Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Pandemrix (GSK investigational influenza GSK2340272A vaccine); Fluarix™; Placebo
Intervention description: 2 doses intramuscular injections; 1 dose intramuscular injection; 1 dose intramuscular injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 145.0
Sex: All
Minimum age: 61 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: influenza infection; GSK Bio's influenza vaccine GSK2340272A

Summary:

      The objective of the study is to evaluate the immunogenicity and safety of GSK Biologicals'
      investigational vaccine GSK2340272A.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects 61 years of age or older at the time of the first vaccination.

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol.

          -  Written informed consent obtained from the subject.

          -  Satisfactory baseline medical assessment by history and physical examination (stable
             health status with no exclusionary medical or psychiatric conditions). Stable health
             status is defined as the absence of health event satisfying the definition of a
             serious adverse event, or a change in an ongoing drug therapy due to therapeutic
             failure or symptoms of drug toxicity, within one month prior to enrolment.

        Exclusion Criteria:

          -  Previous administration of the 2009 Southern Hemisphere or 2009-2010 Northern
             Hemisphere influenza vaccine.

          -  Previous administration of a pandemic influenza vaccine.

          -  Administration of any vaccine within 30 days before first vaccination.

          -  Planned administration of a vaccine not foreseen by the study protocol one month
             (minimum 30 days) after the second vaccination with the GSK2340272A candidate vaccine.

          -  Use of any investigational or non-registered product other than the study vaccine
             within 30 days preceding the first dose of the study vaccines or planned use during
             the study period. Potential subjects in the follow-up phase of a prior investigational
             study may be enrolled if the investigator's judgment is that it will have no effect on
             safety, reactogenicity, or immunogenicity endpoints in this study, and that it does
             not violate the protocol requirements of the prior trial.

          -  Presence of evidence of substance abuse or of neurological or psychiatric diagnoses
             which, although stable, are deemed by the investigator to render the potential subject
             unable/unlikely to provide accurate safety reports.

          -  Presence of an axillary temperature >= 37.5°C, or acute symptoms greater than "mild"
             severity on the scheduled date of first vaccination. NOTE: The subject may be
             vaccinated at a later date, provided symptoms have resolved, vaccination occurs within
             the window specified by the protocol, and all other eligibility criteria continue to
             be satisfied.

          -  Diagnosed with cancer, or treatment for cancer, within 3 years.

               -  Persons with a history of cancer who are disease-free without treatment for 3
                  years or more are eligible.

               -  Persons with a history of histological-confirmed basal cell carcinoma of the skin
                  successfully treated with local excisions only are eligible and may be enrolled
                  within 3 years of diagnosis, but other histological types of skin cancer require
                  a 3-year untreated and disease-free window as above.

               -  Women who are disease free for 3 years or more after the treatment of breast
                  cancer and receiving long-term prophylactic tamoxifen are eligible and may be
                  enrolled.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition including
             history of human immunodeficiency virus (HIV) infection.

          -  Chronic administration of immunosuppressants or other immune modifying drugs within
             six months prior to the first vaccination and during the entire study period.

          -  Receipt of any immunoglobulins and/or any blood products within 3 months preceding the
             first vaccination or planned administration of any of these products during the entire
             study period.

          -  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 aspirin, and without a clinically-apparent
             bleeding tendency, are eligible.

          -  An acute evolving neurological disorder or history of Guillain-Barré syndrome.

          -  Serious chronic disease including any medically significant chronic pulmonary,
             cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined
             by medical history and physical examination. (Subjects suffering from seasonal
             allergies or asthma under inhalative treatment can be included, as well as subjects
             with well controlled underlying diseases).

          -  Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional
             abnormalities, as determined by physical examination or laboratory screening tests.

          -  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.

          -  History of chronic alcohol consumption and/or drug abuse.

          -  Clinically or virologically confirmed influenza infection within 6 months preceding
             the study start.

          -  Any conditions which, in the opinion of the investigator, prevents the subjects from
             participating in the study.