Study to Evaluate the Safety and Immunogenicity of GSK Biological Pandemic Candidate Influenza Vaccine (H1N1) in Children

• Humoral immune response in terms of haemagglutination inhibition (HI) antibodies [ Time Frame: At Day 0, Day 21 and Month 7 ] [ Designated as safety issue: No ]
• Humoral immune response in terms of neutralising antibodies (in a subset of subjects) [ Time Frame: At Day 0, Day 21, Day 42 and Month 7 ] [ Designated as safety issue: No ]
• Occurrence of solicited local and general symptoms [ Time Frame: During a 7-day follow-up period after each vaccination ] [ Designated as safety issue: No ]
• Occurrence of unsolicited symptoms [ Time Frame: During a 21-day follow-up period after each vaccination ] [ Designated as safety issue: No ]
• Occurrence of serious adverse events, adverse events of specific interest/potential immune mediated disease, medically attended event [ Time Frame: During the entire study period (from day 0 to month 12) ] [ Designated as safety issue: No ]

The objective of this study is to evaluate the safety and immunogenicity study of GSK Biologicals' pandemic influenza candidate vaccine (GSK2340272A) in children aged 3 to 9 years.

• Biological: GSK pandemic vaccine GSK2340272A
  2 intramuscular injections
• Biological: GSK pandemic vaccine GSK2340269A
  2 intramuscular injections

• Experimental: Group A
  Subjects receiving GSK23440272A vaccine (standard dose)
  Intervention: Biological: GSK pandemic vaccine GSK2340272A
• Experimental: Group B
  Subjects receiving GSK23440272A vaccine (alternative dose)
  Intervention: Biological: GSK pandemic vaccine GSK2340272A
• Experimental: Group C
  Subjects receiving GSK2340269A vaccine
  Intervention: Biological: GSK pandemic vaccine GSK2340269A

Inclusion Criteria:

• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
• Children, male or female, aged between 3 and 9 years at the time of first study vaccination.
• Written informed consent obtained from the parent(s) or LAR(s) of the subject.
• Healthy children, as established by medical history and clinical examination when entering the study.

Exclusion Criteria:

• 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.
• Clinically or virologically confirmed influenza infection within six months preceding the study start.
• Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
• Have received any seasonal flu vaccine since last year.
• Previous administration of any H1N1 A/California-like vaccine
• 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. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
• 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.
• History of any neurological disorders or seizures.

• Acute disease and/or fever at the time of enrolment:

  • Fever is defined as temperature >= 37.5°C on oral, axillary or tympanic setting, or >= 38°C on rectal setting.
  • Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
• 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.
• Child in Care.