Immunogenicity and Safety Study of 1 and 2 Doses of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine MenACWY-TT (GSK134612) in Toddlers, Persistence up to 5 Years After Vaccination and Co-administration With Pfizer's Prevenar 13™Vaccine
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Meningococcal vaccine GSK134612; Prevenar 13™
Intervention description: 1 or 2 doses administered intramuscularly in the left anterolateral thigh or deltoid region; 1 dose administered intramuscularly in the right anterolateral thigh or deltoid region
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 803.0
Sex: All
Minimum age: 12 Months
Maximum age: 14 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Co-administration; Safety; Persistence; Immunogenicity; Prevenar 13; Meningococcal vaccine; Toddlers; 5 years

Summary:

      The purpose of this study is to compare the immediate and long term (up to 5 years)
      immunogenicity and safety of GSK Biologicals' MenACWY-TT vaccine when given as a single dose
      or as 2 doses to toddlers aged 12 to 14 months. Also, this study will also assess if
      co-administration of GSK Biologicals' MenACWY-TT with the booster dose of Pfizer's Prevenar
      13 adversely impacts the immunogenicity of either of the vaccines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion
             of the investigator, can and will comply with the requirements of the protocol.

          -  A male or female between, and including, 12 and 14 months of age at the time of the
             first vaccination.

          -  Written informed consent obtained from the parent(s)/LAR(s) of the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Vaccination records showing the completion of the full primary vaccination schedule
             with Prevenar 13 and Diphtheria, Tetanus and Pertussis (DTP) containing vaccine
             according to local recommendations at least 5 months before the study entry.

        Exclusion Criteria:

          -  Child in care.

          -  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 in total) of immunosuppressants
             or other immune-modifying drugs within six months prior to the first vaccine dose. For
             corticosteroids, this will mean prednisone 0.5 mg/kg/day, or equivalent. Inhaled and
             topical steroids are allowed.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             within the period starting 30 days before and ending 30 days after the dose of
             vaccines, with the exception of a licensed inactivated influenza vaccine. Measles,
             Mumps Rubella (MMR) vaccine or Measles Mumps Rubella and Varicella (MMRV) vaccine can
             be co-administered with MenACWY-TT and/or Prevenar 13. A DTPa containing vaccine can
             be administered after the last blood sampling (at Visit 2 or 4 depending on the
             group).

          -  Concurrently participating 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 vaccine/product (pharmaceutical product or device).

          -  Previous vaccination against Neisseria meningitidis.

          -  Previous booster vaccination against Streptococcus pneumoniae.

          -  Previous booster vaccination against Corynebacterium diphtheriae, Clostridium tetani
             and Bordetella pertussis.

          -  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 (no laboratory testing required)*

               -  Note: With the exception of HIV rapid testing which will be done for subjects in
                  South Africa.

          -  Family history of congenital or hereditary immunodeficiency.

          -  History of any reaction or hypersensitivity, including to diphtheria toxoid, likely to
             be exacerbated by any component of the vaccines.

          -  Major congenital defects or serious chronic illness.

          -  History of any neurological disorders or seizures, including Guillain-Barré syndrome
             (GBS). History of a simple, single febrile seizure is permitted.

          -  Acute disease and/or fever at the time of enrollment.

          -  Administration of immunoglobulins and/or any blood products within the 3 months
             preceding the first dose of study vaccine or planned administration during the study
             period.