Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age

A Phase II, Randomized, Observer Blind, Controlled, Multicenter Study to Assess Immunogenicity and Antibody Persistence Following Vaccination With GSK's Candidate Combined Measles, Mumps, and Rubella Vaccine (MMR) Versus M-M-R® II as a First Dose, Both Administered Subcutaneously at 12-15 Months of Age, Concomitantly With Hepatitis A Vaccine (HAV), Varicella Vaccine (VV) and Pneumococcal Conjugate Vaccine (PCV) But at Separate Sites.

The purpose of this study is to compare two measles, mumps and rubella conjugate vaccines (manufactured by GSK and Merck and Company ) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. Additionally, antibody persistence will be assessed one and two years after administration of MMR vaccine.

The Protocol Posting has been updated following Protocol amendment 1 and 2, Oct 2009.

Inclusion Criteria:

• Subjects for whom the investigator believes their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
• Male or female between 12 and 15 months of age (e.g. from age 12 months until the day before age 16 months) at the time of 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 three doses of 7-valent pneumococcal conjugate vaccine within the first year of life with the third dose administered at least 30 days prior to enrolment and vaccination with study vaccines.

Exclusion Criteria:

• Use of any investigational or non-registered product (drug or vaccine) 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 (pharmaceutical product or device).
• Chronic administration (defined as more than 14 days) 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 and Hib 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, varicella/zoster and hepatitis A 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 (no laboratory testing required), including human immunodeficiency virus (HIV) 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.
• Hypersensitivity to latex
• Major congenital defects or serious chronic illness.
• History of any neurologic disorders or seizures, including febrile seizures.
• Acute disease at the time of enrolment.
• Administration of polyclonal immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.