Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
meningococcal ACWY · 1 trial · 1 indication
Response to vaccine antigen was defined as: for initially seronegative subjects \[subjects with serum bactericidal assay using rabbit complement (rSBA) titer lower than (\<) 1:8, post-vaccination rSBA titer greater than or equal to (≥) 1:32\] and for initially seropositive (subjects with rSBA titer ≥ 1:8), at least 4-fold increase in rSBA titer from pre to post vaccination.
Local symptom, Grade 3 = pain that prevented normal activity and redness/ swelling spreading beyond (\>) 50 millimeters (mm). General symptom, Grade 3 = symptom that prevented normal activity and fever (orally) \>39.5 °C.
| Arm | Type | Description |
|---|---|---|
| Nimenrix Group | EXPERIMENTAL | Subjects receiving GSK Biologicals' meningococcal vaccine 134612 |
| Mencevax Group | ACTIVE_COMPARATOR | Subjects receiving Mencevax™ ACWY |
| Name | Type | Description |
|---|---|---|
| meningococcal ACWY (vaccine) | BIOLOGICAL | One intramuscular dose. |
| Mencevax™ ACWY | BIOLOGICAL | One subcutaneous dose. |
Inclusion Criteria: * Subjects who the investigator believes that they and/or their parents/ legally acceptable representative can and will comply with the requirements of the protocol. * A male or female between, and including, 11 and 55 years of age at the time of vaccination. * Written informed ...
Meningococcal ACWY is an investigational vaccine being studied for the prevention of meningococcal infections. It is being evaluated in adolescents and adults to assess its ability to generate an immune response against meningococcal serogroups A, C, W, and Y. The vaccine is currently in Phase 2 clinical development.
Meningococcal ACWY is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in the target population.
Meningococcal ACWY is in Phase 2 clinical development. A Phase 2 trial has been completed to evaluate the vaccine's non-inferiority and persistence of immune response up to 5 years. The vaccine is investigational and has not been approved by regulatory authorities.
Meningococcal ACWY has one completed Phase 2 clinical trial, NCT00356369, which enrolled 500 participants in the Philippines and Saudi Arabia. The study evaluated the vaccine in adolescents and adults aged 11 years and older, with an active-controlled design to assess non-inferiority and persistence of immune response.
No, meningococcal ACWY is classified as a vaccine, not a monoclonal antibody. It is designed to elicit an immune response against meningococcal bacteria. The vaccine is being studied for its ability to protect against infections caused by serogroups A, C, W, and Y.