diseases. The product is in Phase 3 clinical development and is evaluated in a lot-to-lot consistency trial conducted in China.
Sinovac PCV13 lot 1 is being developed for pneumococcal infectious diseases. Its Phase 3 trial enrolls healthy volunteers aged 2 years and older in China, evaluating consistency across manufactured lots of the PCV13 vaccine candidate. The program targets prevention of disease caused by Streptococcus pneumoniae serotypes covered by the vaccine.
Sinovac PCV13 lot 1 is made by Sinovac Biotech, Ltd, which trades under the ticker SVA. The company is the developer of the PCV13 vaccine candidate and is running its Phase 3 lot-to-lot consistency study in China.
Sinovac PCV13 lot 1 is in Phase 3 clinical development. It is an investigational vaccine candidate and is not yet approved. The Phase 3 trial is registered as not yet recruiting, with a planned enrollment of 1,125 participants.
Sinovac PCV13 lot 1 is studied in one Phase 3 trial, NCT07832500, titled A Lot-to-Lot Consistency Clinical Trial of PCV13. The trial is randomized, double-blind, and controlled, with planned enrollment of 1,125 healthy volunteers aged 2 years and older in China. It is currently not yet recruiting.
The Phase 3 trial of Sinovac PCV13 lot 1, NCT07832500, plans to enroll 1,125 participants. It is a randomized, double-blind, controlled lot-to-lot consistency study in healthy volunteers aged 2 years and older, conducted in China, and it is not yet recruiting.