Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Meningococcal B Recombinant+ Outer Membrane Vesicle vaccine · 1 trial · 1 indication
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...
It is an investigational vaccine developed by Novartis AG (ticker NVS) that targets Neisseria meningitidis carriage. The vaccine combines recombinant meningococcal B proteins with outer membrane vesicles. It is in Phase 3 development and has been studied in healthy adult volunteers in the United Kingdom.
It is being developed to prevent or reduce Neisseria meningitidis carriage, the condition studied in its clinical program. Carriage refers to the presence of the bacteria in the nose and throat, which is how meningococcal infection spreads between people. The vaccine is investigational and has not been approved for use.
Novartis AG, which trades under the ticker NVS, is the developer of the Meningococcal B Recombinant + Outer Membrane Vesicle vaccine. The company sponsored the Phase 3 carriage trial conducted in the United Kingdom.
The vaccine is in Phase 3 development. Its only listed trial, NCT01214850, is a completed Phase 3 study, and no active trials are currently recorded. It is an investigational vaccine and is not described as approved.
The vaccine has been evaluated in one completed Phase 3 trial, NCT01214850, titled the Novartis Vaccine and Diagnostics Carriage Trial. It enrolled 2,968 healthy adult volunteers of all sexes in the United Kingdom, was randomized, and used an active control. The study examined Neisseria meningitidis carriage.