Comparison of GSK Measles-mumps-rubella-varicella (MMRV) Vaccine Versus PriorixTM
Condition: Varicella; Rubella; Mumps; Measles
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella; Mumps
Intervention: GSK Biological's investigational MMRV vaccine 208136; Priorix™; Varilrix™
Intervention description: Subcutaneous injection; Subcutaneous injection; Subcutaneous injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 450.0
Sex: All
Minimum age: 9 Months
Maximum age: 10 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Mumps; Immunogenicity; Vaccines; Safety; Rubella; Combined Vaccine; Varicella Vaccine; Children; Measles; Humans

Summary:

      The purpose of this study is to assess non-inferiority of two different vaccination regimens
      using GSK Biological's MMRV vaccine (two doses at 9 and 15 months) or Priorix™ (9 months) and
      one dose of MMRV vaccine (15 months) to the current standard of care which is Priorix™
      administered at 9 months of age followed by concomitant administration of Priorix™ with
      Varilrix™ at 15 months of age in a measles endemic environment such as India.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol should be enrolled in the study.

          -  Male or female subjects between and including 9 and 10 months of age at the time of
             the first vaccination.

          -  Written informed consent obtained from the the parent or guardian of the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product other than the study vaccines
             within 30 days preceding the first dose of study vaccine, or planned use during the
             study period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to the first vaccine dose.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             starting 30 days prior to administration of any dose of the study vaccine, up to 42
             days after the vaccine dose with the exception of hepatitis A vaccine and oral
             poliovirus vaccine .

          -  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-registered product.

          -  Previous vaccination against measles, mumps, rubella and varicella.

          -  History of measles, mumps, rubella and/or varicella diseases.

          -  Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to the
             start of the study.

          -  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 neomycin.

          -  Major congenital defects or serious chronic illness.

          -  History of any neurologic disorders or seizures.

          -  Acute disease at the time of enrolment.

          -  Axillary temperature > 37.5°C (99.5°F) / Rectal temperature > 38°C (100.4°F).

          -  Administration of immunoglobulins and/or any blood products during the six months
             before entering the study or planned administration during the study period.

          -  Presence of a susceptible high-risk person in the same household during the study
             period.