One Year Antibody Persistence After a Fourth Dose Boost or Two Catch-Up Doses of Novartis Meningococcal B Recombinant Vaccine Administered Starting From 12 Months of Age and Response to a Third Dose Boost or Two Catch-Up Doses Starting at 24 Months of Age
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Intervention: rMenB+OMV NZ
Intervention description: Subjects will be assigned to a study group based on the group assignment in the parent study (follow-on subjects). In addition, one group of naïve age-matched subjects will be recruited at the same study sites. Subjects who had received 4 doses of rMenB+OMV NZ will have one visit including one blood draw. Subjects who had received two catch-up doses in V72P13E1 will receive a third dose boost and will have 3 blood samples drawn. Naïve subjects will receive two catch-up doses and have 3 blood samples drawn.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 508.0
Sex: All
Minimum age: 23 Months
Maximum age: 27 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Children; Meningococcal disease; Prevention; Vaccination

Summary:

      One year antibody persistence after the fourth dose boost or two catch-up doses administered
      starting from 12 months of age and to evaluate the response to a a third dose boost or two
      catch-up dose starting at 24 months of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and female children, 23 to 27 months of age (naïve children)

          -  Available for all the visits scheduled in the study;

          -  For whom parent(s)/legal guardian(s) have given written informed consent according to
             local regulations after the nature of the study has been explained;

          -  Available for all the visits scheduled in the study;

          -  In good health as determined by medical history, physical examination, clinical
             judgment of the investigator.

          -  Healthy children who participated in the immunogenicity part of V72P13E1 and have
             received their last vaccination 12 months (-30/+60 days) before enrolment in V72P13E2;

          -  Who received all vaccinations with rMenB+OMV NZ in V72P13 and V72P13E1 according to
             the protocols;

          -  Who provided at least the blood sample one month after their fourth dose of rMenB+OMV
             NZ (groups B246_12M12/B246_12M13) or after their second dose of rMenB+OMV NZ (groups
             B13_15_27/B12_14_26) in V72P13E1 according to the protocol;

          -  For whom parent(s)/legal guardian(s) had given written informed consent after the
             nature of the study has been explained;

          -  In good health as determined by medical history, physical examination, clinical
             judgment of the investigator.

        Exclusion Criteria:

          -  Subjects whose parent(s)/legal guardian(s) were unwilling or unable to give written
             informed consent to participate in the study;

          -  History of any meningococcal B vaccine administration;

          -  Previous ascertained or suspected disease caused by N. meningitidis;

          -  For whom parent(s)/legal guardian(s) have given written informed consent according to
             local regulations after the nature of the study has been explained;

          -  History of severe allergic reaction after previous vaccinations or hypersensitivity to
             any vaccine component;

          -  Antibiotics treatment within 6 days prior to enrolment;

          -  Household contact with and/or intimate exposure to an individual with laboratory
             confirmed N. meningitidis;

          -  Any serious chronic or progressive disease

          -  Known or suspected impairment/ alteration of the immune system,

          -  Receipt of, or intent to immunize with another vaccine, within 30 days prior and after
             vaccination with the investigational vaccines (within 14 days for licensed flu
             vaccines)

          -  Significant acute or chronic infection within the previous 7 days or axillary
             temperature ≥38C within the previous day;

          -  Family members and household members of research staff;

          -  Any serious chronic or progressive disease according to the judgment of the
             investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic
             disease, neurological disease or seizure, either associated with fever or as part of
             an underlying neurological disorder or syndrome, autoimmune disease, Human
             Immunodeficiency Virus (HIV) infection or Acquired Immune Deficiency 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, use of systemic corticosteroids or chronic use of inhaled high-potency
             corticosteroids within 30 days prior to enrolment (use of low or moderate doses of
             inhaled steroids is not an exclusion);

          -  Receipt of blood, blood products and/or plasma derivatives or any parenteral
             immunoglobulin preparation within 90 days prior to enrolment;

          -  Participation in another clinical trial within 90 days prior to enrolment or planned
             for during study;

          -  Receipt of, or intent to immunize with any other vaccine(s) within 30 days prior to
             enrolment (exception: flu-vaccines should not be administered within 14 days prior to
             enrolment);

          -  Any condition which, in the opinion of the investigator, might interfere with the
             evaluation of the study objectives.