A Phase 3b, Single-Center, Open-label Study to Assess the Immunogenicity and Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy At-Risk Adults Aged 18 to 65 Years Inclusive.
Condition: Prevention of the Meningococcal Disease
MeSH terms: Meningococcal Infections
Intervention: rMenB+OMV NZ
Intervention description: Recombinant MenB with Outer Member Vesicle (OMV) from the New Zealand strain
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal disease,; Adults

Summary:

      The study will evaluate the immunogenicity and safety of the rMenB+OMV NZ in an adult
      population potentially at risk for meningococcal disease (e.g. lab workers).
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 - 65 years of age inclusive who have given written informed consent at the time of
             enrollment;

          2. 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);

          3. In good health as determined by medical history, physical examination and clinical
             judgment of the investigator;

          4. Who are or might be routinely exposed to cultures of N. meningitidis serogroup B.

        Sponsor's employees are considered eligible to participate in the trial as per inclusion
        criteria.

        Exclusion Criteria:

          1. Pregnancy or nursing (breastfeeding) mothers;

          2. Females of reproductive age who have not used or do not plan to use acceptable birth
             control measures, for the 3 months duration of the study. Oral, injected or implanted
             hormonal contraceptive, diaphragm, condom, intrauterine device 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 for at least 60 days prior
             to study entry;

          3. Any serious chronic or progressive disease according to judgment of the investigator
             (e.g. neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease);

          4. Individuals with history of any progressive or severe neurologic disorder, or seizure
             disorder. A single episode of febrile convulsion is not an exclusion criteria;

          5. History of any serogroup B meningococcal vaccine administration;

          6. Previous known or suspected disease caused by N. meningitidis;

          7. History of severe allergic reaction after previous vaccinations, or hypersensitivity
             to any component of the vaccine;

          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. Subjects who are not able to comprehend and to follow all required study procedures
             for the whole period of the study;

         10. History or any illness/condition that, in the opinion of the investigator, might
             interfere with the results of the study or pose additional risk to the subjects due to
             participation in the study;

         11. Any significant chronic infection;

         12. Known bleeding diathesis or any condition that may be associated with a prolonged
             bleeding time;

         13. Family members and household members of research staff;

         14. Participation in another clinical trial within the last 30 days or planned for during
             study.