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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04193215 | V114 and Acute Otitis Media (V114-032/PNEU-ERA) | PHASE3 | COMPLETED | 7,119 | — | — | Sep 12, 2020 | Dec 22, 2025 | Jan 22, 2026 | 13 | Thailand |
The number of participants with VT-AOM will be presented.
A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.
A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.
A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.
The percentage of participants who died from any cause during the study will be assessed.
| Arm | Type | Description |
|---|---|---|
| V114 | EXPERIMENTAL | Participants will receive an intramuscular (IM) injection. |
| Control | OTHER | - |
| Name | Type | Description |
|---|---|---|
| V114 | BIOLOGICAL | IM injection |
| Pediatric vaccines | OTHER | Standard of care vaccines administered according to the local recommended schedule. |
Inclusion Criteria: * Is healthy (based on a review of medical history and physical examination) * Is male or female, approximately 2 months of age, from 42 days to 90 days of age Exclusion Criteria: * Was born prior to 37 weeks of gestation. * Has a history of invasive pneumococcal disease (IPD)...