Safety Study of Four Candidate Influenza Vaccines to Prevent Influenza Disease in the Elderly Population
Influenza
About this trial
This is an interventional prevention trial for Influenza
Eligibility Criteria
Inclusion Criteria: A male or female aged between 18 and 40 years or aged 65 years or older at the time of the vaccination. Free of obvious health problems as established by medical history and clinical examination before entering into the study. 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 the 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 six months prior to the administration of the study vaccine. History of confirmed influenza infection since a year from the date of previous vaccination. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination History of hypersensitivity to vaccines. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. Acute disease at the time of enrolment. Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Fluarix 18-40 Y Group
Fluarix ≥65 Y Group
Fluarix-AS25 Group
Fluarix-AS50 Group
Fluarix- AS01B Group
Fluarix- AS01E Group
Subjects (aged 18-40 years [Y]) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS25, administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS50, administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01B, administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects (aged ≥ 65 years) received 1 dose of the Fluarix vaccine adjuvanted with AS01E, administered intramuscularly in the deltoid region of the non-dominant arm.