Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine, Fluarix®/Influsplit SSW® (2013/2014 Season), in Adults 18 Years of Age and Older

Launched by GLAXOSMITHKLINE · Jun 20, 2013

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Eligibility criteria

• Inclusion Criteria:
• • Subjects who the investigator believes can and will comply with the requirements of the protocol.
• • A male or female aged 18 years or above at the time of vaccination.
• • Written informed consent obtained from the subject.
• • Healthy subjects or subjects with well-controlled chronic diseases as established by medical history and clinical examination before entering the study.
• • Female subjects of non-childbearing potential may be enrolled in the study.
• • Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
• * 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 vaccination.
• Exclusion Criteria:
• • Participation in previous year's Fluarix registration study (116663).
• • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
• • Chronic administration of immunosuppressants or other immune-modifying drugs within the six months prior to vaccination. Inhaled and topical steroids are allowed.
• • Any administration of a long-acting immune-modifying drug within 6 months before study start, or planned administration during the study period.
• • Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study period.
• • Administration of an influenza vaccine within the twelve months preceding the study vaccination.
• • Receipt of a vaccine other than the study vaccine within 30 days before study vaccination and/or plan to receive any vaccine other than the study vaccine during the entire study period.
• • Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination.
• • Acute disease and/or fever at the time of enrollment.
• • Fever is defined as temperature ≥ 37.5°C/99.5°F on oral, axillary or tympanic setting, or ≥ 38.0°C/100.4°F on rectal setting. The preferred route for recording temperature in this study will be axillary.
• • Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
• • Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• • Chronic underlying disease (such as cancer, chronic obstructive pulmonary disease under oxygen therapy, insulin-dependent diabetes mellitus), not stabilized or clinically serious.
• • History of chronic alcohol consumption and/or drug abuse.
• • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• • History of Guillain-Barré syndrome.
• • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine including latex.
• • Anaphylaxis following the administration of vaccine(s).
• • Pregnant or lactating female.
• • Female planning to become pregnant or planning to discontinue contraceptive precautions.
• • Any condition which, in the opinion of the investigator, prevents the subject from participating in the study or would make intramuscular injection unsafe.