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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07086677 | A Study to Learn About How a New Pneumococcal Vaccine Works in Adults | PHASE1 | ACTIVE NOT_RECRUITING | 380 | — | — | Jul 22, 2025 | Oct 21, 2027 | Apr 8, 2026 | 19 | United States |
Prespecified local reactions (redness, swelling, and pain at the injection site) occurring within 7 days of each dose administered in the study.
Prespecified systemic reactions (fever, vomiting, diarrhea, headache, fatigue, muscle pain, and joint pain) occurring within 7 days of each dose administered in the study.
Adverse Events (AEs) occurring from Dose 1 through 1 month after the last vaccination
Serious Adverse Events (SAEs) occurring from Dose 1 through 6 months after the last vaccination.
Any abnormal hematology or chemistry laboratory values as compared to baseline within 2 weeks after each study intervention.
| Arm | Type | Description |
|---|---|---|
| PG4 vaccine with low dose adjuvant PA-001; dose schedule 1 | EXPERIMENTAL | - |
| PG4 vaccine with low dose adjuvant PA-001; dose schedule 2 | EXPERIMENTAL | - |
| PG4 vaccine with low dose adjuvant PA-002; dose schedule 1 | EXPERIMENTAL | - |
| PG4 vaccine with low dose adjuvant PA-002; dose schedule 2 | EXPERIMENTAL | - |
| PG4 vaccine with high dose adjuvant PA-001; dose schedule 1 | EXPERIMENTAL | - |
| PG4 vaccine with high dose adjuvant PA-001; dose schedule 2 | EXPERIMENTAL | - |
| PG4 vaccine with high dose adjuvant PA-002; dose schedule 1 | EXPERIMENTAL | - |
| PG4 vaccine with high dose adjuvant PA-002; dose schedule 2 | EXPERIMENTAL | - |
| PG4 vaccine; dose schedule 1 | ACTIVE_COMPARATOR | - |
| PG4 vaccine; dose schedule 2 | ACTIVE_COMPARATOR | - |
| 20vPnC; dose schedule 1 | ACTIVE_COMPARATOR | - |
| 20vPnC; dose schedule 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PG4 vaccine in Buffer 1 with low dose PA-001 | BIOLOGICAL | Multivalent pneumococcal conjugate vaccine |
| PG4 in Buffer 1 with low dose PA-002 | BIOLOGICAL | Multivalent pneumococcal conjugate vaccine |
| PG4 in Buffer 1 with high dose PA-001 | BIOLOGICAL | Multivalent pneumococcal conjugate vaccine |
| PG4 vaccine in Buffer 1 with high dose PA-002 | BIOLOGICAL | Multivalent pneumococcal conjugate vaccine |
| PG4 vaccine in Buffer 2 | BIOLOGICAL | Multivalent pneumococcal conjugate vaccine |
| 20-valent pneumococcal conjugate vaccine | BIOLOGICAL | (20vPnC) |
| Saline injection | BIOLOGICAL | Placebo |
Key Inclusion Criteria: * Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. * Participants either with no history of ever receiving a pneumococcal vaccine or who have r...