Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix)
GSK Biolgicals' meningococcal vaccine 134612 · 1 trial · 1 indication
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 | All subjects received GSK Biolgicals' meningococcal vaccine 134612. |
| Group B | ACTIVE_COMPARATOR | Subjects including and above two years of age received Mencevax™ ACWY, subjects below two years of age received Meningitec™. |
| Name | Type | Description |
|---|---|---|
| GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix) | BIOLOGICAL | One intramuscular dose. |
| Mencevax™ ACWY | BIOLOGICAL | One subcutaneous dose. |
| Meningitec™ | BIOLOGICAL | One intramuscular dose. |
Inclusion Criteria: * Subjects who the investigator believes that their parent or guardian can and will comply with the requirements of the protocol. * A male or female between, and including, 1 through 10 years of age at the time of vaccination. * Written informed consent obtained from the parent ...