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.

This is an interventional prevention trial for Chicken-pox Illness (Varicella Virus Disease) focused on measuring Immunogenicity, Varicella, Safety, Human serum albumin, Healthy children, 12 to 23 months Read More

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.