Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Sinovac PCV24 formulation 1, Sinovac PCV24 formulation 2, Sinovac PCV13
Sinovac PCV24 · 7 trials · 2 indications
Non-inferiority criterion: The lower limit of the two-sided 95% CI for the difference (Sinovac-PCV13 minus Prevenar 13™) \> -10% for each serotype at 30 days after dose 2.
Non-inferiority criterion: The lower limit of the two-sided 95% CI for the GMC ratio (Sinovac-PCV13/Prevenar 13™) \> 0.5 for each serotype at 30 days after dose 2.
Proportion of serotype-specific IgG concentration ≥0.35 μg/ml
IgG GMC
| Arm | Type | Description |
|---|---|---|
| Sinovac PCV 13 | EXPERIMENTAL | 250 participants aged 2 months (42 to 89 days) will receive 3 doses of Sinovac PCV13 at approximately 2, 4 and 12-15 months of age.Route of administration is intramuscular injection at anterolateral thigh for infants aged younger than 12 months, and at deltoid muscle of upper arm for children aged older than 12 months. |
| Prevenar 13™ | ACTIVE_COMPARATOR | 250 participants aged 2 months (42 to 89 days) will receive 3 doses of Prevenar 13™ at approximately 2, 4 and 12-15 months of age.Route of administration is intramuscular injection at anterolateral thigh for infants aged younger than 12 months, and at deltoid muscle of upper arm for children aged older than 12 months. |
| Experimental: Sinovac PCV13 | EXPERIMENTAL | Participants aged 6 weeks-5 years will receive 4 doses of Sinovac PCV13 according to different immunization schedules. |
| Active Comparator: Prevnar® | ACTIVE_COMPARATOR | Participants aged 6 weeks-5 years will receive 4 doses of Prevnar 13® according to different immunization schedules. |
| Sinovac PCV24 | EXPERIMENTAL | Sinovac PCV24 (0.5 mL) is administered intramuscularly according to different immunization schedules. |
| Prevnar® | ACTIVE_COMPARATOR | Prevnar® (0.5 mL) is administered intramuscularly according to different immunization schedules. |
| Experimental: Sinovac PCV24 | EXPERIMENTAL | Participants aged 2 months (minimum 42 days)-23 months will receive Sinovac PCV24 according to different immunization schedules. Route of administration is intramuscular injection at anterolateral thigh for infants aged younger than 12 months, and at deltoid muscle of upper arm for children aged older than 12 months. |
| 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. |
| Infants aged 2 months in experimental group | EXPERIMENTAL | 35 participants aged 2 months will be randomized to receive Sinovac PCV13. Route of administration is intramuscular injection at anterolateral aspect of thigh; immunization schedule is 4 doses, including 3 doses (two-month interval) in primary vaccination and a booster dose at the age of 12-15 months. |
| Infants aged 2 months in control group | ACTIVE_COMPARATOR | 35 participants aged 2 months will be randomized to receive PREVNAR 13. Route of administration is intramuscular injection at anterolateral aspect of thigh; immunization schedule is 4 doses, including 3 doses (two-month interval) in primary vaccination and a booster dose at the age of 12-15 months. |
| Children aged 2-5 years in experimental group | EXPERIMENTAL | 35 children aged 2-5 years will be randomized to receive Sinovac PCV13. The route of administration is intramuscular injection at deltoid muscle of the upper arm, and immunization schedule is 1 dose for children aged 2-5 years old. |
| Children aged 2-5 years in control group | ACTIVE_COMPARATOR | 35 children aged 2-5 years will be randomized to receive PREVNAR 13. The route of administration is intramuscular injection at deltoid muscle of the upper arm, and immunization schedule is 1 dose for children aged 2-5 years old. |
| Name | Type | Description |
|---|---|---|
| Sinovac PCV13 | BIOLOGICAL | One dose of Sinovac PCV13 (0.5ml) was administered at 2, 4, and 12-15 months of age. |
| Prevenar 13™ | BIOLOGICAL | One dose of Prevenar 13™ (0.5ml) was administered at 2, 4, and 12-15 months of age. |
| Prevnar® | BIOLOGICAL | One dose of Prevnar® (0.5 mL) is administered intramuscularly. |
| Sinovac PCV24 | BIOLOGICAL | Sinovac PCV24 (0.5 mL) is administered intramuscularly according to different immunization schedules. |
| 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) |
| PREVNAR 13 | BIOLOGICAL | 0.5 mL dose of PREVNAR 13 contains 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides. |
Inclusion Criteria: 1. Health infants aged approximately 2 months (42 to 89 days) 2. Have a parent/legal guardian who has provided written informed consent after being fully informed about the study. 3. Be able to provide the vaccination records since birth. 4. The infant's mother is tested negativ...
Sinovac PCV24 is an investigational pneumococcal vaccine being developed by Sinovac Biotech, Ltd for the prevention of pneumococcal infectious disease. It is in Phase 3 clinical development. The program includes multiple formulations and a PCV13 version, studied in infants and children, including healthy volunteers.
Sinovac PCV24 is being developed for pneumococcal infectious disease. Clinical trials are enrolling infants and children, with study populations starting at 42 days of age and extending up to 5 years. The trials are conducted in healthy volunteers, and the program includes both PCV24 and PCV13 formulations.
Sinovac PCV24 is developed by Sinovac Biotech, Ltd, which trades under the ticker SVA. The company is running the pneumococcal vaccine program, including the PCV24 and PCV13 formulations, across multiple clinical trials in infants and children.
Sinovac PCV24 is in Phase 3 clinical development. The overall program includes 7 trials across Phase 1, Phase 2, and Phase 3, with 4 currently active and 3 completed. Total enrollment across the program is 4,609 participants. The studies are randomized, double-blind, and active-controlled.
Sinovac PCV24 trials include NCT07300644, a Phase 2 study in infants and children aged 2 months to 5 years in China, and NCT06800261, a Phase 1 study in infants aged 2 to 23 months in China. Related PCV13 studies include NCT07593924 in the Philippines and NCT06617715 in China.
Sinovac PCV24 and Sinovac PCV13 are related formulations within the same Sinovac Biotech pneumococcal vaccine program. Sinovac PCV24 is also known as Sinovac PCV24 formulation 1 and formulation 2. The PCV13 version is studied separately, including in a Phase 3 trial in infants aged approximately 2 months.