Safety & Immunogenicity Study of Meningococcal Vaccine GSK134612 Given With Priorix-Tetra™ to 12-23 Month-Old Children
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Meningococcal vaccine GSK134612 (Nimenrix); Priorix-Tetra; Meningitec
Intervention description: Single dose intramuscular injection; 2-dose subcutaneous injection; Single dose intramuscular injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1000.0
Sex: All
Minimum age: 12 Months
Maximum age: 23 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: MMRV vaccine; co-administration; immunogenicity; meningococcal vaccine; conjugate vaccine

Summary:

      The purpose of this study is to demonstrate, in 12-23 month old children, the non-inferiority
      of the meningococcal vaccine 134612 given with Priorix-Tetra.

      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 23 months of age at the time of the
             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 parents' or legal
             guardians' knowledge.

        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 vaccine dose.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             within one month before and 42 days after the first dose of vaccine(s).

          -  Previous vaccination with meningococcal vaccine of serogroup A, C W and/or Y.

          -  History of meningococcal disease.

          -  Previous vaccination against measles, mumps, rubella, and/or varicella.

          -  History of measles, mumps, rubella and/or varicella.

          -  Known exposure to measles, mumps, rubella, varicella or zoster within 30 days prior to
             vaccination.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital
             or secondary), including human immunodeficiency virus (HIV) infection, based on
             medical history and physical examination.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine, including neomycin.

          -  Major congenital defects or serious chronic illness.

          -  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.