ABOUT THIS STUDY
- Healthy male or female subject between the ages of >=18 and <=40 years
- Negative urine pregnancy test for all female subjects of childbearing potential prior to test article administration and at the completion of the study.
- All female or male subjects who are biologically capable of having children must agree to abstinence or commit to the use of a reliable method of birth control during for the duration of the study and for 30 days after early discontinuation. 4. Hemoglobin levels >=12.0 and <=16.5 g/dL for female subjects and >=13.0 and <=18.5 g/dL for male subjects.
- Blood pressure: Systolic blood pressure >90 and <160 mm Hg; Diastolic blood pressure >60 and <95 mm Hg.
- Body weight >=45 and <=120 kg.
- Able to be contacted by telephone during the study period.
- Pregnancy or breastfeeding women
- Prior vaccination with a serogroup B meningococcal vaccine.
- A previous anaphylactic or severe vaccine-associated adverse reaction.
- A known hypersensitivity to any study vaccine components.
- A known or suspected disease of the immune system or those receiving immunosuppressive
therapy, including systemic corticosteroids (excluding topical, inhalation and
- Bleeding diathesis or condition associated with prolonged bleeding time that would
contraindicate intramuscular injection.
- Receipt of any blood products, including gamma globulin, in the period from 6 months
before study vaccination through the study conclusion.
- Receipt of an inactivated vaccine within 14 days before study vaccinations and live
attenuated vaccine within 28 days before study vaccination. This will apply throughout
the study until the last vaccination.
- Any clinically significant chronic disease that, in the investigator's judgment may be
worsened by blood draw.
- Received any investigational drug, vaccine or device within the 30-day period before
study visit 1 and during the conduct of the study.
- History of culture-proven invasive disease caused by N meningitidis or N gonorrhoea.
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