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 developed for the prevention of meningococcal infections. It is being studied in healthy adolescents and adults aged 10 years and older. The program targets Infections, Meningococcal, within the broader infectious disease therapeutic area.
Meningococcal vaccine 134612 is being developed by GSK plc, which trades under the ticker GSK. GSK conducted the clinical studies of the vaccine candidate in the United States and Denmark.
Meningococcal vaccine 134612 is in Phase 2 clinical development. It is an investigational vaccine candidate and has not been approved by the FDA. Two Phase 2 trials have been completed, and no trials are currently active.
Two completed Phase 2 trials have evaluated meningococcal vaccine 134612. NCT00454909 compared the vaccine with Menactra in healthy adolescents and adults aged 10 to 25 years in the United States, enrolling 873 participants. NCT00390143 assessed immune persistence up to 3.5 years in adolescents and adults in Denmark, enrolling 46 participants.
The trials were randomized and actively controlled, with NCT00454909 using Menactra as the comparator. Together the two completed Phase 2 studies enrolled 919 healthy volunteers. NCT00454909 was conducted in the United States, and NCT00390143, a persistence study, was conducted in Denmark.