Novartis Vaccine and Diagnostics Carriage Trial
Condition: N. Meningitidis Carriage
Intervention: Meningococcal B Recombinant + Outer Membrane Vesicle vaccine (rMenB+OMV NZ); MenACWY-CRM conjugate vaccine; Japanese Encephalitis vaccine
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 2968.0
Sex: All
Minimum age: 18 Years
Maximum age: 24 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal vaccines; Meningococcal B; Meningococcal ACWY serogroups

Summary:

      The purpose of this trial was to evaluate the effect of Novartis Vaccine's Meningococcal
      vaccines on carriage of Neisseria meningitidis in a young adult population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects, 18-24 years of age who provided written informed consent at the time
             of enrollment;

          -  Subjects who were available for all the visits scheduled in the study;

          -  Subjects who were in good health as determined by the outcome of medical history,
             physical examination and clinical judgment of the investigator.

        Exclusion Criteria:

          -  History of any serogroup B meningococcal vaccine administration;

          -  Current or previous, confirmed or suspected disease caused by N. meningitidis;

          -  Household contact with and/or intimate exposure to an individual with any laboratory
             confirmed N. meningitidis infection within 60 days of enrollment;

          -  Significant acute or chronic infection within the previous 7 days or fever (defined as
             oral temperature ≥38ºC) within the previous day;

          -  Antibiotics within 3 days (72 hours) prior to enrollment;

          -  Pregnancy or nursing (breastfeeding) mothers;

          -  Females of childbearing age who had not used or did not plan to use acceptable birth
             control measures, for the 12 months duration of the study. Oral, injected or implanted
             hormonal contraceptive, diaphragm, condom, intrauterine device or sexual abstinence
             were 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 30 days prior
             to study entry;

          -  Any serious chronic or progressive disease (e.g., neoplasm, diabetes, cardiac disease,
             hepatic disease, progressive neurological disease or seizure disorder; autoimmune
             disease, human immunodeficiency virus (HIV) infection or acquired immunodeficiency
             syndrome (AIDS), or blood dyscrasias or diathesis, signs of cardiac or renal failure
             or severe malnutrition);

          -  Known or suspected impairment/alteration of the immune system, immunosuppressive
             therapy, including use of corticosteroids in immunosuppressive doses or chronic use of
             inhaled high-potency corticosteroids within the previous 60 days. [Use of topical
             corticosteroids administered during the study in limited areas (i.e., eczema on knees
             or face or elbows) of the body were allowed]; use of immunostimulants;

          -  Receipt of blood, blood products and/or plasma derivatives, or a parenteral
             immunoglobulin preparation within the previous 90 days;

          -  History of severe allergic reactions after previous vaccinations or hypersensitivity
             to any vaccine component;

          -  Participation in another clinical trial within the last 90 days or planned for during
             study;

          -  Family members and household members of research staff;

          -  Any condition which in the opinion of the investigator and/or the Regional MD may
             interfere with the evaluation of the study objectives.