Study of Two Formulations of GSK Biologicals' Varicella Vaccine
Condition: Varicella
MeSH terms: Chickenpox; Herpes Zoster
Intervention: Varilrix (inactivated varicella vaccine)
Intervention description: subcutaneously injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 244.0
Sex: All
Minimum age: 11 Months
Maximum age: 21 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: chickenpox; varicella; two-dose schedule; second year of life

Summary:

      The aim of this study is to evaluate a modified formulation of GSK Biologicals' live
      attenuated varicella vaccine. In vivo pre-clinical data show this change has no negative
      impact on vaccine safety. This present study is undertaken to rule out any negative impact on
      the immunogenicity and safety of GSK Biologicals' live attenuated varicella virus vaccine.
    

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 at the time of the
             first 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 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
             within 30 days prior to the first study vaccine dose until 42 days after second study
             vaccine dose with the exception of oral polio vaccine (OPV) which can be given at any
             time and routine inactivated vaccines which can be administered up to eight days
             before each study vaccine dose.

          -  Previous vaccination against varicella.

          -  Known history of clinical varicella.

          -  Known exposure to varicella within 30 days prior to study start.

          -  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 vaccine(s), including systemic hypersensitivity to neomycin.

          -  Major congenital defects or serious chronic illness.

          -  Acute disease at the time of enrolment. All vaccines can be administered to persons
             with a minor illness.

          -  Axillary temperature ≥ 37.5°C / Rectal temperature ≥ 38°C.

          -  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