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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 ...
GSK Biologicals' meningococcal vaccine 134612 is a vaccine developed for the prevention of meningococcal infections. It is intended for use in children, with clinical evaluation focused on immune response and persistence of protection. The vaccine is designed to protect against Neisseria meningitidis, the bacterium that causes meningococcal disease.
GSK Biologicals' meningococcal vaccine 134612 is being developed by GSK plc, which trades on the New York Stock Exchange under the ticker GSK. GSK Biologicals is the vaccine division of GSK plc, a global pharmaceutical company. The vaccine is part of GSK's meningococcal vaccine portfolio.
GSK Biologicals' meningococcal vaccine 134612 is in Phase 2 clinical development. A Phase 2 trial has been completed, evaluating the vaccine in children. The vaccine is investigational and has not been approved by the FDA for any indication.
GSK Biologicals' meningococcal vaccine 134612 has been studied in one completed Phase 2 clinical trial, NCT00427908. The trial was titled "Study in Children to Evaluate Non-Inferiority and Persistence up to 5 Years of GSK Bio Meningococcal Vaccine 134612" and enrolled 613 children in Finland. It was an active-controlled, randomized study.
Yes, GSK Biologicals' meningococcal vaccine 134612 is also known as Nimenrix. Nimenrix is the brand name for this meningococcal vaccine developed by GSK. The two names refer to the same vaccine candidate.