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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01214850 | Novartis Vaccine and Diagnostics Carriage Trial | PHASE3 | COMPLETED | 2,968 | — | — | Sep 1, 2010 | Jan 1, 2012 | Apr 21, 2016 | 10 | United Kingdom |
Percentages of subjects with carriage of virulent sequence types (ST) of Neisseria meningitidis group B, one month after completion of rMenB+OMV NZ vaccination. The carriage rate of virulent sequence types (ST) of N. meningitidis group B (genogroupable) in subjects, one month after receiving two doses of rMenB+OMV NZ, as compared to the control group, was reported. Virulent ST types are defined as Clonal Complex multi locus sequence typing (MLST) or ST type being the same compared to history data (Clonal Complexes MLST or ST types found to be virulent and causing diseases) from the years 2006 to 2010.
The percentage of subjects with combined carriage rate of N. meningitidis serogroups A, C, W and Y in subjects, one month after receiving a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.
| Arm | Type | Description |
|---|---|---|
| rMenB+OMV | EXPERIMENTAL | Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart |
| MenACWY | EXPERIMENTAL | Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart |
| Control | ACTIVE_COMPARATOR | Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart |
| Name | Type | Description |
|---|---|---|
| Meningococcal B Recombinant + Outer Membrane Vesicle vaccine (rMenB+OMV NZ) | BIOLOGICAL | - |
| MenACWY-CRM conjugate vaccine | BIOLOGICAL | - |
| Japanese Encephalitis vaccine | BIOLOGICAL | - |
Inclusion Criteria: * Healthy subjects, 18-24 years of age who provided written informed consent at the time of enrollment; * Subjects who were available for all the visits scheduled in the study; * Subjects who were in good health as determined by the outcome of medical history, physical examinati...