Comparison of GSK134612 in Subjects Previously Vaccinated Against Meningococcal Disease Versus Non-vaccinated Subjects
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Meningococcal vaccine GSK134612 (Nimenrix)
Intervention description: one dose, as intramuscular injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 271.0
Sex: All
Minimum age: 4 Years
Maximum age: 34 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Booster vaccination; Meningococcal vaccine; Meningococcal disease; Safety; immunogenicity

Summary:

      In this study, subjects who were vaccinated with a meningococcal polysaccharide vaccine in a
      previous study (whose objectives & outcome measures are presented in a separate protocol
      posting with NCT number = 00227422) will be vaccinated with a new vaccine using conjugation
      technology.

      These subjects will be compared to subjects vaccinated with the new vaccine, but who were not
      previously vaccinated with a meningococcal polysaccharide vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Only subjects who the investigator believes that they and/or their parents/guardians
             can and will comply with the requirements of the protocol should be enrolled in the
             study.

          -  For the MPS group, a male or female between, and including, 4.5 and 34 years of age at
             the time of the study vaccination, who has been vaccinated in GSK Biologicals' study
             102394.

          -  For the noMPS group, a male or female between, and including, 4.5 and 34 years of age
             at the time of the study vaccination.

          -  Written informed consent obtained from the subject/ from the parent or guardian of the
             subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Previously completed routine childhood vaccinations to the best of his/her knowledge.

          -  If the subject is female, she must be of non-childbearing potential, or if she is of
             childbearing potential, she must practice adequate contraception for 30 days prior to
             vaccination, have a negative pregnancy test and continue such precautions for 2 months
             after completion of the vaccination series.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine within 30 days preceding administration of the study vaccine, or planned
             use during the complete study period (active phase and extended safety follow-up).

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within six months prior to the study vaccine dose.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             within 30 days of administration of the study vaccine and up to 30 days after the
             study vaccine.

          -  Concurrently participating in another clinical study, at any time during the study
             period (active phase and extended safety follow-up), in which the subject has been or
             will be exposed to an investigational or a non-investigational product (pharmaceutical
             product or device).

          -  For the MPS Group, vaccination against meningococcal disease after completion of study
             102394

          -  For the noMPS group, previous vaccination, or vaccination within the last 10 years,
             against meningococcal disease (of any serogroup).

          -  Previous vaccination against tetanus within 30 days.

          -  History of meningococcal disease.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus (HIV) infection, based on medical history and physical.

          -  A family history of congenital or hereditary immunodeficiency, unless the child has
             previously been documented, through laboratory testing, to have normal immune
             function.

          -  History of reactions or allergic disease likely to be exacerbated by any component of
             the vaccine.

          -  Know hypersensitivity to any component of the vaccine.

          -  Major congenital defects or serious chronic illness.

          -  History of seizures (this criterion does not apply to subjects who have had a single,
             uncomplicated febrile convulsion in the past) or progressive neurological disease.

          -  Acute disease at the time of enrolment

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the first dose of study vaccine or planned administration during the active
             stage of the study period.

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.

          -  History of chronic alcohol consumption and/or drug abuse.