Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mencevax ACWY · 2 trials · 1 indication
Vaccine response defined as: for initially seronegative subjects, antibody titer greater than or equal to (≥) 1:32 and for initially seropositive subjects: antibody titer ≥ 4 fold the pre-vaccination antibody titer. The analysis was performed with the GSK rSBA assay.
Titers are presented as geometric mean titers (GMTs). All subjects underwent testing with the GSK rSBA assay for all 4 serogroups.
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 | - |
| Group B | EXPERIMENTAL | - |
| Group C | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Mencevax ACWY | BIOLOGICAL | One dose, Subcutaneous injection |
| GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612] | BIOLOGICAL | One dose, Intramuscular injection |
| GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix) | BIOLOGICAL | One intramuscular dose. |
| Mencevax™ ACWY | BIOLOGICAL | One subcutaneous dose. |
| Meningitec™ | BIOLOGICAL | One intramuscular dose. |
Inclusion Criteria: All subjects must satisfy all of the following criteria at study entry: * Subjects whom the investigator believes they can and will comply with the requirements of the protocol will be enrolled in the study. * A male or female between, and including, 18 and 25 years of age the ...
Mencevax ACWY is a meningococcal vaccine developed by GSK plc for the prevention of meningococcal infections. It is being studied for use in healthy individuals to protect against infections caused by meningococcal bacteria. The vaccine is currently in Phase 3 clinical development and is not yet approved for use.
Mencevax ACWY is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in different age groups, including children and young adults.
Mencevax ACWY is in Phase 3 clinical development. It has completed two clinical trials, including a Phase 3 study in healthy adults aged 18 to 25 years. The vaccine is investigational and has not been approved by regulatory authorities for public use.
Mencevax ACWY has been evaluated in two completed clinical trials. NCT00427908 was a Phase 2 study in children aged 1 year in Finland, assessing non-inferiority and persistence up to 5 years. NCT01154088 was a Phase 3 study in healthy adults aged 18 to 25 years in Panama, Philippines, and Thailand, comparing the vaccine against Mencevax ACWY.
Mencevax ACWY is classified as a monoclonal antibody in the development pipeline, though it is being studied as a vaccine for meningococcal infections. The clinical trials focus on its immunogenicity and safety in healthy volunteers, with no biomarker selection or genetic targeting involved.