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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00326118 | Study in Toddlers to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC & to Evaluate Persistence up to 5 Years. | PHASE3 | COMPLETED | 433 | — | — | Jun 1, 2006 | Nov 6, 2007 | Aug 24, 2018 | 7 | Australia |
Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of short-term protection.
rSBA-MenC titers greater than or equal to 1:8 titer are indicative of seroprotection.
| Arm | Type | Description |
|---|---|---|
| Meningitec + Hiberix Group | ACTIVE_COMPARATOR | Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm. |
| Menitorix Group | EXPERIMENTAL | Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm. |
| Name | Type | Description |
|---|---|---|
| Haemophilus influenzae type b and meningococcal serogroup C (vaccine) | BIOLOGICAL | One intramuscular dose at 12-18 months of age |
| Priorix™ | BIOLOGICAL | One subcutaneous dose at 12-18 months of age |
| Hiberix™ | BIOLOGICAL | One intramuscular dose at 12-18 months of age. |
| Meningitec™ | BIOLOGICAL | One intramuscular dose at 12-18 months of age |
Inclusion Criteria: Primary phase: * Subjects whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * A male or female between, and including, 12 and 18 months of age at the time of vaccination. * Written informed consent obtained fr...