Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as 0.5 mL of the low dose VAX-31, of the low dose VAX-31, 0.5 mL of the mid dose VAX-31, of the mid dose VAX-31, 0.5 mL of the High-PFS dose VAX-31, of the High-PFS dose VAX-31, 31 valent pneumococcal conjugate vaccine, 31-valent pneumococcal conjugate vaccine
VAX-31 · 5 trials · 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
Solicited local reactions include redness/erythema, swelling/induration, and pain at injection site within 7 days after vaccination in each age group.
Solicited systemic reactions include fever, headache, fatigue, muscle pain, and joint pain.
Percentage of participants in each age group with adverse events (AEs) whose date of onset occurs after the study vaccine and within the 1 month after vaccination.
Percentage of participants with SAEs.
Percentage of participants with NOCIs
Percentage of participants with MAAEs.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 (VAX-31): Prior PPSV23 | EXPERIMENTAL | Participants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1 |
| Cohort 1 (PCV20): Prior PPSV23 | ACTIVE_COMPARATOR | Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1 |
| Cohort 2 (VAX-31): Prior PCV20 | EXPERIMENTAL | Participants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1 |
| Cohort 2 (PCV20): Prior PCV20 | ACTIVE_COMPARATOR | Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1 |
| Cohort 3 (VAX-31): Other prior licensed pneumococcal vaccine or combination | EXPERIMENTAL | Participants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1 |
| Cohort 3 (PCV20): Other prior licensed pneumococcal vaccine or combination | ACTIVE_COMPARATOR | Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1 |
| VAX-31 + SIV | EXPERIMENTAL | Participants will receive a single dose of VAX-31 administered as an intramuscular injection at Day 1, concomitantly administered with SIV, followed by placebo at Month 1. |
| Placebo + SIV | EXPERIMENTAL | Participants will receive placebo administered via intramuscular injection at Day 1, concomitantly administered with SIV, followed by VAX-31 at Month 1. |
| Cohort 1 (VAX-31), participant ≥ 50 years of age | EXPERIMENTAL | Participants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1 |
| Cohort 1 (PCV21), participant ≥ 50 years of age | ACTIVE_COMPARATOR | Participants will receive a single dose of PCV21 (Capvaxive) administered via intramuscular injection at Day 1 |
| Cohort 1 (PCV20), participant ≥ 50 years of age | ACTIVE_COMPARATOR | Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1 |
| Cohort 2 (VAX-31), participant 18-49 years of age | EXPERIMENTAL | Participants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1 |
| Cohort 2 (PCV20), participant 18-49 years of age | ACTIVE_COMPARATOR | Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1 |
| 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. |
| Group 1 | EXPERIMENTAL | Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1. 1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg. |
| Group 2 | EXPERIMENTAL | Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1. 2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg. |
| Group 3 | EXPERIMENTAL | Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1. 3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg. |
| Group 4 | ACTIVE_COMPARATOR | Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1. |
| Name | Type | Description |
|---|---|---|
| 31-valent pneumococcal conjugate vaccine | BIOLOGICAL | 0.5 mL of VAX-31 will be administered into the deltoid muscle |
| PCV20 | BIOLOGICAL | 0.5 mL of the 20-valent pneumococcal conjugate vaccine will be administered into the deltoid muscle |
| Seasonal Influenza Vaccine (SIV) (Flublok) | BIOLOGICAL | 0.5 mL of SIV into the deltoid muscle |
| Placebo | BIOLOGICAL | 0.5mL of placebo (normal saline) into the deltoid muscle |
| 31 valent pneumococcal conjugate vaccine | BIOLOGICAL | 0.5 mL of VAX-31 will be administered into the deltoid muscle |
| PCV21 | BIOLOGICAL | 0.5 mL of the 21 valent pneumococcal conjugate vaccine will be administered into the deltoid muscle |
| 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 |
| 20 valent pneumococcal conjugate vaccine | BIOLOGICAL | 0.5 ml dose of PCV20 was administered into the deltoid muscle at Day 1 |
Inclusion Criteria: * Male or female ≥50 years of age (inclusive) at the time of randomization into the study. * Previous receipt of a licensed pneumococcal vaccine or combination of licensed vaccines, with most recent vaccination ≥1 year prior to randomization; the exception is PCV21, which may ha...
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.