Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life
Condition: Measles; Mumps; Rubella; Measles-Mumps-Rubella Vaccine
MeSH terms: Measles; Rubella; Mumps
Intervention: Priorix; M-M-R II; Varivax; Havrix; Prevnar 13
Intervention description: Subjects receive one dose of either minimum (Inv_MMR_Min) or medium (Inv_MMR_Med) potency lot at Day 0 and a dose of separate potency lot (Inv_MMR_Release) at Day 42, administered subcutaneously in the triceps region of the left arm.; Subjects receive two doses of either Lot 1 or Lot 2, one at Day 0 and one at Day 42, administered subcutaneously in the triceps region of the left arm.; Subjects receive one dose co-administered subcutaneously with the study vaccines (Priorix and M-M-R II), in the triceps region of right arm, at Day 0.; Subjects receive one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the right thigh, at Day 0.; US Subjects receive one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the left thigh, at Day 0.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 4538.0
Sex: All
Minimum age: 12 Months
Maximum age: 15 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Safety; Measles, mumps and rubella diseases; Immunogenicity

Summary:

      The purpose of this study is to evaluate end of shelf-life potency in terms of the
      immunogenicity and safety of GSK Biologicals' trivalent MMR vaccine, by comparing it to Merck
      & Co., Inc.'s MMR vaccine, which is approved for use in the United States (US).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female child between 12 and 15 months of age at the time of vaccination.

          -  The investigator believes that the parent(s) or Legally Acceptable Representative(s)
             (LAR(s)) of the child, can, and will comply with the requirements of the protocol.

          -  Written informed consent obtained from the parent(s)/LAR(s) of the child.

          -  Child is in stable health as determined by investigator's clinical examination and
             assessment of child's medical history.

        For US children only:

        • Child that previously received a 3-dose series of Prevnar 13 with last dose at least 60
        days prior to study entry.

        Exclusion Criteria:

          -  Child in care.

          -  Use of any investigational or non-registered product other than the study vaccine(s)
             during the period starting 30 days before the day of study vaccination or planned use
             during the entire study period.

          -  Concurrently participating in another clinical study, in which the child has been or
             will be exposed to an investigational or a non-investigational product. Chronic
             administration of immunosuppressants, or other immune-modifying drugs during the
             period starting 180 days prior to the first vaccine dose or any planned administration
             of immunosuppressive and immune-modifying drugs during the entire study.

               -  Inhaled and topical steroids are allowed.

          -  Planned administration / administration of a vaccine not foreseen by the study
             protocol during the period starting 30 days prior to study vaccination at Visit 1 and
             ending at Visit 2 (or ending at Visit 3 for the US post-dose 2 sub-cohort). Please
             Note:

               -  Inactivated influenza (Flu) vaccine and Haemophilus influenzae type b conjugate
                  vaccine (Hib) vaccines may be given at any time during the study, including the
                  day of study vaccination (Flu and Hib vaccines must be administered at a
                  different location than the study vaccine/s).

               -  Any age appropriate vaccine may be given starting at Visit 2 (or starting at
                  Visit 3 for the US post-dose 2 sub-cohort), and anytime thereafter.

          -  Administration of immunoglobulins and/or any blood products during the period starting
             180 days prior to study vaccination at Visit 1 or planned administration from the date
             of vaccination through the immunogenicity evaluation at Visit 2, or at Visit 3 for the
             US post-dose 2 sub-cohort.

          -  History of measles, mumps, rubella, varicella/zoster and/or hepatitis A diseases.

          -  Known exposure to measles, mumps, rubella and/or varicella/zoster during the period
             starting 30 days prior to the first study vaccination.

          -  Previous vaccination against measles, mumps, rubella, hepatitis A and/or varicella
             virus.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  A family history of congenital or hereditary immunodeficiency.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccines, including hypersensitivity to neomycin, latex or gelatin.

          -  Blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms
             affecting the bone marrow or lymphatic systems.

          -  Acute disease at the time of enrollment. Acute disease is defined as the presence of a
             moderate or severe illness with or without fever. Fever is defined as temperature
             ≥38°C/100.4°F by any age appropriate route. All vaccines can be administered to
             persons with a minor illness such as diarrhea, mild upper respiratory infection
             without fever.

          -  Active untreated tuberculosis based on medical history.

          -  Any other condition which, in the opinion of the Investigator, prevents the child from
             participating in the study.

        For US children only:

        • A child that previously received a fourth dose of any pneumococcal conjugate vaccine.