Immunogenicity and Safety Study of PriorixTetra™ When Co-administered With Conjugated MenC Vaccine in Healthy Children
Condition: Rubella; Varicella; Measles; Mumps
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella
Intervention: PriorixTetra™; Meningitec
Intervention description: One dose administered subcutaneously; One dose administered intramuscularly
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 716.0
Sex: All
Minimum age: 13 Months
Maximum age: 15 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: safety; healthy; conjugated; immunogenicity; children; MenC vaccine; MMRV vaccine

Summary:

      The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals'
      investigational measles, mumps, rubella and varicella (MMRV) vaccine (GSK208136,
      PriorixTetra™) when co-administered along with conjugated Meningococcal C (MenC) vaccine
      (Meningitec®, Nuron Biotechs' Vaccine) in healthy children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that parent(s)/Legally Acceptable
             Representatives (LAR) can and will comply with the requirements of the protocol.

          -  A male or female between, and including, 13 and 15 months of age at the time of the
             first vaccination.

          -  Written informed consent obtained from the parent(s)/ LAR of the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

        Exclusion Criteria:

          -  Child in care.

          -  Use of any investigational or non-registered product other than the study vaccines
             within 30 days preceding the 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
             starting 30 days prior to the study vaccination/s and ending 42 days after the
             vaccination/s (at Visit 2), with the exception of inactivated influenza (flu) vaccine,
             which may be given at any time during the study, including the day of study
             vaccination/s.

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational or a
             non-investigational product.

          -  Previous vaccination against measles, mumps, rubella, varicella/ herpes zoster and/or
             N. meningitidis serogroup C.

          -  History of measles, mumps, rubella, varicella and/or N. meningitidis serogroup C
             diseases.

          -  Known exposure to measles, mumps, rubella and or varicella starting 30 days prior to
             enrolment.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  Family history of congenital or hereditary immunodeficiency.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine(s).

          -  Major congenital defects or serious chronic illness.

          -  Acute disease and/or fever at the time of enrollment.

          -  Documented human immunodeficiency virus (HIV) positive subject.

          -  Any contraindications as stated in the Summary of Product Characteristics.

          -  Administration of immunoglobulins and/or any blood products within three months prior
             to the first vaccine dose or planned administration during the study period.