Evaluate Vaccine Against Chickenpox and a Combined Vaccine Against 4 Viral Childhood Diseases: Measles, Mumps, Rubella and Chickenpox
Condition: Varicella; Chickenpox Vaccines
MeSH terms: Chickenpox; Herpes Zoster; Rubella
Intervention: Priorix-tetra™; Priorix™; Varilrix™
Intervention description: 2 doses administered subcutaneously, one at Day 0 and the other at Day 42 to subjects in MMRV Group; 2 doses administered subcutaneously, one at Day 0 and the other at Day 42 to subjects in MMR Group and one dose administered subcutaneously at Day 0 to subjects in OKAH Group; 1 dose administered subcutaneously at Day 42 to subjects in OKAH Group
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 5803.0
Sex: All
Minimum age: 11 Months
Maximum age: 22 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      An observer-blind study to evaluate GlaxoSmithKline Biologicals' live attenuated varicella
      vaccine and GlaxoSmithKline Biologicals' combined measles-mumps-rubella-varicella vaccine in
      the prevention of varicella disease in children. The Protocol Posting has been updated in
      order to comply with the FDA Amendment Act, Sep 2007.
    

Eligibility criteria:

        Inclusion criteria:

          -  Subjects for whom the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol for the whole duration of the study.

          -  Male or female subject between 12 and 22 months of age at the time of the first
             vaccination.

          -  Subjects free of obvious health problems, as established by medical history and
             physical examination before entering the study.

          -  Written informed consent obtained from the parents/guardians of the subject after they
             have been informed on the risks and benefits of the study, in a language they clearly
             understand and before performance of any study procedure.

          -  Subjects whose parents/guardians have direct access to telephone/mobile phone.

          -  Subjects:

               1. with at least one sibling (with negative history of varicella
                  disease/vaccination) at home, or

               2. attending day care center, or

               3. attending childminders, i.e. someone taking care of several children, or

               4. who are in contact for at least once a week with other children without a known
                  positive history of varicella disease/vaccination, while playing in close
                  physical contact for more than 5 minutes.

        Exclusion criteria:

          -  Previous vaccination against measles, mumps, rubella and/or varicella.

          -  History of previous measles, mumps, rubella and/or varicella/ herpes zoster diseases.

          -  Known exposure to measles, mumps, rubella and/or varicella/herpes zoster within 30
             days prior to the start of the study.

          -  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 within three months prior
             to the first vaccine dose or planned administration during the study period.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical.

          -  Family history of congenital or hereditary immunodeficiency.

          -  History of allergic diseases or reactions likely to be exacerbated by any component of
             the vaccines, including systemic allergy to egg proteins or neomycin.

          -  Major congenital defects or serious chronic illness.

          -  Residence in the same household as newborns (0-4 weeks of age), pregnant women who are
             varicella-susceptible, persons with a known immunodeficiency or any other persons at
             high risk for varicella.

          -  History of any neurologic disorders or seizures.

          -  Use of any investigational or non-registered product (drug/vaccine other than the
             study vaccines) within 14 days prior to vaccination and planned use during the study
             period.

        Additional exclusion criteria for subjects included in the subset:

        - Administration of a licensed vaccine within 14 days prior to vaccination and planned use
        until approximately 42 days after the last study vaccine dose (Day 84) with the exception
        of oral polio vaccine (OPV).