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Meningococcal ABCWY · 1 trial · 1 indication
The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 1 month after the 3-dose vaccination series was evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:4 dilution using the human Serum Bactericidal Assay (hSBA) against each strain in MenABCWY group and MenACWY group. The data provided is an average of the percentage of subjects without bactericidal activity at 1:4 dilution across all 110 strains.
| Arm | Type | Description |
|---|---|---|
| MenABCWY Group | EXPERIMENTAL | Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study. |
| MenACWY Group | ACTIVE_COMPARATOR | Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study. |
| Name | Type | Description |
|---|---|---|
| Meningococcal ABCWY | BIOLOGICAL | One dose administered intramuscularly in the deltoid area of a non-dominant arm at Month 6 (Visit 1) |
| Placebo | BIOLOGICAL | One dose of placebo administered intramuscularly in the deltoid area of a non-dominant arm at Month 6 (Visit 1) |
Inclusion Criteria: * Adolescents who completed V102\_16 study and received the study vaccines as assigned in the protocol (either two doses of the MenABCWY or one dose each of MenACWY and Placebo). Exclusion Criteria: * Serious, acute, or chronic illnesses. Previous or suspected disease caused b...
Meningococcal ABCWY is an investigational vaccine being developed for the prevention of meningococcal disease, a serious bacterial infection. It is being studied in healthy adolescents to assess its effectiveness, immunogenicity, and safety. The vaccine is designed to protect against multiple serogroups of the Neisseria meningitidis bacteria.
Meningococcal ABCWY 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 adolescent populations.
Meningococcal ABCWY is currently in Phase 2 clinical development. It is an investigational vaccine, meaning it has not been approved by regulatory authorities. Two Phase 2 trials have been completed, and the vaccine is still undergoing clinical evaluation to determine its safety and effectiveness.
Meningococcal ABCWY has been studied in two completed Phase 2 clinical trials. The first, NCT02285777, assessed its effectiveness, immunogenicity, and safety in healthy adolescents in the United States. The second, NCT02946385, evaluated the long-term persistence of antibodies and response to a booster dose in adolescents in Finland and Poland.
Meningococcal ABCWY is a vaccine designed to stimulate the immune system to produce antibodies against Neisseria meningitidis serogroups A, B, C, W, and Y. By inducing an immune response, the vaccine aims to prevent meningococcal disease caused by these bacterial strains.