Persistence and Booster Study of GSK Biologicals' Meningococcal Vaccine (GSK134612) in Healthy Children
Condition: Infections, Meningococcal; Meningococcal Vaccines
MeSH terms: Meningococcal Infections
Intervention: Nimenrix (GSK134612 vaccine); Menjugate
Intervention description: Intramuscular, 1 dose; Intramuscular, 1 dose
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 271.0
Sex: All
Minimum age: 4 Years
Maximum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Immunogenicity; Persistence; Safety; Conjugate vaccine; Meningococcal vaccine

Summary:

      The purpose of the study is to evaluate the persistence of the immune response of GSK134612
      vaccine up to 68 months after vaccination in the primary vaccination study (NCT number =
      NCT00674583) of 2 to 10 year old subjects. This study will also evaluate the safety and
      immunogenicity of a booster dose of GSK134612 vaccine subjects who were primed in the primary
      vaccination study with either GSK134612 vaccine or Menjugate®.

      This protocol posting deals with objectives & outcome measures of the persistence and booster
      epochs. The objectives & outcome measures of the primary epoch are presented in a separate
      protocol posting (NCT number = NCT00674583)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parent(s)/Legally Acceptable
             Representative(s) can and will comply with the requirements of the protocol should be
             enrolled in the study.

          -  A male or female who was primed with MenACWY-TT or Menjugate in the primary
             vaccination study (NCT number = NCT00674583).

          -  Written informed consent obtained from the parent(s)/Legally Acceptable
             Representatives(s) of the subject and written informed assent obtained from the
             subject (at investigator discretion).

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

        All subjects must meet the additional following criteria prior to receiving the booster
        vaccination:

          -  Subjects who had a blood sample taken at Visit 4 during the persistence epoch of the
             current study.

          -  Female subjects of non-childbearing potential may be enrolled in the study.

          -  Female subjects of childbearing potential may be enrolled in the study, if the
             subject:

               -  has practiced adequate contraception for 30 days prior to vaccination, and

               -  has a negative pregnancy test on the day of vaccination, and

               -  has agreed to continue adequate contraception during the entire treatment period
                  and for 2 months after completion of the vaccination series.

        Exclusion Criteria:

          -  Child in care.

          -  Use of any investigational or non-registered product within 30 days preceding the
             first persistence blood sample or planned use within 30 days preceding a blood sample
             during the study period.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs during the study period. (For corticosteroids, prednisone <10
             mg/day, or equivalent, inhaled and topical steroids are allowed).

          -  Concurrently participating in another clinical study or planned participation in
             another clinical study, in which the subject has been or will be exposed to an
             investigational or a non-investigational product within 30 days of a blood sample.

          -  History of meningococcal disease.

          -  Administration of a meningococcal polysaccharide or a meningococcal polysaccharide
             conjugate vaccine since the previous vaccination in the primary vaccination study (NCT
             number = NCT00674583).

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus infection, based on medical history and physical
             examination.

          -  Serious chronic illness.

          -  Administration of immunoglobulins and/or blood products within the 3 months preceding
             the subject's first visit.

          -  Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.

          -  Subjects in contact with somebody suffering from an invasive infection with
             meningococcal serogroups A, C, Y or W-135.

          -  Subjects living in a geographic area where local outbreak with meningococcal serogroup
             C has occurred.

        Exclusion criteria for booster vaccination to be checked at Visit 4 (Month 68)

          -  Child in care.

          -  Use of any investigational or non-registered product within 30 days preceding the
             booster vaccination or planned use during the study period.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within six months prior to the booster vaccination. (For
             corticosteroids, prednisone <10 mg/day, or equivalent, inhaled and topical steroids
             are allowed).

          -  Vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, B,
             C, W-135, and/or Y since the previous vaccination in the primary vaccination study
             (NCT number = NCT00674583).

          -  History of meningococcal disease.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus infection, based on medical history and physical
             examination.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the booster vaccination or planned administration during the study period.

          -  Concurrently participating in another clinical study or planned participation in
             another clinical study, at any time during the study period, (from the time of the
             booster until the end of the study) in which the subject has been or will be exposed
             to an investigational or a non-investigational product.

          -  Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.

          -  Hypersensitivity to latex.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             within the last 30 days of the dose of vaccine(s) with the exception of a licensed
             inactivated influenza vaccine.

          -  Previous vaccination with tetanus toxoids within the last 30 days.

          -  A family history of congenital or hereditary immunodeficiency, until the immune
             competence of the potential vaccine recipient is demonstrated.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Serious chronic illness.

          -  History of any neurological disorders or seizures (although subjects with a prior
             history of a single episode of benign febrile seizures may be allowed to participate
             in the study).

          -  Acute disease and/or fever at the time of vaccination.

          -  History of chronic alcohol consumption and/or drug abuse.

          -  History of hypotonic-hyporesponsive episodes (HHEs) following vaccination.

          -  Subjects in contact with somebody suffering from an invasive infection with
             meningococcal serogroups A, C, Y or W-135.

          -  Subjects living in a geographic area where local outbreak with meningococcal serogroup
             C has occurred.

          -  Pregnant or lactating female.

          -  Female of child-bearing potential planning to become pregnant or planning to
             discontinue contraceptive precautions.