Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Fluviral® (2012/2013 Season) in Adults
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluviral®
Intervention description: 1 dose administered intramuscularly in deltoid region of non-dominant arm at Day 0
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 113.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Immunogenicity; Influenza; Safety; Adults; Fluviral

Summary:

      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.
    

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 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.