immunogenicity and safety study of glaxosmithkline (gsk) biologicals' trivalent split virion influenza vaccine fluviral™ (2013-2014 season) in adults aged 18 years and older

Conditions: Influenza

Summary: the purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of fluviral™ containing the influenza strains recommended for the 2013-2014 season in adults aged 18 years and older.


Eligibility criteria:
inclusion criteria: * subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * a male or female 18 years of age and older at the time of the first vaccination. * written informed consent obtained from the subject. * healthy subjects or subjects with well-controlled chronic disease, as established by medical history and clinical examination before entering into 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 the vaccination dose. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine 30 days preceding the dose of study vaccine, or planned use during the study period. * chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. for corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. inhaled and topical steroids are allowed. * any administration of a long-acting immune-modifying drug (e.g. rituximab, infliximab etc.) within 6 months before study start, or planned administration during the study period. * administration of any influenza vaccine within 6 months preceding the study start or planned use of such vaccines during the study period. * administration of any other vaccine(s) within 30 days prior to study enrollment or during the study period. * clinically or virologically confirmed influenza infection within the 6 months preceding the study vaccination. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required): * history of human immunodeficiency virus (hiv) infection, * cancer or treatment for cancer, within 3 years of study enrollment. persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible. * acute disease and/or fever at the time of enrollment. * acute disease is defined as the presence of a short term, moderate or severe illness, with or without fever. * fever is defined as temperature ≥ 38.0°c/100.4°f for oral, axillary or tympanic route. the preferred route for recording temperature in this study will be oral. * subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator. * significant acute or chronic, uncontrolled medical or psychiatric or neurological illness. "uncontrolled" is defined as: * requiring institution of new medical or surgical treatment within one month prior to study enrollment, or * requiring the re-institution of a previously discontinued medication or medical treatment within one month prior to study enrollment, or * requiring a change in medication dosage in the one month prior to study enrollment due to uncontrolled symptoms or drug toxicity (elective dosage adjustments in stable subjects are acceptable), or * hospitalization or an event fulfilling the definition of a sae within one month prior to study enrollment. * acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * subjects who participated in the registration trial \[116664 (flu q-tiv-014)\] for fluviral™ 2012/2013 conducted in the 2012-2013 season. * presence of blood dyscrasias, including hemoglobinopathies and myelo- or lymphoproliferative disorder. * a history of any demyelinating disease including multiple sclerosis and guillain-barré syndrome. * administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study vaccine or planned administration during the study period. * any known or suspected allergy to any constituent of fluviral™ and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury. * a history of severe adverse reaction to a previous influenza vaccination. * pregnant or lactating female. * history of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports. * any condition which, in the opinion of the investigator, prevents the subject from participation in the study or would make the intramuscular injection unsafe.

Keywords: immunogenicity trivalent safety adults elderly influenza