Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK Biologicals' meningococcal vaccine GSK134612 · 1 trial · 1 indication
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...
GSK134612 is an investigational meningococcal vaccine being developed by GSK plc for the prevention of meningococcal infections. It is currently in Phase 3 clinical development. The vaccine is designed for use in healthy children, with a completed trial evaluating it in children aged 2 years and older.
GSK134612 is a meningococcal vaccine, meaning it is designed to elicit an immune response against Neisseria meningitidis, the bacterium that causes meningococcal disease. It is being studied for its ability to protect against meningococcal infections, which can cause meningitis and septicemia.
GSK134612 is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The vaccine is part of GSK's infectious disease portfolio and is currently in Phase 3 clinical development for the prevention of meningococcal infections.
GSK134612 is in Phase 3 clinical development. It is an investigational meningococcal vaccine, meaning it has not yet been approved by regulatory authorities. A Phase 3 trial has been completed, evaluating the vaccine in healthy children aged 2 years and older.
GSK134612 has one completed Phase 3 clinical trial, registered as NCT00674583. This trial, titled 'Comparison of GSK Biologicals' Meningococcal Vaccine (GSK134612) and Licensed MenC-CRM197 Vaccine in Healthy Children,' enrolled 414 participants in France and Germany. The study was active-controlled and randomized, comparing GSK134612 to a licensed meningococcal vaccine.
No, GSK134612 is not the same as the MenC-CRM197 vaccine. In the Phase 3 clinical trial NCT00674583, GSK134612 was compared against a licensed MenC-CRM197 vaccine as an active control. GSK134612 is an investigational meningococcal vaccine being developed by GSK plc, while MenC-CRM197 is a licensed comparator vaccine.