Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sinovac Low-dosage PCV24 · 1 trial · 1 indication
Incidence of adverse reactions of different doses of PCV24 in adults aged ≥18 years within 30 days after vaccination
OPA GMT 30 days after vaccination
Proportion of OPA antibody titer increase≥four folds 30 days after vaccination
IgG GMC 30 days after vaccination
Proportion of IgG antibody concentration increase≥four folds 30 days after vaccination
| Arm | Type | Description |
|---|---|---|
| Low-dosage PCV24 (phase Ib) | EXPERIMENTAL | 12 Participants aged 18-49years and 12 Participants aged ≥50years will receive Sinovac Low-dosage PCV24 . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose |
| Middle-dosage PCV24(phase Ib) | EXPERIMENTAL | 12 Participants aged 18-49 years and 12 Participants aged ≥50years will receive Sinovac Middle-dosage PCV24 . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose |
| High-dosage PCV24(phase Ib) | EXPERIMENTAL | 12 Participants aged 18-49years will receive Sinovac High-dosage PCV24 . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose |
| Pneumovax®(phase Ib) | ACTIVE_COMPARATOR | 12 Participants aged 18-49years and 6 Participants aged ≥50years will receive Pneumovax®(PPV23) . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose |
| Low-dosage PCV24(phase II) | EXPERIMENTAL | 50 Participants aged 18-49years and 50 Participants aged ≥50years will receive Sinovac Low-dosage PCV24 . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose |
| Middle-dosage PCV24(phase II) | EXPERIMENTAL | 50 Participants aged 18-49years and 50 Participants aged ≥50years will receive Sinovac Middle-dosage PCV24 . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose |
| Pneumovax®(phase II) | ACTIVE_COMPARATOR | 50 Participants aged 18-49years and 50 Participants aged ≥50years will receive Pneumovax®(PPV23) . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose |
| Name | Type | Description |
|---|---|---|
| Sinovac Low-dosage PCV24 | BIOLOGICAL | One dose of Sinovac Low-dosage PCV24 (0.5mL) |
| Sinovac Middle-dosage PCV24 | BIOLOGICAL | One dose of Sinovac Middle-dosage PCV24(0.5mL) |
| Sinovac High-dosage PCV24 | BIOLOGICAL | One dose of Sinovac High-dosage PCV24(0.5mL) |
| Pneumovax® | BIOLOGICAL | One dose of PPV23 manufactured by MSD |
Inclusion Criteria: 1. Healthy adults aged ≥18 years, who can provide legal identification documents 2. Fully understand and agree to sign the informed consent form 3. Willing and able to follow all study procedures and stay in contact during the study Exclusion Criteria: 1. Received any pneumoco...
Sinovac Low-dosage PCV24 is an investigational pneumococcal conjugate vaccine being developed for the prevention of pneumococcal infectious disease. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
Sinovac Low-dosage PCV24 is being developed by Sinovac Biotech, Ltd, a biopharmaceutical company traded on the NASDAQ under the ticker symbol SVA. The company is conducting clinical trials for this vaccine candidate in China.
Sinovac Low-dosage PCV24 is in Phase 1 clinical development. It is an investigational vaccine and has not been approved for commercial use. The Phase 1 trial has been completed, and the vaccine remains under clinical investigation.
Sinovac Low-dosage PCV24 has one completed Phase 1 clinical trial registered as NCT07543198, titled "Clinical Trial of PCV24 in Adults Aged ≥18 Years." The trial enrolled 385 participants in China and was a randomized, double-blind, active-controlled study.
Sinovac Low-dosage PCV24 is a pneumococcal conjugate vaccine designed to elicit an immune response against pneumococcal bacteria, which cause pneumococcal infectious disease. The vaccine is intended to stimulate the production of antibodies that neutralize the bacteria and prevent infection.
Sinovac Low-dosage PCV24 is a specific formulation of the PCV24 vaccine candidate developed by Sinovac Biotech. The low-dosage designation refers to the dose strength being evaluated in clinical trials, distinguishing it from other PCV24 formulations that may be in development.