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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01018732 | A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY | PHASE2 | COMPLETED | 155 | — | — | Jan 1, 2010 | Jul 1, 2010 | Jul 15, 2015 | 3 | United States |
Persistence of antibody response was measured by the percentage of subjects who showed a serum bactericidal activity with human complement(hSBA) \>= 8 \[i.e. percentage of subjects with hsBA titer \>=8\] in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y
Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) and reported as hSBA Geometric mean titer (GMT) in previously vaccinated subjects and in age-matched meningococcal vaccine-naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y
| Arm | Type | Description |
|---|---|---|
| I: MenACWY-CRM vaccine | EXPERIMENTAL | Subjects had been given one dose of Meningococcal ACWY (MenACWY) vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago. All subjects were given one dose of the Men ACWY in the present study. |
| II: Licensed Polysaccharide Meningococcal vaccine | EXPERIMENTAL | Subjects had been given one dose of a licensed MenACWY polysaccharide meningococcal vaccine (Menomune) 5 years ago. All subjects were given one dose of Men ACWY vaccine in the present study. |
| III: Meningococcal Naive | EXPERIMENTAL | Subjects were age matched with groups 1 and 2 (age inclusive: 16 years to 23 years) and enrolled at visit 1 and given one dose of Men ACWY vaccine during the present study. |
| Name | Type | Description |
|---|---|---|
| Novartis Meningococcal (MenACWY-CRM) vaccine | BIOLOGICAL | All subjects will have blood draws at Day 1, Day 8, and Day 29. |
Inclusion Criteria: * Healthy adolescents or adults (age 16-23 years inclusive), either previously enrolled in the parent study or naïve to meningococcal vaccination. * Female subjects were to be negative for pregnancy Exclusion Criteria: * History of meningococcal disease * Receipt of any mening...