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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02285777 | Assessing the Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents | PHASE2 | COMPLETED | 189 | — | — | Dec 1, 2014 | Jun 11, 2015 | Sep 24, 2018 | 8 | United States |
The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 1 month after the 3-dose vaccination series was evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:4 dilution using the human Serum Bactericidal Assay (hSBA) against each strain in MenABCWY group and MenACWY group. The data provided is an average of the percentage of subjects without bactericidal activity at 1:4 dilution across all 110 strains.
| Arm | Type | Description |
|---|---|---|
| MenABCWY Group | EXPERIMENTAL | Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study. |
| MenACWY Group | ACTIVE_COMPARATOR | Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study. |
| Name | Type | Description |
|---|---|---|
| Meningococcal ABCWY | BIOLOGICAL | One dose administered intramuscularly in the deltoid area of a non-dominant arm at Month 6 (Visit 1) |
| Placebo | BIOLOGICAL | One dose of placebo administered intramuscularly in the deltoid area of a non-dominant arm at Month 6 (Visit 1) |
Inclusion Criteria: * Adolescents who completed V102\_16 study and received the study vaccines as assigned in the protocol (either two doses of the MenABCWY or one dose each of MenACWY and Placebo). Exclusion Criteria: * Serious, acute, or chronic illnesses. Previous or suspected disease caused b...