Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MenABCWY
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 by Novartis AG for the prevention of meningococcal disease. It is designed to cover meningococcal serogroups A, B, C, W, and Y, with OMV referring to outer membrane vesicles. It has completed Phase 2 clinical testing in healthy adolescents and young adults.
MenABCWY+OMV is being developed for the prevention of meningococcal disease, an infectious disease caused by Neisseria meningitidis. The vaccine candidate targets serogroups A, B, C, W, and Y. Its clinical trials enrolled healthy adolescents and young adults aged 10 years and older in the United States and Poland.
MenABCWY+OMV is developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the Phase 2 clinical program evaluating the vaccine candidate in healthy adolescents and young adults.
MenABCWY+OMV is in Phase 2 development. Both of its recorded clinical trials have been completed, and no trials are currently active. The vaccine candidate is investigational and has not been approved by the FDA for any indication.
MenABCWY+OMV has been studied in two completed Phase 2 trials. NCT02140762 evaluated the effectiveness, immunogenicity, and safety of the meningococcal ABCWY vaccine in 305 healthy adolescents in the United States. NCT01992536 was a placebo-controlled extension study of a booster dose given 24 months after the primary series, enrolling 194 participants in the United States and Poland.
Yes, MenABCWY+OMV is also known as MenABCWY. The two names refer to the same investigational vaccine candidate from Novartis AG. The OMV designation refers to outer membrane vesicles included in the formulation, while MenABCWY describes the meningococcal serogroups A, B, C, W, and Y that the vaccine targets.