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rMenB+OMV NZ · 2 trials · 2 indications
The immunogenicity was assessed to evaluate the human serum bactericidal activity (hSBA) against the indicator strains of N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and M10713 strain at baseline and at one month after the second vaccination.
The immunogenicity was assessed to evaluate the hSBA in terms of geometric mean ratios within subjects against the indicator strains of N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 at one month after the second vaccination versus baseline.
The immunogenicity was assessed to evaluate the hSBA titers ≥ 1:5 in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine.
The immunogenicity was assessed to evaluate the human serum bactericidal activity titers ≥ 1:8 in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine.
The antibody responses were assessed to evaluate the four fold increase in human serum bactericidal activity titers in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine.
The antibody responses were assessed to evaluate the geometric mean concentrations as measured by Enzyme Linked Immunosorbent Assay (ELISA) in terms of percentages of subjects for the vaccine antigen 287-953 following a two dose vaccination schedule with rMenB+OMV NZ vaccine at baseline and at one month the second vaccination.
The antibody responses were assessed to evaluate the geometric mean ratios as measured by ELISA within the subjects for the vaccine antigen 287-953 following a two dose vaccination schedule with rMenB+OMV NZ vaccine at one month after the second vaccination versus baseline.
The antibody responses were assessed to evaluate the four fold increases in ELISA concentrations as measured by ELISA to the vaccine antigen 287-953 following a two dose vaccination schedule with rMenB+OMV NZ vaccine at one month the second vaccination over baseline.
The number of subjects with solicited local and systemic adverse events after receiving rMenB+OMV NZ (a two dose vaccination schedule) collected from day 1 through day 7 are reported.
Safety was assessed as the number of subjects who reported unsolicited adverse events as collected from Day 1 to Day 91 following rMenB+OMV vaccination (a two dose schedule). Unsolicited adverse events were collected from day 1 through day 7 after each vaccination, while serious adverse events, medically attended adverse events and adverse events leading to withdrawal from study were reported from day 1 through day 91.
Safety was assessed as the number of subjects who reported Serious Adverse Events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, as collected from day 1 to day 91 following vaccination with rMenB+OMV NZ (a two dose schedule ) are reported.
The percentage of subjects with serum bactericidal activity(hSBA)titer ≥1:5 after receiving three doses of rMenB+OMV NZ vaccine were evaluated to demonstrate sufficient immune response following rMenB+OMV NZ vaccination, when given concomitantly with routine infant vaccines to healthy infants. The serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA). The immune response was considered sufficient for groups B+R246 and B+R234 if the lower limit of the 2-sided 95% confidence interval was ≥ 70% for all three strains.
Safety and Tolerability of 3 Doses of rMenB was assessed in terms of the number of subjects who reported solicited local and systemic adverse events when administered concomitantly with routine infant vaccines at 2,4,6 months of age (B+R246) to when rMenB+OMV NZ and routine vaccines were administered separately (group B246\_R357).
| Arm | Type | Description |
|---|---|---|
| rMenB+OMV NZ | EXPERIMENTAL | A single 0.5mL dose of the study vaccine will be administered intramuscularly in the deltoid muscle. |
| B+R246 | EXPERIMENTAL | Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations. |
| B246_R357 | EXPERIMENTAL | Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age. |
| B+R234 | EXPERIMENTAL | Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations. |
| R234 | ACTIVE_COMPARATOR | Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age. |
| Name | Type | Description |
|---|---|---|
| rMenB+OMV NZ | BIOLOGICAL | Recombinant MenB with Outer Member Vesicle (OMV) from the New Zealand strain |
| combined diphtheria,tetanus,pertussis+polio+Hepatitis B+Haemophilus influenzae B vaccine | BIOLOGICAL | - |
| Pneumococcal vaccine | BIOLOGICAL | - |
Inclusion Criteria: 1. 18 - 65 years of age inclusive who have given written informed consent at the time of enrollment; 2. Who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period); 3. In good health as determined by medic...
rMenB is an investigational vaccine being developed for the prevention of meningococcal disease, including meningococcal infections and meningococcal meningitis. It is intended for use in healthy individuals, with clinical trials conducted in infants, toddlers, children, and adolescents.
rMenB 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 2 clinical development.
rMenB is in Phase 2 clinical development. It has completed seven clinical trials with a total enrollment of 5,555 participants. The vaccine is investigational and has not been approved by regulatory authorities.
rMenB has completed several Phase 2 trials, including NCT00433914 in healthy infants in the United Kingdom, NCT00661713 in healthy adolescents in Chile, NCT00944034 as a booster dose in toddlers across multiple European countries, and NCT01026974 as an extension study in UK children.
rMenB is a recombinant meningococcal B vaccine designed to elicit an immune response against Neisseria meningitidis serogroup B, the bacteria that cause meningococcal disease. Clinical trials evaluated its safety, tolerability, and immunogenicity, measuring antibody responses after vaccination.
rMenB is a meningococcal B recombinant vaccine. In clinical trials, it was studied alone and in combination with an outer membrane vesicle (OMV) component, referred to as rMenB plus OMV NZ, to assess antibody persistence and booster responses.