Safety and Tolerability Study of GlaxoSmithKline (GSK)1557484A Vaccine in Adults at Occupational Risk for Influenza A (H5N1) Exposure
Condition: Influenza; Influenza Vaccines
MeSH terms: Influenza, Human; Influenza in Birds
Intervention: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia)
Intervention description: 2 doses administered intramuscularly (IM) in deltoid region of arm at the Day 0 and Day 21 visits.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccine; Occupational exposure; Influenza; H5N1

Summary:

      The purpose of this study is to evaluate the safety and tolerability of GSK Biologicals'
      vaccine GSK1557484A against pandemic avian (H5N1) influenza in adults at occupational risk of
      exposure to the virus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who, in the opinion of the investigator can and will comply with the
             requirements of the protocol.

          -  Male or female adults ≥18 years of age at time of first study vaccination.

          -  Written informed consent obtained from the subject.

          -  Subjects who are at risk of occupational exposure to H5N1 influenza viruses based on
             exposure, or potential exposure during either (a) laboratory operations with live H5N1
             virus, (b) production of H5N1 vaccines, or (c) conduct of epidemiological
             investigations of H5N1 cases.

          -  Stable health status as defined by absence of a 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 30 days prior to enrollment.

          -  Female subjects of non-childbearing potential may be enrolled in the study.
             Non-childbearing potential is defined as current tubal ligation, hysterectomy,
             ovariectomy or post-menopause.

          -  Female subjects of childbearing potential may be enrolled in the study, if they have
             practiced adequate contraception for 30 days prior to vaccination, and have a negative
             pregnancy test on the day of vaccination, and agree to practice adequate contraception
             for two months following the last dose of vaccine.

        Exclusion Criteria:

          -  Presence or evidence 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 a temperature ≥ 38.0ºC (≥100.4ºF) 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.

          -  Significant risk of complications from intramuscular injections due to disorder of
             coagulation. Persons receiving prophylactic antiplatelet medications, e.g., low-dose
             aspirin, and without a clinically-apparent bleeding tendency, are eligible. Assessment
             of risk of injection complications should be made in the context of individual subject
             risk of H5N1 virus infection.

          -  An acute evolving neurological disorder or Guillain Barré Syndrome within 42 days of
             receipt of prior seasonal or pandemic influenza vaccine.

          -  Administration of an inactive vaccine within 14 days or of a live attenuated vaccine
             within 30 days before the first dose of study vaccine.

          -  Planned administration of any vaccine other than the study vaccine before Day 42.

          -  Any known or suspected allergy to any constituent of influenza vaccines or component
             used in the manufacturing process of the study vaccine including 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 before the first vaccination.

          -  Lactating or nursing women.

          -  Any condition which, in the opinion of the investigator, prevents the subject from
             participating in the study.