Immunogenicity & Safety Study of GSK Biologicals' 208136 Vaccine Formulated With New Measles and Rubella Working Seeds
Condition: Measles; Varicella; Mumps; Rubella
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella
Intervention: Priorix-Tetra (combined measles-mumps-rubella-varicella vaccine); GSK Biologicals' 208136, new formulation
Intervention description: Vaccine will be administered subcutaneously in the left upper arm (deltoid region); Vaccine will be administered subcutaneously in the left upper arm (deltoid region)
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 501.0
Sex: All
Minimum age: 11 Months
Maximum age: 21 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Working seed virus; Rubella; Mumps; Varicella; Combined measles-mumps-rubella-varicella vaccine; Pediatric immunization; Measles

Summary:

      This study is undertaken to generate clinical data on GSK Biologicals' combined
      measles-mumps-rubella-varicella vaccine manufactured with measles and rubella obtained from
      newly established working seed viruses which are one passage further than the current working
      seed viruses. The measles-mumps-rubella-varicella vaccine manufactured with the current
      working seed viruses will serve as comparator.

      A seed lot system is a system according to which successive batches of a vaccine are derived
      from the same master seed virus. For routine production, a working seed lot is prepared from
      the master seed virus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol (e.g. completion of the diary cards,
             return for follow-up visits) should be enrolled in the study.

          -  A male or female between, and including, 11 and 21 months of age (e.g. from age
             11months until the day before age 22 months) at the time of the first vaccination.

          -  Written informed consent obtained from the parent or guardian of the subject after
             they have been advised on the risks and benefits of the study in a language they
             clearly understand, and before performance of any study procedure.

          -  Free of obvious healthy problems as established by medical history and clinical
             examination before entering into the study.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) 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) of immunosuppressants or other
             immune-modifying drugs within six months prior to the first vaccine dose.

          -  Administration of immunoglobulins and/or any blood products during the six months
             before entering the study or planned administration during the study period.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             within 30 days prior to until 42 days after each study vaccine dose with the exception
             of oral polio vaccine (OPV) which can be given at any time and routine inactivated
             vaccines such as pneumococcal, meningococcal or Haemophilus influenzae type b
             conjugate vaccines, inactivated influenza or diphtheria/tetanus containing vaccines
             which can be administered up to eight days before each study vaccine dose.

          -  Previous vaccination against measles, mumps, rubella and/or varicella.

          -  History of measles, mumps, rubella and/or varicella/zoster diseases.

          -  Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to
             study start.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus (HIV) infection.

          -  A family history of congenital or hereditary immunodeficiency.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine(s), including systemic hypersensitivity to neomycin.

          -  Major congenital defects or serious chronic illness.

          -  History of any neurologic disorders or seizures.

          -  Acute disease at the time of enrolment.

          -  Rectal temperature ≥38°C or axillary temperature >=37.5°C at the time of vaccination.

          -  Residence in the same household as a high risk person e.g.:

          -  New-born infants (0-4 weeks of age)

          -  Pregnant women who have a negative history of chickenpox

          -  Persons with known immunodeficiency