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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04490499 | A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013) | PHASE3 | COMPLETED | 207 | — | — | Sep 2, 2020 | Dec 29, 2020 | Jul 27, 2022 | 10 | Finland |
Participant serum samples were collected for analysis with an enhanced chemiluminescence (ECi) assay to determine the concentration of antibodies to hepatitis B surface antigen (HBsAg). Response rate was the percentage of participants with a protective hepatitis B surface antibody (anti-HBs) level of ≥ 10 mIU/mL at Day 30 post-challenge.
| Arm | Type | Description |
|---|---|---|
| HBVAXPRO™ | EXPERIMENTAL | Healthy children vaccinated approximately 8-9 years previously with a 2- or 3-dose infant series and toddler dose of Vaxelis® who will receive a single dose of Hepatitis B vaccine challenge (HBVAXPRO™). |
| Name | Type | Description |
|---|---|---|
| HBVAXPRO™ | BIOLOGICAL | Single 0.5 mL intramuscular dose |
Inclusion Criteria: * Is healthy (based on a review of medical history and targeted physical examination) based on the clinical judgment of the investigator. * Has participated in Protocol V419-007 and received a 3 + 1 Vaxelis® schedule or participated in Protocol V419-008 and received a 2 + 1 Vaxe...