Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06617715 | Clinical Trial of 13-Valent Pneumococcal Conjugate Vaccine | PHASE3 | RECRUITING | 3,080 | — | — | Oct 23, 2024 | Jul 30, 2026 | Jan 28, 2026 | 1 | China |
| NCT07300644 | Clinical Trial of PCV24 in Infants and Children Aged 2 Months to 5 Years | PHASE2 | RECRUITING | 420 | — | — | Nov 25, 2025 | Dec 1, 2027 | Dec 24, 2025 | 3 | China |
| NCT06800261 | Clinical Trial of PCV24 in Infants Aged 2-23 Months | PHASE1 | RECRUITING | 180 | — | — | May 8, 2025 | Jun 1, 2026 | Jan 28, 2026 | 2 | China |
| NCT06183216 | A Phase 1b Clinical Trial of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine | PHASE1 | COMPLETED | 140 | — | — | Jan 4, 2024 | Mar 26, 2025 | Jan 28, 2026 | 1 | China |
Proportion of serotype-specific IgG concentration ≥0.35 μg/ml
IgG GMC
| Arm | Type | Description |
|---|---|---|
| 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 (0.5 mL) is administered intramuscularly. |
| 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. Healthy infants or children who are aged 2 months (at least 6 weeks), 7-11 months, 12-23 months and 2-5 years (before the 6th birthday); 2. Participants' guardians provide legal identity document and participants' vaccination record; 3. Participants' guardians understand and ...