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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07425392 | Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Prior Pneumococcal Vaccination | PHASE3 | ACTIVE NOT_RECRUITING | 752 | — | — | Feb 9, 2026 | Mar 1, 2027 | May 14, 2026 | 30 | United States |
| NCT07365826 | A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age | PHASE3 | ACTIVE NOT_RECRUITING | 1,390 | — | — | Jan 12, 2026 | Mar 1, 2027 | May 15, 2026 | 25 | United States |
| NCT07284654 | Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Immunobridging to Adults 18-49 | PHASE3 | ACTIVE NOT_RECRUITING | 4,049 | — | — | Dec 1, 2025 | Jan 1, 2027 | May 15, 2026 | 30 | United States |
| NCT06151288 | Safety, Tolerability, and Immunogenicity Study of a 31-Valent Pneumococcal Conjugate Vaccine (VAX-31) in Adults | PHASE1 | COMPLETED | 1,015 | — | — | Nov 8, 2023 | Jul 17, 2024 | Jul 28, 2025 | 25 | United States |
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 |
| 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 |
| 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...