- Evidence of a personally signed and dated informed consent document (ICD) indicating
that the subject (and a legally authorized representative) has been informed of all
pertinent aspects of the study.
- Parent /legally authorized representative and subjects who are willing and able to
comply with scheduled visits, laboratory tests, and other study procedures.
- Male or female subject aged greater than or equal to 10 and enrollment.
- Available for the entire study period and can be reached by telephone.
- Healthy subject as determined by medical history, physical examination, and judgment
of the investigator.
- Has received full series (5-dose series is preferred, 4-dose catch up series is
allowed) of diphtheria, tetanus and pertussis (whole cell or acellular) vaccines per
country specific recommendations applicable at the time of receipt.
- Male and female subjects of childbearing potential must agree to use a highly
effective method of contraception throughout the study.
- Previous vaccination with any meningococcal serogroup B vaccine.
- Vaccination with any diphtheria, tetanus or pertussis vaccine within 5 years of the
first study vaccination.
- Previous vaccination with any MCV4 vaccine.
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with MCV4 and/or Tdap vaccine.
- Subjects receiving any allergen immunotherapy with a non-licensed product or receiving
allergen immunotherapy with a licensed product and are not on stable maintenance
doses.
- Bleeding diathesis or condition associated with prolonged bleeding time that would
contraindicate intramuscular injection.
- A known or suspected defect 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, those receiving chronic systemic (oral, intravenous or intramuscular)
corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects with
terminal complement deficiency may not be included.
- History of culture-proven disease caused by Neisseria meningitidis or Neisseria
gonorrhoea.
- Significant neurological disorder or history of seizure (excluding simple febrile
seizure).
- Receipt of any blood products, including immunoglobulin within 6 months before the
first study vaccination.
- Current chronic use of systemic antibiotics.
- Any neuroinflammatory or autoimmune condition, including, but not limited to,
transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.