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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06720038 | A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants | PHASE2 | ACTIVE NOT_RECRUITING | 900 | — | — | Nov 25, 2024 | Dec 1, 2027 | May 15, 2026 | 48 | United States, Puerto Rico |
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 subjects with unsolicited AE
Percentage of subjects with MAAE
Percentage of subjects with SAE
Percentage of subjects with NOCI
| Arm | Type | Description |
|---|---|---|
| VAX-31 Low | EXPERIMENTAL | Participants will receive 4 doses of VAX-31 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of four dose levels. |
| VAX-31 Mid | EXPERIMENTAL | Participants will receive 4 doses of VAX-31 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of four dose levels. |
| VAX-31 High | EXPERIMENTAL | Participants will receive 4 doses of VAX-31 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of four 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. |
| VAX-31 High-PFS | EXPERIMENTAL | Participants will receive 4 doses of VAX-31 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of four dose levels. |
| Name | Type | Description |
|---|---|---|
| 0.5 mL of the low dose VAX-31 | BIOLOGICAL | 31 valent pneumococcal conjugate vaccine |
| 0.5 mL of the mid dose VAX-31 | BIOLOGICAL | 31 valent pneumococcal conjugate vaccine |
| 0.5 mL of the high dose VAX-31 | BIOLOGICAL | 31 valent pneumococcal conjugate vaccine |
| 0.5 mL dose of PCV20 | BIOLOGICAL | 20 valent pneumococcal conjugate vaccine |
| 0.5 mL of the High-PFS dose VAX-31 | BIOLOGICAL | 31 valent pneumococcal conjugate vaccine |
Inclusion Criteria: 1. Healthy male or female infant ≥42 days to ≤89 days. 2. Full-term infant at least 37 weeks gestational age at birth. 3. Afebrile for ≥72 hours with an tympanic or rectal temperature \<38.0°C (\<100.4°F) before receipt of study vaccine.\*Criterion applies to each vaccination. I...