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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00808028 | A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents | PHASE2 | COMPLETED | 538 | — | — | Feb 1, 2009 | Mar 1, 2014 | Apr 14, 2015 | 27 | Australia, Poland +1 |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | dose level 1 rLP2086 vaccine |
| 2 | EXPERIMENTAL | dose level 2 rLP2086 vaccine |
| 3 | EXPERIMENTAL | dose level 3 rLP2086 vaccine |
| 4 | PLACEBO_COMPARATOR | normal saline (placebo) |
| Name | Type | Description |
|---|---|---|
| meningococcal B rLP2086 vaccine. | BIOLOGICAL | vaccine, 0.5 mL, 0 - 2 - 6 to 9 months |
| normal saline (placebo) | OTHER | vaccine, 0.5 mL, 0 - 2 - 6 to 9 months |
Inclusion Criteria: * Healthy male or female subjects between the ages of \>=11 and \<=18 years at the time of enrollment. * Negative urine pregnancy test for all female subjects. * Parent/legal guardian or subject under supervision of the parent/legal guardian must be able to complete all relevant...