Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Meningococcal B Recombinant vaccine rMenB+OMV NZ · 1 trial · 1 indication
Percentage of subjects with SBA titers ≥1:4 against each of the three indicators strains H44/76, 5/99 and NZ98/254 of N. Meningitidis serogroup B, at one month after second vaccination, are reported for each group.
| Arm | Type | Description |
|---|---|---|
| rMenB | EXPERIMENTAL | Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study. |
| Placebo/MenACWY | ACTIVE_COMPARATOR | Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study. |
| Name | Type | Description |
|---|---|---|
| Meningococcal B Recombinant vaccine rMenB+OMV NZ | BIOLOGICAL | Subjects were randomized to one of two treatment groups to receive intramuscular (IM) vaccination with two doses of rMenV+OMV NZ vaccine (0.5 mL) in the non-dominant arm, one month apart. Subjects were followed for two months. |
| Placebo | BIOLOGICAL | Subjects were randomized to one of two treatment groups to receive intramuscular (IM) injection of saline solution followed by one dose of MenACWY-CRM vaccine (0.5 mL), one month apart. Subjects were followed for two months. |
| Meningococcal ACWY-CRM conjugate vaccine | BIOLOGICAL | Subjects were randomized to one of two treatment groups to receive intramuscular (IM) injection of saline solution followed by one dose of MenACWY-CRM vaccine (0.5 mL), one month apart. Subjects were followed for two months. |
Inclusion Criteria: 1. Adolescents 11-17 years of age inclusive who have given their written assent and whose parent or legal guardian has given written informed consent at the time of enrollment; 2. Available for all the visits scheduled in the study (i.e. not planning to leave the area before the...
Meningococcal B Recombinant vaccine rMenB+OMV NZ is an investigational vaccine being developed for the prevention of Meningococcal Disease, a serious bacterial infection. It is currently in Phase 3 clinical development and has been studied in adolescents aged 11 to 17 years.
Meningococcal B Recombinant vaccine rMenB+OMV NZ is being developed by Novartis AG, a global healthcare company traded on the New York Stock Exchange under the ticker symbol NVS. The vaccine is currently in Phase 3 clinical trials for the prevention of Meningococcal Disease.
Meningococcal B Recombinant vaccine rMenB+OMV NZ is in Phase 3 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. One Phase 3 trial has been completed, and the vaccine is being studied for the prevention of Meningococcal Disease.
Meningococcal B Recombinant vaccine rMenB+OMV NZ has been studied in one completed Phase 3 clinical trial, identified as NCT01973218. This trial evaluated the safety and immunogenicity of two doses of the vaccine in adolescents aged 11 to 17 years in South Korea, with a total enrollment of 264 participants.
Meningococcal B Recombinant vaccine rMenB+OMV NZ is not FDA approved. It is an investigational vaccine currently in Phase 3 clinical development for the prevention of Meningococcal Disease. The vaccine has completed one Phase 3 trial, but regulatory approval has not been granted.