Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sinovac PCV24 formulation 1 · 2 trials · 1 indication
Incidence of adverse reactions within 30 days after vaccination
| Arm | Type | Description |
|---|---|---|
| Experimental group 1 | EXPERIMENTAL | 12 participants aged 6-17 years and 30 participants aged 2-5 years will be randomized to receive Sinovac PCV24 formulation 1. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose. |
| Experimental group 2 | EXPERIMENTAL | 12 participants aged 6-17 years and 30 participants aged 2-5 years will be randomized to receive Sinovac PCV24 formulation 2. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose. |
| Active control group | ACTIVE_COMPARATOR | 30 participants aged 2-5 years will be randomized to receive Prevenar13®. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose. |
| Experimental: Sinovac PCV24 formulation 1 | EXPERIMENTAL | 48 participants will be randomized to receive Sinovac PCV24 formulation 1. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose. |
| Experimental: Sinovac PCV24 formulation 2 | EXPERIMENTAL | 48 participants will be randomized to receive Sinovac PCV24 formulation 2. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose. |
| Active control: Pneumovax® | ACTIVE_COMPARATOR | 48 participants will be randomized to receive Pneumovax®. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose. |
| Placebo: Normal saline | PLACEBO_COMPARATOR | 24 participants will be randomized to receive placebo. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose. |
| Name | Type | Description |
|---|---|---|
| Sinovac PCV24 formulation 1 | BIOLOGICAL | One dose of Sinovac PCV24 formulation 1(0.5mL) |
| Sinovac PCV24 formulation 2 | BIOLOGICAL | One dose of Sinovac PCV24 formulation 2(0.5mL) |
| Prevenar13® | BIOLOGICAL | One dose of PCV13 manufactured by Pfizer |
| Pneumovax® | BIOLOGICAL | One dose of Pneumovax® (0.5 mL) contains 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F saccharides. |
| Placebo | BIOLOGICAL | 0.5 mL of 0.9%NaCl solution (normal saline) |
Inclusion Criteria: 1. Healthy volunteers who are aged 2-17 years; 2. Participants and their guardians provide legal proof of identity, as well as vaccination record (for children aged 2-5 years); 3. Participants' guardians understand and voluntarily sign the informed consent form; participants age...
Sinovac PCV24 formulation 1 is an investigational pneumococcal conjugate vaccine being developed for the prevention of pneumococcal infectious disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The vaccine is designed to protect against infections caused by Streptococcus pneumoniae bacteria.
Sinovac PCV24 formulation 1 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 PCV24 formulation 1 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in adults and one in children aged 2-17 years. The vaccine remains investigational and has not received regulatory approval for commercial use.
Sinovac PCV24 formulation 1 has completed two Phase 1 clinical trials. NCT06474377 enrolled 170 healthy adults aged 18 years and older in China, and NCT06550830 enrolled 119 healthy children aged 2-17 years in China. Both trials were randomized, double-blind, and active-controlled studies for pneumococcal infectious disease.
Sinovac PCV24 formulation 1 is a pneumococcal conjugate vaccine designed to stimulate the immune system to produce antibodies against Streptococcus pneumoniae. The vaccine is intended to prevent pneumococcal infectious disease by inducing protective immunity against multiple pneumococcal serotypes.