Immunogenicity and safety study of PriorixTetra™ when co-administered with conjugated MenC vaccine in healthy children

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.

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.