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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01154088 | Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Versus Mencevax™ ACWY in Healthy 18-25 Year Olds | PHASE3 | COMPLETED | 1,170 | — | — | Aug 27, 2010 | Dec 30, 2010 | Nov 26, 2018 | 3 | Panama, Philippines +1 |
| NCT00427908 | Study in Children to Evaluate Non-Inferiority and Persistence up to 5 Years of GSK Bio Meningococcal Vaccine 134612 | PHASE2 | COMPLETED | 613 | — | — | Feb 7, 2007 | Dec 3, 2007 | Jun 4, 2018 | 11 | Finland |
Vaccine response defined as: for initially seronegative subjects, antibody titer greater than or equal to (≥) 1:32 and for initially seropositive subjects: antibody titer ≥ 4 fold the pre-vaccination antibody titer. The analysis was performed with the GSK rSBA assay.
Titers are presented as geometric mean titers (GMTs). All subjects underwent testing with the GSK rSBA assay for all 4 serogroups.
Vaccine response was defined as: * for initially seronegative subjects, post vaccination rSBA titer ≥ 1:32 * for initially seropositive subjects, at least 4-fold increase in rSBA titer from pre to post vaccination.
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | - |
| Group B | EXPERIMENTAL | - |
| Group C | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Mencevax ACWY | BIOLOGICAL | One dose, Subcutaneous injection |
| GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612] | BIOLOGICAL | One dose, Intramuscular injection |
| GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix) | BIOLOGICAL | One intramuscular dose. |
| Mencevax™ ACWY | BIOLOGICAL | One subcutaneous dose. |
| Meningitec™ | BIOLOGICAL | One intramuscular dose. |
Inclusion Criteria: All subjects must satisfy all of the following criteria at study entry: * Subjects whom the investigator believes they can and will comply with the requirements of the protocol will be enrolled in the study. * A male or female between, and including, 18 and 25 years of age the ...