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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01682876 | Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 Through 10 Years of Age. | PHASE3 | COMPLETED | 715 | — | — | Oct 7, 2012 | May 30, 2014 | Jun 14, 2019 | 19 | United States |
Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 97.5% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, by serum bactericidal assay using human complement (hSBA) at 1 month after one vaccination or two vaccinations of MenACWY-CRM given two months apart. Seroresponse is defined as: a. postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer \<1:4; b. for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer.
Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 95% CI, directed against N. meningitidis serogroups A, C, W and Y, by hSBA at 1 month after one vaccination or two vaccinations of MenACWY-CRM. Seroresponse -postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer \<1:4 and for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer.
| Arm | Type | Description |
|---|---|---|
| 2 through 5 years (1 Vac) MenACWY-CRM 1 | PLACEBO_COMPARATOR | Subjects 2 through 5 years received one vaccination of MenACWY-CRM |
| 2 through 5 years (2 Vac) MenACWY-CRM 2 | ACTIVE_COMPARATOR | Subjects 2 through 5 years received two vaccinations of MenACWY-CRM |
| 6 through 10 years (1 Vac) MenACWY-CRM 3 | PLACEBO_COMPARATOR | Subjects 6 through 10 years received one vaccination of MenACWY-CRM |
| 6 through 10 years (2 Vac) MenACWY-CRM 4 | ACTIVE_COMPARATOR | Subjects 6 through 10 years received two vaccinations of MenACWY-CRM |
| Name | Type | Description |
|---|---|---|
| MenACWY-CRM | BIOLOGICAL | The investigational meningococcal (groups A, C, Y, and W-135 vaccine) oligosaccharide diphtheria CRM197 conjugate vaccine (MenACWY-CRM) was administered intramuscularly in the nondominant arm |
Inclusion Criteria: * Healthy children, 2 to 10 years of age who have up to date routine childhood vaccination, according to U.S. ACIP recommendations Exclusion Criteria: 1. Unwilling or unable to give written informed assent or consent to participate in the study. 2. Perceived to be unreliable o...