- Male or female subject aged 12 to sentinel-cohort enrollment, Or,12 to
- Subjects must have received all vaccinations in the relevant National Immunization
Program (NIP) for their age group.
- Subject is determined to be in good health by medical history, physical examination,
and judgment of the investigator.
- Previous vaccination with any meningococcal serogroup B vaccine.
- Previous vaccination with HAV vaccine, or requirement to receive nonstudy HAV vaccine
during Stage 1 of the study.
- Contraindication to vaccination with any HAV vaccine or known latex allergy.
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Bleeding diathesis or condition associated with prolonged bleeding time that would
contraindicate intramuscular injection.
- A known or suspected disorder of the immune system that would prevent an immune
response to the vaccine, such as subjects with congenital or acquired defects in
B-cell function or those receiving systemic immunosuppressive therapy. Subjects with
terminal complement deficiency may be included.
- History of microbiologically proven disease caused by N meningitidis or Neisseria
- Significant neurologic disorder or history of seizure (excluding simple febrile
- Receipt of any blood products, including immunoglobulin, within 6 months before the
first study vaccination until the end of Stage 1.
- Current chronic use of systemic antibiotics.
- Received any investigational drugs, vaccines or devices within 28 days before
administration of the first study vaccination and/or during study participation.
- Any neuroinflammatory or autoimmune condition, including but not limited to transverse
myelitis, uveitis, optic neuritis, and multiple sclerosis.