Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Meningococcal ABCWY, MenABCWY
Meningococcal ABCWY Vaccine · 2 trials · 2 indications
The immunogenicity of MenABCWY or rMenB+OMV vaccines, is measured as the percentage of subjects with High-Throughput Human Serum Bactericidal Assay (HT-hSBA) titers greater or equal than (≥) Lower limit of quantification (LLOQ) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
The immunogenicity of MenABCWY or rMenB+OMV vaccines, is measured as the HT-hSBA geometric mean titers (GMTs) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.
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 |
|---|---|---|
| ABCWY_ 0_2 Group | EXPERIMENTAL | Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study |
| ABCWY_0_2_6 Group | EXPERIMENTAL | Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study |
| B_0_2 Group | EXPERIMENTAL | Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study |
| ABCWY_ 0_6 Group | EXPERIMENTAL | Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study |
| ABCWY Naive Group | ACTIVE_COMPARATOR | Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study |
| rMenB+OMV Naive Group | ACTIVE_COMPARATOR | Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study |
| 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 Vaccine | BIOLOGICAL | Intramuscular injection of one booster dose at Day 1 to follow-on subjects in the ABCWY\_ 0\_2 Group, ABCWY\_ 0\_2\_6 Group and ABCWY\_ 0\_6 Group, primed with 2 or 3 doses of the study vaccine and 2 doses at Days 1 and 61 to naïve subjects in the ABCWY naïve group. |
| Meningococcal B Recombinant vaccine | BIOLOGICAL | Intramuscular injection of one booster dose of the rMenB+OMV vaccine to subjects in the B\_0\_2 group, primed with 2 doses of the vaccine and intramuscular injection of 2 doses at Days 1 and 61 in the deltoid area of the non-dominant arm to naïve subjects in the rMenB+OMV Naïve group. |
| 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: Follow-on Participants * Subjects from Finland and Poland previously enrolled in study V102\_15 (NCT02212457) who have received all planned meningococcal vaccinations in the study * Who have not received any additional meningococcal vaccination since the last meningococcal vacc...
The Meningococcal ABCWY vaccine is an investigational vaccine developed by GSK plc for protection against meningococcal disease, an infection caused by Neisseria meningitidis bacteria. It is designed to cover meningococcal serogroups A, B, C, W, and Y in a single product. It is in Phase 2 clinical development and is not yet approved.
The Meningococcal ABCWY vaccine is being studied for the prevention of meningococcal infections and meningococcal disease, which can include meningitis and bloodstream infection. Clinical trials have evaluated it in healthy adolescents, a group at elevated risk for meningococcal disease. It remains investigational and is not approved for use.
The Meningococcal ABCWY vaccine is developed by GSK plc, which trades on the New York Stock Exchange under the ticker GSK. GSK conducted the Phase 2 clinical program for the vaccine, including studies run in the United States, Finland, and Poland.
The Meningococcal ABCWY vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by the FDA or any other regulatory agency. The completed Phase 2 studies enrolled adolescents and assessed immune responses, long-term antibody persistence, and safety.
The Meningococcal ABCWY vaccine has been evaluated in Phase 2 trials including NCT02946385, which assessed antibody persistence two years after vaccination and response to a booster in adolescents in Finland and Poland, and NCT02285777, which assessed effectiveness, immunogenicity, and safety in healthy adolescents in the United States. Both trials are completed.
Yes. Meningococcal ABCWY is an alternative name for the Meningococcal ABCWY vaccine, the investigational GSK plc product designed to target meningococcal serogroups A, B, C, W, and Y. Both names refer to the same Phase 2 vaccine candidate.