Study to Evaluate the Immunogenicity and Safety of an Investigational Pandemic Influenza Vaccine in Children

Safety and Immunogenicity of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine (GSK1562902A) in Children Aged 6 to 35 Months

The objective of the study is to evaluate the immunogenicity and safety of prime-boost vaccination schedule of GSK Biologicals' investigational vaccine GSK1562902A.

This protocol posting was modified according to the protocol amendment 2 (dated 16-June-2011). The impacted section is eligibility criteria.

Inclusion Criteria:

• Subjects who the investigator believes that parents/Legally Acceptable Representatives (LARs) can and will comply with the requirements of the protocol.
• Children, male or female between, and including, 6 and 35 months of age at the time of first study vaccination.
• Written informed consent obtained from the parent(s)/LAR(s) of the subject.
• Healthy children as established by medical history and clinical examination before entering the study.
• Parent/LAR access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
• Subjects who are likely to reside in the vicinity of the study centre for the duration of the study. In studies using the home-based model for vaccination and follow-up, subjects who are likely to remain in the vicinity of the area where they were recruited.

Exclusion Criteria:

• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Planned administration of any vaccine 30 days prior and 21 days after any study vaccine administration.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines such as egg protein or thiomersal.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of any neurological disorders or seizures.
• 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 tests.
• Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned administration during the study period.
• Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.
• Child in care.
• Previous vaccination at any time with an H5N1 vaccine.
• Medical history of physician-confirmed infection with a H5N1 virus.