An Efficacy Study of GlaxoSmithKline (GSK) Biologicals' Candidate Influenza Vaccine GSK2321138A in Children

• First occurrence of culture-confirmed influenza A and/or B disease as defined in the primary outcome measure due to antigenically-matching influenza strains [ Time Frame: During the surveillance period (approximately 6 to 8 months) ] [ Designated as safety issue: No ]
• First occurrence of culture-confirmed influenza A and/or B disease as defined in the primary outcome measure due to any influenza strains [ Time Frame: During the surveillance period (approximately 6 to 8 months) ] [ Designated as safety issue: No ]
• First occurrence of Reverse transcription polymerase chain reaction (RT-PCR) confirmed moderate to severe influenza A and/or B [ Time Frame: During the surveillance period (approximately 6 to 8 months) ] [ Designated as safety issue: No ]
• First occurrence of AOM with RT-PCR confirmed influenza A and/or B infection due to any influenza strain identified at any time starting 7 days before the onset of AOM and ending 7 days after end of AOM [ Time Frame: During the surveillance period (approximately 6 to 8 months) ] [ Designated as safety issue: No ]
• First occurrence of Lower Respiratory Illnesses (LRI) with RT-PCR confirmed influenza A and/or B infection due to any influenza strain identified at any time starting 7 days before the onset of LRI and ending 7 days after end of LRI [ Time Frame: During the surveillance period (approximately 6 to 8 months) ] [ Designated as safety issue: No ]
• First occurrence of RT-PCR confirmed severe influenza A and/or B [ Time Frame: During the surveillance period (approximately 6 to 8 months) ] [ Designated as safety issue: No ]
• Humoral immune response in terms of haemagglutination-inhibition (HI) antibody titres against vaccine strains contained in the influenza candidate vaccine (in immuno subcohort of subjects only) [ Time Frame: At Days 0 and 28/56 ] [ Designated as safety issue: No ]
• Occurence of Solicited local and general symptoms [ Time Frame: 7 days (Day 0-Day 6) after each vaccination ] [ Designated as safety issue: No ]
• Occurence of unsolicited adverse events (AEs) [ Time Frame: 28 days (Day 0-Day 27) after each vaccination ] [ Designated as safety issue: No ]
• Occurence of AEs with medically attended visits (MAV) [ Time Frame: Entire study period (6 to 8 months) ] [ Designated as safety issue: No ]
• Occurence of serious adverse events (SAEs) [ Time Frame: Entire study period (6 to 8 months) ] [ Designated as safety issue: No ]
• Occurence of immune-Mediated-Diseases (pIMDs) [ Time Frame: Entire study period (6 to 8 months) ] [ Designated as safety issue: No ]

• First occurrence of culture-confirmed influenza A and/or B disease as defined in the primary outcome measure due to antigenically-matching influenza strains [ Time Frame: during the surveillance period (approximately 6 to 8 months) ] [ Designated as safety issue: No ]
• First occurrence of culture-confirmed influenza A and/or B disease as defined in the primary outcome measure due to any influenza strains [ Time Frame: during the surveillance period (approximately 6 to 8 months) ] [ Designated as safety issue: No ]
• First occurrence of RT-PCR confirmed moderate to severe influenza A and/or B [ Time Frame: during the surveillance period (approximately 6 to 8 months) ] [ Designated as safety issue: No ]
• First occurrence of AOM with RT-PCR confirmed influenza A and/or B infection due to any influenza strain identified at any time starting 7 days before the onset of AOM and ending 7 days after end of AOM [ Time Frame: during the surveillance period (approximately 6 to 8 months) ] [ Designated as safety issue: No ]
• First occurrence of LRI with RT-PCR confirmed influenza A and/or B infection due to any influenza strain identified at any time starting 7 days before the onset of LRI and ending 7 days after end of LRI [ Time Frame: during the surveillance period (approximately 6 to 8 months) ] [ Designated as safety issue: No ]
• First occurrence of RT-PCR confirmed severe influenza A and/or B [ Time Frame: during the surveillance period (approximately 6 to 8 months) ] [ Designated as safety issue: No ]
• Humoral immune response in terms of haemagglutination-inhibition (HI) antibody titres against vaccine strains contained in the influenza candidate vaccine (in immuno subcohort of subjects only) [ Time Frame: at Days 0 and 28/56 ] [ Designated as safety issue: No ]
• Occurence of Solicited local and general symptoms [ Time Frame: 7 days (Day 0-Day 6) after each vaccination ] [ Designated as safety issue: No ]
• Occurence of unsolicited adverse events (AEs) [ Time Frame: 28 days (Day 0-Day 27) after each vaccination ] [ Designated as safety issue: No ]
• Occurence of AEs with medically attended visits (MAV) [ Time Frame: Entire study period (6 to 8 months) ] [ Designated as safety issue: No ]
• Occurence of SAEs [ Time Frame: Entire study period (6 to 8 months) ] [ Designated as safety issue: No ]
• Occurence of immune-Mediated-Diseases (pIMDs) [ Time Frame: Entire study period (6 to 8 months) ] [ Designated as safety issue: No ]

The purpose of this study is to evaluate the efficacy, immunogenicity and safety of GSK Biologicals' influenza candidate vaccine GSK2321138A when compared to non-influenza vaccine comparators in children 6 to 35 months of age. Recruitment will encompass 3 independent cohorts: a first cohort in the Northern Hemisphere (2011-2012), a second cohort in subtropical countries (2012), and possibly a third cohort in the Northern Hemisphere (2012-2013). Recruitment of this last cohort will be based on the outcome of an interim analysis for benefit/futility (2012).

• Biological: Influenza vaccine GSK2321138A
  Intramuscular injection
• Biological: Havrix Junior
  Intramuscular injection administered to subjects aged 12 months or older
• Biological: Wyeth Prevenar
  Intramuscular injection administered to subjects less than 12 months of age
• Biological: Sanofi Pasteur Varivax/ProVarivax
  Intramuscular injection administered to subjects more than 12 months of age
• Biological: Varilrix
  Subcutaneous injection administered to subjects more than 12 months of age

• Experimental: FLU group
  Subjects will receive the candidate influenza vaccine GSK2321138A.
  Intervention: Biological: Influenza vaccine GSK2321138A
• Active Comparator: Control group
  In function of their age and Flu-vaccine status, subjects will receive Prevenar or Havrix and possibly a varicella vaccine (Varilrix or Varivax/ProVarivax).
  Interventions:

  • Biological: Havrix Junior
  • Biological: Wyeth Prevenar
  • Biological: Sanofi Pasteur Varivax/ProVarivax
  • Biological: Varilrix

Inclusion Criteria:

• Subjects who the investigator believes that their parents/Legally Acceptable Representative (LARs) can and will comply with the requirements of the protocol.
• A male or female between, and including, 6 and 35 months of age at the time of first vaccination; children are eligible regardless of history of influenza vaccination.
• Written informed consent obtained from the parent(s) /LAR(s) of the subject.
• Subjects in stable health as determined by medical history and clinical examination before entering into the study.

Exclusion Criteria:

• Child in care.
• Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Prior receipt of any influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use of such vaccines during the study period.
• Children with underlying illness who are at risk of complications of influenza and for whom yearly (seasonal) influenza vaccination is recommended in their respective country.
• Any confirmed or suspected immunosuppressive or immunodeficient condition (including HIV), based on medical history and physical examination.
• Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose. Inhaled and topical steroids are allowed.
• Administration of immunoglobulins and/ or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period.
• Any known or suspected allergy to any constituent of influenza vaccines, non-influenza vaccine comparators and latex; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous vaccination.
• Any contraindication to intramuscular injection.
• Acute disease and/or fever at the time of enrolment.
• Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.

• Additional criteria for children ≥ 12 months of age:

  • Prior receipt of any licensed varicella vaccine* or any licensed hepatitis A vaccine or planned use of these vaccines during the study period. Other routine registered childhood vaccinations are permitted.

    * For countries with varicella vaccine administered as 2-dose schedule, prior receipt of a single dose of a varicella vaccine is allowed if administered at least 2 weeks before the first study vaccination.

  • Any history of hepatitis A or varicella diseases.

• Additional criteria for children 6 - 11 months of age in countries without universal mass vaccination recommendation for pneumococcal vaccine:

  • Prior receipt of any pneumococcal conjugated vaccine or planned use of this vaccine during the study period. Other routine registered childhood vaccinations are permitted.