Evaluate Safety & Immunogenicity of a Pandemic Influenza Vaccine (GSK1562902A) in Children

• Geometric mean titers of serum antibodies [ Time Frame: At day 0 ] [ Designated as safety issue: No ]
• Seroconversion rates [ Time Frame: At day 21 ] [ Designated as safety issue: No ]
• Seroconversion factors [ Time Frame: At day 21 ] [ Designated as safety issue: No ]
• Seroprotection rates [ Time Frame: At day 0 ] [ Designated as safety issue: No ]
• Percentage, intensity and relationship to vaccination of solicited local and general signs and symptoms [ Time Frame: During a 7 day follow-up period after each vaccination ] [ Designated as safety issue: No ]
• Percentage, intensity and relationship to vaccination of solicited local and general signs and symptoms [ Time Frame: During a 21 day follow-up period after the first vaccination, during a 30-day follow-up period after the second vaccination ] [ Designated as safety issue: No ]
• Occurrence of serious adverse events [ Time Frame: During the entire study (Day 0 to Day Month 24) ] [ Designated as safety issue: No ]
• Descriptive statistics (mean, median, minimum, maximum) of selected biochemistry parameters [ Time Frame: At each scheduled time point ] [ Designated as safety issue: No ]
• Number and percentage of subjects with normal or abnormal values for each selected biochemistry parameter [ Time Frame: At each scheduled time point ] [ Designated as safety issue: No ]
• Geometric mean titers of serum antibodies - day 21 [ Time Frame: At day 21 ] [ Designated as safety issue: No ]
• Geometric mean titers of serum antibodies - day 42 [ Time Frame: At day 42 ] [ Designated as safety issue: No ]
• Geometric mean titers of serum antibodies - 6 months [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
• Geometric mean titers of serum antibodies - 12 months [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
• Geometric mean titers of serum antibodies - 24 months [ Time Frame: At 24 months ] [ Designated as safety issue: No ]
• Seroconversion rates - day 42 [ Time Frame: At day 42 ] [ Designated as safety issue: No ]
• Seroconversion rates - 6 months [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
• Seroconversion rates - 12 months [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
• Seroconversion rates - 24 months [ Time Frame: At 24 months ] [ Designated as safety issue: No ]
• Seroconversion factors - day 42 [ Time Frame: At day 42 ] [ Designated as safety issue: No ]
• Seroconversion factors - 6 months [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
• Seroconversion factors - 12 months [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
• Seroconversion factors - 24 months [ Time Frame: At 24 months ] [ Designated as safety issue: No ]
• Seroprotection rates - day 21 [ Time Frame: At day 21 ] [ Designated as safety issue: No ]
• Seroprotection rates - day 42 [ Time Frame: At day 42 ] [ Designated as safety issue: No ]
• Seroprotection rates - 6 months [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
• Seroprotection rates - 12 months [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
• Seroprotection rates - 24 months [ Time Frame: At 24 months ] [ Designated as safety issue: No ]

• Serum neutralizing antibody titers tested [ Time Frame: At days 0, 21, 42, Month 6, Month 12 and Month 24 ] [ Designated as safety issue: No ]
• GMTs of serum neutralizing antibodies [ Time Frame: At days 0, 21, 42, Month 6, Month 12 and Month 24 ] [ Designated as safety issue: No ]
• Seroconversion rates [ Time Frame: At days 21, 42, Month 6, Month 12 and Month 24 ] [ Designated as safety issue: No ]
• Seroprotection rates [ Time Frame: At 6 months, 12 months and 24 months ] [ Designated as safety issue: No ]

The present study is designed to evaluate in children (aged between 3 and 9 years) the immunogenicity and safety of different antigen doses of the candidate vaccine (GSK1562902A) administered following a two-administration schedule (21 days apart). Subjects in the control group will receive Fluarix. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

• Biological: Pandemic Influenza Vaccine (GSK1562902A)
  2 doses, intramuscular injection, 3 different formulations are tested
• Biological: Fluarix
  2 doses, intramuscular injection

• Experimental: Group A
  Intervention: Biological: Pandemic Influenza Vaccine (GSK1562902A)
• Experimental: Group B
  Intervention: Biological: Pandemic Influenza Vaccine (GSK1562902A)
• Experimental: Group C
  Intervention: Biological: Pandemic Influenza Vaccine (GSK1562902A)
• Active Comparator: Group D
  Intervention: Biological: Fluarix

Inclusion Criteria:

• Children who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
• Children aged between and including 3 and 9 years of age at the time of first vaccination.
• Written informed consent obtained from the parent(s) or guardian of the subject.
• Healthy children as established by medical history and clinical examination before entering the study.
• Subjects who are likely to reside in the vicinity of the study center for the duration of the study.

Exclusion criteria:

• Use of any investigational or non-registered product (drug or vaccine) other than the investigational vaccine within 30 days prior to the enrolment in this study, or planned use during the study period.
• Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination, with the exception of routine childhood inoculations which cannot be delayed, but which must not be administered on the same day as the investigational vaccine candidate.
• Administration of the interpandemic influenza vaccine 21 days prior to Day 0 or up to Day 51.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the enrolment in this study.
• Any chronic drug therapy to be continued during the study period, with the exception of inhalative treatment for seasonal allergies or asthma.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
• History of hypersensitivity to vaccines.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines used in this study.
• History of any neurological disorders or seizures.
• Acute disease at the time of enrolment.
• Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study or planned during the study.
• Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study