Immunogenicity and Safety of Vaccine GSK2340272A (H1N1) and GSK Biologicals Fluarix™ Vaccine When Co-administered in Elderly
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Pandemrix (Influenza vaccine GSK2340272A); Fluarix™; Placebo
Intervention description: Intramuscular injection, 2 doses; Intramuscular injection, 1 dose; Intramuscular injection, 1 dose
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 168.0
Sex: All
Minimum age: 61 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: GSK Bio's influenza vaccine GSK2340272A; Influenza infection

Summary:

      The purpose of the present study is to assess the immunogenicity, safety and reactogenicity
      of a two-dose schedule with vaccine GSK2340272A when co-administered with GSK Biologicals'
      Fluarix™ vaccine either at the time of first or second vaccination in elderly subjects aged
      61 years and older.
    

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.

          -  Access to a consistent means of telephone contact.

        Exclusion Criteria:

          -  Previous administration of the 2009 Southern Hemisphere or 2009-2010 Northern
             Hemisphere seasonal 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 vaccine GSK2340272A.

          -  Use of any investigational or non-registered product (drug or vaccine) 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 (i.e., no treatment)
             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 oral temperature >= 37.5°C, or acute symptoms greater than "mild"
             severity on the scheduled date of first vaccination.

          -  Diagnosed with cancer, or treatment for cancer, within 3 years.

          -  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.

          -  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
             anti-platelet 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 as determined by medical history and physical examination.

          -  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.

          -  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.