Safety and Immunogenicity of Novartis Meningococcal B Vaccine Formulated With OMV Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years
Condition: Meningococcal Disease; Meningococcal Meningitis
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Intervention: Serogroup B meningococcal vaccine
Intervention description: All subjects will receive two rMenB+OMV NZ vaccinations one month apart and will be followed for a total of 2 months. Subjects will be randomized to 1 of 2 treatment arms to receive either two doses of rMenB+OMV NZ vaccine Lot 1 or two doses of rMenB+OMV NZ Lot 2.
A total of 2 blood samples will be collected (at the first vaccination and 1 month after the 2nd vaccination). An additional blood draw will be collected in a subset of approximately 160 subjects (approximately 80 subjects in Group 1 and approximately 80 subjects in Group 2) at 2 weeks after the second vaccination
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 344.0
Sex: All
Minimum age: 11 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal Meningitis; prevention, vaccination; adolescents

Summary:

      The primary objective of this study is to demonstrate the equivalence of rMenB+OMV NZ lot 1
      to rMenB+OMV NZ lot 2 when administered to adolescents, as measured by human serum
      bactericidal activity (hSBA) geometric mean titers (GMTs) against 3 N. meningitidis serogroup
      B reference strains (H44/76, 5/99, and NZ98/254) and as measured by ELISA geometric mean
      concentrations (GMCs) against vaccine antigen 287-953, approximately 30 days after a primary
      vaccination course of two doses administered one month apart.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects (11-17 years of age inclusive) who have given their written
             assent and whose parents or legal guardians have given written informed consent at the
             time of enrollment

          -  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)

          -  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 vaccination

          -  Current or previous, confirmed or suspected disease caused by N. meningitidis

          -  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
             axillary temperature ≥ 38.0 °C) within the previous day

          -  Antibiotic use within 3 days (72 hours) prior to enrollment

          -  Pregnancy or nursing (breastfeeding) mothers

          -  Females of childbearing age who have not used or do not plan to use acceptable birth
             control measures, for the 2 months duration of the study. 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, Known or suspected impairment/alteration
             of the immune system

          -  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