Immunogenicity and Safety of PrepandrixTM in Korean Subjects Aged 18 to 60 Years Old
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Prepandrix™; Fluarix™
Intervention description: 2 doses administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).; 1 dose administered intramuscularly in the deltoid region of non-dominant arm.
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 131.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza vaccine

Summary:

      This study will evaluate the immunogenicity and the safety of PrepandrixTM in Korean
      subjects. A second group of subjects will receive FluarixTM vaccine as control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes can and will comply with the requirements of
             the protocol. Or subjects who the investigator believes that parent(s)/Legally
             Acceptable Representative(s) can and will comply with the requirements of the
             protocol.

          -  Korean male or female subject between, and including, 18 and 60 years of age at the
             time of the first vaccination.

          -  Written informed consent obtained from the subject/ from the parent(s)/ Legally
             Acceptable Representative(s).

          -  Healthy subjects or free of acute aggravation of the health status 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.

          -  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, has a negative
             pregnancy test on the day of vaccination, and has agreed to continue adequate
             contraception during the entire treatment period and for two months after completion
             of the vaccination series.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product other than the study vaccines
             within 30 days preceding the first dose of study vaccine, or planned use during the
             study period.

          -  Acute disease and/or fever at the time of enrollment.

          -  Subjects with a minor illness without fever may be enrolled at the discretion of the
             investigator.

          -  Diagnosed with cancer, or treatment for cancer, within the past three years.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             history of human immunodeficiency virus (HIV) infection.

          -  Family history of congenital or hereditary immunodeficiency.

          -  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
             antiplatelet medications, e.g., low-dose aspirin, and without any clinically-apparent
             bleeding tendency, are eligible.

          -  History of any neurological disorders or seizures.

          -  An acute evolving neurological disorder or history of Guillan-Barré syndrome.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to the first vaccine dose.

          -  Any administration of long-acting immune-modifying drugs within three months before
             study start, or a planned administration during the study period.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the first dose of study vaccine or planned administration during the study
             period.

          -  Clinically or virologically diagnosed influenza infection within six months preceding
             the study start.

          -  Administration of any vaccines within 30 days before vaccination, or planned
             administration during the study start.

          -  Previous vaccination against influenza with any seasonal or pandemic vaccine within
             six months preceding the administration of the study vaccine.

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational or a
             non-investigational product.

          -  History of allergy or reactions likely to be exacerbated by any component of the
             vaccines, including history of a severe adverse reaction to a previous dose of
             influenza vaccine.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.

          -  Child in care.