Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Measles, Mumps and Rubella (MMR) Vaccine (209762) Compared to Merck & Co., Inc.'s MMR Vaccine in Healthy Children 12 to 15 Months of Age
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: 1 dose administered subcutaneously in the triceps region of left arm at Day 0; 1 dose administered subcutaneously in the triceps region of left arm at Day 0; 1 dose administered subcutaneously in the triceps region of right arm at Day 0; 1 dose administered intramuscularly in the anterolateral region of the right thigh at Day 0; 1 dose administered intramuscularly in the anterolateral region of the left thigh at Day 0 to subjects recruited in US
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1742.0
Sex: All
Minimum age: 12 Months
Maximum age: 15 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Rubella; Healthy children; Measles; Safety; Mumps; 12 to 15 months; Immunogenicity

Summary:

      The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals'
      trivalent MMR (Priorix), comparing it to Merck's MMR vaccine (M-M-R II), which is approved
      for use in the US in healthy children 12 to 15 months of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female child between 12 and 15 months of age (e.g., from the 1 year birthday
             until the day before age 16 months) at the time of vaccination.

          -  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.

          -  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: a child who received all routine vaccinations as per ACIP
             recommendations prior to study entry: completion of hepatitis B and rotavirus series
             and completion of the primary series of diphtheria, tetanus, pertussis, poliovirus,
             Haemophilus influenzae type b (Hib) and pneumococcal vaccines. The 3-dose infant
             series of Prevnar 13 should be completed at least 60 days prior to study vaccination.

        Exclusion Criteria:

          -  Child in care.

          -  Use of any investigational or non-registered product (drug or vaccine) 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 (pharmaceutical
             product or device).

          -  Chronic administration (defined as 14 or more consecutive days) of immunosuppressants,
             or other immune-modifying drugs during the period starting 180 days prior to the study
             vaccination at Visit 1 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 the day of study vaccination at Visit 1
             and ending at Visit 2. Please Note:

               -  Inactivated influenza (Flu) vaccine and monovalent 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 before the 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 (no laboratory testing required).

          -  Blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms
             affecting the bone marrow or lymphatic systems.

          -  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.

          -  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
             ≥38.0°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 PCV-13
             vaccine.