Safety, Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)

• Humoral immune response in terms of H1N1 haemagglutination inhibition (HI) antibodies [ Time Frame: At Day 0 ] [ Designated as safety issue: No ]
• Humoral immune response in terms of H1N1 haemagglutination inhibition (HI) antibodies [ Time Frame: At Day 42 ] [ Designated as safety issue: No ]

• Humoral immune response in terms of HI antibodies [ Time Frame: Day 0, 21, 42, and at Month 11-12 ] [ Designated as safety issue: No ]
• Humoral immune response in terms of neutralizing antibodies (in all subjects aged 6 to 11 months and a subset of subjects randomly selected using GSK SBIR) [ Time Frame: Day 0, 21, 42, Month 6, and at Month 11-12 ] [ Designated as safety issue: No ]
• Occurrence of local and general symptoms [ Time Frame: During a 7-day (day 0-6) follow-up period after each vaccination ] [ Designated as safety issue: No ]
• Occurrence of unsolicited symptoms [ Time Frame: During a 21-day (day 0-20) follow-up period after the first vaccination, and during a 62-day follow-up period after the second vaccination ] [ Designated as safety issue: No ]
• Occurrence of adverse events of specific interest / potential immune-mediated disorders, of serious adverse events, and of medically attended events [ Time Frame: From the beginning up to the study end (day 0 - month 12) ] [ Designated as safety issue: No ]
• Safety evaluation in terms of biochemical parameters [ Time Frame: Day 0, 21 and 42 ] [ Designated as safety issue: No ]

• Humoral immune response in terms of neutralizing antibodies [ Time Frame: Day 0, 21, 42, Month 6, Month 6+7 Days, Month 12 and Month 18 ] [ Designated as safety issue: No ]
• Occurrence of 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 (day 0-20) follow-up period after the first vaccination, during a 62-day follow-up period after the second vaccination, and during a 30 day follow up period after the booster vaccination ] [ Designated as safety issue: No ]
• Humoral immune response in terms of HI antibodies [ Time Frame: Day 0, 21, 42, Month 6, Month 6+7 Days, Month 12 and Month 18 ] [ Designated as safety issue: No ]
• Occurrence of adverse events of specific interest, of serious adverse events, and of medically attended visits [ Time Frame: From the beginning up to the study end (day 0 - month 18) ] [ Designated as safety issue: No ]
• Safety evaluation in terms of biochemical parameters [ Time Frame: Day 0, 21, 42, Month 6 and Month 6 + 7 Days ] [ Designated as safety issue: No ]

This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 6 and 35 months.

This protocol posting has been updated following protocol amendment 4, March 2010. The protocol posting sections impacted are number of subjects, primary and secondary endpoints and intervention.

• Influenza A Virus, H1N1 Subtype
• Influenza Infection

• Experimental: Group A
  Subjects in this group will receive investigational vaccine regimen according to a protocol specified schedule different from Group B
  Intervention: Biological: Pandemic influenza vaccine GSK2340272A
• Experimental: Group B
  Subjects in this group will receive investigational vaccine regimen according to a protocol specified schedule different from Group A
  Intervention: Biological: Pandemic influenza vaccine GSK2340272A

• Chu DW, Hwang SJ, Lim FS, Oh HM, Thongcharoen P, Yang PC, Bock HL, Dramé M, Gillard P, Hutagalung Y, Tang H, Teoh YL, Ballou RW; H5N1 Flu Study Group for Hong Kong, Singapore, Taiwan and Thailand. Immunogenicity and tolerability of an AS03(A)-adjuvanted prepandemic influenza vaccine: a phase III study in a large population of Asian adults. Vaccine. 2009 Dec 9;27(52):7428-35. Epub 2009 Aug 13.
• Carmona A, Omeñaca F, Tejedor JC, Merino JM, Vaman T, Dieussaert I, Gillard P, Arístegui J. Immunogenicity and safety of AS03-adjuvanted 2009 influenza A H1N1 vaccine in children 6-35 months. Vaccine. 2010 Aug 16;28(36):5837-44. Epub 2010 Jun 29.

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 6 and 35 months 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.
• 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.

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.
• 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.
• 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
• 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.