Immunogenicity and safety of GlaxoSmithKline Biologicals' MMRV vaccine vs. ProQuad® in children 12-14 months of age

Subjects for whom the investigator believes their parents/guardians can and will comply with the requirements of the protocol.

• Male or female between 12 and 14 months of age at the time of first vaccination.
• Written informed consent obtained from the parent/guardian of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Have previously received 3 doses of 7-valent pneumococcal conjugate vaccine within the first year of life.

Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

• 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.
• 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 from 30 days prior to vaccination until 42 days after vaccination, except for influenza vaccine.
• Previous vaccination against measles, mumps, rubella and/or varicella.
• Previous vaccination against hepatitis A or receipt of a fourth dose of pneumococcal conjugate vaccine.
• History of measles, mumps, rubella and/or varicella/zoster diseases.
• Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the study.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination, including human immunodeficiency virus infection.
• A family history of congenital or hereditary immunodeficiency.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• Major congenital defects or serious chronic illness.
• History of any neurologic disorders or seizures. Uncomplicated febrile convulsions are not an exclusion criterion.
• Residence in the same household as the following persons: − New-born infants (0-4 weeks of age). − Pregnant mother/women with a negative history of chickenpox disease and without recorded vaccination against chickenpox. − Pregnant women at or beyond 28 weeks gestation regardless of varicella vaccination status or varicella disease history. − Persons with known immunodeficiency.
• Acute disease at the time of enrolment. All vaccines can be administered to persons with a minor illness.
• Administration of polyclonal immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
• Contra-indications to commercially available vaccines used in this study (Havrix®, Prevnar®, ProQuad®).