A Study to Evaluate the Safety and Immunogenicity of a Prime-boost Schedule of GSK Biologicals' Influenza Vaccine in Children

Safety and Immunogenicity Study of a Prime-boost Schedule of GSK Biologicals' Influenza Vaccine GSK1562902A in Children Aged 3 to 17 Years

The purpose of this study is to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' influenza vaccine in children aged 3 to 17 years.

In this study Influenza vaccine GSK1562902A is the primary study vaccine and Havrix™ will be administered as the active comparator and not co-administered along with the study vaccine.Therefore, there exist no relation between the vaccines administered in this study. As the study will be carried out in Philippines, Havrix™ vaccine will be used as an active comparator instead of saline placebo to offer an advantage to the subjects.

Inclusion Criteria:

All subjects must satisfy ALL the following criteria at study entry:

• Subjects for whom the investigator believes that the parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol .

• A male or female child 3 to 17 years of age inclusive, at the time of the first vaccination.

• Written informed consent obtained from the subject's parent or guardian. Assent obtained from the subject when applicable.

• Good general health as established by medical history and clinical examination before entering into the study.

• Comprehension by the subject's parent or guardian of the study requirements, ability to comprehend and comply with procedures for collection of short- and long-term safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.

• Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device (i.e., a common-use phone serving multiple rooms or apartments).

• 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 series.

Exclusion Criteria:

The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:

• Child in care
• 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 21 days after any study vaccine administration.
• Active participation in other clinical trials.
• Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed.
• Acute disease and/or fever at the time of enrolment:
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
• Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
• An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
• Receipt of any immunoglobulins and/or any blood products within 9 months of study enrolment or planned administration of any of these products during the study period.
• Any known or suspected allergy to any constituent of influenza vaccines ; a history of anaphylactic-type reaction to vaccine components or a history of severe adverse reaction to a previous influenza vaccine.
• History of seizures or progressive neurological disease.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.
• Diagnosed with cancer or any chronic severe disease.
• Previous administration of any H5N1 vaccine.