Immunogenicity and Safety Study of PriorixTetra™ When Co-administered With Conjugated MenC Vaccine in Healthy Children

• Immunogenicity with respect to the components of MMRV when administered concomitantly with MenC as compared to MMRV alone [ Time Frame: 42 days after vaccination ] [ Designated as safety issue: No ]
• Immunogenicity with respect to the MenC conjugate vaccine when administered concomitantly with MMRV as compared to MenC conjugate vaccine alone [ Time Frame: 42 days after vaccination ] [ Designated as safety issue: No ]

• Immunogenicity with respect to the components of MMRV when administered concomitantly with MenC as compared to MMRV alone. [ Time Frame: 42 days after vaccination ] [ Designated as safety issue: No ]
• Immunogenicity with respect to the MenC conjugate vaccine when administered concomitantly with MMRV as compared to MenC conjugate vaccine alone. [ Time Frame: 42 days after vaccination ] [ Designated as safety issue: No ]

• Immunogenicity with respect to the components of MMRV when administered concomitantly with MenC as compared to MMRV alone [ Time Frame: 42 days after vaccination ] [ Designated as safety issue: No ]
• Occurrence of solicited local symptoms [ Time Frame: Within 4 days after each vaccination (Day 0-3) ] [ Designated as safety issue: No ]
• Occurrence of solicited general symptoms [ Time Frame: Within 43 days after vaccination (Day 0 - 42) ] [ Designated as safety issue: No ]
• Occurrence of unsolicited symptoms [ Time Frame: Within 43 days after each vaccination (Day 0-42) ] [ Designated as safety issue: No ]
• Occurrence of Serious Adverse Events (SAEs) [ Time Frame: Throughout the study (from Day 0 to approximately Month 4) ] [ Designated as safety issue: No ]

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

• Varicella
• Rubella
• Measles
• Mumps

• Biological: Priorix Tetra
  One dose administered subcutaneously
  Other Name: MMRV vaccine
• Biological: Meningitec
  One dose administered intramuscularly
  Other Name: MenC vaccine

• Active Comparator: Group A
  Subjects in this arm will receive MMRV vaccine at Visit 1 (Day 0) and MenC vaccine at Visit 2 (Days 35-49).
  Interventions:

  • Biological: Priorix Tetra
  • Biological: Meningitec
• Experimental: Group B
  Subjects will receive MMRV vaccine and MenC vaccine at Visit 1 (Day 0).
  Interventions:

  • Biological: Priorix Tetra
  • Biological: Meningitec
• Active Comparator: Group C
  Subjects will receive Men C vaccine at Visit 1 (Day 0) and MMRV vaccine at Visit 2 (Day 35-49).
  Interventions:

  • Biological: Priorix Tetra
  • Biological: Meningitec

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.