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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01210885 | Immunogenicity and Safety of Different rMenB Plus MenACWY Formulations in Adolescents | PHASE2 | COMPLETED | 495 | — | — | Dec 1, 2010 | Jul 1, 2011 | Oct 24, 2011 | 8 | Chile, Colombia +1 |
| Arm | Type | Description |
|---|---|---|
| Group I: Investigational MenABCWY Formulation 1 | EXPERIMENTAL | - |
| Group II: Investigational MenABCWY Formulation 2 | EXPERIMENTAL | - |
| Group III: Investigational MenABCWY Formulation 3 | EXPERIMENTAL | - |
| Group IV: Investigational MenABCWY Formulation 4 | EXPERIMENTAL | - |
| Group V: Active comparator investigational MenB | ACTIVE_COMPARATOR | - |
| Group VI: Active comparator MenACWY | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Meningococcal Vaccine | BIOLOGICAL | MenABCWY combination vaccine containing four different rMenB formulations with MenACWY, intramuscular (IM) administration, vaccination at 0 and 2 months. |
Inclusion Criteria: Individuals eligible to be enrolled into this study are male and female subjects: 1. 11-18 years at the time of enrollment; 2. who have given their written consent/assent and whose parents or legal guardians have given written informed consent at the time of enrollment; 3. who ...