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...
Serogroup B meningococcal vaccine is an investigational vaccine being studied for the prevention of meningococcal disease, including meningococcal meningitis. It is designed for use in healthy adolescents, with clinical trials enrolling individuals aged 11 years and older.
Serogroup B meningococcal vaccine is being developed by Novartis AG, a global healthcare company traded on the New York Stock Exchange under the ticker NVS. The vaccine is currently in clinical development for the prevention of meningococcal disease.
Serogroup B meningococcal vaccine is in Phase 3 clinical development. It has completed two clinical trials, including a Phase 2 study and a Phase 3 study, both of which were randomized, double-blind, and placebo-controlled. The vaccine remains investigational and is not yet approved.
Serogroup B meningococcal vaccine has been studied in two completed clinical trials. NCT00297817 was a Phase 2 study in 203 healthy adolescents in the United States. NCT01423084 was a Phase 3 study in 344 healthy adolescents aged 11-17 years in Australia and Canada.
In clinical trials, serogroup B meningococcal vaccine was administered to healthy adolescents aged 11 years and older. The studies were randomized, double-blind, and placebo-controlled, meaning participants received either the vaccine or a placebo, and neither the participants nor the researchers knew which was given.