The purpose of this study is to evaluate the safety and immunogenicity of GSK influenza
vaccine candidate compared to a licensed trivalent influenza vaccine in adults.
Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains.HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains
Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains.
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs).
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s).
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Inclusion Criteria:
- Healthy subjects as established by medical history and clinical examination before
entering into the study.
- Subjects who the investigator believes can and will comply with the requirements of
the protocol should be enrolled in the study.
- A male or female between, and including, 18 and 60 years of age at the time of the
vaccination.
- Written informed consent obtained from the subject.
- If the subject is female, she must be of non-childbearing potential, if she is of
childbearing potential, she must practice adequate contraception for 30 days prior to
vaccination, have a negative pregnancy test and continue such precautions for 2
months after completion of the vaccination series.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine(s) within 30 days preceding the administration 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 3 months prior to administration of the vaccine.
- Administration of a vaccine not foreseen in the study protocol from 30 days before
vaccination up to 21 days post vaccination.
- Confirmed influenza infection within a year preceding the study start.
- Administration of an influenza vaccine during Northern Hemisphere season 2007-2008.
- 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 (pharmaceutical product or device).
- 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
the vaccine(s).
- Acute disease at the time of enrolment.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
functional abnormality, as determined by physical examination or laboratory screening
tests.
- Administration of immunoglobulins and/or any blood products within the three months
preceding the administration of study vaccine or planned administration during the
study period.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive
precautions.
- History of chronic alcohol consumption and/or drug abuse.
- Any condition which, in the opinion of the investigator, prevents the subject from
participating in the study.
- History of administration of experimental/licensed vaccine.
