Combined Study - Phase 3b MenB Long Term Persistence in Adolescents
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: rMenB+OMV NZ (Meningococcal (Group B) multi component recombinant adsorbed vaccine)
Intervention description: One dose of the vaccine administered intramuscularly in the deltoid area of the non-dominant arm.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 531.0
Sex: All
Minimum age: 15 Years
Maximum age: 24 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Nervous System Diseases; Meningitis; Central Nervous System Diseases

Summary:

      The purpose/aim of this study is to assess 1) the long-term persistence (4 to 7.5 years after
      the last dose) of bactericidal activity following primary vaccination with rMenB+OMV NZ in
      adolescents [who previously participated in parent studies V72_41 (NCT0142384) and V72P10
      (NCT00661713)] and 2) the kinetics of immune response following booster vaccination with
      rMenB+OMV NZ
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inclusion Criterion for follow-on subjects:

          -  Individuals who participated to Study V72_41 or V72P10 and have completed vaccination
             with rMenB+OMV NZ according to a 2-dose schedule

        Inclusion Criterion for naïve subjects:

          -  Individuals of 15 through 21 years of age on the day of informed consent and assent as
             applicable (according to the subject's age) for subjects enrolled at sites that
             participated to Study V72_41.

          -  17 through 24 years of age on the day of informed consent and assent as applicable
             (according to the subject's age) for subjects enrolled at sites that participated to
             Study V72P10.

        Inclusion Criteria for all subjects:

          -  Individuals who have voluntarily given written informed consent after the nature of
             the study has been explained according to local regulatory requirements, prior to
             study entry.

          -  Individuals who can comply with study procedures including follow-up.

          -  Males Or Females of non-childbearing potential Or Females of childbearing potential
             who are using an effective birth control method .

        Exclusion Criteria for all subjects

        Exclusion Criterion for follow-on subjects:

        • Received a third dose of a Meningococcal group B vaccine prior to enrolment in this
        study.

        Exclusion Criterion for naïve subjects:

        • Received any other Meningococcal group B vaccines prior to enrolment in this study.

        Exclusion Criteria for all subjects:

          -  Progressive, unstable or uncontrolled clinical conditions.

          -  Hypersensitivity, including allergy, to any component of vaccines or medical equipment
             whose use is foreseen in this study.

          -  Abnormal function of the immune system.

          -  Received immunoglobulins or any blood products within 180 days prior to informed
             consent and assent as applicable (according to the subject's age).

          -  Received an investigational or non-registered medicinal product within 30 days prior
             to informed consent and assent as applicable (according to the subject's age).

          -  Study personnel as an immediate family or household member.

          -  Any other clinical condition that, in the opinion of the investigator, might pose
             additional risk to the subject due to participation in the study.

          -  Positive results at the urine pregnancy test performed before study vaccination.