immunogenicity of a split, cell-based, inactivated, trivalent influenza vaccine in healthy adult subjects

Conditions: Influenza; Orthomyxoviruses; Myxovirus Infection

Summary: primary objective: to describe the immune response to a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects. secondary objective: to describe the safety following a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects.

this is a multi-center study in healthy adult subjects. all subjects will receive a single dose of one of the influenza vaccine formulations and will provide blood samples for immunogenicity assessment.

Eligibility criteria:
inclusion criteria : * healthy male or female subject, aged ≥ 18 to \< 50 years on the day of inclusion * informed consent form signed * able to attend all scheduled visits and to comply with all trial procedures * for a woman of childbearing potential: a negative urine pregnancy test and documented use of an effective method of contraception or abstinence for at least four weeks pre vaccination and up until three weeks post-vaccination exclusion criteria : * subject currently breast-feeding. * participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination. * planned participation in another clinical trial during the present trial period. * prior participation in the phase i trial of flu interpan (per.c6) vaccine (study gce01). * congenital or history of acquired immunodeficiency, or immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months. * systemic corticosteroid therapy as except the use of topical or inhalant corticosteroids * systemic hypersensitivity to egg proteins, chicken proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances. * chronic illness at a stage that could interfere with trial conduct or completion (chronic illness may include, but is not limited to, cardiac, renal or auto-immune disorders, or diabetes). * receipt of blood or blood-derived products in the 3 months preceding vaccination. * receipt of any vaccination in the 4 weeks preceding vaccination, or planned receipt of any vaccination in the 4 weeks following the trial vaccination. * history of influenza infection (confirmed either clinically, serologically or microbiologically) within the 6 months preceding vaccination. * previous vaccination against influenza (in the 6 months preceding the trial vaccination). * planned receipt of any other 2007-2008 influenza vaccine. * thrombocytopenia or bleeding disorder contraindicating intramuscular (im) vaccination. * subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent. * history of guillain-barré syndrome * current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures * any other condition which in the opinion of the investigator would pose a health risk to the participant or interfere with the evaluation of the vaccine.

Keywords: influenza orthomyxoviruses split-virion inactivated influenza vaccine cell-based vaccine adults