Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mencevax · 1 trial · 2 indications
Vaccine response was defined as an rSBA titer of at least 1:32 in subjects initially seronegative (\< 1:8) and as 4-fold increase in titer from pre- to post-vaccination in subjects initially seropositive (≥ 1:8).
Grade 3 symptom was defined as symptom that prevented normal, everyday activities.
| Arm | Type | Description |
|---|---|---|
| Nimenrix Group | EXPERIMENTAL | Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. |
| Mencevax ACWY Group | ACTIVE_COMPARATOR | Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm. |
| Name | Type | Description |
|---|---|---|
| Nimenrix | BIOLOGICAL | Single dose, intramuscular injection |
| Mencevax | BIOLOGICAL | Single dose, subcutaneous injection |
Inclusion Criteria: * Subjects who the investigator believes that their parents or guardians 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 vaccination. * Written informed consent obtained from the parent or...
Mencevax is a meningococcal vaccine developed for the prevention of meningococcal infections. It has been studied in children aged 2 to 10 years. In its Phase 3 trial, Mencevax was used as the active comparator against which another meningococcal vaccine candidate was assessed for non-inferiority.
Mencevax is developed by GSK plc, which trades under the ticker GSK. GSK conducted the Phase 3 study of Mencevax as a comparator vaccine in a pediatric meningococcal immunization trial.
Mencevax has been evaluated in a Phase 3 clinical trial. That trial, NCT00514904, is completed. The study enrolled 1,504 participants and was an active-controlled, randomized trial without double blinding, conducted in India, Lebanon, the Philippines, and Saudi Arabia.
Mencevax was studied in the Phase 3 trial NCT00514904, titled Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax in 2-10 Year Old Subjects. The trial is completed, enrolled 1,504 healthy volunteers aged 2 years and older, and took place across India, Lebanon, the Philippines, and Saudi Arabia.
In NCT00514904, Mencevax served as the active control against which the meningococcal vaccine GSK134612 was tested for non-inferiority. The Phase 3 study enrolled 1,504 children aged 2 to 10 years across India, Lebanon, the Philippines, and Saudi Arabia, and it is now completed.