Consistency Study of GlaxoSmithKline (GSK) Biologicals' MMR Vaccine (209762) (Priorix) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine (M-M-R II), in Children 12 to 15 Months of Age
Condition: Rubella; Measles; Mumps
MeSH terms: Measles; Rubella
Intervention: Priorix; M-M-R II; Varivax; Havrix; Prevnar 13
Intervention description: Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.; Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.; Subjects receive 1 dose of VV vaccine which is administered subcutaneously in the triceps region of the right arm.; Subjects receive 1 dose of HAV vaccine which is administered intramuscularly in the anterolateral region of the right thigh.; US subjects receive 1 dose of PCV-13 vaccine which is administered intramuscularly in the anterolateral region of the left thigh.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 5016.0
Sex: All
Minimum age: 12 Months
Maximum age: 15 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Safety; Consistency study; Measles, mumps and rubella diseases; Healthy children; Immunogenicity

Summary:

      The purpose of this study is to evaluate consistency in terms of the immune response to three
      different lots of GSK Biologicals' trivalent MMR vaccine manufactured to target potencies,
      and compare its immunogenicity 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 only (i.e., no doses given
        as Prevnar/Prevenar), with the 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 (i.e., 30 days
             prior to Day 0) 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.

               -  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
             during the period starting 30 days prior to study vaccination at Visit 1 and ending at
             Visit 2. Please Note:

               -  Inactivated influenza (Flu) vaccine and Haemophilus influenzae type b conjugate
                  vaccine (Hib) vaccines may be given at any time, including the day of study
                  vaccination (Flu and Hib vaccines must be administered at a different location
                  than the study vaccine/s).

               -  Any other age appropriate vaccine may be given starting at Visit 2 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.

          -  History of measles, mumps, rubella, varicella/zoster and/or hepatitis A disease.

          -  Known exposure to measles, mumps, rubella and/or varicella/zoster during the period
             starting within 30 days prior to 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. 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:

          -  Child that previously received a vaccination with heptavalent Prevnar/Prevenar (prior
             vaccination should be with 3 doses of Prevnar 13 only).

          -  Child that previously received a fourth dose of any pneumococcal conjugate vaccine.