Monovalent H5N1 Vaccine GSK1557484A in Children 6 Months to < 18 Years of Age

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01310413
• Collaborator: (none)
• Enrollment: 842
• Locations: 17
• Arms: 7
• Actual Duration (Months): 34.7
• Patients Per Site: 49.5
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

This study will assess safety and immunogenicity of GSK Biologicals' H5N1 flu candidate vaccine GSK1557484A in children 6 months to < 18 years of age.

Condition or Disease	Intervention/Treatment	Phase
Influenza; Influenza Vaccines	Biological: Influenza A (H5N1) Virus monovalent vaccine; Biological: Saline placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 842 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Safety and Immunogenicity of Monovalent H5N1 Vaccine GSK1557484A in Children 6 Months to < 18 Years of Age
• Actual Study Start Date: Mar 7, 2011
• Actual Primary Completion Date: Jul 21, 2011
• Actual Study Completion Date: Jan 26, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Influenza A (H5N1) adjuvanted 6-<36M Group Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Biological: Influenza A (H5N1) Virus monovalent vaccine; All subjects will receive 2 doses administered as an intramuscular (IM) injection.
Experimental: Influenza A (H5N1) Virus monovalent vaccine 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Biological: Influenza A (H5N1) Virus monovalent vaccine; All subjects will receive 2 doses administered as an intramuscular (IM) injection.
Experimental: Influenza A (H5N1) Virus monovalent vaccine 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Biological: Influenza A (H5N1) Virus monovalent vaccine; All subjects will receive 2 doses administered as an intramuscular (IM) injection.
Placebo Comparator: Placebo 6-<36M Group Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Biological: Saline placebo; All subjects will receive 2 doses administered as an intramuscular (IM) injection.
Placebo Comparator: Placebo 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Biological: Saline placebo; All subjects will receive 2 doses administered as an intramuscular (IM) injection.
Placebo Comparator: Placebo 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Biological: Saline placebo; All subjects will receive 2 doses administered as an intramuscular (IM) injection.
Experimental: Placebo/Influenza A (H5N1) adjuvanted Group Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 of was administered in the deltoid region of the non-dominant arm and Dose 2 in the deltoid region of the dominant arm.	Biological: Influenza A (H5N1) Virus monovalent vaccine; All subjects will receive 2 doses administered as an intramuscular (IM) injection.

Outcome Measures

Primary Outcome Measures

1. Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain. [At Day 42.]

   A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40.

Secondary Outcome Measures

1. Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain. [At Days 0 and 21]

   HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10.

2. Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain. [At Days 0 and 21]

   A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40.

3. Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain. [At Days 21 and 42]

   A subject seroconverted for HI antibodies against the H5N1 A/Indonesia virus strain (A/INDO) was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer higher than or equal to (>=) 1:40, or with a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer. As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.

4. Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain. [At Days 21 and 42]

   GMI also known as the seroconversion factor (SCF) or geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination reciprocal HI titre for the vaccine virus.

5. Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain. [At Day 0 and Day 182.]

   HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10. Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.

6. Number of Subjects Seroprotected as Regards Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain. [At Day 0 and Day 182]

   A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40. As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.

7. Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain [At Day 42.]

   HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10. As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.

8. Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain. [At Day 182]

   A subject seroconverted for HI antibodies against the H5N1 A/Indonesia virus strain (A/INDO) was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer higher than or equal to (>=) 1:40, or with a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer.

9. Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain. [At Day 182]

   GMI also known as the seroconversion factor (SCF) or geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination reciprocal HI titre for the vaccine virus.

10. Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain. [At Day 0 and Day 385]

    HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10. As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.

11. Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain. [At Day 0 and Day 385]

    A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40. As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.

12. Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain. [At Day 385]

    A subject seroconverted for HI antibodies against the H5N1 A/Indonesia virus strain (A/INDO) was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer higher than or equal to (>=) 1:40, or with a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer.

13. Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain. [At Day 385.]

    GMI also known as the seroconversion factor (SCF) or geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.

14. Microneutralization (MN) Antibody Titers Against the H5N1 A/Indonesia and H5N1 A/Vietnam Virus Strains. [At Days 0, 42, 182 and 385]

    MN HI antibody titers against the H5N1 A/Indonesia (A/INDO) and H5N1 A/Vietnam (A/VIET) virus strains were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:28.

15. Number of Subjects Seropositive for Microneutralization (MN) Antibodies Against the H5N1 A/Indonesia Virus Strain. [At Days 0 and 42]

16. Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the H5N1 A/Indonesia and H5N1 A/Vietnam Virus Strains. [At Day 42]

    VRR for MN was defined as as the incidence rate of vaccinees with a 4-fold increase in post vaccination reciprocal titer relative to Day 0.

17. Number of Subjects Reporting Solicited Local Symptoms. [During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 1)]

    Solicited local symptoms assessed were pain, redness and swelling. "Any" was defined as any occurrence of the specified solicited local symptom reported, regardless of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm).

18. Number of Subjects Reporting Solicited Local Symptoms. [During the 7-day (Days U0-U6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 2)]

    Solicited local symptoms assessed were pain and swelling. "Any" was defined as any occurrence of the specified solicited local symptom reported, regardless of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm).

19. Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms. [During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 1)]

    Solicited general symptoms assessed in subjects of less than 6 years of age were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature (T) higher than or equal to (>=) 38.0 degrees Celsius (°C)]. "Any" was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Any fever was defined as axillary temperature above 38.0 degrees Celsius (°C). Grade 3 fever was axillary temperature >= 39.0°C.

20. Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms. [During the 7-day (Days U0-U6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 2)]

    Solicited general symptoms assessed in subjects of less than 6 years of age were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature (T) higher than or equal to (>=) 38.0 degrees Celsius (°C)]. "Any" was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Any fever was defined as axillary temperature above 38.0 degrees Celsius (°C). Grade 3 fever was axillary temperature >=39.0°C.

21. Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms. [During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 1)]

    Solicited general symptoms assessed in subjects of at least 6 years of age were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and fever [axillary temperature (T) >= 38.0 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diaorrhea and/or abdominal pain. "Any" was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever was axillary temperature >= 39.0°C.

22. Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms. [During the 7-day (Days U0-U6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 2)]

    Solicited general symptoms assessed in subjects of at least 6 years of age were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and fever [axillary temperature (T) >= 38.0 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diaorrhea and/or abdominal pain. "Any" was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever was axillary temperature >= 39.0°C.

23. Number of Subjects With Medically-attended Adverse Events (MAEs) [From Day 0 up to Day 385]

    MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination. Any MAE was defined as atleast 1 MAE experienced.

24. Number of Subjects With Medically-attended Adverse Events (MAEs) [From Day U0 up to Day U385]

    MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination. Any MAE was defined as atleast 1 MAE experienced.

25. Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs) [From Day 0 up to Day 385]

    Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. "Any pIMD" was defined as at least one pIMD experienced by the study subject.

26. Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs) [From Day U0 to Day U385]

    Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. "Any pIMD" was defined as at least one pIMD experienced by the study subject.

27. Number of Subjects Reporting Pregnancies, and Outcomes of These Reported Pregnancies [From Day 0 up to Day 385]

28. Number of Subjects Reporting Pregnancies, and Outcomes of These Reported Pregnancies [From Day U0 to Day U385]

29. Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALAT) and Aspartate Aminotransferase (ASAT) [From Day 0 up to Day 385]

    Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.

30. Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Total Bilirubin (T-BIL) and Bilirubin Conjugated/Direct (BIL-C/D) [From Day 0 up to Day 385]

    Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.

31. Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) [From Day 0 up to Day 385]

    Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.

32. Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Basophils (BAS) and Eosinophils (EOS) [From Day 0 up to Day 385]

    Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.

33. Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Haematocrit (Hcr) and Haemoglobin (Hgb) [From Day 0 up to Day 385]

    Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.

34. Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Neutrophils (NEU) and Platelets (PLA) [From Day 0 up to Day 385]

    Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.

35. Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Lymphocytes (LYM) and Monocytes (MON) [From Day 0 up to Day 385]

    Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.

36. Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Red and White Blood Cells (RBC and WBC) [From Day 0 up to Day 385]

    Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.

37. Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). [During the 21-day (Days 0-20) post-vaccination period following Dose 1 of vaccine/placebo]

    An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. "Any" was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.

38. Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). [During the 21-day (Days 21-41) post-vaccination period following Dose 2 of vaccine/placebo]

    An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. "Any" was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.

39. Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). [During the 42-day (Days 0-41) post-vaccination period following Dose 1 of vaccine/placebo]

    An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. "Any" was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.

40. Number of Subjects Reporting Serious Adverse Events (SAEs) [From Day 0 up to Day 385]

    A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.

41. Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). [During the 21-day (Days U0-U20) post-vaccination period following Dose 1 of Influenza A (H5N1) Virus monovalent vaccine]

    An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. "Any" was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.

42. Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). [During the 21-day (Days U21-U41) post-vaccination period following Dose 2 of Influenza A (H5N1) Virus monovalent vaccine]

    An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. "Any" was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.

43. Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). [During the 42-day (Days U0-U41) post-vaccination period following Dose 1 of Influenza A (H5N1) Virus monovalent vaccine]

    An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. "Any" was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. As the study is still ongoing and data per age group are not available, results are presented for the groups pooled by vaccine/placebo administered. This outcome measure will be amended when data by age group become available.

44. Number of Subjects Reporting Serious Adverse Events (SAEs) [From Day U0 up to Day U385]

    A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• A male or female child >= 6 months and < 18 years of age at the time of first vaccination.

• Written informed consent obtained from the subject's parent/guardian.

• Documentation of assent for children 9 to < 18 years of age (or as deemed mandatory by local practice).

• Satisfactory baseline medical assessment by history and physical examination

• Parent/guardian and subject access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.

• Parents/guardians and subjects who the investigator believes understand the requirements of the protocol and can and will comply with them.

• Female subjects of non-childbearing potential may be enrolled in the study.

• Female subjects of childbearing potential must

• have practiced adequate contraception for 30 days prior to vaccination, and

• have a negative pregnancy test on the day of each vaccination, and

• have agreed to continue adequate contraception for 2 months after completion of the vaccination series.

Exclusion Criteria:

• Medical history of physician-confirmed infection with an H5N1 virus.

• Previous vaccination at any time with an H5N1 vaccine.

• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/product, or planned use during the study period.

• Presence of significant acute or chronic, uncontrolled medical or psychiatric illness.

• Presence of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject or parent/guardian unable/unlikely to provide accurate safety reports.

• Evidence of current subject or parent/guardian substance abuse, including alcohol, by medical history.

• Presence of a temperature >= 38.0ºC by any method, or acute symptoms greater than "mild" severity on the scheduled date of first dose.

• Diagnosed with cancer, or treatment for cancer, within 3 years.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

• Receipt of systemic glucocorticoids within 1 month prior to first dose of test article or any other cytotoxic or immunosuppressive drug within 6 months prior to first dose of test article. Receipt of any immunoglobulins and/or any blood products within 3 months of first test article administration or planned administration of any of these products during the study period.

• Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.

• An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.

• Administration of an inactivated seasonal influenza vaccine within 14 days, or of a live, attenuated seasonal influenza vaccine within 30 days before the first test article dose, or of any other vaccine(s) not foreseen by the study protocol within 30 days before the first test article dose.

• Planned administration of any vaccine(s) not foreseen by the study protocol through completion of the "Day 42" visit.

• Any known or suspected allergy to any constituent of influenza vaccines or history of severe reaction to any previous influenza vaccination.

• Known pregnancy, or a positive urine pregnancy test result prior to each test article dose.

• Lactating or nursing.

• Child in care.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Paramount	California	United States	90723
2	GSK Investigational Site	Sacramento	California	United States	95816
3	GSK Investigational Site	Newton	Kansas	United States	67114
4	GSK Investigational Site	Bardstown	Kentucky	United States	40004
5	GSK Investigational Site	Metairie	Louisiana	United States	70006
6	GSK Investigational Site	Saint Louis	Missouri	United States	63141
7	GSK Investigational Site	Omaha	Nebraska	United States	68134
8	GSK Investigational Site	Henderson	Nevada	United States	89014
9	GSK Investigational Site	Cleveland	Ohio	United States	44121
10	GSK Investigational Site	Fort Worth	Texas	United States	76135
11	GSK Investigational Site	San Angelo	Texas	United States	76904
12	GSK Investigational Site	Coquitlam	British Columbia	Canada	V3K 3P4
13	GSK Investigational Site	Hamilton	Ontario	Canada	L8L 5G8
14	GSK Investigational Site	Sudbury	Ontario	Canada	P3E 1H5
15	GSK Investigational Site	Sherbrooke	Quebec	Canada	J1H 1Z1
16	GSK Investigational Site	Sherbrooke	Quebec	Canada	J1J 2G2
17	GSK Investigational Site	Khon Kaen		Thailand	40002

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Publications

• Izurieta P et al. (2018) Reactogenicity and safety of AS03B-adjuvanted H5N1 influenza vaccine in children: an open-label, one-way, crossover trial. Asian Biomed (Res Rev News). 11(4):359-364.
• Kosalaraksa P, Jeanfreau R, Frenette L, Drame M, Madariaga M, Innis BL, Godeaux O, Izurieta P, Vaughn DW. AS03B-adjuvanted H5N1 influenza vaccine in children 6 months through 17 years of age: a phase 2/3 randomized, placebo-controlled, observer-blinded trial. J Infect Dis. 2015 Mar 1;211(5):801-10. doi: 10.1093/infdis/jiu548. Epub 2014 Oct 6.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01310413
• Other Study ID Numbers: 114464; 2012-001683-29
• First Posted: Mar 8, 2011
• Last Update Posted: Nov 1, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: Influenza; H5N1; Pandemic
• Additional relevant MeSH terms: Influenza, Human; Influenza in Birds

Study Results

Participant Flow

Recruitment Details	The study included a first 385-days Blinded Phase (all subjects), followed by a 385-days Unblinded Phase. In this phase, subjects who received the placebo in the Blinded Phase were offered, after completing the Blinded Phase, 2 doses of Influenza A (H5N1) Virus monovalent vaccine administered for Dose 1 within a short delay of Day 385 (Day U0).
Pre-assignment Detail	A total of 842 subjects were enrolled in the study in its Blinded Phase part. This number was later amended down to 838, following corrections for wrong subject number allocation and randomization errors.

Arm/Group Title	Influenza A (H5N1) Adjuvanted 6-<36M Group	Influenza A (H5N1) Adjuvanted 3-<9Y Group	Influenza A (H5N1) Adjuvanted 9-<18Y Group	Placebo 6-<36M Group	Placebo 3-<9Y Group	Placebo 9-<18Y Group	Placebo/Influenza A (H5N1) Adjuvanted Group
Arm/Group Description	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non-dominant arm and Dose 2 in the deltoid region of the dominant arm.
Period Title: Day 0 to Day 385
STARTED	199	198	210	75	76	80	0
COMPLETED	172	190	203	67	73	77	0
NOT COMPLETED	27	8	7	8	3	3	0
Period Title: Day 0 to Day 385
STARTED	0	0	0	0	0	0	155
COMPLETED	0	0	0	0	0	0	152
NOT COMPLETED	0	0	0	0	0	0	3

Baseline Characteristics

Arm/Group Title	Influenza A (H5N1) Adjuvanted 6-<36M Group	Influenza A (H5N1) Adjuvanted 3-<9Y Group	Influenza A (H5N1) Adjuvanted 9-<18Y Group	Placebo 6-<36M Group	Placebo 3-<9Y Group	Placebo 9-<18Y Group	Total
Arm/Group Description	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Total of all reporting groups
Overall Participants	199	198	210	75	76	80	838
Age (Months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Months]	21.7 (8.17)	70.5 (21.71)	160.8 (28.21)	22.6 (8.17)	65.2 (20.2)	156.0 (31.29)	84.9 (61.40)
Sex: Female, Male (Count of Participants)
Female	92 46.2%	90 45.5%	103 49%	39 52%	35 46.1%	42 52.5%	401 47.9%
Male	107 53.8%	108 54.5%	107 51%	36 48%	41 53.9%	38 47.5%	437 52.1%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
Description	A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40.
Time Frame	At Day 42.

Outcome Measure Data

Analysis Population Description

The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 42 were available.

Arm/Group Title	Influenza A (H5N1) Adjuvanted 6-<36M Group	Influenza A (H5N1) Adjuvanted 3-<9Y Group	Influenza A (H5N1) Adjuvanted 9-<18Y Group	Placebo 6-<36M Group	Placebo 3-<9Y Group	Placebo 9-<18Y Group
Arm/Group Description	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	175	185	203	64	71	76
Number [Subject]	175	184	201	0	0	1

2. Secondary Outcome

Title	Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
Description	HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10.
Time Frame	At Days 0 and 21

Outcome Measure Data

Analysis Population Description

The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 42 were available.

Arm/Group Title	Influenza A (H5N1) Adjuvanted 6-<36M Group	Influenza A (H5N1) Adjuvanted 3-<9Y Group	Influenza A (H5N1) Adjuvanted 9-<18Y Group	Placebo 6-<36M Group	Placebo 3-<9Y Group	Placebo 9-<18Y Group
Arm/Group Description	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	182	184	204	67	71	76
A/INDO, Day 0 [N=182;184;204;67;71;76]	5.3	5.6	5.7	5.3	5.6	5.4
A/INDO, Day 21 [N=179;184;204;67;70;76]	38.7	44.6	35.3	5.2	5.4	5.4

3. Secondary Outcome

Title	Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
Description	A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40.
Time Frame	At Days 0 and 21

Outcome Measure Data

Analysis Population Description

The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 42 were available.

Arm/Group Title	Influenza A (H5N1) Adjuvanted 6-<36M Group	Influenza A (H5N1) Adjuvanted 3-<9Y Group	Influenza A (H5N1) Adjuvanted 9-<18Y Group	Placebo 6-<36M Group	Placebo 3-<9Y Group	Placebo 9-<18Y Group
Arm/Group Description	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	182	184	204	67	71	76
A/INDO, Day 0 [N=182;184;204;67;71;76]	1	2	1	0	0	0
A/INDO, Day 21 [N=179;184;204;67;70;76]	105	110	108	0	1	0

4. Secondary Outcome

Title	Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.
Description	A subject seroconverted for HI antibodies against the H5N1 A/Indonesia virus strain (A/INDO) was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer higher than or equal to (>=) 1:40, or with a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer. As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.
Time Frame	At Days 21 and 42

Outcome Measure Data

Analysis Population Description

Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.

Arm/Group Title	Influenza A (H5N1) Adjuvanted 6-<36M Group	Influenza A (H5N1) Adjuvanted 3-<9Y Group	Influenza A (H5N1) Adjuvanted 9-<18Y Group	Placebo 6-<36M Group	Placebo 3-<9Y Group	Placebo 9-<18Y Group
Arm/Group Description	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	179	185	204	67	71	76
A/INDO, Day 21 [N=179;183;204;67;70;76]	103	107	105	0	0	0
A/INDO, Day 42 [N=175;184;203;64;71;76]	175	183	201	0	0	1

5. Secondary Outcome

Title	Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.
Description	GMI also known as the seroconversion factor (SCF) or geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination reciprocal HI titre for the vaccine virus.
Time Frame	At Days 21 and 42

Outcome Measure Data

Analysis Population Description

The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 42 were available.

Arm/Group Title	Influenza A (H5N1) Adjuvanted 6-<36M Group	Influenza A (H5N1) Adjuvanted 3-<9Y Group	Influenza A (H5N1) Adjuvanted 9-<18Y Group	Placebo 6-<36M Group	Placebo 3-<9Y Group	Placebo 9-<18Y Group
Arm/Group Description	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	179	185	204	67	71	76
A/INDO, Day 21 [N=179;183;204;67;70;76]	7.3	8.0	6.2	1.0	1.0	1.0
A/INDO, Day 42 [N=175;184;203;64;71;76]	148.5	96.9	72.4	1.0	1.0	1.1

6. Secondary Outcome

Title	Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
Description	HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10. Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.
Time Frame	At Day 0 and Day 182.

Outcome Measure Data

Analysis Population Description

Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.

Arm/Group Title	Influenza A (H5N1) Adjuvanted 6-<36M Group	Influenza A (H5N1) Adjuvanted 3-<9Y Group	Influenza A (H5N1) Adjuvanted 9-<18Y Group	Placebo 6-<36M Group	Placebo 3-<9Y Group	Placebo 9-<18Y Group
Arm/Group Description	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	107	101	100	36	37	35
A/INDO, Day 0 [N=107;101;100;36;37;35]	5.1	5.2	5.6	5.3	5.2	5.4
A/INDO, Day 182 [N=84;89;87;29;34;31]	90.6	57.4	50.2	5.0	5.4	5.4

7. Secondary Outcome

Title	Number of Subjects Seroprotected as Regards Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
Description	A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40. As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.
Time Frame	At Day 0 and Day 182

Outcome Measure Data

Analysis Population Description

Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.

Arm/Group Title	Influenza A (H5N1) Adjuvanted 6-<36M Group	Influenza A (H5N1) Adjuvanted 3-<9Y Group	Influenza A (H5N1) Adjuvanted 9-<18Y Group	Placebo 6-<36M Group	Placebo 3-<9Y Group	Placebo 9-<18Y Group
Arm/Group Description	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	182	184	204	67	71	76
A/INDO, Day 0 [N=182;184;204;67;71;76]	1	2	1	0	0	0
A/INDO, Day 182 [N=84;89;87;29;34;31]	80	75	63	0	0	0

8. Secondary Outcome

Title	Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain
Description	HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10. As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.
Time Frame	At Day 42.

Outcome Measure Data

Analysis Population Description

The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 42 were available.

Arm/Group Title	Influenza A (H5N1) Adjuvanted 6-<36M Group	Influenza A (H5N1) Adjuvanted 3-<9Y Group	Influenza A (H5N1) Adjuvanted 9-<18Y Group	Placebo 6-<36M Group	Placebo 3-<9Y Group	Placebo 9-<18Y Group
Arm/Group Description	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	175	185	203	64	71	76
Geometric Mean (95% Confidence Interval) [Titer]	777.1	543.8	416.2	5.1	5.4	5.8

9. Secondary Outcome

Title	Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.
Description	A subject seroconverted for HI antibodies against the H5N1 A/Indonesia virus strain (A/INDO) was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer higher than or equal to (>=) 1:40, or with a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer.
Time Frame	At Day 182

Outcome Measure Data

Analysis Population Description

The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 182, which included 50% of evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 182 were available

Arm/Group Title	Influenza A (H5N1) Adjuvanted 6-<36M Group	Influenza A (H5N1) Adjuvanted 3-<9Y Group	Influenza A (H5N1) Adjuvanted 9-<18Y Group	Placebo 6-<36M Group	Placebo 3-<9Y Group	Placebo 9-<18Y Group
Arm/Group Description	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	SSubjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	84	89	87	29	34	31
Number [Subject]	80	75	61	0	0	0

10. Secondary Outcome

Title	Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.
Description	GMI also known as the seroconversion factor (SCF) or geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination reciprocal HI titre for the vaccine virus.
Time Frame	At Day 182

Outcome Measure Data

Analysis Population Description

The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 182, which included 50% of evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 182 were available

Arm/Group Title	Influenza A (H5N1) Adjuvanted 6-<36M Group	Influenza A (H5N1) Adjuvanted 3-<9Y Group	Influenza A (H5N1) Adjuvanted 9-<18Y Group	Placebo 6-<36M Group	Placebo 3-<9Y Group	Placebo 9-<18Y Group
Arm/Group Description	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	84	89	87	29	34	31
Geometric Mean (95% Confidence Interval) [Ratio]	17.8	11.0	8.8	1.0	1.1	1.0

11. Secondary Outcome

Title	Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
Description	HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10. As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.
Time Frame	At Day 0 and Day 385

Outcome Measure Data

Analysis Population Description

Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.

Arm/Group Title	Influenza A (H5N1) Adjuvanted 6-<36M Group	Influenza A (H5N1) Adjuvanted 3-<9Y Group	Influenza A (H5N1) Adjuvanted 9-<18Y Group	Placebo 6-<36M Group	Placebo 3-<9Y Group	Placebo 9-<18Y Group
Arm/Group Description	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	182	184	204	67	71	76
A/INDO, Day 0 [N=182;184;204;67;71;76]	5.3	5.6	5.7	5.3	5.6	5.4
A/INDO, Day 385 [N=63;85;95;26;34;36]	65.6	32.8	21.6	5.1	5.4	5.3

12. Secondary Outcome

Title	Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
Description	A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40. As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.
Time Frame	At Day 0 and Day 385

Outcome Measure Data

Analysis Population Description

Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.

Arm/Group Title	Influenza A (H5N1) Adjuvanted 6-<36M Group	Influenza A (H5N1) Adjuvanted 3-<9Y Group	Influenza A (H5N1) Adjuvanted 9-<18Y Group	Placebo 6-<36M Group	Placebo 3-<9Y Group	Placebo 9-<18Y Group
Arm/Group Description	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	182	184	204	67	71	76
A/INDO, Day 0 [N=182, 184,204,67,71,76]	1	2	1	0	0	0
A/INDO, Day 385 [N=63;85;95;26;34;36]	54	47	27	0	0	0

13. Secondary Outcome

Title	Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.
Description	A subject seroconverted for HI antibodies against the H5N1 A/Indonesia virus strain (A/INDO) was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer higher than or equal to (>=) 1:40, or with a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer.
Time Frame	At Day 385

Outcome Measure Data

Analysis Population Description

The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 385, which included 50% of evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 385 were available

Arm/Group Title	Influenza A (H5N1) Adjuvanted 6-<36M Group	Influenza A (H5N1) Adjuvanted 3-<9Y Group	Influenza A (H5N1) Adjuvanted 9-<18Y Group	Placebo 6-<36M Group	Placebo 3-<9Y Group	Placebo 9-<18Y Group
Arm/Group Description	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	63	85	95	26	34	36
Number [Subjects]	53	45	23	0	0	0

14. Secondary Outcome

Title	Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.
Description	GMI also known as the seroconversion factor (SCF) or geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Time Frame	At Day 385.

Outcome Measure Data

Analysis Population Description

The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 385, which included 50% of evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 385 were available

Arm/Group Title	Influenza A (H5N1) Adjuvanted 6-<36M Group	Influenza A (H5N1) Adjuvanted 3-<9Y Group	Influenza A (H5N1) Adjuvanted 9-<18Y Group	Placebo 6-<36M Group	Placebo 3-<9Y Group	Placebo 9-<18Y Group
Arm/Group Description	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	63	85	95	26	34	36
Geometric Mean (95% Confidence Interval) [Fold increase]	12.1	5.5	3.6	1.0	0.9	1.0

15. Secondary Outcome

Title	Microneutralization (MN) Antibody Titers Against the H5N1 A/Indonesia and H5N1 A/Vietnam Virus Strains.
Description	MN HI antibody titers against the H5N1 A/Indonesia (A/INDO) and H5N1 A/Vietnam (A/VIET) virus strains were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:28.
Time Frame	At Days 0, 42, 182 and 385

Outcome Measure Data

Analysis Population Description

Analysis was done on the Day 42, 182 and 385 ATP cohorts for immunogenicity, that is, 50 percent of the evaluable subjects with 2 doses of vaccine/placebo administered and for whom assay results for antibodies against vaccine-homologous H5N1 haemagglutinin (HA) antigen were available for the Days 0, 42, 182 and 385 time points.

Arm/Group Title	Influenza A (H5N1) Adjuvanted 6-<36M Group	Influenza A (H5N1) Adjuvanted 3-<9Y Group	Influenza A (H5N1) Adjuvanted 9-<18Y Group	Placebo 6-<36M Group	Placebo 3-<9Y Group	Placebo 9-<18Y Group
Arm/Group Description	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	36	39	40	10	11	11
A/INDO, Day 0 [N=36;37;40;7;10;11]	14.00	15.67	15.54	15.46	14.00	14.91
A/INDO, Day 42 [N=34;37;40;6;10;11]	855.62	657.60	380.62	14.00	14.00	14.91
A/INDO, Day 182 [N=33;39;33;10;10;9]	216.82	130.32	104.18	16.11	14.00	17.67
A/INDO, Day 385 [N=25;33;37;8;11;9]	166.64	108.59	82.26	15.27	14.91	16.33
A/VIET, Day 0 [N=36;36;40;7;10;11]	14.83	19.84	24.88	17.11	16.08	20.47
A/VIET, Day 42 [N=34;37;40;6;10;11]	68.18	71.15	65.25	17.69	19.87	28.14
A/VIET, Day 182 [N=33;39;33;10;10;9]	48.77	44.11	61.67	19.82	17.24	24.14
A/VIET, Day 385 [N=25;33;37;8;11;9]	59.83	38.62	47.73	14.00	18.07	35.42

16. Secondary Outcome

Title	Number of Subjects Seropositive for Microneutralization (MN) Antibodies Against the H5N1 A/Indonesia Virus Strain.
Time Frame	At Days 0 and 42

Outcome Measure Data

Analysis Population Description

Analysis was done on the Day 42 According-to-Protocol cohort for immunogenicity, that is, all evaluable subjects with 2 doses of vaccine/placebo administered and for whom assay results for antibodies against vaccine-homologous H5N1 haemagglutinin (HA) antigen were available for the Days 0 and 42 time points.

Arm/Group Title	Influenza A (H5N1) Adjuvanted 6-<36M Group	Influenza A (H5N1) Virus Monovalent Vaccine 3-<9Y Group	Influenza A (H5N1) Virus Monovalent Vaccine 9-<18Y Group	Placebo 6-<36M Group	Placebo 3-<9Y Group	Placebo 9-<18Y Group
Arm/Group Description	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	36	37	40	7	10	11
At Day 0	0	6	5	1	0	1
At Day 42	34	37	40	0	0	1

17. Secondary Outcome

Title	Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the H5N1 A/Indonesia and H5N1 A/Vietnam Virus Strains.
Description	VRR for MN was defined as as the incidence rate of vaccinees with a 4-fold increase in post vaccination reciprocal titer relative to Day 0.
Time Frame	At Day 42

Outcome Measure Data

Analysis Population Description

Analysis was done on the Day 42 According-to-Protocol cohort for immunogenicity, that is, all evaluable subjects with 2 doses of vaccine/placebo administered and for whom assay results for antibodies against vaccine-homologous H5N1 haemagglutinin (HA) antigen were available for the Days 0 and 42 time points.

Arm/Group Title	Influenza A (H5N1) Adjuvanted 6-<36M Group	Influenza A (H5N1) Adjuvanted 3-<9Y Group	Influenza A (H5N1) Adjuvanted 9-<18Y Group	Placebo 6-<36M Group	Placebo 3-<9Y Group	Placebo 9-<18Y Group
Arm/Group Description	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	34	37	40	6	11	11
A/INDO [N=34;37;40;6;10;11]	34	37	39	0	0	0
A/VIET [N=34;36;40;6;10;11]	30	26	16	0	1	0

18. Secondary Outcome

Title	Number of Subjects Reporting Solicited Local Symptoms.
Description	Solicited local symptoms assessed were pain, redness and swelling. "Any" was defined as any occurrence of the specified solicited local symptom reported, regardless of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm).
Time Frame	During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 1)

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented, solely on subjects with results available/accessible.

Arm/Group Title	Influenza A (H5N1) Adjuvanted Group	Placebo Group
Arm/Group Description	This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	603	229
Any pain	405	69
Grade 3 pain	25	4
Any redness	29	0
Grade 3 redness	1	0
Any swelling	41	1
Grade 3 swelling	1	0

19. Secondary Outcome

Title	Number of Subjects Reporting Solicited Local Symptoms.
Description	Solicited local symptoms assessed were pain and swelling. "Any" was defined as any occurrence of the specified solicited local symptom reported, regardless of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm).
Time Frame	During the 7-day (Days U0-U6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 2)

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Placebo/Placebo/ Influenza A (H5N1) Adjuvanted Group
Arm/Group Description	Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non-dominant arm and Dose 2 in the deltoid region of the dominant arm.
Measure Participants	154
Any Pain	111
Grade 3 Pain	8
Any Redness	6
Grade 3 Redness	0
Any Swelling	5
Grade 3 Swelling	0

20. Secondary Outcome

Title	Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms.
Description	Solicited general symptoms assessed in subjects of less than 6 years of age were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature (T) higher than or equal to (>=) 38.0 degrees Celsius (°C)]. "Any" was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Any fever was defined as axillary temperature above 38.0 degrees Celsius (°C). Grade 3 fever was axillary temperature >= 39.0°C.
Time Frame	During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 1)

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Influenza A (H5N1) Adjuvanted Group	Placebo Group
Arm/Group Description	This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, PInfluenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	294	122
Any Drowsiness	101	29
Grade 3 Drowsiness	9	2
Related Drowsiness	81	21
Any Irritability/fussiness	128	40
Grade 3 Irritability/fussiness	10	2
Related Irritability/fussiness	111	33
Any Loss of appetite	79	29
Grade 3 Loss of appetite	8	4
Related Loss of appetite	63	20
Any Fever	59	21
Grade 3 Fever	14	5
Related Fever	41	14

21. Secondary Outcome

Title	Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms.
Description	Solicited general symptoms assessed in subjects of less than 6 years of age were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature (T) higher than or equal to (>=) 38.0 degrees Celsius (°C)]. "Any" was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Any fever was defined as axillary temperature above 38.0 degrees Celsius (°C). Grade 3 fever was axillary temperature >=39.0°C.
Time Frame	During the 7-day (Days U0-U6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 2)

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Placebo/ Influenza A (H5N1) Adjuvanted Group
Arm/Group Description	Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non-dominant arm and Dose 2 in the deltoid region of the dominant arm.
Measure Participants	79
Any Drowsiness	23
Grade 3 Drowsiness	1
Related Drowsiness	17
Any Irritability/Fussiness	28
Grade 3 Irritability/Fussiness	1
Related Irritability/Fussiness	23
Any Loss of appetite	18
Grade 3 Loss of appetite	0
Related Loss of appetite	13
Any Fever	4
Grade 3 Fever	2
Related Fever	3

22. Secondary Outcome

Title	Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms.
Description	Solicited general symptoms assessed in subjects of at least 6 years of age were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and fever [axillary temperature (T) >= 38.0 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diaorrhea and/or abdominal pain. "Any" was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever was axillary temperature >= 39.0°C.
Time Frame	During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 1)

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Influenza A (H5N1) Adjuvanted Group	Placebo Group
Arm/Group Description	This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	309	107
Any fatigue	89	19
Grade 3 fatigue	4	2
Related fatigue	77	16
Any gastrointestinal symptoms	43	18
Grade 3 gastrointestinal symptoms	4	2
Related gastrointestinal symptoms	27	11
Any headache	100	18
Grade 3 headache	8	3
Related headache	87	15
Any joint pain	50	9
Grade 3 joint pain	2	0
Related joint pain	43	8
Any muscle aches	123	17
Grade 3 muscle aches	7	1
Related muscle aches	114	14
Any shivering	25	7
Grade 3 shivering	2	1
Related shivering	19	5
Any sweating	25	4
Grade 3 sweating	2	0
Related sweating	22	1
Any fever	19	3
Grade 3 fever	5	1
Related fever	13	2

23. Secondary Outcome

Title	Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms.
Description	Solicited general symptoms assessed in subjects of at least 6 years of age were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and fever [axillary temperature (T) >= 38.0 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diaorrhea and/or abdominal pain. "Any" was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever was axillary temperature >= 39.0°C.
Time Frame	During the 7-day (Days U0-U6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 2)

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Placebo/Influenza A (H5N1) Adjuvanted Group
Arm/Group Description	Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non-dominant arm and Dose 2 in the deltoid region of the dominant arm.
Measure Participants	75
Any Fatigue	18
Grade 3 Fatigue	1
Related Fatigue	13
Any Gastrointestinal	7
Grade 3 Gastrointestinal	0
Related Gastrointestinal	5
Any Headache	24
Grade 3 Headache	1
Related Headache	20
Any Increased Sweating	5
Grade 3 Increased Sweating	0
Related Increased Sweating	3
Any Joint Pain	14
Grade 3 Joint Pain	0
Related Joint Pain	12
Any Muscle Aches	34
Grade 3 Muscle Aches	0
Related Muscle Aches	28
Any Shivering (Chills)	7
Grade 3 Shivering (Chills)	2
Related Shivering (Chills)	4
Any Fever	1
Grade 3 Fever	0
Related Fever	0

24. Secondary Outcome

Title	Number of Subjects With Medically-attended Adverse Events (MAEs)
Description	MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination. Any MAE was defined as atleast 1 MAE experienced.
Time Frame	From Day 0 up to Day 385

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Influenza A (H5N1) Adjuvanted Group	Placebo Group
Arm/Group Description	This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	607	231
Number [Subject]	189	77

25. Secondary Outcome

Title	Number of Subjects With Medically-attended Adverse Events (MAEs)
Description	MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination. Any MAE was defined as atleast 1 MAE experienced.
Time Frame	From Day U0 up to Day U385

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Placebo/ Influenza A (H5N1) Adjuvanted Group
Arm/Group Description	Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non-dominant arm and Dose 2 in the deltoid region of the dominant arm.
Measure Participants	155
Number [Subject]	36

26. Secondary Outcome

Title	Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)
Description	Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. "Any pIMD" was defined as at least one pIMD experienced by the study subject.
Time Frame	From Day 0 up to Day 385

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Influenza A (H5N1) Adjuvanted Group	Placebo Group
Arm/Group Description	This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	607	231
Number [Subject]	1	1

27. Secondary Outcome

Title	Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)
Description	Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. "Any pIMD" was defined as at least one pIMD experienced by the study subject.
Time Frame	From Day U0 to Day U385

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Placebo/ Influenza A (H5N1) Adjuvanted Group
Arm/Group Description	Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non-dominant arm and Dose 2 in the deltoid region of the dominant arm.
Measure Participants	155
Number [Subject]	0

28. Secondary Outcome

Title	Number of Subjects Reporting Pregnancies, and Outcomes of These Reported Pregnancies
Time Frame	From Day 0 up to Day 385

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Influenza A (H5N1) Adjuvanted Group	Placebo Group
Arm/Group Description	This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	607	231
Subject(s) with any pregnancy	2	0
Subject(s) with related pregnancy	0	0
Spontaneous abortion	1	0
Healthy live birth	1	0

29. Secondary Outcome

Title	Number of Subjects Reporting Pregnancies, and Outcomes of These Reported Pregnancies
Time Frame	From Day U0 to Day U385

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Placebo/ Influenza A (H5N1) Adjuvanted Group
Arm/Group Description	Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 of was administered in the deltoid region of the non-dominant arm and Dose 2 in the deltoid region of the dominant arm.
Measure Participants	155
Number [Subject]	0

30. Secondary Outcome

Title	Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALAT) and Aspartate Aminotransferase (ASAT)
Description	Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
Time Frame	From Day 0 up to Day 385

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Influenza A (H5N1) Adjuvanted Group	Placebo Group
Arm/Group Description	This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	606	231
ALAT, PRE Unknown [N=606,231]	15	4
ALAT, PRE Below [N=606,231]	0	0
ALAT, PRE Normal [N=606,231]	586	221
ALAT, PRE Above [N=606,231]	5	6
ALAT, Day 42 Unknown [N=583,220]	17	4
ALAT, Day 42 Below [N=583,220]	0	0
ALAT, Day 42 Normal [N=583,220]	562	212
ALAT, Day 42 Above [N=583,220]	4	4
ALAT, Day 182 Unknown [N=304,110]	6	0
ALAT, Day 182 Below [N=304,110]	0	0
ALAT, Day 182 Normal [N=304,110]	289	110
ALAT, Day 182 Above [N=304,110]	9	0
ALAT, Day 385 Unknown [N=251,104]	5	0
ALAT, Day 385 Below [N=251,104]	0	0
ALAT, Day 385 Normal [N=251,104]	245	100
ALAT, Day 385 Above [N=251,104]	1	4
ASAT, PRE Unknown [N=606,231]	15	4
ASAT, PRE Below [N=606,231]	0	0
ASAT, PRE Normal [N=606,231]	577	219
ASAT, PRE Above [N=606,231]	14	8
ASAT, Day 42 Unknown [N=583,220]	19	4
ASAT, Day 42 Below [N=583,220]	0	0
ASAT, Day 42 Normal [N=583,220]	552	208
ASAT, Day 42 Above [N=583,220]	12	8
ASAT, Day 182 Unknown [N=304,110]	8	0
ASAT, Day 182 Below [N=304,110]	0	0
ASAT, Day 182 Normal [N=304,110]	284	108
ASAT, Day 182 Above [N=304,110]	12	2
ASAT, Day 385 Unknown [N=251,104]	7	0
ASAT, Day 385 Below [N=251,104]	0	0
ASAT, Day 385 Normal [N=251,104]	240	100
ASAT, Day 385 Above [N=251,104]	4	4

31. Secondary Outcome

Title	Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Total Bilirubin (T-BIL) and Bilirubin Conjugated/Direct (BIL-C/D)
Description	Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
Time Frame	From Day 0 up to Day 385

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Influenza A (H5N1) Adjuvanted Group	Placebo Group
Arm/Group Description	This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	606	231
T-BIL, PRE Unknown [N=606,231]	15	4
T-BIL, PRE Below [N=606,231]	0	0
T-BIL, PRE Normal [N=606,231]	587	224
T-BIL, PRE Above [N=606,231]	4	3
T-BIL, Day 42 Unknown [N=583,220]	16	4
T-BIL, Day 42 Below [N=583,220]	0	0
T-BIL, Day 42 Normal [N=583,220]	558	214
T-BIL, Day 42 Above [N=583,220]	9	2
T-BIL, Day 182 Unknown [N=304,110]	6	0
T-BIL, Day 182 Below [N=304,110]	0	0
T-BIL, Day 182 Normal [N=304,110]	296	110
T-BIL, Day 182 Above [N=304,110]	2	0
T-BIL, Day 385 Unknown [N=251,104]	7	1
T-BIL, Day 385 Below [N=251,104]	0	0
T-BIL, Day 385 Normal [N=251,104]	240	102
T-BIL, Day 385 Above [N=251,104]	4	1
BIL-C/D, PRE Unknown [N=606,231]	15	4
BIL-C/D, PRE Below [N=606,231]	0	0
BIL-C/D, PRE Normal [N=606,231]	591	226
BIL-C/D, PRE Above [N=606,231]	0	1
BIL-C/D, Day 42 Unknown [N=583,220]	16	4
BIL-C/D, Day 42 Below [N=583,220]	0	0
BIL-C/D, Day 42 Normal [N=583,220]	558	214
BIL-C/D, Day 42 Above [N=583,220]	9	2
BIL-C/D, Day 182 Unknown [N=304,110]	7	0
BIL-C/D, Day 182 Below [N=304,110]	0	0
BIL-C/D, Day 182 Normal [N=304,110]	297	110
BIL-C/D, Day 182 Above [N=304,110]	0	0
BIL-C/D, Day 385 Unknown [N=251,104]	8	1
BIL-C/D, Day 385 Below [N=251,104]	0	0
BIL-C/D, Day 385 Normal [N=251,104]	240	103
BIL-C/D, Day 385 Above [N=251,104]	3	0

32. Secondary Outcome

Title	Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN)
Description	Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
Time Frame	From Day 0 up to Day 385

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Influenza A (H5N1) Adjuvanted Group	Placebo Group
Arm/Group Description	This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&amp;lt;12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&amp;gt;=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	607	231
CREA, PRE Unknown [N=606,231]	15	4
CREA, PRE Below [N=606, 231]	142	61
CREA, PRE Within [N=606, 231]	447	165
CREA, PRE Above [N=606, 231]	2	1
CREA, Day 42 Unknown [N=583,220]	17	4
CREA, Day 42 Below [N=583,220]	130	48
CREA, Day 42 Within [N=583,220]	432	166
CREA, Day 42 Above [N=583,220]	4	2
CREA, Day 182 Unknown [N=304,110]	6	1
CREA, Day 182 Below [N=304,110]	66	26
CREA, Day 182 Within [N=304,110]	231	83
CREA, Day 182 Above [N=304,110]	1	0
CREA, Day 385 Unknown [N=251,104]	6	0
CREA, Day 385 Below [N=251,104]	51	24
CREA, Day 385 Within [N=251,104]	191	80
CREA, Day 385 Above [N=251,104]	3	0
BUN, PRE Unknown [N=606,231]	15	4
BUN, PRE Below [N=606,231]	13	4
BUN, PRE Within [N=606,231]	553	218
BUN, PRE Above [N=606,231]	25	5
BUN, Day 42 Unknown [N=583,220]	17	4
BUN, Day 42 Below [N=583,220]	11	3
BUN, Day 42 Within [N=583,220]	531	209
BUN, Day 42 Above [N=583,220]	24	4
BUN, Day 182 Unknown [N=304,110]	6	0
BUN, Day 182 Below [N=304,110]	8	2
BUN, Day 182 Within [N=304,110]	281	105
BUN, Day 182 Above [N=304,110]	9	3
BUN, Day 385 Unknown [N=251,104]	7	0
BUN, Day 385 Below [N=251,104]	3	2
BUN, Day 385 Within [N=251,104]	237	100
BUN, Day 385 Above [N=251,104]	4	2

33. Secondary Outcome

Title	Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Basophils (BAS) and Eosinophils (EOS)
Description	Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
Time Frame	From Day 0 up to Day 385

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Influenza A (H5N1) Adjuvanted Group	Placebo Group
Arm/Group Description	This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	607	231
BAS, PRE Unknown [N=606,231]	29	12
BAS, PRE Below [N=606,231]	0	0
BAS, PRE Within [N=606,231]	576	219
BAS, PRE Above [N=606,231]	1	0
BAS, Day 42 Unknown [N=583,220]	34	13
BAS, Day 42 Below [N=583,220]	0	0
BAS, Day 42 Within [N=583,220]	549	207
BAS, Day 42 Above [N=583,220]	0	0
BAS, Day 182 Unknown [N=304,110]	17	2
BAS, Day 182 Below [N=304,110]	0	0
BAS, Day 182 Within [N=304,110]	287	108
BAS, Day 182 Above [N=304,110]	0	0
BAS, Day 385 Unknown [N=251,104]	6	3
BAS, Day 385 Below [N=251,104]	0	0
BAS, Day 385 Within [N=251,104]	245	101
BAS, Day 385 Above [N=251,104]	0	0
EOS, PRE Unknown [N=606,231]	29	12
EOS, PRE Below [N=606,231]	68	19
EOS, PRE Within [N=606,231]	473	187
EOS, PRE Above [N=606,231]	36	13
EOS, Day 42 Unknown [N=583,220]	34	13
EOS, Day 42 Below [N=583,220]	49	15
EOS, Day 42 Within [N=583,220]	452	175
EOS, Day 42 Above [N=583,220]	48	17
EOS, Day 182 Unknown [N=304,110]	17	2
EOS, Day 182 Below [N=304,110]	33	11
EOS, Day 182 Within [N=304,110]	237	85
EOS, Day 182 Above [N=304,110]	17	12
EOS, Day 385 Unknown [N=251,104]	6	3
EOS, Day 385 Below [N=251,104]	32	17
EOS, Day 385 Within [N=251,104]	198	77
EOS, Day 385 Above [N=251,104]	15	7

34. Secondary Outcome

Title	Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Haematocrit (Hcr) and Haemoglobin (Hgb)
Description	Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
Time Frame	From Day 0 up to Day 385

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Influenza A (H5N1) Adjuvanted Group	Placebo Group
Arm/Group Description	This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&amp;lt;12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&amp;gt;=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	607	231
Hcr, PRE Unknown [N=606,231]	26	10
Hcr, PRE Below [N=606,231]	53	21
Hcr, PRE Within [N=606,231]	480	181
Hcr, PRE Above [N=606,231]	47	19
Hcr, Day 42 Unknown [N=583,220]	19	7
Hcr, Day 42 Below [N=583,220]	45	13
Hcr, Day 42 Within [N=583,220]	477	178
Hcr, Day 42 Above [N=583,220]	42	22
Hcr, Day 182 Unknown [N=304,110]	12	2
Hcr, Day 182 Below [N=304,110]	38	7
Hcr, Day 182 Within [N=304,110]	238	91
Hcr, Day 182 Above [N=304,110]	16	10
Hcr, Day 385 Unknown [N=251,104]	5	3
Hcr, Day 385 Below [N=251,104]	18	12
Hcr, Day 385 Within [N=251,104]	215	85
Hcr, Day 385 Above [N=251,104]	13	4
Hgb, PRE Unknown [N=606,231]	26	10
Hgb, PRE Below [N=606,231]	61	26
Hgb, PRE Within [N=606,231]	497	182
Hgb, PRE Above [N=606,231]	22	13
Hgb, Day 42 Unknown [N=583,220]	19	8
Hgb, Day 42 Below [N=583,220]	69	19
Hgb, Day 42 Within [N=583,220]	476	185
Hgb, Day 42 Above [N=583,220]	19	8
Hgb, Day 182 Unknown [N=304,110]	11	2
Hgb, Day 182 Below [N=304,110]	42	16
Hgb, Day 182 Within [N=304,110]	241	89
Hgb, Day 182 Above [N=304,110]	10	3
Hgb, Day 385 Unknown [N=251,104]	5	3
Hbg, Day 385 Below [N=251,104]	27	15
Hbg, Day 385 Within [N=251,104]	210	84
Hbg, Day 385 Above [N=251,104]	9	2

35. Secondary Outcome

Title	Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Neutrophils (NEU) and Platelets (PLA)
Description	Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
Time Frame	From Day 0 up to Day 385

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Influenza A (H5N1) Adjuvanted Group	Placebo Group
Arm/Group Description	This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	607	231
NEU, PRE Unknown [N=606,231]	29	12
NEU, PRE Below [N=606,231]	26	10
NEU, PRE Within [N=606,231]	534	202
NEU, PRE Above [N=606,231]	17	7
NEU, Day 42 Unknown [N=583,220]	34	13
NEU, Day 42 Below [N=583,220]	29	8
NEU, Day 42 Within [N=583,220]	505	189
NEU, Day 42 Above [N=583,220]	15	10
NEU, Day 182 Unknown [N=304,110]	17	2
NEU, Day 182 Below [N=304,110]	14	3
NEU, Day 182 Within [N=304,110]	266	105
NEU, Day 182 Above [N=304,110]	7	0
NEU, Day 385 Unknown [N=251,104]	6	3
NEU, Day 385 Below [N=251,104]	12	3
NEU, Day 385 Within [N=251,104]	227	96
NEU, Day 385 Above [N=251,104]	6	2
PLA, PRE Unknown [N=606,231]	35	17
PLA, PRE Below [N=606,231]	3	0
PLA, PRE Within [N=606,231]	518	187
PLA, PRE Above [N=606,231]	50	27
PLA, Day 42 Unknown [N=583,220]	32	12
PLA, Day 42 Below [N=583,220]	1	0
PLA, Day 42 Within [N=583,220]	500	184
PLA, Day 42 Above [N=583,220]	50	24
PLA, Day 182 Unknown [N=304,110]	20	5
PLA, Day 182 Below [N=304,110]	0	0
PLA, Day 182 Within [N=304,110]	260	96
PLA, Day 182 Above [N=304,110]	24	9
PLA, Day 385 Unknown [N=251,104]	8	8
PLA, Day 385 Below [N=251,104]	1	0
PLA, Day 385 Within [N=251,104]	234	94
PLA, Day 385 Above [N=251,104]	8	2

36. Secondary Outcome

Title	Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Lymphocytes (LYM) and Monocytes (MON)
Description	Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
Time Frame	From Day 0 up to Day 385

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Influenza A (H5N1) Adjuvanted Group	Placebo Group
Arm/Group Description	This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	607	231
LYM, PRE Unknown [N=606,231]	29	12
LYM, PRE Below [N=606,231]	7	1
LYM, PRE Within [N=606,231]	441	161
LYM, PRE Above [N=606,231]	129	57
LYM, Day 42 Unknown [N=583,220]	34	13
LYM, Day 42 Below [N=583,220]	6	2
LYM, Day 42 Within [N=583,220]	446	162
LYM, Day 42 Above [N=583,220]	97	43
LYM, Day 182 Unknown [N=304,110]	17	2
LYM, Day 182 Below [N=304,110]	0	1
LYM, Day 182 Within [N=304,110]	235	93
LYM, Day 182 Above [N=304,110]	52	14
LYM, Day 385 Unknown [N=251,104]	6	3
LYM, Day 385 Below [N=251,104]	0	0
LYM, Day 385 Within [N=251,104]	223	86
LYM, Day 385 Above [N=251,104]	22	15
MON, PRE Unknown [N=606,231]	29	12
MON, PRE Below [N=606,231]	94	46
MON, PRE Within [N=606,231]	480	170
MON, PRE Above [N=606,231]	3	3
MON, Day 42 Unknown [N=583,220]	34	13
MON, Day 42 Below [N=583,220]	110	37
MON, Day 42 Within [N=583,220]	434	167
MON, Day 42 Above [N=583,220]	5	3
MON, Day 182 Unknown [N=304,110]	17	2
MON, Day 182 Below [N=304,110]	61	20
MON, Day 182 Within [N=304,110]	221	88
MON, Day 182 Above [N=304,110]	5	0
MON, Day 385 Unknown [N=251,104]	6	3
MON, Day 385 Below [N=251,104]	31	18
MON, Day 385 Within [N=251,104]	211	83
MON, Day 385 Above [N=251,104]	3	0

37. Secondary Outcome

Title	Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Red and White Blood Cells (RBC and WBC)
Description	Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
Time Frame	From Day 0 up to Day 385

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Influenza A (H5N1) Adjuvanted Group	Placebo Group
Arm/Group Description	This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	607	231
RBC, PRE Unknown [N=606,231]	26	10
RBC, PRE Below [N=606,231]	25	4
RBC, PRE Within [N=606,231]	504	198
RBC, PRE Above [N=606,231]	51	19
RBC, Day 42 Unknown [N=583,220]	19	8
RBC, Day 42 Below [N=583,220]	21	6
RBC, Day 42 Within [N=583,220]	496	189
RBC, Day 42 Above [N=583,220]	47	17
RBC, Day 182 Unknown [N=304,110]	11	2
RBC, Day 182 Below [N=304,110]	13	5
RBC, Day 182 Within [N=304,110]	266	93
RBC, Day 182 Above [N=304,110]	14	10
RBC, Day 385 Unknown [N=251,104]	5	3
RBC, Day 385 Below [N=251,104]	8	2
RBC, Day 385 Within [N=251,104]	214	90
RBC, Day 385 Above [N=251,104]	24	9
WBC, PRE Unknown [N=606,231]	29	12
WBC, PRE Below [N=606,231]	27	9
WBC, PRE Within [N=606,231]	543	207
WBC, PRE Above [N=606,231]	7	3
WBC, Day 42 Unknown [N=583,220]	34	13
WBC, Day 42 Below [N=583,220]	38	8
WBC, Day 42 Within [N=583,220]	508	198
WBC, Day 42 Above [N=583,220]	3	1
WBC, Day 182 Unknown [N=304,110]	17	2
WBC, Day 182 Below [N=304,110]	21	7
WBC, Day 182 Within [N=304,110]	264	101
WBC, Day 182 Above [N=304,110]	2	0
WBC, Day 385 Unknown [N=251,104]	6	3
WBC, Day 385 Below [N=251,104]	15	6
WBC, Day 385 Within [N=251,104]	230	94
WBC, Day 385 Above [N=251,104]	0	1

38. Secondary Outcome

Title	Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
Description	An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. "Any" was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Time Frame	During the 21-day (Days 0-20) post-vaccination period following Dose 1 of vaccine/placebo

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Influenza A (H5N1) Adjuvanted Group	Placebo Group
Arm/Group Description	This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, PInfluenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	607	231
Number [Subject]	153	63

39. Secondary Outcome

Title	Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
Description	An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. "Any" was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Time Frame	During the 21-day (Days 21-41) post-vaccination period following Dose 2 of vaccine/placebo

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Influenza A (H5N1) Adjuvanted Group	Placebo Group
Arm/Group Description	This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and PInfluenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	593	224
Number [Subject]	135	54

40. Secondary Outcome

Title	Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
Description	An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. "Any" was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Time Frame	During the 42-day (Days 0-41) post-vaccination period following Dose 1 of vaccine/placebo

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Influenza A (H5N1) Adjuvanted Group	Placebo Group
Arm/Group Description	This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	607	231
Number [Subject]	243	97

41. Secondary Outcome

Title	Number of Subjects Reporting Serious Adverse Events (SAEs)
Description	A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Time Frame	From Day 0 up to Day 385

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Influenza A (H5N1) Adjuvanted Group	Placebo Group
Arm/Group Description	This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Measure Participants	607	231
Number [Subject]	8	4

42. Secondary Outcome

Title	Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
Description	An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. "Any" was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Time Frame	During the 21-day (Days U0-U20) post-vaccination period following Dose 1 of Influenza A (H5N1) Virus monovalent vaccine

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Placebo/Influenza A (H5N1) Virus Monovalent Vaccine Group
Arm/Group Description	Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non-dominant arm and Dose 2 in the deltoid region of the dominant arm.
Measure Participants	155
Number [Subject]	21

43. Secondary Outcome

Title	Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
Description	An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. "Any" was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Time Frame	During the 21-day (Days U21-U41) post-vaccination period following Dose 2 of Influenza A (H5N1) Virus monovalent vaccine

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Placebo/Influenza A (H5N1) Adjuvanted Group
Arm/Group Description	Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 of was administered in the deltoid region of the non-dominant arm and Dose 2 in the deltoid region of the dominant arm.
Measure Participants	155
Number [Subject]	27

44. Secondary Outcome

Title	Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
Description	An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. "Any" was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. As the study is still ongoing and data per age group are not available, results are presented for the groups pooled by vaccine/placebo administered. This outcome measure will be amended when data by age group become available.
Time Frame	During the 42-day (Days U0-U41) post-vaccination period following Dose 1 of Influenza A (H5N1) Virus monovalent vaccine

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Placebo/Influenza A (H5N1) Virus Monovalent Vaccine Group
Arm/Group Description	Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non-dominant arm and Dose 2 in the deltoid region of the dominant arm.
Measure Participants	155
Number [Subject]	41

45. Secondary Outcome

Title	Number of Subjects Reporting Serious Adverse Events (SAEs)
Description	A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Time Frame	From Day U0 up to Day U385

Outcome Measure Data

Analysis Population Description

Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Arm/Group Title	Placebo/Influenza A (H5N1) Adjuvanted Group
Arm/Group Description	Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 of was administered in the deltoid region of the non-dominant arm and Dose 2 in the deltoid region of the dominant arm.
Measure Participants	155
Number [Subject]	2

Adverse Events

Time Frame	Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration.
Adverse Event Reporting Description	For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Arm/Group Title	Influenza A (H5N1) Adjuvanted Group		Placebo Group		Placebo/Influenza A (H5N1) Adjuvanted Group
Arm/Group Description	This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3≤9Y and Influenza A (H5N1) adjuvanted 9≤18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (≥12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).		This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9≤18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (≥) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).		Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6≤36M, Placebo 3≤9Y or Placebo 9≤18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6≤36M, Placebo 3≤9Y and Placebo 9≤18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non-dominant arm and Dose 2 in the deltoid region of the dominant arm.
All Cause Mortality
	Influenza A (H5N1) Adjuvanted Group		Placebo Group		Placebo/Influenza A (H5N1) Adjuvanted Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Influenza A (H5N1) Adjuvanted Group		Placebo Group		Placebo/Influenza A (H5N1) Adjuvanted Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/607 (1.3%)		4/231 (1.7%)		2/155 (1.3%)
Blood and lymphatic system disorders
Lymphadenitis	0/607 (0%)		1/231 (0.4%)		0/155 (0%)	0
Gastrointestinal disorders
Inguinal hernia	1/607 (0.2%)		0/231 (0%)		0/155 (0%)	0
Infections and infestations
Infectious mononucleosis	2/607 (0.3%)		0/231 (0%)		0/155 (0%)	0
Influenza	1/607 (0.2%)		0/231 (0%)		0/155 (0%)	0
Pneumonia	1/607 (0.2%)		0/231 (0%)		0/155 (0%)	0
Upper respiratory tract infection	1/607 (0.2%)		0/231 (0%)		0/155 (0%)	0
Scarlet fever	0/607 (0%)		0/231 (0%)		1/155 (0.6%)
Injury, poisoning and procedural complications
Skeletal injury	1/607 (0.2%)		0/231 (0%)		0/155 (0%)	0
Wound	0/607 (0%)		0/231 (0%)		1/155 (0.6%)
Metabolism and nutrition disorders
Dehydration	1/607 (0.2%)		0/231 (0%)		0/155 (0%)	0
Type 1 diabetes mellitus	0/607 (0%)		1/231 (0.4%)		0/155 (0%)	0
Nervous system disorders
Febrile convulsion	1/607 (0.2%)		0/231 (0%)		0/155 (0%)	0
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	1/607 (0.2%)		0/231 (0%)		0/155 (0%)	0
Psychiatric disorders
Suicidal ideation	0/607 (0%)		1/231 (0.4%)		0/155 (0%)	0
Respiratory, thoracic and mediastinal disorders
Asthma	0/607 (0%)		1/231 (0.4%)		0/155 (0%)	0
Bronchial hyperreactivity	1/607 (0.2%)		0/231 (0%)		0/155 (0%)	0
Other (Not Including Serious) Adverse Events
	Influenza A (H5N1) Adjuvanted Group		Placebo Group		Placebo/Influenza A (H5N1) Adjuvanted Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	502/607 (82.7%)		189/231 (81.8%)		124/155 (80%)
Gastrointestinal disorders
Diarrhoea	13/607 (2.1%)		12/231 (5.2%)		3/155 (1.9%)
General disorders
Pain	405/603 (67.2%)		69/229 (30.1%)		111/154 (72.1%)
Swelling	41/603 (6.8%)		1/229 (0.4%)		5/154 (3.2%)
Drowsiness	101/294 (34.4%)		29/122 (23.8%)		23/79 (29.1%)
Irritability/fussiness	128/294 (43.5%)		40/122 (32.8%)		28/79 (35.4%)
Loss of appetite	79/294 (26.9%)		29/122 (23.8%)		18/79 (22.8%)
Fever (axillary temperature >= 38.0°C)	59/294 (20.1%)		21/122 (17.2%)		4/79 (5.1%)
Fatigue	89/309 (28.8%)		19/107 (17.8%)		18/75 (24%)
Gastrointestinal disorders	43/309 (13.9%)		18/107 (16.8%)		7/75 (9.3%)
Headache	100/309 (32.4%)		18/107 (16.8%)		24/75 (32%)
Joint pain at other location	50/309 (16.2%)		9/107 (8.4%)		14/75 (18.7%)
Muscle aches	123/309 (39.8%)		17/107 (15.9%)		34/75 (45.3%)
Shivering	25/309 (8.1%)		7/107 (6.5%)		7/75 (9.3%)
Sweating	25/309 (8.1%)		4/107 (3.7%)		5/75 (6.7%)
Fever (axillary temperature >= 38.0°C)	19/309 (6.1%)		3/107 (2.8%)		1/75 (1.3%)
Infections and infestations
Nasopharyngitis	29/607 (4.8%)		18/231 (7.8%)		10/155 (6.5%)
Respiratory, thoracic and mediastinal disorders
Cough	36/607 (5.9%)		17/231 (7.4%)		9/155 (5.8%)
Rhinorrhoea	27/607 (4.4%)		13/231 (5.6%)		3/155 (1.9%)

Limitations/Caveats

[Not Specified]

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