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Meningococcal oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal multicomponent recombinant vaccine+ OMV · 2 trials · 3 indications
Non-inferiority of immune response of two doses of two different formulations of MenABCWY vaccine to a single dose of MenACWY vaccine as measured by the percentage of subjects with hSBA seroresponse against N.meningitidis serogroups A,C,W and Y. Seroresponse is defined as: 1. For subjects with a pre-vaccination hSBA titer \< 1:4, a post-vaccination hSBA titer ≥ 1:8; 2. For subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the prevaccination titer. Functional bactericidal antibodies directed against serogroups A,C,W,Y meningococci were measured with a serum bactericidal activity assay using human serum as the source of exogenous complement (hSBA).
The overall desirability index (DI) used to identify the optimal formulation of the combination vaccine was based on immunogenicity and reactogenicity parameters (on a scale of 0 to 1, with 0 for an undesirable response and 1 for a highly desirable response) as follows: Between-group ratios of hSBA GMTs were calculated, adjusted for prevaccination titer and center, against serogroups A, C, W, and Y (ABCWY+OMV group or ABCWY+qOMV group vs. Placebo/ACWY group) and against the 4 serogroup B test strains (ABCWY+OMV group or ABCWY+qOMV group vs. rMenB+OMV group). Reactogenicity was measured by the percentage of doses associated with severe local and systemic solicited AEs within 3 days following vaccination. Each immunogenicity and reactogenicity endpoint was assigned its own DI based on predefined desirability functions. The overall DI was calculated using the weighted geometric mean of the DI values of each of the ten parameters to derive an overall DI for each formulation.
Antibody response was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥1:8 and associated 95% CI, directed against to N meningitidis serogroups A, C, W, and Y at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7).
Antibody response was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥1:5 and associated 95% CI, directed against to Serogroup B Test Strains at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7)
| Arm | Type | Description |
|---|---|---|
| ABCWY+OMV | EXPERIMENTAL | Subjects in this group received two doses of "Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine" plus Outer Membrane Vesicles (OMV) administered two months apart. |
| ABCWY+qOMV | EXPERIMENTAL | Subjects in this group received two doses of "Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine" plus one quarter dose of Outer Membrane Vesicles (qOMV) administered two months apart. |
| rMenB+OMV | ACTIVE_COMPARATOR | Subjects in this group received two doses of "Meningococcal (group B) multicomponent recombinant adsorbed vaccine",administered two months apart. |
| MenACWY | ACTIVE_COMPARATOR | Subjects in this group received a dose of placebo followed by one dose of "Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine" administered two months later. |
| 3ABCWY | EXPERIMENTAL | Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study |
| 2ABCWY | EXPERIMENTAL | Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study |
| 3ABx2CWY | EXPERIMENTAL | two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study |
| 2ABx2CWY | EXPERIMENTAL | two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study |
| 3ABCWY+OMV | EXPERIMENTAL | Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study |
| 2ABCWY+OMV | EXPERIMENTAL | Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study |
| 3ABCWYqOMV | EXPERIMENTAL | Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study |
| 2ABCWYqOMV | EXPERIMENTAL | Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study |
| 3B | ACTIVE_COMPARATOR | Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study |
| 2B | ACTIVE_COMPARATOR | Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study |
| 1ACWY | ACTIVE_COMPARATOR | One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study |
| Name | Type | Description |
|---|---|---|
| Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + OMV. | BIOLOGICAL | Two injections of a combined vaccine formulation, Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus OMV. |
| Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV. | BIOLOGICAL | Two injections of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV. |
| Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine. | BIOLOGICAL | One injection of saline solution placebo and one of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine. |
| Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + qOMV. | BIOLOGICAL | Two injections of a combined vaccine formulation, Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus a quarter dose of OMV. |
| Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine | BIOLOGICAL | The lyophilized Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine reconstituted with one dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine |
| Meningococcal (group B) multicomponent recombinant adsorbed vaccine | BIOLOGICAL | Liquid Meningococcal (group B) multicomponent recombinant adsorbed vaccine |
| Tdap | BIOLOGICAL | Sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components intended for intramuscular injection |
Inclusion Criteria: * Healthy adolescents aged 10 through 25 years of age inclusive at the time of enrollment. Exclusion Criteria: * History of any meningococcal vaccine administration; * Current or previous, confirmed or suspected disease caused by N. meningitidis; * Pregnant or nursing (breastf...
It is an investigational combination vaccine designed to protect against invasive meningococcal disease. It combines a meningococcal groups A, C, W, and Y oligosaccharide diphtheria CRM-197 conjugate with a meningococcal group B multicomponent recombinant vaccine plus outer membrane vesicles (OMV). It is being developed by Novartis AG.
It is being studied for the prevention of invasive meningococcal disease and meningococcal disease, including meningococcal meningitis. The vaccine targets meningococcal serogroups A, C, W, Y, and B in a single combination regimen. It is investigational and has not been approved for use.
Novartis AG (ticker NVS) is the developer of this combination meningococcal vaccine. The company sponsored the Phase 2 clinical trials evaluating the vaccine in adolescents and young adults.
It is in Phase 2 development. Two completed Phase 2 trials have evaluated the vaccine, and no active trials are currently listed. It is investigational and has not been approved by the FDA.
Two completed Phase 2 trials have studied this vaccine: NCT01367158, which evaluated a third dose in adolescents in Chile, Colombia, and Panama, and NCT01272180, which assessed different formulations in adolescents and young adults in the United States and Poland. Both trials enrolled healthy volunteers.