Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as of the low dose VAX-31, of the mid dose VAX-31, of the High-PFS dose VAX-31, 31-valent pneumococcal conjugate vaccine
VAX-31 · 5 trials · 2 indications
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 a 31-valent pneumococcal conjugate vaccine developed by Vaxcyte for the prevention of pneumococcal disease. It is an investigational vaccine in Phase 3 clinical development and has received Breakthrough Therapy designation from the FDA. It is studied in adults 50 years and older and in healthy infants.
VAX-31 is being developed for pneumococcal disease and pneumococcal vaccines, targeting prevention of disease caused by pneumococcal bacteria. Its clinical program evaluates safety, tolerability, and immunogenicity in adults aged 50 and older, adults 18 to 49, and healthy infants.
VAX-31 is made by Vaxcyte, Inc., a biopharmaceutical company that trades under the ticker PCVX. Vaxcyte is the developer of the 31-valent pneumococcal conjugate vaccine and sponsors its clinical trial program.
VAX-31 is in Phase 3 clinical development. It is investigational and is being evaluated in Phase 3 trials in adults, alongside a Phase 2 study in healthy infants. The FDA has granted VAX-31 Breakthrough Therapy designation.
VAX-31 has been studied in four trials. Phase 3 studies include NCT07425392 in previously vaccinated adults 50 and older, NCT07365826 with influenza vaccine coadministration, and NCT07284654, a completed immunobridging study. A Phase 2 infant study is NCT06720038.
Yes. VAX-31 is the same as the 31-valent pneumococcal conjugate vaccine, also written as 31 valent pneumococcal conjugate vaccine. Trial documents also refer to dose levels such as 0.5 mL of the low dose, mid dose, and High-PFS dose of VAX-31.