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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01973218 | Safety and Immunogenicity Study of Two Doses of Novartis Meningococcal Serogroup B Recombinant Vaccine in Adolescents Aged 11-17 Years. | PHASE3 | COMPLETED | 264 | — | — | Nov 1, 2013 | Apr 1, 2014 | Oct 30, 2015 | 7 | South Korea |
Percentage of subjects with SBA titers ≥1:4 against each of the three indicators strains H44/76, 5/99 and NZ98/254 of N. Meningitidis serogroup B, at one month after second vaccination, are reported for each group.
| Arm | Type | Description |
|---|---|---|
| rMenB | EXPERIMENTAL | Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study. |
| Placebo/MenACWY | ACTIVE_COMPARATOR | Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study. |
| Name | Type | Description |
|---|---|---|
| Meningococcal B Recombinant vaccine rMenB+OMV NZ | BIOLOGICAL | Subjects were randomized to one of two treatment groups to receive intramuscular (IM) vaccination with two doses of rMenV+OMV NZ vaccine (0.5 mL) in the non-dominant arm, one month apart. Subjects were followed for two months. |
| Placebo | BIOLOGICAL | Subjects were randomized to one of two treatment groups to receive intramuscular (IM) injection of saline solution followed by one dose of MenACWY-CRM vaccine (0.5 mL), one month apart. Subjects were followed for two months. |
| Meningococcal ACWY-CRM conjugate vaccine | BIOLOGICAL | Subjects were randomized to one of two treatment groups to receive intramuscular (IM) injection of saline solution followed by one dose of MenACWY-CRM vaccine (0.5 mL), one month apart. Subjects were followed for two months. |
Inclusion Criteria: 1. Adolescents 11-17 years of age inclusive who have given their written assent and whose parent or legal guardian has given written informed consent at the time of enrollment; 2. Available for all the visits scheduled in the study (i.e. not planning to leave the area before the...