A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Candidate Vaccine (GSK2321138A) Manufactured Using a New Process in Adults and Children

Exclusion Criteria

• •Adults aged 18-49 years cohort:
• •Child in care.
• •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• •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 or device).
• •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose. Inhaled and topical steroids are allowed.
• •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
• •Any administration of a long-acting immune-modifying drug within 6 months before study start, or planned administration during the study period.
• •Administration of an influenza vaccine during the 6 months preceding entry into the study.
• •Administration of a vaccine not foreseen by the study protocol within 30 days before vaccination or planned administration during the study period.
• •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.
• •Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
• •Acute or un-controlled, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
• •Any history of Guillain-Barré Syndrome.
• •Acute disease and/or fever at the time of enrolment. Fever is defined as temperature ≥ 38.0ºC/100.4ºF.
• •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 contra-indication to intramuscular administration of influenza vaccines.
• •Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
• •Pediatric cohort
• •Child in care.
• •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• •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 or device).
• •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccination dose. Inhaled and topical steroids are allowed.
• •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
• •Any administration of a long-acting immune-modifying drug within 6 months before study start, or planned administration during the study period.
• •Administration of an influenza vaccine during the 6 months preceding entry into the study.
• •Administration of a vaccine not foreseen by the study protocol within 30 days before vaccination or planned administration during the study period.
• •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.
• •Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
• •Acute or un-controlled, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
• •Any history of Guillain-Barré Syndrome.
• •Acute disease and/or fever at the time of enrolment. Fever is defined as temperature ≥ 38.0ºC/100.4ºF.
• •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 contra-indication to intramuscular administration of influenza vaccines.
• •Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.