Approval Probability
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MenABCWY+OMV · 2 trials · 1 indication
The combined percentage of subjects without bactericidal activity at 1:4 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at one month after the second injection. The percentage of subjects without bactericidal activity at 1:4 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains. Least Square (LS)-mean computed from the generalized linear model.
Percentages of subjects having HT-hSBA seroresponse against N. meningitidis serogroups A, C, W and Y, following administration of a booster dose of MenABCWY, in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102\_03 (NCT01272180). Seroresponse to N. meningitidis serogroups A, C, W and Y is defined as: for subjects with a pre-vaccination HT-hSBA titer \< 1:4, a post-vaccination hSBA titer ≥ 1:8; for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.
Percentage of subjects reporting HT-hSBA titers ≥ 1:5 against strains of N. meningitidis serogroups B at baseline (Day 1) and one month (Day 30) following administration of a booster dose of MenABCWY, in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102\_03 (NCT01272180).
| Arm | Type | Description |
|---|---|---|
| MenABCWY | EXPERIMENTAL | Subjects received one dose of MenABCWY vaccine at day 1 and a second dose after 2 months |
| Placebo/MenACWY | ACTIVE_COMPARATOR | Subjects received one dose of placebo at day 1 and one dose of MenACWY vaccine after 2 months |
| Ia: MenABCWY+OMV | EXPERIMENTAL | Investigational |
| Ib: Placebo | PLACEBO_COMPARATOR | Saline |
| IIa: MenABCWY+¼OMV | EXPERIMENTAL | Investigational |
| IIb: Placebo | PLACEBO_COMPARATOR | Saline |
| IIIa: MenABCWY+OMV | EXPERIMENTAL | Investigational |
| IIIb: MenABCWY+¼OMV | EXPERIMENTAL | Investigational |
| IVa: MenABCWY+OMV | EXPERIMENTAL | Investigational |
| IVb: MenABCWY+¼OMV | EXPERIMENTAL | Investigational |
| IVc: Placebo | PLACEBO_COMPARATOR | Saline |
| Name | Type | Description |
|---|---|---|
| MenABCWY | BIOLOGICAL | Subjects received one dose of 0.5 mL MenABCWY vaccine (intramuscular (IM) injection) at day 1 and a second dose after 2 months. |
| Placebo | OTHER | 0.5 mL saline solution (IM) |
| MenACWY | BIOLOGICAL | Subjects received one dose of 0.5 mL placebo (IM) at day 1 and one dose of 0.5 mL MenACWY vaccine (IM) after 2 months. |
| MenABCWY+OMV | BIOLOGICAL | Vaccine contains rMenB (50 µg per antigen) with 25 µg of OMV (a "full" dose) plus the fully lyophilized MenACWY vaccine |
| MenABCWY+¼OMV | BIOLOGICAL | Vaccine contains rMenB (50 µg per antigen) with 6.25 µg OMV (1/4 dose) plus the fully lyophilized MenACWY vaccine |
Inclusion Criteria: * Adolescents from 10-18 years of age, generally in good health, and available for all study visits, who/whose legally acceptable representative has given written informed consent at the time of enrollment. * Female subjects of childbearing potential must have a negative urine p...
MenABCWY+OMV is an investigational vaccine being developed for the prevention of meningococcal disease. It is currently in Phase 2 clinical development and has been studied in healthy adolescents and young adults.
MenABCWY+OMV is being developed by Novartis AG, which trades on the New York Stock Exchange under the ticker symbol NVS.
MenABCWY+OMV is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. Two Phase 2 trials have been completed.
MenABCWY+OMV has been studied in two completed Phase 2 trials. NCT01992536 evaluated a booster dose in adolescents and young adults, and NCT02140762 assessed effectiveness, immunogenicity, and safety in healthy adolescents.
MenABCWY+OMV is a vaccine candidate that includes the MenABCWY components plus an outer membrane vesicle (OMV). The clinical trials listed for this asset are specifically for the MenABCWY vaccine, which is the same drug candidate.