Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02140762 | Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents | PHASE2 | COMPLETED | 305 | — | — | May 1, 2014 | Feb 1, 2015 | Sep 12, 2018 | 8 | United States |
| NCT01992536 | Phase 2, Observer-Blind, Placebo-Controlled, Randomized, Multi-Center Extension Study to Evaluate the Safety and Immunogenicity of a Booster Dose of a MenABCWY Vaccine Administered 24 Months Following the Primary Series to Adolescents and Young Adults Who Participated in V102_03 (NCT01272180) | PHASE2 | COMPLETED | 194 | — | — | Dec 1, 2013 | Apr 1, 2015 | Oct 25, 2016 | 13 | United States, Poland |
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...