A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Adults
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Quadrivalent seasonal influenza vaccine GSK2282512A; FluLavalTM-VB; FluLavalTM-YB
Intervention description: Single intramuscular dose; Single intramuscular dose; Single intramuscular dose
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1707.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza

Summary:

      This study is designed to test the immunogenicity and safety of an investigational influenza
      vaccine, in adults compared to two other influenza vaccines.

      This study will also evaluate the lot-to-lot consistency of three vaccine lots.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes can and will comply with the requirements of
             the protocol

          -  A male or female 18 years of age or older, in stable health, as established by medical
             history and physical examination before entering into the study.

          -  Written informed consent obtained from the subject.

          -  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.

          -  Female subjects of non-childbearing potential may be enrolled in the study.

          -  Female subjects of childbearing potential may be enrolled in the study, if the
             subject:

          -  - has practiced adequate contraception for 30 days prior to vaccination, and

          -  - has a negative pregnancy test on the day of vaccination, and

          -  - has agreed to continue adequate contraception during the entire treatment period and
             for 2 months after completion of the vaccination series.

        Exclusion Criteria:

          -  Use of an investigational / non-registered product other than the study vaccines
             within 30 days before study vaccination or planned use during study period.

          -  Planned administration or administration of a licensed vaccine within 30 days before
             study vaccination.

          -  Prior receipt of 2010/2011 influenza vaccine.

          -  Receipt of any investigational or approved influenza vaccine within six months of the
             first study visit.

          -  Any known or suspected allergy to any constituent of influenza vaccines ; a history of
             anaphylactic-type reaction to constituent of vaccine; or a history of severe adverse
             reaction to a previous influenza vaccine.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccines.

          -  History of Guillain-Barre syndrome within 6 weeks of receipt of prior inactivated
             influenza virus vaccine.

          -  Presence or 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.

          -  Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional
             abnormality, based on history and physical examination.

          -  Presence of significant uncontrolled chronic medical or neuropsychiatric illness,
             based on history and physical examination

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  Any significant disorder of coagulation or treatment with Coumadin derivatives or
             heparin

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within 3
             months prior to the first vaccine/product dose.

          -  Administration of immunoglobulins and/or any blood products within the 3 months
             preceding the first dose of study vaccine or planned administration during the study
             period.

          -  Pregnant or lactating female.

          -  Fever at the time of enrolment.

          -  Acute disease at the time of enrolment

          -  Any other condition which, in the opinion of the Investigator, prevents the subject
             from participating in the study.