Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
serogroup B meningococcal vaccine · 2 trials · 2 indications
Consistency of the immune response of the two lots of rMenB+OMV NZ will be assessed at one month after the second vaccination based on the ratio of the vaccine lot hSBA GMTs for each of three serogroup B reference strains (H44/76, 5/99, and NZ98/254) and based on the ratio of Enzyme-linked Immunosorbent Assay (ELISA) GMCs for vaccine antigen 287-953. The equivalence interval will be (0.5, 2.0).
The immune response of two different lots of rMenB+OMV NZ is evaluated in terms of ELISA GMCs against vaccine antigen 287-953.
| Arm | Type | Description |
|---|---|---|
| MenB Lot 1 | EXPERIMENTAL | MenB vaccine Lot 1: 2 doses administered 1 month apart |
| MenB Lot 2 | ACTIVE_COMPARATOR | MenB vaccine Lot 2: 2 doses administered 1 month apart |
| Arm 1: rMenB | EXPERIMENTAL | - |
| Arm 2: rMenB + OMV | EXPERIMENTAL | - |
| Arm 3: Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Serogroup B meningococcal vaccine | BIOLOGICAL | All subjects will receive two rMenB+OMV NZ vaccinations one month apart and will be followed for a total of 2 months. Subjects will be randomized to 1 of 2 treatment arms to receive either two doses of rMenB+OMV NZ vaccine Lot 1 or two doses of rMenB+OMV NZ Lot 2. A total of 2 blood samples will be collected (at the first vaccination and 1 month after the 2nd vaccination). An additional blood draw will be collected in a subset of approximately 160 subjects (approximately 80 subjects in Group 1 and approximately 80 subjects in Group 2) at 2 weeks after the second vaccination |
Inclusion Criteria: * Male and female subjects (11-17 years of age inclusive) who have given their written assent and whose parents or legal guardians have given written informed consent at the time of enrollment * who are available for all the visits scheduled in the study (i.e., not planning to l...
The serogroup B meningococcal vaccine is an investigational vaccine developed by Novartis AG for the prevention of meningococcal disease, including meningococcal meningitis, caused by serogroup B bacteria. It is a vaccine modality studied in healthy adolescents aged 11 years and older.
The serogroup B meningococcal vaccine is being studied for the prevention of meningococcal disease and meningococcal meningitis caused by serogroup B Neisseria meningitidis. Clinical trials have enrolled healthy adolescent volunteers aged 11 years and older in Australia, Canada, and the United States.
Novartis AG, which trades under the ticker NVS, is the developer of the serogroup B meningococcal vaccine. The company sponsored the clinical trials evaluating the vaccine in healthy adolescents.
The serogroup B meningococcal vaccine is in Phase 3 development. It is investigational and has been evaluated in two completed clinical trials, one Phase 3 and one Phase 2, with a combined enrollment of 547 participants.
Two completed trials have studied the serogroup B meningococcal vaccine: NCT01423084, a Phase 3 trial of 344 healthy adolescents aged 11 to 17 in Australia and Canada, and NCT00297817, a Phase 2 trial of 203 healthy adolescents in the United States. Both were randomized, double-blind, and placebo-controlled.