Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136
Condition: Measles; Varicella; Mumps; Rubella
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella; Mumps
Intervention: PriorixTM; VarilrixTM; Priorix-Tetra®
Intervention description: Subcutaneous administration in left upper arm; Subcutaneous administration in right upper arm; Subcutaneous injection in left upper arm
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 475.0
Sex: All
Minimum age: 11 Months
Maximum age: 24 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: second year of life; one-dose schedule; varicella; rubella; measles; mumps

Summary:

      This Phase 3b study is being conducted for the purpose of registration of the GSK208136
      vaccine in Korea.
    

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.

          -  A male or female between, and including 11 and 24 months of age, at the time of the
             vaccination.

          -  Written informed consent obtained from 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 (drug or vaccine) other than the
             study vaccine(s) within 30 days preceding the 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 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 the study vaccine dose with the exception
             of inactivated vaccines such as pneumococcal, Haemophilus influenzae type b conjugate
             vaccines, inactivated influenza, hepatitis A or B vaccine or
             diphtheria/tetanus-containing vaccines which can be administered up to eight days
             before the 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.

          -  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