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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07247188 | Study of a Single Dose of a 21-valent Pneumococcal Conjugate Vaccine in Children and Adolescents With Sickle Cell Disease | PHASE3 | RECRUITING | 100 | — | — | Jan 20, 2026 | Jan 7, 2027 | Apr 15, 2026 | 7 | United States, Dominican Republic |
Unsolicited (spontaneously reported) systemic AEs after injection of a pneumococcal vaccine
SAEs and AESIs are collected throughout the study period
Ab (antibody) concentrations for each pneumococcal serotype measured by electro-chemiluminescence (ECL) assay
| Arm | Type | Description |
|---|---|---|
| Investigated Vaccine: PCV21 | EXPERIMENTAL | Participants will receive 1 intramuscular injection of the pneumococcal vaccine |
| Comparator Vaccine: 20vPCV | ACTIVE_COMPARATOR | Participants will receive 1 intramuscular injection of the pneumococcal vaccine |
| Name | Type | Description |
|---|---|---|
| PCV21 | BIOLOGICAL | Investigational pneumococcal conjugate vaccine |
| 20vPCV | BIOLOGICAL | 20-valent pneumococcal conjugate vaccine |
Inclusion Criteria: AGE * Aged 2 to 17 years on the day of inclusion. TYPE OF PARTICIPANT AND DISEASE CHARACTERISTICS * Participants who have a documented diagnosis of sickle cell disease (SCD) in their medical record. SEX, CONTRACEPTIVE/BARRIER METHOD AND PREGNANCY TESTING REQUIREMENTS * A pa...