A Safety and Immune Study of 2 Types of GlaxoSmithKline's Varicella Vaccines Given as a 2-doses Course to Healthy Children 12-23 Months of Age.
Condition: Chicken-pox Illness (Varicella Virus Disease); Chickenpox
MeSH terms: Virus Diseases; Chickenpox; Herpes Zoster
Intervention: Varilrix HSA-free; Varilrix™
Intervention description: 2 doses will be administered, one at Day 0 and the other at Day 42; 2 doses will be administered, one at Day 0 and the other at Day 42
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1236.0
Sex: All
Minimum age: 12 Months
Maximum age: 23 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Immunogenicity; Varicella; Safety; Human serum albumin; Healthy children; 12 to 23 months

Summary:

      The purpose of this study is to evaluate the safety and immunogenicity of 2 formulations of
      GSK Biologicals' varicella vaccines given as a 2-dose course in the second year of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects' parent(s)/ LAR(s) who, in the opinion of the investigator, can and will
             comply with the requirements of the protocol.

          -  A male or female between, and including, 12 and 23 months of age (i.e. 12 months to a
             day before 24 months) at the time of the first study vaccination.

          -  Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to
             performing any study specific procedure.

          -  Subjects in stable health as determined by investigator's clinical examination and
             assessment of subject's medical history.

          -  Subjects must have had prior administration of a dose of measles, mumps and rubella
             (MMR) vaccine at least 30 days (Day -31 or earlier) prior to study vaccination at Day
             0.

        Exclusion Criteria:

          -  Child in care.

          -  Use of any investigational or non-registered product other than the study vaccines
             during the period starting 30 days before the day of study vaccination (i.e., 30 days
             prior to Visit 1/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 (defined as 14 or more consecutive days) 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 live viral vaccine not foreseen by the
             study protocol during the period starting 30 days prior to study vaccination at Visit
             1/Day 0 until study end. Non study live viral vaccines can be administered at Visit 3
             (Day 84) after completion of study procedures.

          -  Planned administration/ administration of an inactivated vaccine not foreseen by the
             study protocol during the period starting 7 days prior to each vaccination (at Visit
             1/Day 0 and Visit 2/Day 42) and ending 14 days after each vaccination. Outside of this
             period, non-study inactivated vaccines can be administered as per standard of care.

          -  Administration of immunoglobulins and/or any blood products during the period starting
             180 days prior to the first vaccine dose or planned administration from the date of
             first study vaccination through the entire study.

          -  History of varicella or zoster.

          -  Known exposure to varicella/zoster during the period starting within 30 days prior to
             first study vaccination.

          -  Previous vaccination against varicella.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination (no laboratory testing required).

          -  Subjects with blood dyscrasias, leukemia, and lymphomas of any type.

          -  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 or latex.

          -  Major congenital defects or serious chronic illness.

          -  Acute disease and/or fever at the time of enrolment.

               -  Fever is defined as temperature ≥38. 0°C/100.4°F by any age appropriate route.

               -  Subjects with a minor illness without fever may be enrolled at the discretion of
                  the investigator.

          -  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.