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 developed by Novartis AG for the prevention of meningococcal disease caused by serogroup B bacteria. It is a recombinant vaccine that combines recombinant proteins with outer membrane vesicles from the New Zealand strain. It is designed to stimulate immune protection against meningococcal B infection.
Meningococcal B Recombinant vaccine rMenB+OMV NZ is being developed for the prevention of meningococcal disease, which is caused by Neisseria meningitidis serogroup B. The vaccine is intended for use in adolescents aged 11 to 17 years, as studied in its clinical trial. It aims to provide active immunization against this bacterial infection.
Meningococcal B Recombinant vaccine rMenB+OMV NZ is being developed by Novartis AG, a pharmaceutical company traded under the ticker NVS. Novartis conducted the clinical development of this vaccine candidate for meningococcal disease.
Meningococcal B Recombinant vaccine rMenB+OMV NZ is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by the FDA. The Phase 3 trial for this vaccine has been completed.
Meningococcal B Recombinant vaccine rMenB+OMV NZ has been studied in one completed Phase 3 clinical trial, NCT01973218. This trial evaluated the safety and immunogenicity of two doses of the vaccine in adolescents aged 11 to 17 years in South Korea. It was a randomized, double-blind, active-controlled study that enrolled 264 healthy volunteers.