safety and immunogenicity study of gsk biologicals' seasonal influenza candidate vaccine (gsk2321138a)

Conditions: Influenza

Summary: this study is designed to assess the safety and immunogenicity of a gsk biologicals' investigational vaccine gsk2321138a in adults 18 years old and older. this study is also designed to assess the lot-to-lot consistency of vaccine gsk2321138a. the blinding will be double blind for all groups except for the gsk2604409a group which will be open.


Eligibility criteria:
inclusion criteria: * a male or female 18 years of age or older at the time of the first vaccination * subjects who the investigator believes can and will comply with the requirements of the protocol. * written informed consent obtained from the subject. * healthy subjects or those with chronic well-controlled disease as established by physical 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 urine 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 any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of the study vaccine or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period. * administration of an influenza vaccine during the 6 months preceding entry into the study. * planned administration / administration of a vaccine not foreseen by the study protocol within 30 days before vaccination and up to day 21. * any contra-indication to intramuscular administration of the influenza vaccines. * history of hypersensitivity/anaphylaxis to a previous dose of influenza vaccine, history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. * any administration of a long-acting immune-modifying drug within 3 months before study start, or planned administration during the study period. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * acute disease and/or fever at the time of enrolment. * acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * history of guillain-barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine. * administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study. * history of chronic alcohol consumption and/or drug abuse. * any condition which, in the opinion of the investigator, prevents the subject from participating in the study * pregnant or lactating female.

Keywords: influenza infection gsk biologicals influenza vaccine gsk2321138a