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Meningococcal ABCWY Vaccine · 1 trial · 1 indication
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.
| 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 |
| 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. |
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...
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.