immunogenicity and safety study of gsk biologicals' meningococcal vaccine gsk 134612 versus menactra® in healthy adolescents/adults

Conditions: Infections, Meningococcal

Summary: the purpose of this observer-blind study is to evaluate the safety and immunogenicity of gsk biologicals' meningococcal vaccine gsk134612 as compared to menactra® in subjects 10 through 25 years of age. in addition, this study will compare the immunogenicity of two lots of gsk 134612 vaccine.


Eligibility criteria:
inclusion criteria: all subjects must satisfy all of the following criteria at study entry: * subjects whom the investigator believes that they and/or their parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol. * a male or female between, and including, 10 and 25 years of age at the time of the vaccination. * written informed consent obtained from the subject/from the parent or legally acceptable representative(s) of the subject. assent will be obtained from subjects who are still legally minors in line with local rules and regulations. * healthy subjects as established by medical history and clinical examination before entering into the study. * previously completed routine childhood vaccinations to the best of subject's/legally acceptable representative(s)'s knowledge. * 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 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 (defined as more than 14 days) 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. * previous vaccination with meningococcal polysaccharide or conjugate vaccine. * previous vaccination with vaccine components within the last month. * history of meningococcal disease. * 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 is demonstrated. * history of allergic reactions or disease likely to be exacerbated by any component of either vaccine, or by dry natural rubber latex. * history of any neurologic disorders, including guillain-barré syndrome. * major congenital defects or serious chronic illness. * acute disease at the time of enrollment. * 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. * child in care. * 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: neisseria meningitidis adult adolescent safety vaccines, conjugate meningococcal vaccines immunogenicity