Safety and Immunogenicity Study of Two Doses of Novartis Meningococcal Serogroup B Recombinant Vaccine in Adolescents Aged 11-17 Years.
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Intervention: Meningococcal B Recombinant vaccine rMenB+OMV NZ; Placebo; Meningococcal ACWY-CRM conjugate vaccine
Intervention description: Subjects were randomized to one of two treatment groups to receive intramuscular (IM) vaccination with two doses of rMenV+OMV NZ vaccine (0.5 mL) in the non-dominant arm, one month apart. Subjects were followed for two months.; Subjects were randomized to one of two treatment groups to receive intramuscular (IM) injection of saline solution followed by one dose of MenACWY-CRM vaccine (0.5 mL), one month apart. Subjects were followed for two months.; Subjects were randomized to one of two treatment groups to receive intramuscular (IM) injection of saline solution followed by one dose of MenACWY-CRM vaccine (0.5 mL), one month apart. Subjects were followed for two months.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 264.0
Sex: All
Minimum age: 11 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis, adolescents, Meningococcal B

Summary:

      The purpose of the study was to assess the immunogenicity and safety of two doses of Novartis
      Meningococcal B Recombinant (rMenB+OMV NZ) vaccine administered one month apart (0, 1 month
      schedule) in Korean adolescents aged between 11 to 17 years.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adolescents 11-17 years of age inclusive who have given their written assent and whose
             parent or legal guardian has given written informed consent at the time of enrollment;

          2. 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 the outcome of medical history, physical examination
             and clinical judgment of the investigator;

          4. With a negative urine pregnancy test (for female subjects only).

        Exclusion Criteria:

          1. History of any meningococcal vaccine administration;

          2. Current or previous, confirmed or suspected disease caused by N. meningitidis;

          3. Household contact with and/or intimate exposure to an individual with any laboratory
             confirmed N. meningitidis infection within 60 days of enrollment;

          4. Pregnancy or nursing (breastfeeding) mothers;

          5. Female subjects who have not used or do not plan to use acceptable birth control
             measures, for the 2 months duration of the study;

          6. Any serious chronic or progressive disease;

          7. Family members and household members of research staff;

          8. Any condition which in the opinion of the investigator may interfere with the
             evaluation of the study objectives;

          9. Significant acute or chronic infection within the previous 7 days or fever within 3
             days prior to enrolment;

         10. Antibiotics within 6 days prior to enrollment;

         11. Known or suspected impairment/alteration of the immune system, immunosuppressive
             therapy;

         12. Receipt of blood, blood products and/or plasma derivatives, or a parenteral
             immunoglobulin preparation within the previous 90 days;

         13. History of severe allergic reactions after previous vaccinations or hypersensitivity
             to any vaccine component;

         14. Receipt of or intent to immunize with any other vaccine(s) within 30 days prior and
             throughout the study period;

         15. Participation in another clinical trial within the last 90 days or planned for during
             study.