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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00322361 | Modified Process Hepatitis B Vaccine in Healthy Neonates (V232-056) | PHASE2 | COMPLETED | 566 | — | — | May 1, 2006 | Jul 1, 2007 | Mar 16, 2017 | - | — |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Modified Process Hepatitis B Vaccine |
| 2 | ACTIVE_COMPARATOR | Recombivax HB™ |
| Name | Type | Description |
|---|---|---|
| Comparator: RECOMBIVAX HB™ | BIOLOGICAL | RECOMBIVAX HB™ 3 x 5-mcg regimen administered via intramuscular injection. |
| Comparator: Modified process Hepatitis B Vaccine | BIOLOGICAL | Modified Process Hepatitis B 3 x 5-mcg regimen administered via intramuscular injection. |
Inclusion Criteria: * Healthy male and female full-term (37-42 weeks gestation) neonates (birth to 10 days of age) * Born to mothers with documented negative test for HBsAg within 9 months prior to delivery Exclusion Criteria: * Infant born to mother with no prenatal care * Known or suspected imp...