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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06550830 | Clinical Trial of PCV24 in Children Aged 2-17 Years | PHASE1 | COMPLETED | 119 | — | — | Sep 7, 2024 | Jun 25, 2025 | Jan 28, 2026 | 1 | China |
| NCT06474377 | Clinical Trial of PCV24 in Adults | PHASE1 | COMPLETED | 170 | — | — | Jun 21, 2024 | Feb 26, 2025 | Apr 16, 2025 | 1 | China |
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...