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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00387569 | Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers | PHASE1 | COMPLETED | 99 | — | — | Oct 1, 2006 | Mar 1, 2008 | May 8, 2008 | 1 | Australia |
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Experimental (20ug); Active Comparator/Placebo |
| Cohort 2 | EXPERIMENTAL | Experimental (60ug); Active Comparator/Placebo |
| Cohort 3 | EXPERIMENTAL | Experimental (200ug); Active Comparator/Placebo |
| Name | Type | Description |
|---|---|---|
| MnB vaccine rLP8026 | BIOLOGICAL | MnB vaccine at 20ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively) |
Inclusion Criteria * Aged 18- to 36-months * Healthy male or female subjects Exclusion Criteria * Prior vaccination with a serogroup B meningococcal vaccine * Prior history of any invasive meningococcal disease