Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Recombinant meningococcal B+ OMV NZ · 1 trial · 2 indications
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...
Recombinant meningococcal B+ OMV NZ is an investigational vaccine being studied for the prevention of meningococcal disease, including meningococcal meningitis. It is intended for use in healthy adults at risk of infection. The vaccine is currently in Phase 3 clinical development.
Recombinant meningococcal B+ OMV NZ is being developed by Novartis AG, which trades under the ticker NVS. The company is conducting clinical trials to evaluate the vaccine's safety in healthy adults at risk for meningococcal disease.
Recombinant meningococcal B+ OMV NZ is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 3b study has been completed to assess its safety in healthy at-risk adults.
Recombinant meningococcal B+ OMV NZ has one completed clinical trial, NCT01478347, a Phase 3b study assessing the safety of the vaccine in healthy at-risk adults in Italy. The trial enrolled 18 participants aged 18 years and older and was not randomized or blinded.
Recombinant meningococcal B+ OMV NZ is classified as a monoclonal antibody modality, though it is being developed as a vaccine against meningococcal disease. It is designed to elicit an immune response to prevent infection in at-risk adult populations.