Safety and Immunogenicity of H1N1 Vaccine With Trivalent Inactivated Seasonal Influenza Vaccine in Adults

Exclusion Criteria

• •Previous vaccination with an H1N1v-like virus vaccine or a medical history of physician-confirmed infection with an H1N1v-like virus.
• •Prior receipt at any time of any seasonal influenza vaccine.
• •Planned administration of any vaccine not foreseen by the study protocol between Day 0 and the Day 63 phlebotomy.
• •Administration of any licensed vaccine within 4 weeks before the first study vaccine dose.
• •Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• •Receipt of systemic glucocorticoids within one month prior to study enrolment, or any other cytotoxic or immunosuppressive drug within six months of study enrolment. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors or imiquimod are allowed.
• •Receipt of any immunoglobulins and/or any blood products within three months of study enrolment or planned administration of any of these products during the study period.
• •Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
• •Presence of a temperature \>= 38.0ºC (\>=100.4ºF), or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
• •Diagnosed with cancer, or treatment for cancer, within 3 years.
• •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• •Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.
• •An acute evolving neurological disorder or history of Guillain-Barré syndrome within six weeks of receipt of seasonal influenza vaccine.
• •Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
• •Known pregnancy or a positive urine beta-human chorionic gonadotropin test result prior to first vaccination.
• •Lactating or nursing women.