Comparison of GSK134612 in Subjects Previously Vaccinated Against Meningococcal Disease Versus Non-vaccinated Subjects
Comparison of GSK134612 in Subjects Previously Vaccinated Against Meningococcal Disease Versus Non-vaccinated Subjects
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.
GSK Biologicals has developed a meningococcal conjugate vaccine (GSK134612). This candidate
 vaccine has been shown to be well tolerated and immunogenic in toddlers, children aged 3-5
 years, and adolescents/young adults. Repeated vaccinations with unconjugated meningococcal
 polysaccharide vaccine has shown to induce hyporesponsiveness to re-vaccination, this for
 serogroup C, and a recent publication suggest the same may be true for other serogroups.

 This study will evaluate GSK Biologicals' candidate vaccine's ability to induce satisfactory
 immune response for the serogroups it contains across subjects 4.5 through 34 years of age
 who previously received a tetravalent meningococcal polysaccharide vaccine when aged 2-30
 years. A non-randomised age-strata matched group of subjects, who have not previously
 received (or not received within the preceding 10 years) any meningococcal vaccine, will also
 be administered the GSK134612 vaccine for comparison.
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.