Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Pumarix™; Pandemrix ™
Intervention description: Two doses administered intramuscularly (IM), the first in the deltoid region of the non-dominant arm and the second in the deltoid region of the dominant arm.; Two doses administered intramuscularly (IM), the first in the deltoid region of the non-dominant arm and the second in the deltoid region of the dominant arm.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 780.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; GSK 1557484A vaccine

Summary:

      The purpose of this study is to evaluate the safety and immune response of two-doses of GSK
      Biologicals' candidate influenza vaccine GSK 1557484A with or without adjuvant in adults. The
      Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female adults 18 to 64 years of age at time of first vaccination, inclusive.

          -  Good general health as assessed by medical history and physical examination.

          -  Access to a consistent means of telephone contact

          -  Written informed consent obtained from the subject.

          -  Comprehension of the study requirements, expressed availability for the required study
             period, and ability to attend scheduled visits.

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol should be enrolled in the study.

        Exclusion Criteria:

          -  Presence of significant acute or chronic, uncontrolled medical or psychiatric illness

          -  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.

          -  Blood pressure abnormalities

          -  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 histologically-confirmed basal cell carcinoma of the skin
             successfully treated with local excision only are excepted and may enroll, but other
             histologic types of skin cancer are exclusionary.

          -  Women who are disease-free 3 years or more after treatment for breast cancer and
             receiving long-term prophylactic tamoxifen are excepted and may enroll.

          -  Presence of an oral temperature ≥ 37.8º 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 cytotoxic or immunosuppressive drug within 6 months of study enrollment.

          -  Any significant disorder of coagulation or treatment with Coumadin derivatives or
             heparin.

          -  Administration of any non-influenza vaccines within 30 days before study enrollment or
             during the study period.

          -  Use of any investigational or non-registered product (drug or vaccine) or planned
             participation in another investigational study within 30 days prior to study
             enrollment, or during the study period.

          -  Receipt of any immunoglobulins and/or any blood products within 3 months of study
             enrollment or planned administration of any of these products during the study period.

          -  Any known or suspected allergy to any constituent of influenza vaccines.

          -  Known pregnancy or a positive urine beta-human chorionic gonadotropin (ß-hCG) test
             result prior to dosing on Study Days 0 or 21.

          -  Lactating or nursing.

          -  Women of child bearing potential who lack a history of reliable contraceptive
             practices.

          -  Known receipt of analgesic or antipyretic medication on the day of treatment