Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Fluviral® (2012/2013 Season) in Adults
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Fluviral® (2012/2013 Season) in Adults
This study is designed to test the immunogenicity in terms of Hemagglutination Inhibition
 (HI) antibodies against each of the three vaccine influenza strains and reactogenicity and
 safety of Fluviral® containing the influenza strains recommended for the 2012-2013 season.
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 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.

 -  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.

 Exclusion Criteria:

 -  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.

 -  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 enrolment or
 during the 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 enrolment.

 -  Significant acute or chronic, uncontrolled medical or psychiatric or neurological
 illness.

 -  Any confirmed or suspected immunosuppressive or immunodeficient condition.

 -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
 functional abnormality, as determined by physical examination or laboratory screening
 tests.

 -  Insulin-dependent diabetes mellitus.

 -  Presence of blood dyscrasias, including hemoglobinopathies and myelo- or
 lymphoproliferative disorder.

 -  Chronic administration of immunosuppressants or other immune-modifying drugs within
 six months prior to the vaccine dose.

 -  A history of any demyelinating disease including Multiple Sclerosis and Guillain-Barré
 syndrome.

 -  History of chronic alcohol abuse and/or drug abuse as deemed by the investigator to
 render the potential subject unable/unlikely to provide accurate safety reports.

 -  Any significant disorder of coagulation that increases the risk of intramuscular
 injections or treatment with coumadin derivatives or heparin. Persons receiving
 prophylactic antiplatelet medications, e.g. low-dose aspirin, and without a
 clinically-apparent bleeding tendency are eligible.

 -  Administration of immunoglobulins and/or any blood products within the three months
 preceding the administration of the study vaccine or planned during the study.

 -  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 and/or lactating/nursing female.

 -  Any condition which, in the opinion of the investigator, prevents the subject from
 participation in the study.