Safety & Immunogenicity of 1 Dose of GSK134612 in Children 12-14 Months and 3-5 Years Old
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Conjugated meningococcal ACWY-TT (vaccine); DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib); DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™); Meningitec™; Mencevax™ACWY
Intervention description: One intramuscular dose during the primary vaccination; One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only; One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only; One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age; One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (Group E) and intramuscular administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (Groups A and E)
Intervention MeSH terms: Edetic Acid; Vaccines; Pentetic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Enrollment: 461.0
Sex: All
Minimum age: 12 Months
Maximum age: 60 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Safety; Meningococcal vaccine; Dose selection; Toddlers; Immunogenicity; Conjugate vaccine; Reactogenicity; Children

Summary:

      The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one
      dose of four different formulations of the MenACWY conjugate vaccine when given to healthy
      children aged 12-14 months and 3-5 years. The selection of the best formulation will be based
      on data obtained up to one month after the vaccine dose.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Eligibility criteria:

        Inclusion criteria:

          -  Subjects who the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol.

          -  A male or female between, and including 12 and 14 months or 3 and 5 years of age at
             the time of the first vaccination.

          -  Written informed consent obtained from the parent or guardian of the subject.

          -  Free of obvious health problems as established by medical history and clinical
             examination before entering into the study.

          -  Previously completed routine childhood vaccinations to the best of his/her
             parents'/guardians' knowledge. For pertussis vaccination, the children aged 12-14
             months should have been vaccinated with an acellular pertussis vaccine.

        Exclusion criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days preceding the first dose of study vaccine, 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 first vaccine dose.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             within one month of the first dose of vaccine and up to one month after administration
             of each study vaccine dose with the exception of oral polio vaccine (OPV).

          -  Previous vaccination against meningococcal serogroup A, C, W-135 or Y disease.

          -  Administration of a H. influenzae type b, diphtheria or tetanus vaccine within 3
             months before the first dose of vaccine.

          -  For subjects aged 12-14 months at enrolment:

               -  For Austria: DTPa-HBV-IPV/Hib booster vaccination in the second year of life:
                  these booster vaccines will be given at Visit 2.

               -  For Greece: DTPa-IPV/Hib booster vaccination in the second year of life: these
                  booster vaccines will be given at Visit 2.

          -  History of meningococcal serogroup A, C, W-135 or Y disease.

          -  Known exposure to meningococcal serogroup A, C, W-135 or Y disease within the previous
             year.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus (HIV) infection.

          -  A family history of congenital or hereditary immunodeficiency.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Major congenital defects or serious chronic illness.

          -  History of any neurologic disorders or seizures.

          -  Acute disease at the time of enrolment.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the first dose of study vaccine or planned administration during the study
             period.