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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00356369 | Study in Adolescents/Adults to Evaluate Non-inferiority&Persistence up to 5 Years of GSK Bio MenACWY Conjugate Vaccine | PHASE2 | COMPLETED | 500 | — | — | Dec 23, 2006 | Feb 28, 2008 | Jul 3, 2018 | 3 | Philippines, Saudi Arabia |
Response to vaccine antigen was defined as: for initially seronegative subjects \[subjects with serum bactericidal assay using rabbit complement (rSBA) titer lower than (\<) 1:8, post-vaccination rSBA titer greater than or equal to (≥) 1:32\] and for initially seropositive (subjects with rSBA titer ≥ 1:8), at least 4-fold increase in rSBA titer from pre to post vaccination.
Local symptom, Grade 3 = pain that prevented normal activity and redness/ swelling spreading beyond (\>) 50 millimeters (mm). General symptom, Grade 3 = symptom that prevented normal activity and fever (orally) \>39.5 °C.
| Arm | Type | Description |
|---|---|---|
| Nimenrix Group | EXPERIMENTAL | Subjects receiving GSK Biologicals' meningococcal vaccine 134612 |
| Mencevax Group | ACTIVE_COMPARATOR | Subjects receiving Mencevax™ ACWY |
| Name | Type | Description |
|---|---|---|
| meningococcal ACWY (vaccine) | BIOLOGICAL | One intramuscular dose. |
| Mencevax™ ACWY | BIOLOGICAL | One subcutaneous dose. |
Inclusion Criteria: * Subjects who the investigator believes that they and/or their parents/ legally acceptable representative can and will comply with the requirements of the protocol. * A male or female between, and including, 11 and 55 years of age at the time of vaccination. * Written informed ...