evaluation of safety and immunogenicity of gsk bio's influenza vaccine gsk576389a after repeated vaccination in elderly adults

Conditions: Influenza

Summary: since influenza vaccines are administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profile of gsk biologicals' influenza vaccine gsk576389a will be re-evaluated after repeated vaccine administration. in this study, the subjects previously enrolled in study 104887 will receive a dose with the 2007-2008 season's formulations of fluarix or gsk576389a. only subjects who were previously enrolled in study 104887 are eligible for participation in this study.

this study is a year 2 revaccination study. first year revaccination was done in study 104887 (nct00386698). primary study was study 104886 (nct00318149). this study involves 2 age groups (based on primary study): subjects enrolled in the ≥ 65 years age group in the primary study. subjects enrolled in the 18-40 years age group in the primary study. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007

Eligibility criteria:
inclusion criteria: * subjects who were previously vaccinated with glaxosmithkline biologicals fluarix™ or gsk576389a investigational vaccines in the 104887 study (nct00386698). * subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. * a male or female aged between 19 and 42 years or 66 years and older at the time of the vaccination. * written informed consent obtained from the subject. * free of an acute aggravation of the health status as established by clinical evaluation before entering into the study. * 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: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days prior to vaccination, or planned use during the study period. * administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. planned administration of a vaccine not foreseen by the study protocol up to 21 days after vaccination. * planned administration of an influenza vaccine other than the study vaccines during the entire study period. * vaccination against influenza since january 2007 with the northern hemisphere 2007/2008 influenza vaccine or 2006/2007 influenza vaccine. * history of confirmed influenza infection since the date of previous vaccination. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. (for corticosteroids, this will mean prednisone, or equivalent, ≥0.5 mg/kg/day. inhaled and topical steroids are allowed.) * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * history of hypersensitivity to a previous dose of influenza vaccine. * history of allergy or reactions likely to be exacerbated by any component of the vaccine(s) * acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) or pre-existing laboratory screening tests. * acute disease at the time of enrolment. (acute disease is defined as the presence of a moderate or severe illness with or without fever. all vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. axillary temperature \<37.5°c / oral temperature of \<37.5°c). * administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration during the study. * any medical conditions in which intramuscular injections are contraindicated. * pregnant or lactating female. * female planning to become pregnant or planning to discontinue contraceptive precautions.

Keywords: influenza vaccine gsk576389a fluarix influenza infection