A study of immunogenicity and safety of GSK Biologicals’ influenza vaccine FLU-Q-QIV in adults aged 18 years and older

Subjects who the investigator believes that they can and will comply with the requirements of the protocol.

• Written informed consent obtained from the subject
• Male and female adults, 18 years of age and older in stable health as determined by investigator’s clinical examination and assessment of subjects’ medical history.
• 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, and – has a negative pregnancy test on the day of vaccination, and – has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination

Administration of any influenza vaccine within 6 months preceding the study start or planned use of such vaccines during the study period.

• Administration of any other vaccine(s) within 30 days prior to study enrolment or during the study period.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
• Acute disease and/or fever at the time of enrolment.
• Significant acute or chronic, uncontrolled medical or psychiatric illness.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, based on history and physical examination.
• Insulin-dependent diabetes mellitus.
• Presence of blood dyscrasias, including hemoglobinopathies and myelo- or lymphoproliferative disorder.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to study vaccine dose.
• A history of any demyelinating disease including Multiple Sclerosis and Guillain-Barré syndrome.
• Presence of an active neurological disorder.
• History of chronic alcohol abuse and/or drug abuse as deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
• Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin. Persons receiving prophylactic anti-platelet medications, e.g. low-dose aspirin, and without a clinically apparent bleeding tendency are eligible
• Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
• Any known or suspected allergy to any constituent of FLU-Q-QIV and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury.
• A history of severe adverse reaction to a previous influenza vaccination.
• Pregnant and/or lactating/nursing female.
• Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.