Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age
Condition: Rubella; Mumps; Measles; Measles-Mumps-Rubella Vaccine
MeSH terms: Measles; Rubella; Mumps
Intervention: GSK Biological's investigational vaccine 209762; M-M-R® II (Merck and Co); Varivax®; Havrix®; Prevnar®
Intervention description: Subcutaneous injection, one dose; Subcutaneous injection, one dose; Subcutaneous injection, one dose; Intramuscular injection, one dose; Intramuscular injection, one dose
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 1259.0
Sex: All
Minimum age: 12 Months
Maximum age: 15 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Measles, Mumps, Rubella, Varicella Vaccine; Children; Immunogenicity; Safety; Humans; Combined Vaccine; Vaccines

Summary:

      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.
    

Eligibility criteria:

        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.