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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01274897 | A Multi-center, Observer-blind, Placebo-controlled, Randomized Study to Evaluate the Immunogenicity and Safety of MenACWY in Adolescents and Adults in Korea | PHASE3 | COMPLETED | 450 | — | — | Dec 1, 2010 | Mar 1, 2011 | Oct 16, 2012 | 8 | South Korea |
Immunogenicity was measured as the percentage of subjects with hSBA response and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y by serum bactericidal assay using human complement, human serum bactericidal assay (hSBA), at day 29 (28 days after MenACWY-CRM vaccination). Seroresponse is defined as: 1. for subjects with a pre-vaccination hSBA titer \< 1:4, a postvaccination hSBA titer ≥ 1:8. 2. for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.
| Arm | Type | Description |
|---|---|---|
| MenACWY-CRM | EXPERIMENTAL | Subjects received one dose of MenACWY-CRM conjugate vaccine. |
| Placebo | PLACEBO_COMPARATOR | Subjects received the saline placebo. |
| Name | Type | Description |
|---|---|---|
| Novartis MenACWY-CRM | BIOLOGICAL | All subjects had blood drawn at Day 1 and Day 29. |
| Saline Placebo | BIOLOGICAL | All subjects had blood drawn at Day 1 and Day 29. |
Inclusion Criteria: Individuals eligible for enrollment in this study were those: 1. who were 11-55 years of age inclusive and who, after the nature of the study had been explained: 1. had given written assent and/or for whom the parent/legal representative had provided written informed consen...