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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00317109 | Study to Asses DTPw-HBV/Hib at 15-18 Months (m) and Mencevax™ ACW at 24 to 30 m in Primed Subjects | PHASE3 | COMPLETED | 168 | — | — | Apr 19, 2006 | May 17, 2007 | Jun 6, 2018 | 3 | South Africa |
| NCT00291343 | Immune Response & Safety of GSK Biologicals' Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study | PHASE3 | COMPLETED | 296 | — | — | Feb 1, 2006 | Mar 15, 2007 | Jun 6, 2018 | 2 | Philippines |
Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:128.
Antibody cut-offs were higher than or equal to (≥) 1:128
| Arm | Type | Description |
|---|---|---|
| AC primed Group | EXPERIMENTAL | - |
| AC unprimed Group | ACTIVE_COMPARATOR | - |
| TRITANRIX™-HEPB/HIB-MENAC +MENCEVAX™ ACWY GROUP | EXPERIMENTAL | Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age. |
| TRITANRIX™-HEPB/HIBERIX™+MENCEVAX™ ACWY GROUP | ACTIVE_COMPARATOR | Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age. |
| Name | Type | Description |
|---|---|---|
| Tritanrix™- HepB | BIOLOGICAL | One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months |
| Hiberix™ | BIOLOGICAL | One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months |
| Mencevax™ ACW | BIOLOGICAL | One subcutaneous dose during the booster vaccination study in subjects aged 24 to 30 months |
| Mencevax™ ACWY | BIOLOGICAL | One full subcutaneous dose in subjects aged 24 to 30 months or 1/5th of a dose intramuscular in subjects aged 30 to 36 months |
Inclusion Criteria: * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * A male or female between, and including, 15 and 18 months of age at the time of vaccination. * Written informed consent obtained from the parent or ...