immunogenicity and safety of meningococcal vaccine gsk 134612 versus mencevax™ acwy in healthy 18-25 year olds

Conditions: Infections, Meningococcal

Summary: the purpose of the observer-blinded study is to determine the immunogenicity and safety of one dose of glaxosmithkline (gsk) biologicals' meningococcal vaccine gsk 134612 compared to one dose of mencevax™ acwy in healthy subjects 18-25 years of age. in addition, this study will compare the immunogenicity of two lots of gsk's 134612 vaccine.


Eligibility criteria:
inclusion criteria: all subjects must satisfy all of the following criteria at study entry: * subjects whom the investigator believes they can and will comply with the requirements of the protocol will be enrolled in the study. * a male or female between, and including, 18 and 25 years of age 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. * female subjects of non-childbearing potential may be enrolled in the study. * female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception during the entire treatment period and for 2 months after vaccination. exclusion criteria: the following criteria should be checked at the time of study entry. if any exclusion criterion applies, the subject must not be included in the study: * use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination. (for corticosteroids, this will mean prednisone \<10 mg/day, or equivalent, is allowed. inhaled and topical steroids are allowed). * planned administration/administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine, with the exception of any licensed inactivated influenza vaccine, including h1n1 vaccine. * previous vaccination with meningococcal polysaccharide vaccine within the last five years. * previous vaccination with meningococcal conjugate vaccine. * previous vaccination with tetanus-toxoid or tetanus-toxoid containing vaccine within the last month. * history of meningococcal disease. * seropositive for hiv or hbsag (for subjects in the philippines only). * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus 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 has been demonstrated. * history of reactions or allergic disease likely to be exacerbated by any component of either vaccine. * history of any neurologic disorders, including guillain-barré syndrome. * 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. * bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.

Keywords: adolescent vaccine, conjugate adult neisseria meningitidis immunogenicity meningococcal vaccine safety