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

• Humoral immune response in terms of investigational vaccine HI antibodies [ Time Frame: at Visit 1 (Day 0), Visit 3 (Day 28), Visit 4 (Day 56),Visit 6 (study Month 4), Visit 7 (study Month 5) and Visit 9 (study Month 11) ] [ Designated as safety issue: No ]
• Humoral immune response in terms of investigational vaccine neutralising antibodies [ Time Frame: at Visit 1 (Day 0), Visit 3 (Day 28), Visit 4 (Day 56),Visit 6 (study Month 4), Visit 7 (study Month 5) and Visit 9 (study Month 11) ] [ Designated as safety issue: No ]
• Evaluation of immune response to components of the routine immunisation vaccines [ Time Frame: At visit 6 (study Month 4) and/or at visit 9 (study Month 11) ] [ Designated as safety issue: No ]
• Percentage, intensity and relationship to vaccination of local and general solicited symptoms [ Time Frame: During the 7-days follow-up after each investigational vaccine administration ] [ Designated as safety issue: No ]
• Occurrence of local and general solicited symptoms [ Time Frame: During the 7-days follow-up after each investigational vaccine administration ] [ Designated as safety issue: No ]
• Percentage, intensity and relationship to vaccination of unsolicited adverse events [ Time Frame: During the 28-day follow-up after each investigational vaccine administration ] [ Designated as safety issue: No ]
• Occurrence of MAEs, AESIs, SAEs and relationship to vaccination [ Time Frame: Throughout the study (from day 0 to Month 11) ] [ Designated as safety issue: No ]

The purpose of this study is to assess the safety and immunogenicity of two doses of the H1N1 candidate vaccine administered in children aged between 8 and 12 weeks at the time of first vaccination.

• Biological: GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine
  Two doses; intramuscular administration
• Biological: InfanrixTM-IPV/Hib
  Routine infant immunisation vaccine, three doses administered intramuscularly
• Biological: Prevenar
  Routine infant immunisation vaccine, three doses administered intramuscularly

• Experimental: Group A
  Subjects will receive two doses of investigational vaccine regimen according to a 0-28 day schedule
  Interventions:

  • Biological: GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine
  • Biological: InfanrixTM-IPV/Hib
  • Biological: Prevenar
• Experimental: Group B
  Subjects will receive two doses of investigational vaccine regimen according to a 0-4 month schedule
  Interventions:

  • Biological: GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine
  • Biological: InfanrixTM-IPV/Hib
  • Biological: Prevenar

Inclusion Criteria:

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

• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LARs) can and will comply with the requirements of the protocol
• Children, male or female, aged between 8 and 12 weeks 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 when entering the study.
• 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.
• Born after a gestation period of >= 36 to <= 42 weeks.

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:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
• Acute disease at the time of enrolment.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
• History of any neurological disorders or seizures.
• A family history of congenital or hereditary immunodeficiency.
• Receipt of systemic glucocorticoids within one month of study enrolment, or any other cytotoxic or immunosuppressive drug since birth.
• Administration of any vaccines within two weeks before study enrolment.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study.
• Previous administration of any H1N1 vaccine, of any seasonal influenza vaccine.
• Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b, and/or Streptococcus pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations.
• History of intercurrent diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b disease.
• Major congenital defects or serious chronic illness.
• Child in care.
• Any known or suspected allergy to any constituent of the influenza, DTPa-IPV/Hib and pneumococcal study vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza, DTPa-IPV/Hib and pneumococcal vaccine.