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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01352793 | A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years | PHASE3 | COMPLETED | 5,715 | — | — | Nov 1, 2012 | Sep 1, 2014 | Mar 11, 2015 | 86 | United States, Australia +10 |
An adverse event (AE) was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.
A medically attended AE was defined as a non-serious AE that required medical attention.
A medically attended AE was defined as a non-serious AE that required medical attention.
A medically attended AE was defined as a non-serious AE that required medical attention.
| Arm | Type | Description |
|---|---|---|
| rLP2086 vaccine | EXPERIMENTAL | rLP2086 vaccine |
| control | OTHER | The control treatment will be HAVRIX vaccine at month 0 and 6 and a normal saline injection at month 2. |
| Name | Type | Description |
|---|---|---|
| rLP2086 vaccine | BIOLOGICAL | 120 mcg, 3 doses, at month 0, 2, and 6. |
| control | BIOLOGICAL | HAVRIX: 720 EL.U. or 1440 EL.Ul, 2 doses, at month 0 and 6. Placebo: normal saline injection, 1 dose, at month 2. |
Inclusion Criteria: * Healthy subjects aged 10 to 25 years. Exclusion Criteria: * Previous vaccination with Hepatitis A virus vaccine * Previous vaccination with investigational meningococcal B vaccine * History of culture-proven N. meningitidis serogroup B disease * Any neuroinflammatory or auto...