Co-Administration of Meningococcal Vaccine GSK134612 With Infanrix Hexa™ Versus Individual Administration of Each Vaccine
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Meningococcal vaccine GSK134612; Infanrix™ hexa; Meningitec™
Intervention description: Single dose intramuscular injection; Single dose intramuscular 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: 793.0
Sex: All
Minimum age: 12 Months
Maximum age: 23 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal vaccine; Immunogenicity; Routine infancy vaccination; Safety

Summary:

      The purpose of this study is to demonstrate, in 12-23 months old subjects, the
      non-inferiority of meningococcal vaccine GSK134612 co-administered with Infanrix hexa™,
      compared to each vaccine administered individually and to licensed meningococcal vaccine
      Meningitec™.

      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
             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.

          -  Documented three-dose primary vaccination with DTPa, hepatitis B, inactivated polio
             and Haemophilus influenzae type b conjugate vaccines, completed at least 180 days
             before administration of the first study vaccination.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccines 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 any vaccine not foreseen by the study
             protocol, including measles, mumps, rubella, varicella and pneumococcal vaccines,
             within 30 days before the first dose of vaccine(s) and 30 days after the last dose of
             vaccine(s).

          -  Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W
             and/or Y.

          -  Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup
             A, C, W and/or Y.

          -  Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B,
             poliomyelitis or Haemophilus influenzae type b.

          -  History of meningococcal disease.

          -  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 reactions or allergic disease likely to be exacerbated by any component of
             the vaccine(s).

          -  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.

        Additional criteria for subjects receiving Infanrix hexa™

          -  Hypersensitivity reaction due to previous vaccination with Infanrix hexa™.

          -  Encephalopathy defined as an acute, severe central nervous system disorder occurring
             within 7 days following vaccination and generally consisting of major alterations in
             consciousness, unresponsiveness, generalised or focal seizures that persist more than
             a few hours, with failure to recover within 24 hours.