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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05844423 | Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Infants | PHASE2 | COMPLETED | 802 | — | — | Mar 29, 2023 | Aug 25, 2025 | Sep 11, 2025 | 32 | United States |
Solicited local reactions include erythema, edema, and tenderness at the injection site
Solicited systemic reactions include fever, irritability, decreased appetite, decreased sleep, and increased sleep
Percentage of participants with related SAE
| Arm | Type | Description |
|---|---|---|
| VAX-24 Low | EXPERIMENTAL | Participants will receive 4 doses of VAX-24 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of three dose levels. |
| VAX-24 Mid | EXPERIMENTAL | Participants will receive 4 doses of VAX-24 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of three dose levels. |
| VAX-24 Mixed | EXPERIMENTAL | Participants will receive 4 doses of VAX-24 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of three dose levels. |
| PCV20 | ACTIVE_COMPARATOR | Participants will receive 4 doses of PCV20 administered as an intramuscular injection of the standard dose at 2, 4, 6, and 12-15 months of age. |
| Name | Type | Description |
|---|---|---|
| 0.5 ml dose of 1.1 mcg VAX-24 | BIOLOGICAL | 24 valent pneumococcal conjugate vaccine |
| 0.5 ml dose of PCV20 | BIOLOGICAL | 20 valent pneumococcal conjugate vaccine |
| 0.5 ml dose of 2.2 mcg VAX-24 | BIOLOGICAL | 24 valent pneumococcal conjugate vaccine |
| 0.5 ml dose of 2.2/4.4 mcg VAX-24 | BIOLOGICAL | 24 valent pneumococcal conjugate vaccine |
Inclusion Criteria: 1. Healthy male or female infant ≥42 days to ≤89 days (inclusive). 2. Full-term infant at least 37 weeks gestational age at birth. 3. Afebrile for ≥72 hours with a rectal temperature \<38.0°C (\<100.4°F) or axillary temperature \<37.8°C (\<100.0°F) before receipt of study vaccin...