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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01434680 | Evaluating the Comparative Safety and Immunogenicity of Three Lots of Novartis Meningococcal C Conjugate Vaccine in Healthy Toddlers | PHASE2 | COMPLETED | 992 | — | — | Sep 1, 2011 | Nov 1, 2012 | Apr 25, 2017 | 11 | Poland |
Immunogenicity was measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs)against N meningitidis type C, at day 29 after a single vaccination when administered to toddlers to assess the equivalence of MenC-CRM LIQ to MenC-CRM EMV and MenC-CRM ROS to MenC-CRM EMV.
| Arm | Type | Description |
|---|---|---|
| MenC-CRM LIQ (Liquid Formulation) | EXPERIMENTAL | Subjects received 1 injection of MenC-CRM vaccine,liquid formulation. |
| MenC-CRM ROS (Rosia) | EXPERIMENTAL | Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy |
| MenC-CRM EMV (Emeryville) | ACTIVE_COMPARATOR | Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA |
| Name | Type | Description |
|---|---|---|
| MenC-CRM LIQ | BIOLOGICAL | One dose of MenC-CRM vaccine, liquid formulation |
| MenC-CRM ROS | BIOLOGICAL | One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy. |
| MenC-CRM EMV | BIOLOGICAL | One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA. |
Inclusion Criteria: 1. Healthy 12 - 23 (inclusive) month-old male or female toddlers. 2. A parent/legal guardian was given written informed consent after the nature of the study has been explained. 3. Available for both the visits scheduled in the study. 4. In good health as determined by medical h...