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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00262028 | Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Children | PHASE2 | COMPLETED | 910 | — | — | Apr 1, 2005 | Nov 1, 2006 | Feb 11, 2016 | 1 | United States |
Number of subjects (2-10 years of age) achieving with hSBA titers ≥1:4 against Neisseria meningitidis serogroups A,C,W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
| Arm | Type | Description |
|---|---|---|
| MenACWY-CRM (2-10 years) | EXPERIMENTAL | Subjects received one dose of investigational MenACWY-CRM conjugate vaccine |
| MenACWY-CRM (12-23 months) | EXPERIMENTAL | Subjects received one dose of investigational MenACWY-CRM conjugate vaccine |
| MenACWY-PS (2-10 years) | ACTIVE_COMPARATOR | Subjects received one dose of licensed comparator MenACWY polysaccharide (MenACWY-PS) vaccine |
| MenACWY-CRM+PnC (12-15 months) | EXPERIMENTAL | Subjects received one dose of MenACWY-CRM vaccine alone or concomitantly with PnC |
| MenACWY-CRM+DTaP (16-23 months) | EXPERIMENTAL | Subjects received one dose of MenACWY-CRM vaccine alone or concomitantly with DTaP |
| Name | Type | Description |
|---|---|---|
| MenACWY-CRM Vaccine | BIOLOGICAL | - |
| MenACWY-PS Vaccine | BIOLOGICAL | - |
Inclusion Criteria: * Group 1: Healthy children 2-10 years of age; * Group 2: Healthy toddlers 12-23 months of age; who are up to date with age appropriate immunizations for diphtheria, tetanus, pertussis, polio, hepatitis B, Hemophilus influenzae type b, and pneumococcus. Exclusion Criteria: * G...