Antibody Persistence, and Safety and Tolerability of a Booster Dose of the Meningococcal B Vaccine After the Completion of the Vaccination Course in Study V72_28
Condition: Meningoccocal Disease; Meningococcal Meningitis
MeSH terms: Meningitis, Meningococcal; Meningitis
Intervention: Bexsero® vaccine (1 dose at study month zero); Bexsero® vaccine (2 doses 1 month apart)
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 851.0
Sex: All
Minimum age: 35 Months
Maximum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal B disease,; Antibody persistence

Summary:

      The aim of this extension study is to explore the antibody persistence 24 to 36 months after
      the last dose of vaccine, in infants that received a two or three dose primary series plus a
      booster dose at 11 months of age, of the Novartis meningococcal B vaccine (Bexsero®) in
      groups I to III of the parent V72_28 study.

      This study will also explore the antibody persistence 24 to 36 months after two catch-up
      doses of the Novartis meningococcal B vaccine (Bexsero®) administered in children (2 to 10
      years old) in group IV of the parent V72_28 study.
    

Eligibility criteria:

        Inclusion Criteria:

        For naïve subjects newly enrolled:

          1. Healthy infants and children according to the following age groups:

               1. Healthy subjects from 35 to 47 months of age, (only applicable to group K) (The
                  age window is defined as the first day the subject turns 35 months of age up to
                  the day before the subject turns 48 months of age),

               2. Healthy subjects 4 to 7 years of age (only applicable to group L) (The age window
                  is defined as the first day the subject turns 4 years of age up to the day before
                  the subject turns 8 years of age).

               3. Healthy subjects 8 to 12 years of age (only applicable to group M) (The age
                  window is defined as the first day the subject turns 8 years of age up to the day
                  before the subject turns 13 years of age).

          2. for whom a parent/legal guardian has given written informed consent after the nature
             of the study has been explained;

          3. for whom a parent/legal guardian confirmed availability for the visit scheduled in the
             study;

          4. in good health as determined by medical history, physical examination, clinical
             judgment of the investigator.

        For Subjects who participated in the V72_28 study (Follow-on Subjects):

          1. for whom a parent/legal guardian has given written informed consent after the nature
             of the study has been explained;

          2. for whom a parent/legal guardian confirmed availability for the visit scheduled in the
             study;

          3. in good health as determined by medical history, physical examination, clinical
             judgment of the investigator

          4. who have completed the vaccination course in the V72_28 study and have received their
             last vaccination 24 to 36 months before enrollment in V72_28E1

        Exclusion Criteria:

        For naïve subjects newly enrolled:

          1. History of any serogroup B meningococcal vaccine administration;

          2. Previous known or suspected disease caused by N. meningitidis;

          3. Household contact with and/or intimate exposure to an individual with laboratory
             confirmed N. meningitidis infection or colonization;

          4. History of severe allergic reaction after previous vaccinations or hypersensitivity to
             any component of the vaccine;

          5. Pregnancy or nursing (breastfeeding) mothers;

          6. Females of childbearing age who have not used or do not plan to use acceptable birth
             control measures, for the duration of the study. Oral, injected or implanted hormonal
             contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine
             device, surgical sterilization, transdermal delivery, congenital sterility 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 at least two
             months prior to study entry;

          7. 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

          8. History of seizure, any progressive neurological disease or Guillain Barré Syndrome
             (exception: one self-limited febrile seizure is acceptable).

          9. Known bleeding diathesis or any condition that may be associated with a prolonged
             bleeding time.

         10. Subject's parent(s) or legal guardian(s) are not able to comprehend and to follow all
             required study procedures for the whole period of the study.

         11. Intent to participate in another clinical study during this study.

         12. Family members and household members of study staff;

         13. History or any illness/condition which, in the opinion of the investigator, might
             interfere with the evaluation of the study objectives or pose additional risk to the
             subjects due to participation in the study.

         14. Any significant chronic infection.

         15. Any serious chronic or progressive disease according to judgment of the investigator
             (e.g. neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).

        For Subjects who participated in the V72_28 study (Follow-on Subjects):

        Exclusion criteria are the same as for naïve subjects, with the exception of criterion 1.