Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of Age
Condition: Measles-Mumps-Rubella
MeSH terms: Measles; Rubella; Mumps
Intervention: Priorix; M-M-R II; Kinrix; ProQuad
Intervention description: One dose administered subcutaneously in the triceps region of the right arm.; One dose administered subcutaneously in the triceps region of the right arm.; One dose administered by deep intramuscular injection in the upper left deltoid.; One dose administered subcutaneously in the triceps region of the left arm.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4011.0
Sex: All
Minimum age: 4 Years
Maximum age: 6 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Safety; Measles, mumps and rubella diseases; Immunogenicity

Summary:

      The purpose of this study is to support licensure of GSK Biologicals' MMR vaccine (Priorix®)
      in the US by generating immunogenicity and safety data in contrast to the US standard of
      care, Merck's MMR vaccine (M-M-R®II), when given as a second dose to children four to six
      years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they and/or their parent(s) or LAR/s can
             and will comply with the requirements of the protocol.

          -  Male or female subjects 4 to 6 years of age at the time of vaccination.

          -  Written informed consent is obtained from the parent(s)/LAR(s) of the subject (assent
             will be obtained from subjects in line with local rules and regulations).

          -  Subjects in stable health as determined by investigator's physical examination and
             assessment of subjects' medical history.

          -  Subjects received either a single dose of M-M-R II, M-M-R VaxPro or ProQuad in the
             second year of life.

          -  For subjects enrolled in the sub-cohort receiving co-administered DTaP-IPV and VV:

               -  subjects received previous DTaP vaccine doses with INFANRIX® and/or PEDIARIX® for
                  the first three doses and INFANRIX® for the fourth dose of the DTaP-containing
                  vaccine.

               -  subjects received a first dose of VV in the second year of life.

        Exclusion Criteria:

          -  Child in care.

          -  Use of any investigational or non-registered product other than the study vaccine
             during the period starting 30 days before the day of study vaccination/s or planned
             during the entire study period.

          -  Previous vaccination with a second dose of measles, mumps, rubella containing
             vaccine/s.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs during
             the period starting 180 days prior to Day 0 or any planned administration of
             immunosuppressive and immune-modifying drugs during the entire study. Inhaled and
             topical steroids are allowed.

          -  Administration of immunoglobulins and/or any blood products during the period starting
             180 days before entering the study or planned administration from the date of
             vaccination through the immunogenicity evaluation at Visit 2.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             during the period starting 30 days prior to the study vaccination/s and ending 42 days
             after the vaccination/s (at Visit 2), with the exception of live intranasal or
             inactivated influenza (flu) vaccine, which may be given at any time during the study,
             including the day of study vaccination/s. Inactivated influenza vaccine must be
             administered at a different location from the study vaccine. Any age appropriate
             vaccine may be given starting at Visit 2, and anytime thereafter.

          -  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.

          -  History of measles, mumps, and/or rubella disease.

          -  Known exposure to measles, mumps and/or rubella during the period starting 30 days
             prior to enrollment.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine(s), including systemic hypersensitivity to neomycin or gelatin.

          -  Blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms
             affecting the bone marrow or lymphatic systems.

          -  Acute disease at the time of enrollment. Acute disease is defined as the presence of a
             moderate or severe illness with or without fever. Fever is defined as temperature
             ≥38°C (100.4°F) measured by any age appropriate route. All vaccines can be
             administered to persons with a minor illness such as diarrhea, mild upper respiratory
             infection without fever.

          -  Active untreated tuberculosis according to the subject's medical history.

          -  Any other condition which, in the opinion of the investigator, prevents the subject
             from participating in the study.

        In addition, for subjects enrolled in the sub-cohort receiving co-administered DTaP-IPV+VV:

          -  Previous vaccination with a second dose of varicella-containing vaccine.

          -  Receipt of any varicella-containing vaccine during the period starting 90 days before
             the day of study vaccination.

          -  History of varicella/zoster disease.

          -  Known exposure to varicella/zoster during the period starting 30 days prior to
             enrollment.

          -  History of diphtheria, tetanus, pertussis, and/or poliomyelitis disease.

          -  Vaccination against diphtheria, tetanus, pertussis or polio given after the second
             year of life.

          -  Occurrence of transient thrombocytopenia or neurological complications following an
             earlier immunization against diphtheria and/or tetanus toxoids.

          -  Following a previous administration of DTP vaccine: temperature ≥40.6°C (>105°F)
             during the period starting 48 hours not due to another identifiable cause, collapse or
             shock-like state during the period starting 48 hours, persistent, inconsolable crying
             lasting three hours or more within 48 hours, seizures with or without fever occurring
             during the period starting three days, or encephalopathy of unknown aetiology
             occurring during the period starting 7 days of a previous administration of DTP
             vaccine.

          -  Hypersensitivity reaction to any component of the DTaP-IPV and/or varicella vaccines.