Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Sinovac PCV24
Sinovac PCV13 · 5 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. |
| 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. |
| 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 PCV13 is an investigational 13-valent pneumococcal polysaccharide conjugate vaccine being developed for the prevention of pneumococcal infectious diseases. It is being studied in infants and children to protect against infections caused by Streptococcus pneumoniae bacteria. The vaccine is currently in Phase 3 clinical development.
Sinovac PCV13 targets Streptococcus pneumoniae, the bacterium responsible for pneumococcal infectious diseases. As a 13-valent conjugate vaccine, it is designed to elicit an immune response against 13 pneumococcal serotypes. The vaccine is being evaluated in clinical trials for its ability to prevent pneumococcal disease in infants and young children.
Sinovac PCV13 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 in China and the Philippines.
Sinovac PCV13 is in Phase 3 clinical development. A Phase 3 trial (NCT07593924) is planned in the Philippines for infants approximately 2 months old, with an enrollment target of 500 participants. The vaccine is investigational and has not been approved by regulatory authorities.
Sinovac PCV13 has been studied in several clinical trials. A Phase 1b trial (NCT06183216) in China has been completed with 140 participants. A Phase 3 trial (NCT07593924) in the Philippines is not yet recruiting, with an expected enrollment of 500 infants. The vaccine is also being evaluated under the name PCV24 in additional trials.
Sinovac PCV13 is also known as Sinovac PCV24. Clinical trials under the PCV24 name are evaluating the vaccine in infants and children aged 2 months to 5 years, including a Phase 1 trial (NCT06800261) and a Phase 2 trial (NCT07300644), both recruiting in China.