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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01478347 | A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk Adults | PHASE3 | COMPLETED | 18 | — | — | May 1, 2013 | Nov 1, 2014 | Mar 27, 2015 | 1 | Italy |
The number of subjects with serious adverse events (SAE), medically attended adverse events and adverse events (AEs) leading to premature withdrawal, following two injections of rMenB+OMV NZ vaccine are reported.
The number of subjects (who had received two injections of rMenB + OMV NZ vaccine in the part I of this study) reporting unsolicited AEs during the safety follow-up in part II of the study, are reported. Unsolicited AEs in part two of the study include - AEs considered to be related to blood draw procedure and all SAEs.
| Arm | Type | Description |
|---|---|---|
| rMenB+OMV NZ | EXPERIMENTAL | Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of Recombinant meningococcal B (rMenB) + Outer Membrane Vesicle (OMV NZ) vaccine, 2 months apart, in part I of the study, were enrolled for optional blood draws and safety follow-up in part II of the study. |
| Name | Type | Description |
|---|---|---|
| Recombinant meningococcal B + OMV NZ | BIOLOGICAL | 2 injections 2 months apart |
Inclusion criteria: 1. 18 - 65 years of age inclusive who have given written informed consent at the time of enrollment; 2. Able to comprehend and follow all required study procedures; 3. Who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the en...