A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine.
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: GSK1562902A; GSK1562902A
Intervention description: new-processed (NP), administered intramuscularly in the deltoid region of the non-dominant arm; comparative-processed (CP), administered intramuscularly in the deltoid region of the non-dominant arm
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 320.0
Sex: All
Minimum age: 18 Years
Maximum age: 59 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pandemic influenza

Summary:

      This observer-blind study is designed to show the immunological non-inferiority of
      Thiomersal-free-processed pandemic influenza vaccine as compared to the
      Thiomersal-containing-processed pandemic influenza vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol should be enrolled in the study.

          -  A male or female aged 18 to 60 years at the time of the first vaccination.

          -  Written informed consent obtained from the subject.

          -  Good general health as established by medical history and clinical examination before
             entering into the study.

          -  Access to a consistent means of telephone contact, which may be either in the home or
             at the workplace, land line or mobile, but NOT a pay phone or other multiple-user
             device

          -  Comprehension of the study requirements, ability to comprehend and comply with
             procedures for collection of short- and long-term safety data, expressed availability
             for the required study period, and ability and willingness to attend scheduled visits.

          -  If the subject is female, she must be of non-childbearing potential, or if she is of
             childbearing potential, she must practice adequate contraception for 30 days prior to
             vaccination, have a negative pregnancy test and continue such precautions for 2 months
             after completion of the vaccination series.

        Exclusion Criteria:

          -  Evidence of substance abuse or of neurological or psychiatric diagnoses which, even if
             clinically stable, are deemed by the investigator to render the potential subject
             unable/unlikely to provide accurate safety reports.

          -  Diagnosed with cancer, or treatment for cancer, within 3 years.

          -  An oral temperature ≥ 37.8 º C or acute symptoms greater than "mild" severity on the
             scheduled date of first vaccination.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition including
             history of human immunodeficiency virus (HIV) infection.

          -  Receipt of systemic glucocorticoids (prednisone ≥ 5 mg/kg/day for more than 14
             consecutive days) within 1 month of study enrolment, or any other cytotoxic or
             immunosuppressive drug within 6 months of study enrolment.

          -  Any significant disorder of coagulation or treatment with Coumarin derivatives or
             Heparin.

          -  Administration of any vaccines within 30 days before study enrolment.

          -  Previous administration of any H5N1 vaccine.

          -  Previous administration of vaccines with adjuvants similar to those used in the
             investigational vaccine.

          -  Use of any investigational or non-registered product (drug or vaccine) or planned
             participation in another investigational study within 30 days prior to study
             enrolment, or during the 180 days following the first test article dose. Use of any
             investigational or non-registered product with immunosuppressive properties is
             exclusionary at any time during the trial.

          -  Receipt of any immunoglobulins and/or any blood products within 3 months of study
             enrolment or planned administration of any of these products during the study period.

          -  Any known or suspected allergy to any constituent of influenza vaccines (including egg
             proteins or mercurial preservatives); a history of anaphylactic-type reaction to
             consumption of eggs; or a history of severe adverse reaction to a previous influenza
             vaccine.

          -  Known pregnancy or a positive urine beta-human chorionic gonadotropin (β-hCG) test
             result prior to either vaccination.

          -  Lactating women.

          -  Women of child bearing potential who lack a history of reliable contraceptive
             practices. The provision of this history does NOT replace the requirement to perform,
             and obtain negative results in pregnancy urine tests prior to treatments.

          -  Known use of an analgesic or antipyretic medication within 12 hours prior to first
             treatment.