Immunogenicity and Safety of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Volunteers, Seven Years of Age and Older
Condition: Rubella; Mumps; Measles
MeSH terms: Measles; Rubella; Mumps
Intervention: Priorix®; Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine
Intervention description: 1 dose administered as a subcutaneous (SC) injection.; 1 dose administered subcutaneously.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 996.0
Sex: All
Minimum age: 7 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Measles, mumps and rubella diseases; Safety; Immunogenicity

Summary:

      The purpose of this study is to evaluate the immunogenicity and safety of GSK's trivalent MMR
      (Priorix®), comparing it to Merck"s MMR vaccine (M-M-R®II), which is approved for use in the
      US.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they and/or their parent(s) or Legally
             Acceptable Representative(s) (LAR) can and will comply with the requirements of the
             protocol.

          -  Male or female subjects 7 years of age or older and born after December 31, 1956*.
             *The only exception to this is health care workers born before 1957 without other
             evidence of immunity to mumps for which one dose of a live mumps virus vaccine is
             recommended; therefore this population is eligible for enrollment in this study.

          -  For all children 7-17 years of age:

               -  Written documentation of prior receipt of 1 dose of MMR vaccine administered on
                  or after the first birthday.

          -  For all adults 18 years of age and older:

               -  Prior receipt (written or verbal history) of at least one dose of MMR vaccine.

               -  Birth in the US.

          -  Written informed consent obtained from the subject or from the parent(s)/LAR(s) of the
             subject (assent will be obtained from subjects who are still legally minors in line
             with local rules and regulations).

          -  Subjects in stable health as determined by investigator's physical examination and
             assessment of subjects' medical history.

          -  Female subjects of non-childbearing potential may be enrolled in the study.

               -  Non-childbearing potential is defined as pre-menarche, current tubal ligation,
                  hysterectomy, or ovariectomy or post-menopause.

          -  Female subjects of childbearing potential may be enrolled in the study, if the subject

               -  Has agreed to be abstinent or practiced adequate contraception during the entire
                  period starting 30 days prior to vaccination(s) until 3 months after receipt of
                  the study vaccination and

               -  has a negative pregnancy test on the day of vaccination.

        Exclusion Criteria:

          -  Child in care.

          -  For all children 7-17 years of age:

               -  Previous receipt of more than 1 dose of a measles-containing vaccine.

          -  Use of any investigational or non-registered product other than the study vaccine(s),
             during the period starting 30 days preceding the day of study vaccination, (i.e. 30
             days prior to Day 0) or planned use during the entire study period.

          -  Receipt of any measles, mumps or rubella-containing vaccine during the period starting
             42 days before the day of study vaccination (i.e. 42 days prior to Day 0).

          -  Chronic administration (defined as 14 or more consecutive days) of immunosuppressants
             or other immune-modifying drugs during the period starting 180 days before study
             vaccination or any planned administration of 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 prior to study vaccination through the immunogenicity evaluation at Visit 2
             or Visit 3 (for one-dose or two-dose cohort, respectively).

          -  Planned administration/ administration of any live viral vaccine not foreseen by the
             study protocol during the period starting 30 days prior to study vaccination and
             ending at Visit 2. Live intranasal influenza vaccine or any inactivated vaccine
             required in the age group may be given at any time, including the day of study
             vaccination.

          -  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, or rubella disease.

          -  Known exposure to measles, mumps, or rubella, during the period starting 30 days
             before study start (i.e. 30 days prior to Day 0).

          -  %