Immunogenicity and Safety of Meningococcal Vaccine GSK134612 Given as 1 or 2 Doses to Healthy 9-12 Months Old Toddlers.
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Meningococcal vaccine GSK134612
Intervention description: One or 2 intramuscular injections.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 385.0
Sex: All
Minimum age: 9 Months
Maximum age: 9 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Neisseria meningitidis;; Humans;; Meningococcal vaccines;; Safety; Vaccines, conjugate;; Toddlers;; Immunogenicity;

Summary:

      The purpose of the study is to characterize the safety and immunogenicity of 1 dose of
      GSK134612 vaccine at 12 months of age and of GSK134612 vaccine administered as 2 doses at 9
      and 12 months of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects whose parents/guardians the investigator believes can and will comply with
             the requirements of the protocol

          -  A male or female of 9 months of age (has not attained 10 months of age) at the time of
             enrollment.

          -  Up to date on vaccinations based on ACIP recommendations and the standard practice at
             the investigational site.

          -  Written informed consent obtained from parents/guardian of the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days preceding enrollment, 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 vaccine dose.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             within 1 month of a dose of study vaccine(s), with the exception of influenza vaccine.

          -  Planned administration of a tetanus toxoid (TT) containing vaccine throughout the
             active phase of the study (through one month after the last vaccination).

          -  Previous vaccination with meningococcal polysaccharide or conjugate vaccine of
             serogroup A, C W and/or Y.

          -  History of meningococcal diseases.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital
             or secondary), including human immunodeficiency virus (HIV) infection, based on
             medical history and physical examination (no laboratory testing is required).

          -  A family history of congenital or hereditary immunodeficiency, until the immune
             competence of the potential vaccine recipient is demonstrated.

          -  History of reactions or allergic disease 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 enrollment.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the first dose of study vaccine or planned administration during the active
             phase of the study (through one month after the last dose of study vaccine).