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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07543198 | Clinical Trial of PCV24 in Adults Aged ≥18 Years | PHASE1 | COMPLETED | 385 | — | — | Jun 18, 2025 | Feb 26, 2026 | Apr 21, 2026 | 1 | China |
Incidence of adverse reactions of different doses of PCV24 in adults aged ≥18 years within 30 days after vaccination
OPA GMT 30 days after vaccination
Proportion of OPA antibody titer increase≥four folds 30 days after vaccination
IgG GMC 30 days after vaccination
Proportion of IgG antibody concentration increase≥four folds 30 days after vaccination
| Arm | Type | Description |
|---|---|---|
| Low-dosage PCV24 (phase Ib) | EXPERIMENTAL | 12 Participants aged 18-49years and 12 Participants aged ≥50years will receive Sinovac Low-dosage PCV24 . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose |
| Middle-dosage PCV24(phase Ib) | EXPERIMENTAL | 12 Participants aged 18-49 years and 12 Participants aged ≥50years will receive Sinovac Middle-dosage PCV24 . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose |
| High-dosage PCV24(phase Ib) | EXPERIMENTAL | 12 Participants aged 18-49years will receive Sinovac High-dosage PCV24 . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose |
| Pneumovax®(phase Ib) | ACTIVE_COMPARATOR | 12 Participants aged 18-49years and 6 Participants aged ≥50years will receive Pneumovax®(PPV23) . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose |
| Low-dosage PCV24(phase II) | EXPERIMENTAL | 50 Participants aged 18-49years and 50 Participants aged ≥50years will receive Sinovac Low-dosage PCV24 . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose |
| Middle-dosage PCV24(phase II) | EXPERIMENTAL | 50 Participants aged 18-49years and 50 Participants aged ≥50years will receive Sinovac Middle-dosage PCV24 . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose |
| Pneumovax®(phase II) | ACTIVE_COMPARATOR | 50 Participants aged 18-49years and 50 Participants aged ≥50years will receive Pneumovax®(PPV23) . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose |
| Name | Type | Description |
|---|---|---|
| Sinovac Low-dosage PCV24 | BIOLOGICAL | One dose of Sinovac Low-dosage PCV24 (0.5mL) |
| Sinovac Middle-dosage PCV24 | BIOLOGICAL | One dose of Sinovac Middle-dosage PCV24(0.5mL) |
| Sinovac High-dosage PCV24 | BIOLOGICAL | One dose of Sinovac High-dosage PCV24(0.5mL) |
| Pneumovax® | BIOLOGICAL | One dose of PPV23 manufactured by MSD |
Inclusion Criteria: 1. Healthy adults aged ≥18 years, who can provide legal identification documents 2. Fully understand and agree to sign the informed consent form 3. Willing and able to follow all study procedures and stay in contact during the study Exclusion Criteria: 1. Received any pneumoco...