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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00674583 | Comparison of GSK Biologicals' Meningococcal Vaccine (GSK134612) and Licensed MenC-CRM197 Vaccine in Healthy Children | PHASE3 | COMPLETED | 414 | — | — | May 9, 2008 | Jan 8, 2009 | Nov 18, 2019 | 31 | France, Germany |
Vaccine response to MenC was defined as: -for initially seronegative subjects \[i.e. rSBA-MenC titer below (\<) 1:8\], antibody titer greater than or equal to (≥) 1:32; -for initially seropositive (i.e. rSBA-MenC titer ≥ 1:8), antibody titer post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
| Arm | Type | Description |
|---|---|---|
| Nimenrix Group | EXPERIMENTAL | Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0. |
| Menjugate Group | ACTIVE_COMPARATOR | Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' meningococcal vaccine GSK134612 | BIOLOGICAL | Intramuscular administration, 1 dose |
| Menjugate | BIOLOGICAL | Intramuscular administration, 1 dose |
Inclusion Criteria: * Subjects whose parents/guardians, the investigator believes can and will comply with the requirements of the protocol. * A male or female between, and including, 2 and 10 years of age at the time of the vaccination. * Written informed consent obtained from the parent(s) or gua...