A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk Adults
A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk Adults
The proposed study will evaluate the safety of the rMenB+OMV NZ in an adult population
 potentially at risk for meningococcal disease (e.g. lab workers).

 In the second part of the study additional blood samples of high responding vaccinated
 subjects will be collected for the purpose of generating a control serum panel for the human
 serum bactericidal assay (hSBA) tests.
Inclusion criteria:

 1. 18 - 65 years of age inclusive who have given written informed consent at the time of
 enrollment;

 2. Able to comprehend and follow all required study procedures;

 3. Who are available for all the visits scheduled in the study (i.e., not planning to
 leave the area before the end of the study period);

 4. In good health as determined by the outcome of medical history, physical examination
 and clinical judgment of the investigator;

 5. Who were or might be routinely exposed to N. meningitidis cultures

 Inclusion criteria for protocol part 2

 1. 18 - 65 years of age inclusive;

 2. At least 50 kg weight;

 3. Blood pressure within the following ranges: Systolic 110-180; Diastolic 60-100;

 4. Regular pulse rate (50-90 beats per minute) - exceptions are acceptable upon
 investigator's judgment;

 5. Hematocrit higher than: 32% for women and 35% for males;

 6. Visit 3 sera suitable as control for standardization of the SBA as confirmed by the
 central laboratory.

 Exclusion criteria:

 1. History of any serogroup B meningococcal vaccine administration

 2. History of severe allergic reactions after previous vaccinations or hypersensitivity
 to any vaccine component;

 3. Pregnancy or nursing (breastfeeding) mothers;

 4. Females of childbearing age who have not used or do not plan to use acceptable birth
 control measures, for the duration of the study. Oral, injected or implanted hormonal
 contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine
 device, surgical sterilization, transdermal delivery, congenital sterility or sexual
 abstinence are considered acceptable forms of birth control. If sexually active the
 subject must have been using one of the accepted birth control methods at least one
 months prior to study entry;

 5. Known or suspected autoimmune disease or impairment/alteration of the immune system
 resulting from (for example):

 6. Receipt of any chronic immunosuppressive therapy

 7. Receipt of any chronic immunostimulants

 8. Immune deficiency disorder, or known HIV infection

 9. Known bleeding diathesis or any condition that may be associated with a prolonged
 bleeding time.

 10. History or any illness/condition which, in the opinion of the investigator, might
 interfere with the evaluation of the study objectives or pose additional risk to the
 subjects due to participation in the study.

 11. Any significant chronic infection.

 12. Any serious chronic or progressive disease according to judgment of the investigator
 (e.g. neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).

 Exclusion criteria for protocol part 2:

 1. Known or suspected autoimmune disease;

 2. Any serious chronic or progressive disease according to judgment of the investigator
 (e.g. neoplasm, diabetes, cardiovascular, renal, hepatic, immunological, metabolic,
 urogenital, hematological, gastrointestinal, central nervous system disease);

 3. Known bleeding diathesis or any condition that may be associated with a prolonged
 bleeding time;

 4. History of fainting or seizure episodes;

 5. Pregnancy

 6. Any significant chronic infection;

 7. Significant acute infections within the previous 2 weeks;

 8. Known or suspected autoimmune disease or impairment/alteration of the immune system
 resulting from (for example):

 Receipt of any chronic immunosuppressive therapy; Receipt of any chronic
 immunostimulants; Immune deficiency disorder, or known HIV infection;

 9. Significant acute illness within the previous 7 days or body temperature 38.0 C within
 the previous 3 days;

 10. Receipt of systemic antibiotics within the previous 3 days (72 hours).