a study to evaluate the safety and immunogenicity of gsk biologicals' seasonal influenza vaccine in adults

Conditions: Influenza

Summary: this study is designed to test the immunogenicity and safety of an investigational influenza vaccine, in adults compared to two other influenza vaccines. this study will also evaluate the lot-to-lot consistency of three vaccine lots.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes can and will comply with the requirements of the protocol * a male or female 18 years of age or older, in stable health, as established by medical history and physical examination before entering into the study. * written informed consent obtained from the subject. * access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line, or mobile, but not a pay phone or other multiple-user device. * 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 completion of the vaccination series. exclusion criteria: * use of an investigational / non-registered product other than the study vaccines within 30 days before study vaccination or planned use during study period. * planned administration or administration of a licensed vaccine within 30 days before study vaccination. * prior receipt of 2010/2011 influenza vaccine. * receipt of any investigational or approved influenza vaccine within six months of the first study visit. * any known or suspected allergy to any constituent of influenza vaccines ; a history of anaphylactic-type reaction to constituent of vaccine; or a history of severe adverse reaction to a previous influenza vaccine. * history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. * history of guillain-barre syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine. * presence or evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subject unable / unlikely to provide accurate safety reports. * acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, based on history and physical examination. * presence of significant uncontrolled chronic medical or neuropsychiatric illness, based on history and physical examination * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * any significant disorder of coagulation or treatment with coumadin derivatives or heparin * chronic administration of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine/product dose. * administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period. * pregnant or lactating female. * fever at the time of enrolment. * acute disease at the time of enrolment * any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.

Keywords: influenza