Immunogenicity and Safety of GlaxoSmithKline Biologicals' MMRV Vaccine vs. ProQuad® in Children 12-14 Months of Age
Condition: Varicella; Rubella; Mumps; Measles
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella
Intervention: Priorix-Tetra™ (MMRV vaccine 208136); ProQuad®; Havrix®; Prevnar®
Intervention description: One subcutaneous injection.; One subcutaneous injection.; Two intramuscular injections.; One intramuscular injection.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 1851.0
Sex: All
Minimum age: 12 Months
Maximum age: 14 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccines; Rubella; Varicella Vaccine; Children; Humans; Mumps; Immunogenicity; Safety; Measles; Combined Vaccine

Summary:

      The purpose of this observer blinded study is to provide information on vaccine
      immunogenicity and reactogenicity in comparison with the US standard of care (ProQuad®) when
      administered with Hepatitis A vaccine and Pneumococcal vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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®).