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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02012998 | Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO in Healthy Children Vaccinated 10 Years Ago With 3 Doses of HEXAVAC or INFANRIX HEXA | PHASE3 | COMPLETED | 751 | — | — | Jan 1, 2014 | Feb 1, 2015 | Sep 11, 2017 | 10 | Italy |
| Arm | Type | Description |
|---|---|---|
| HBVAXPRO Challenge dose | EXPERIMENTAL | HBVAXPRO 5µg |
| Name | Type | Description |
|---|---|---|
| HBVAXPRO 5µg | BIOLOGICAL | 0.5mL intramuscular injection |
Inclusion Criteria: * Healthy child * Child vaccinated with 3 doses of HEXAVAC or 3 doses of INFANRIX HEXA as infant * Child vaccinated with the third dose of HEXAVAC or INFANRIX HEXA at least 10 years prior to challenge dose Exclusion Criteria: * Receipt of more than 3 doses of any Hepatitis B c...