study in children to evaluate non-inferiority and persistence up to 5 years of gsk bio meningococcal vaccine 134612

Conditions: Infections, Meningococcal

Summary: this study has 2 phases, a vaccination phase and a long-term follow-up phase. in the vaccination phase of this study, the new meningococcal vaccine 134612 will be evaluated in children using mencevax™ acwy (in children above 2 years) or meningitec™ (in children below 2 years) as controls. in the long-term follow-up phase of the study, the long-term protection offered by the vaccines will be assessed up to 5 years after vaccination. subjects will be randomized in the primary vaccination phase of the study; no new subjects will be enrolled during the long-term follow-up phase of the study.

subjects will be enrolled in 3 age strata. subjects including and above two years of age will receive either gsk biologicals meningococcal vaccine 134612 or mencevax™ acwy, subjects below two years of age will receive either gsk biologicals meningococcal vaccine 134612 or meningitec™. all subjects will have 7 blood samples taken: prior and one month after vaccination and one, two, three, four and five years after vaccination. the protocol posting has been updated in order to comply with the fda amendment act, september 2007.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parent or guardian can and will comply with the requirements of the protocol. * a male or female between, and including, 1 through 10 years of age at the time of vaccination. * written informed consent obtained from the parent or guardian of the subject. * free of obvious health problems as established by medical history and clinical examination before entering into the study. * previously completed routine childhood vaccinations to the best of his/her parents/guardians' knowledge. exclusion criteria: for the primary phase: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. * planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s). * previous vaccination with meningococcal polysaccharide vaccine of serogroup a, c, w, and/or y (for subjects below 6 years) or within the last five previous years (for subjects 6 years old or above). * previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup a, c, w, and/or y. * previous vaccination with tetanus toxoid containing vaccine within the last 28 days. * history of meningococcal disease due to serogroup a, c, w, or y. * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection. * a family history of congenital or hereditary immunodeficiency. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * major congenital defects or serious chronic illness. * history of any neurologic disorders or seizures. * 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 study period. for the long term persistence phase: * history of meningococcal serogroup a, c, w, and/or y disease. * administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine not planned in the protocol.

Keywords: meningococcal serogroups a, c, w-135 and/or y diseases conjugate vaccine immunogenicity meningococcal vaccine persistence non-inferiority