Immunogenicity and Safety Study of FluarixTM Vaccine in Children Who Have Previously Been Vaccinated With PandemrixTM

Inclusion Criteria

• Subjects having previously been immunized with only one single dose of Pandemrix at the age of 10-17 years inclusive.
• Subjects having received Pandemrix at least six months prior to study enrolment.
• Subjects who the investigator believes that subject and/or parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol
• Written informed consent obtained from the subject/ the parent(s)/LAR(s) of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Subjects or Parent(s)/LAR(s) with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device

Exclusion Criteria

• Active participation in other clinical trials.
• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
• Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
• Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
• Acute disease and/or fever at the time of enrolment:
• Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
• Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned use during the study.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
• Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
• History of seizures or progressive neurological disease.
• Subjects having received an H1N1v pandemic vaccine other than Pandemrix or having received the 2010/2011 seasonal influenza vaccine.
• If the subject is female and 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 two months after completion of the vaccination series.
• Child in care.