primary study to demonstrate non-inferiority and immunogenicity of gsk biologicals' meningococcal vaccine 134612

Conditions: Infections, Meningococcal

Summary: this study will demonstrate the non-inferiority of gsk biologicals' meningococcal vaccine 134612 when given in an experimental co-administration versus vaccine 134612 alone and versus the experimental co-administration alone in healthy subjects aged 11 through 17 years. there will be 3 groups in this study.

all subjects of groups a and b will have 4 blood samples taken, all subjects of group c will have 3 blood samples taken. 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 they and/or their parents/guardians can and will comply with the requirements of the protocol * a male or female between, and including, 11 and 17 years of age at the time of the first dose of vaccine. * 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/the parents'/guardians' knowledge. * if the subject is female and of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two 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(s) within 30 days preceding the first 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 first vaccine dose. * planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine. * previous vaccination with meningococcal polysaccharide vaccine of serogroup a, c, w-135 and/or y within the last five years. * previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup a, c, w-135 and/or y. * previous vaccination with tetanus toxoid within the last month. * previous vaccination with hepatitis a and/or hepatitis b vaccine. * seropositivity for hepatitis a igg, hepatitis b surface antigen, hepatitis b core antibody and/or hepatitis b surface antigen at screening. * history of hepatitis a, hepatitis b and/or neisseria meningitidis infection. * known exposure to hepatitis a and/or hepatitis b virus within three months preceding the first dose of study vaccine. * any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (hiv) infection, based on medical history and physical examination. * a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated. * history of reactions or allergic disease likely to be exacerbated by any component of either vaccine. * major congenital defects or serious chronic illness. * acute disease at the time of enrolment. * administration of immunoglobulins and/or any blood products within the three months preceding the dose of study vaccine or planned administration during the study period. * pregnant or lactating female. * history of chronic alcohol consumption and/or drug abuse. * female planning to become pregnant or planning to discontinue contraceptive precautions.

Keywords: non-inferiority adolescents meningococcal vaccine