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Also known as MenABCWY vaccine
MenABCWY+OMV vaccine · 1 trial · 2 indications
The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 2 and 3 and are considered final in Company's judgement.
Antibody levels against N. meningitidis serogroups A, C, W and Y in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years earlier, and in Naïve subjects as measured by the percentages of subjects with hSBA ≥ 8.
Antibody levels against N. meningitidis serogroup B test strains in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years earlier, and in Naïve subjects as measured by the percentages of Subjects with hSBA ≥ 5. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.
GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years earlier, and in Naïve subjects. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.
The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 6 and 7 and are considered final in Company's judgement.
GMRs as measure of the immune response against N. meningitidis serogroups A, C, W and Y and serogroup B test strains in previously vaccinated subjects, and in Naïve subjects of similar age. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.
| Arm | Type | Description |
|---|---|---|
| MenABCWY+OMV Group | EXPERIMENTAL | Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1. |
| MenACWY Group | EXPERIMENTAL | Subjects who received MenACWY vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study. |
| Naive Group | EXPERIMENTAL | Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. |
| Name | Type | Description |
|---|---|---|
| MenABCWY+OMV vaccine | BIOLOGICAL | Intramuscular injection of a single dose at Day 1 to subjects in the MenABCWY+OMV Group or as a 2 doses at Day 1 and Day 31, one month apart, to subjects in the MenACWY and Naive Groups. |
Inclusion Criteria: 1. Individuals who received either 2 doses of MenABCWY+OMV or a single dose of MenACWY followed by a dose of placebo, with the last study vaccine given approximately 48 to 56 months before study V102\_02E2 (NCT01367158), who received Tdap only in V102\_02E1 (NCT01367158) study a...
MenABCWY vaccine is an investigational vaccine being developed by GSK plc for the prevention of meningococcal disease, including meningitis and other meningococcal infections. It is designed for use in healthy adolescents and adults, with clinical trials evaluating its immunogenicity and safety in individuals aged 10 to 25 years.
MenABCWY vaccine targets Neisseria meningitidis, the bacterium that causes meningococcal disease. The vaccine is designed to provide protection against multiple serogroups of the bacteria, including serogroups A, B, C, W, and Y, as indicated by its name. It is being studied for its ability to elicit an immune response against these strains.
MenABCWY vaccine is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in healthy adolescents and adults.
MenABCWY vaccine is in Phase 3 clinical development. It has completed Phase 2 and Phase 3 trials, with one Phase 2 trial currently active but not recruiting. The vaccine is investigational and has not been approved by regulatory authorities.
MenABCWY vaccine has been studied in several clinical trials, including NCT02451514, NCT03587207, NCT04707391, and NCT05087056. These trials evaluated antibody persistence, booster responses, immune interference, and different dosing schedules in healthy adolescents and adults across multiple countries.
MenABCWY vaccine is not the same as MenACWY vaccine. MenABCWY is designed to cover serogroups A, B, C, W, and Y, while MenACWY covers only serogroups A, C, W, and Y. Clinical trials have studied MenABCWY in individuals previously primed with MenACWY vaccine.