Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Meningococcal vaccine 134612 · 2 trials · 1 indication
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Subjects aged 10 years (\< 11 years) vaccinated with meningococcal vaccine GSK134612. |
| Group B | EXPERIMENTAL | Subjects aged 11 to 25 years vaccinated with meningococcal vaccine GSK134612. |
| Group C | ACTIVE_COMPARATOR | Subjects aged 11 to 25 years vaccinated with Menactra®. |
| Name | Type | Description |
|---|---|---|
| Meningococcal vaccine 134612 | BIOLOGICAL | Single dose intramuscular injection. |
| Menactra® | BIOLOGICAL | Single dose intramuscular injection. |
| Mencevax™ ACWY | BIOLOGICAL | One subcutaneous dose during the primary study |
Inclusion Criteria: * Subjects whom the investigator believes can and will comply with the requirements of the protocol. * A male or female between, and including, 10 and 25 years of age (has not attained his/her 26th birthday) at the time of the vaccination. * Written informed consent obtained fro...
Meningococcal vaccine 134612 is an investigational vaccine being developed for the prevention of meningococcal infections. It is currently in Phase 2 clinical development and has been studied in healthy adolescents and adults. The vaccine is designed to elicit an immune response against meningococcal disease, though it is not yet approved for commercial use.
Meningococcal vaccine 134612 is being developed by GSK plc, a global biopharmaceutical company. GSK is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in healthy adolescents and adults. The company's ticker symbol is GSK.
Meningococcal vaccine 134612 is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. Two Phase 2 trials have been completed, with a total of 919 participants enrolled across studies conducted in Denmark and the United States.
Meningococcal vaccine 134612 has been evaluated in two completed Phase 2 clinical trials. NCT00390143 assessed persistence of immune response up to 3.5 years in 46 adolescents and adults in Denmark. NCT00454909 compared the vaccine to Menactra in 873 healthy adolescents and adults aged 10-25 years in the United States.
Meningococcal vaccine 134612 is designed to stimulate the immune system to produce antibodies against Neisseria meningitidis, the bacteria that cause meningococcal disease. By inducing a protective immune response, the vaccine aims to prevent infections caused by this pathogen. The exact mechanism involves the presentation of meningococcal antigens to the immune system.