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Meningococcal group B Vaccine, rMenB+OMV NZ · 1 trial · 1 indication
Human serum bactericidal activity (hSBA) titers against each of the serogroup B indicator strains-H44/76,5/99,NZ98/254 \& M10713 after receiving 4 doses of rMenB+OMV NZ / MenACWY vaccines, concomitantly administered, versus corresponding response in subjects who received rMenB+OMV NZ administered alone, were presented in terms of vaccine group specific geometric mean titers (GMTs). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.
hSBA titers against N. meningitidis serogroups A, C, W-135 and Y after receiving four doses of either rMenB+OMV NZ / MenACWY concomitantly administered versus corresponding response in subjects who received MenACWY administered alone were presented in terms of vaccine group specific GMTs. This outcome measure applies to only rMenB+ACWY and MenACWY groups as the serogroups A,C,W-135 \& Y were assessed only for these two groups.
| Arm | Type | Description |
|---|---|---|
| rMenB+ACWY | EXPERIMENTAL | Approximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age. |
| rMENB | ACTIVE_COMPARATOR | Approximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age. |
| MenACWY | ACTIVE_COMPARATOR | Approximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age. |
| Name | Type | Description |
|---|---|---|
| Meningococcal group B Vaccine, rMenB+OMV NZ | BIOLOGICAL | 4 doses administered intramuscularly on Days 1, 61, 121 and 301 with blood draw visits at Days 1, 151, 301 and 331 and who will receive reminder calls at 2 and 4 days after each vaccination visit and safety calls on Days 201 and 251. |
| Meningococcal ACWY Conjugate Vaccine, MenACWY | BIOLOGICAL | 4 doses administered intramuscularly on Days 1, 61, 121 and 301 with blood draw visits at Days 1, 151, 301 and 331 and who will receive reminder calls at 2 and 4 days after each vaccination visit and safety calls on Days 201 and 251. |
Inclusion Criteria: 1. Healthy 3-month old infants (85-119 days, inclusive) at time of Visit 1 whose parents/legal guardians have given written informed consent after the nature of the study has been explained. 2. Available for all the visits scheduled in the study. 3. In good health as determined ...
Meningococcal group B Vaccine, rMenB+OMV NZ is an investigational vaccine used for the prevention of meningococcal infections, specifically those caused by group B meningococcal bacteria. It is being developed for use in infants to protect against this serious bacterial infection.
Meningococcal group B Vaccine, rMenB+OMV NZ is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The vaccine is currently in Phase 3 clinical development.
Meningococcal group B Vaccine, rMenB+OMV NZ is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and immunogenicity.
Meningococcal group B Vaccine, rMenB+OMV NZ has one completed Phase 3 clinical trial, identified as NCT02106390. This trial evaluated the safety and immunogenicity of the vaccine when administered concomitantly with a MenACWY conjugate vaccine to healthy infants, enrolling 750 participants in Argentina and Mexico.
Yes, Meningococcal group B Vaccine, rMenB+OMV NZ is also known as rMenB+OMV NZ. The alternative name is commonly used in clinical and scientific contexts to refer to this same investigational meningococcal group B vaccine.