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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06182124 | A Study to Learn About the Safety and Immune Response of a New Pneumococcal Vaccine in Adults | PHASE1 | ACTIVE NOT_RECRUITING | 558 | — | — | Dec 20, 2023 | May 23, 2026 | Oct 14, 2025 | 18 | United States |
Prespecified local reactions (redness, swelling, and pain at the injection site) after vaccination
Prespecified systemic events (fever, headache, fatigue, muscle pain, and joint pain) after vaccination
Adverse events occurring within 1 month after vaccination
SAEs occurring within 6 months after vaccination
Related SAEs occurring through 12 months after vaccination
| Arm | Type | Description |
|---|---|---|
| Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 1 | EXPERIMENTAL | Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 1. This is a possible candidate for continuation in Phase 2 (Stage 2, 3, and 4). |
| Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 2 | EXPERIMENTAL | Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 2. This is a possible candidate for continuation in Phase 2 (Stage 2, 3, and 4). |
| Phase 1 (Stage 1) and Phase 2 (Stage 2): 20-valent pneumococcal conjugate vaccine (20vPnC) | ACTIVE_COMPARATOR | Participants to receive a single injection of 20vPnC. |
| Phase 2 (Stage 3): a licensed pneumococcal comparator vaccine | ACTIVE_COMPARATOR | Participants to receive a single injection of a licensed pneumococcal comparator vaccine. |
| Phase 2 (Stage 4): Multivalent Pneumococcal Vaccine - Formulation 3 | EXPERIMENTAL | Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 3. |
| Phase 2 (Stage 4): Multivalent Pneumococcal Vaccine - Formulation 4 | EXPERIMENTAL | Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 4. |
| Name | Type | Description |
|---|---|---|
| Multivalent Pneumococcal Vaccine - Formulation 1 | BIOLOGICAL | Multivalent pneumococcal conjugate vaccine. This is a possible candidate for continuation in Phase 2 (Stages 2, 3, and 4). |
| Multivalent Pneumococcal Vaccine - Formulation 2 | BIOLOGICAL | Multivalent pneumococcal conjugate vaccine. This is a possible candidate for continuation in Phase 2 (Stages 2, 3, and 4). |
| 20-valent pneumococcal conjugate vaccine (20vPnC) | BIOLOGICAL | 20-valent pneumococcal conjugate vaccine (20vPnC) |
| Licensed pneumococcal comparator vaccine | BIOLOGICAL | A licensed pneumococcal comparator vaccine |
| Multivalent Pneumococcal Vaccine - Formulation 3 | BIOLOGICAL | Multivalent pneumococcal conjugate vaccine |
| Multivalent Pneumococcal Vaccine - Formulation 4 | BIOLOGICAL | Multivalent pneumococcal conjugate vaccine |
Inclusion Criteria: * Male or female participants ≥18 to\<50 years of age (Stage 1) and ≥50 years of age (Stage 2, Stage 3, and Stage 4) at the time of consent * Adults determined by clinical assessment to be eligible for the study, including adults with preexisting stable disease within 12 weeks b...