Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Influenza Vaccine GSK1247446A With Various Formulations in Subjects Aged 18-64 Years
- Only subjects who the investigator believes that they can and will comply with the
requirements of the protocol .
- A male or female between, and including, 18 - 64 years of age at the time of
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history and clinical examination before
entering into the study.
- If the subject is female, she must be of non-childbearing potential or if she is of
childbearing potential, she must have a negative pregnancy test, practice adequate
contraception for 30 days prior to vaccination, and continue such precautions for 2
months after completion of the vaccination series.
- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned
use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs within three months prior to the first vaccine dose
- Administration of a vaccine not foreseen by the study protocol from 30 days before
vaccination, up to 21 days after vaccination.
- History of hypersensitivity to a previous dose of influenza vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination
- History of allergic disease or reactions likely to be exacerbated by any component of
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
functional abnormality, as determined by physical examination or laboratory screening
- Confirmed influenza infection within a year preceding the study start.
- Administration of an influenza vaccine within a year preceding the study start.
- 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
- Pregnant or lactating female.
- Concurrent participation 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
- Acute disease at the time of enrolment.
- History of chronic alcohol consumption and/or drug abuse.
- Female planning to become pregnant or planning to discontinue contraceptive
- Any condition which, in the opinion of the investigator, prevents the subject from
participating in the study.
- History of administration of experimental/licensed vaccine containing squalene and/or
tocopherol within the last 12 months.