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 developed by Novartis AG for the prevention of meningococcal disease, including meningococcal meningitis. It is designed to protect against Neisseria meningitidis serogroup B and is being studied in healthy at-risk adults.
Recombinant meningococcal B+ OMV NZ is being developed for the prevention of meningococcal disease and meningococcal meningitis caused by serogroup B. It is intended for use in healthy at-risk adults aged 18 years and older.
Recombinant meningococcal B+ OMV NZ targets the F9 exogenous protein. By directing an immune response against this target, the vaccine aims to provide protection against meningococcal disease.
Recombinant meningococcal B+ OMV NZ is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical program for this meningococcal vaccine candidate.
Recombinant meningococcal B+ OMV NZ is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by the FDA. The Phase 3 program includes one completed trial.
Recombinant meningococcal B+ OMV NZ has been studied in a single Phase 3b trial, NCT01478347, titled a study to assess the safety of Novartis meningococcal B recombinant vaccine when administered in healthy at-risk adults. The trial was completed in Italy with 18 participants.