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Also known as 0.5 mL of the low dose VAX-31
of the low dose VAX-31 · 1 trial · 1 indication
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...
VAX-31 is an investigational pneumococcal vaccine being studied for use in healthy infants. It is designed to help prevent pneumococcal disease, which is caused by Streptococcus pneumoniae bacteria. The vaccine is currently in Phase 2 clinical development and has not yet been approved by regulatory authorities.
VAX-31 is a pneumococcal vaccine, meaning it targets Streptococcus pneumoniae bacteria. The vaccine is intended to elicit an immune response against pneumococcal strains to prevent infections such as pneumonia, bacteremia, and meningitis. It is being evaluated for its safety, tolerability, and immunogenicity in infants.
VAX-31 is being developed by Vaxcyte, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol PCVX. The company is conducting clinical trials to evaluate the vaccine's safety and effectiveness in preventing pneumococcal disease.
VAX-31 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The vaccine is being studied in a clinical trial to assess its safety, tolerability, and immunogenicity in healthy infants.
VAX-31 is being evaluated in a Phase 2 clinical trial with the identifier NCT06720038. This study is assessing the safety, tolerability, and immunogenicity of VAX-31 in healthy infants. The trial is active but not recruiting, with an enrollment of 900 participants across the United States and Puerto Rico.
Yes, VAX-31 is also known as 0.5 mL of the low dose VAX-31. This alternative name refers to a specific formulation or dosage of the vaccine being tested in clinical trials. Both names refer to the same investigational pneumococcal vaccine developed by Vaxcyte, Inc.