lot consistency, immuno, safety of meningococcal vaccine gsk134612 given with fluarix™ to 18-55 year-old adults

Conditions: Infections, Meningococcal

Summary: the purpose of this study is to demonstrate, in 18-55 year old adults, the consistency of different manufactured lots of meningococcal vaccine gsk134612, the non-inferiority of gsk134612 compared to licensed meningococcal vaccine mencevax™, the non-inferiority of gsk134612 when given in an experimental co-administration with fluarix™ compared to gsk134612 given alone and the immunogenicity of gsk134612 given with fluarix™. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.

multicentre study with 5 treatment groups. three groups will receive three different manufactured lots of gsk134612, one group will receive one lot of gsk134612 given in an experimental co-administration with fluarix™, the control group will receive mencevax™. the study will be conducted in a double-blind manner with respect to the 3 lots of gsk134612 vaccine. the study will be 'open' between the groups receiving gsk134612 and the group receiving gsk134612 + fluarix™ and the mencevax™ group. each subject will have 2 blood samples taken for immunogenicity analyses, one prior to vaccination and one taken 30 days later.

Eligibility criteria:
inclusion criteria: for all subjects: * subjects who the investigator believes that they can and will comply with the requirements of the protocol. * a male or female between, and including, 18 and 55 years of age at the time of the vaccination. * written informed consent obtained from 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: for all subjects: * 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 within the last five previous years. * previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup a, c, w, and/or y. * previous vaccination with tetanus toxoid within the last month. * history of meningococcal disease. * 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 the 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 first 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. additional criteria for subjects receiving fluarix™ co-administration: * history of hypersensitivity to a previous dose of influenza vaccine. * history of reactions or allergy likely to be exacerbated by any component of the vaccine including egg, chicken protein, formaldehyde, thimerosal, gentamicin sulfate, or sodium deoxycholate. * history of administration of an influenza vaccine outside of this study, during current flu season.

Keywords: immunogenicity meningococcal serogroups a, c, w-135 and/or y disease co-administration meningococcal vaccine lot-to-lot consistency conjugate vaccine