Comparison of GSK Biologicals' Meningococcal Vaccine (GSK134612) and Licensed MenC-CRM197 Vaccine in Healthy Children
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: GSK Biologicals' meningococcal vaccine GSK134612; Menjugate
Intervention description: Intramuscular administration, 1 dose; Intramuscular administration, 1 dose
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 414.0
Sex: All
Minimum age: 2 Years
Maximum age: 10 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Conjugate vaccine; Meningococcal disease; Immunogenicity; Meningococcal vaccine; Safety

Summary:

      The purpose of the study is to investigate whether or not GSK Biologicals' meningococcal
      vaccine GSK134612 is inferior to a licensed MenC-CRM197 conjugate vaccine in terms of vaccine
      antibody response against meningococcal serogroup C disease.
    

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 between, and including, 2 and 10 years of age at the time of the
             vaccination.

          -  Written informed consent obtained from the parent(s) 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.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccines within 30 days preceding the study vaccine dose, or planned use during
             the study period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to the vaccine dose..

          -  Administration of a vaccine not foreseen by the study protocol during the period
             starting from one month before the dose of the study vaccine and ending 30 days after.

          -  Concurrently participating in another clinical study or planned participation in
             another clinical study, at any time during the study period, in which the subject has
             been or will be exposed to an investigational or a non-investigational product.

          -  Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C W-135
             and/or Y (for subjects below 6 years) or within the last five years (for subjects 6
             years old and above).

          -  Previous vaccination with meningococcal polysaccharide conjugate vaccine serogroups A,
             C, W-135 and/or Y.

          -  History of meningococcal disease.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus (HIV) infection, based on medical history and physical
             examination.

          -  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.

          -  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 study vaccine dose or planned administration during the study period.

        Exclusion criteria for specified regions in France

          -  Subjects in contact with somebody suffering from an invasive infection with
             meningococcal serogroups A, C, Y or W-135, or

          -  Subjects living in a geographic area in France where local outbreak with meningococcal
             serogroup C has occurred and would thus be likely to participate in a vaccination
             campaign against meningococcal serogroup C.