Safety and Immunogenicity of H1N1 Vaccines in Children Aged 6 Months to Less Than 9 Years of Age

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00976820
• Collaborator: (none)
• Enrollment: 323
• Locations: 30
• Arms: 4
• Actual Duration (Months): 17
• Patients Per Site: 10.8
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The purpose of this study is to characterize the safety and immune response of the H1N1 (swine) flu vaccines GSK2340274A and GSK2340273A in children 6 months to less than 9 years of age.

This Protocol Posting has been updated following the Protocol amendment 1 & 2, September and October 2009. The sections impacted are study design, objectives and analysis methods.

Condition or Disease	Intervention/Treatment	Phase
Influenza	Biological: GSK2340274A; Biological: GSK2340273A	Phase 2

Detailed Description

Collaborators: United States Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority

Study Design

• Study Type: Interventional
• Actual Enrollment: 323 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Study to Evaluate the Safety and Immunogenicity of A/California/7/2009 (H1N1)V-like Vaccines GSK2340274A and GSK2340273A in Children 6 Months to Less Than 9 Years of Age
• Actual Study Start Date: Oct 20, 2009
• Actual Primary Completion Date: Mar 21, 2011
• Actual Study Completion Date: Mar 21, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arepanrix/F1 Group Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh [for children under (<) 12 months of age]. The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Biological: GSK2340274A; Two intramuscular injections
Experimental: Arepanrix/F2 Group Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Biological: GSK2340274A; Two intramuscular injections
Experimental: GSK2340273A/F1 Group Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Biological: GSK2340273A; Two intramuscular injections
Experimental: GSK2340273A/F2 Group Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Biological: GSK2340273A; Two intramuscular injections

Outcome Measures

Primary Outcome Measures

1. Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis [At Day 21]

   A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer lower than (<) 10 and a post-vaccination reciprocal HI titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.

2. Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis [At Day 21]

   A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.

3. Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis [At Day 21]

   A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.

4. Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis [At Day 42]

   A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.

5. Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis [At Day 42]

   A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.

6. Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis [At Day 0]

   A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.

7. Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis [At Day 21]

   A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.

8. Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis [At Day 0]

   A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.

9. Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis [At Day 21]

   A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.

10. Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis [At Day 0]

    A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.

11. Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis [At Day 21]

    A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.

12. Number of Seroprotected Subjects Against Flu A/CAL/7/09 Strain - First Analysis [At Day 0]

    A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.

13. Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis [At Day 42]

    A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.

14. Number of Seroprotected Subjects Against Flu A/CAL/7/09 Strain - Second Analysis [At Day 0]

    A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.

15. Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis [At Day 42]

    A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.

16. Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis [At Day 21]

    SCF 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.

17. Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - First Analysis [At Day 21]

    SCF 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.

18. Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Second Analysis [At Day 21]

    SCF 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.

19. Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - First Analysis [At Day 42]

    SCF 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.

20. Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Second Analysis [At Day 42]

    SCF 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.

Secondary Outcome Measures

1. Number of Seropositive Subjects for HI Antibodies - Preliminary Analysis [At Day 0 (PRE) and at Day 21]

   A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.

2. Number of Seropositive Subjects for HI Antibodies - First Analysis [At Day 0 (PRE) and at Day 21]

   A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.

3. Number of Seropositive Subjects for HI Antibodies - Second Analysis [At Day 0 (PRE) and at Day 21]

   A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.

4. Number of Seropositive Subjects for HI Antibodies - First Analysis [At Day 0 (PRE) and at Day 42]

   A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.

5. Number of Seropositive Subjects for HI Antibodies - Second Analysis [At Day 0 (PRE) and at Day 42]

   A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.

6. Number of Seropositive Subjects for HI Antibodies [At Day 0 (PRE) and at Day 182]

   A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.

7. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis [At Day 0 (PRE) and at Day 21]

   Titers are presented as geometric mean titers (GMTs) and measured in titers.

8. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - First Analysis [At Day 0 (PRE) and at Day 21]

   Titers are presented as geometric mean titers (GMTs) and measured in titers.

9. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Second Analysis [At Day 0 (PRE) and at Day 21]

   Titers are presented as geometric mean titers (GMTs) and measured in titers.

10. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - First Analysis [At Day 0 (PRE) and at Day 42]

    Titers are presented as geometric mean titers (GMTs) and measured in titers.

11. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Second Analysis [At Day 0 (PRE) and at Day 42]

    Titers are presented as geometric mean titers (GMTs) and measured in titers.

12. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain [At Day 0 (PRE) and at Day 182]

    Titers are presented as geometric mean titers (GMTs) and measured in titers.

13. Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain [At Day 182]

    A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer lower than (<) 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.

14. Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain [At Day 0 (PRE) and at Day 182]

    A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.

15. Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain [At Day 182]

    SCF 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.

16. Number of Seropositive Subjects for Neutralizing Antibodies Against Flu A/Neth/602/09 Influenza Strain [At Day 0 (PRE) and at Day 21]

    A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:8. The vaccine strain assessed was Flu A/Neth/602/09 H1N1.

17. Titers for Neutralizing Antibodies Against the Flu A/Neth/602/09 Influenza Strain [At Day 0 (PRE) and at Day 21]

    Titers are presented as geometric mean titers (GMTs) and measured in titers.

18. Number of Seropositive Subjects for Neutralizing Antibodies Against Flu A/Neth/602/09 Influenza Strain [At Day 0 (PRE) and at Day 42]

    A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:8. The vaccine strain assessed was Flu A/Neth/602/09 H1N1.

19. Titers for Neutralizing Antibodies Against the Flu A/Neth/602/09 Influenza Strain [At Day 0 (PRE) and at Day 42]

    Titers are presented as geometric mean titers (GMTs) and measured in titers.

20. Number of Subjects With Vaccine Responses for Neutralizing Antibody Concentrations [At Day 0 (PRE) and at Day 21]

    Vaccine responses are defined as the incidence rate of vaccinated subjects with at least a 4-fold increase in post vaccination reciprocal titer relative to that prior to first vaccination. The vaccine strain assessed was Flu A/Neth/602/09 H1N1.

21. Number of Subjects With Vaccine Responses for Neutralizing Antibody Concentrations [At Day 0 (PRE) and at Day 42]

    Vaccine response was defined as at least a 4-fold increase in post vaccination reciprocal titer relative to that prior to first vaccination. The vaccine strain assessed was Flu A/Neth/602/09.

22. Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Preliminary Analysis [During the 7-day (Days 0-6) post-vaccination period]

    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

23. Number of Subjects With Any and Grade 3 Solicited Local Symptoms - First Analysis [During the 7-day (Days 0-6) post-vaccination period following each dose and across doses]

    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

24. Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Second Analysis [During the 7-day (Days 0-6) post-vaccination period following each dose and across doses]

    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

25. Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis [During the 7-day (Days 0-6) post-vaccination period]

    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 loss of appetite= not eating at all. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

26. Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis [During the 7-day (Days 0-6) post-vaccination period]

    Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating, temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

27. Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis [During the 7-day (Days 0-6) post-vaccination period following each dose and across doses]

    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

28. Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis [During the 7-day (Days 0-6) post-vaccination period following each dose and across doses]

    Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, and shivering, sweating, temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (° C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

29. Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis [During the 7-day (Days 0-6) post-vaccination period following each dose and across doses]

    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

30. Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis [During the 7-day (Days 0-6) post-vaccination period following each dose and across doses]

    Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

31. Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis [At Day 0 (PRE), at Day 7 and at Day 21]

    Among haematological parameters assessed were basophils [BAS], eosinophils [EOS], hematocrit [HCT], hemoglobin level [HGB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelet count [PLC], red blood cells [RBC] and white blood cells [WBC]. Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.

32. Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis [At Day 0 (PRE), at Day 7 and at Day 21]

    Biochemical parameters assessed for lab abnormalities were alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin [BLR], bilirubin conjugated/direct [BCD], creatinine [CRE] and blood urea nitrogen [BUN]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.

33. Number of Subjects With Haematological Laboratory Abnormalities - First Analysis [At Day 0 (PRE), at Day 7, at Day 21 and at Day 42]

    Among haematological parameters assessed were basophils [BAS], eosinophils [EOS], hematocrit [HCT], hemoglobin level [HGB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelet count [PLC], red blood cells [RBC] and white blood cells [WBC]. Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.

34. Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis [At Day 0 (PRE), at Day 7, at Day 21 and at Day 42]

    Biochemical parameters assessed for lab abnormalities were alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin [BLR], bilirubin conjugated/direct [BCD], creatinine [CRE] and blood urea nitrogen [BUN]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.

35. Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis [At Day 0 (PRE), at Day 7 and at Day 21]

    Among haematological parameters assessed were basophils [BAS], eosinophils [EOS], hematocrit [HCT], hemoglobin level [HGB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelet count [PLC], red blood cells [RBC] and white blood cells [WBC], Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.

36. Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis [At Day 0 (PRE), at Day 7, at Day 21 and at Day 42]

    Biochemical parameters assessed for lab abnormalities were alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin [BLR], bilirubin conjugated/direct [BCD], creatinine [CRE] and blood urea nitrogen [BUN]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.

37. Number of Subjects With Haematological Laboratory Abnormalities [At Day 182]

    Among haematological parameters assessed were basophils [BAS], eosinophils [EOS], hematocrit [HCT], hemoglobin level [HGB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelet count [PLC], red blood cells [RBC] and white blood cells [WBC]. Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.

38. Number of Subjects With Biochemical Laboratory Abnormalities [At Day 182]

    Biochemical parameters assessed for lab abnormalities were alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin [BLR], bilirubin conjugated/direct [BCD], creatinine [CRE] and blood urea nitrogen [BUN]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.

39. Number of Subjects With Any Unsolicited Adverse Events (AEs) - Preliminary Analysis [Within 21 days (Days 0-20) post vaccination]

    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

40. Number of Subjects With Any Unsolicited Adverse Events (AEs) - First Analysis [Within 42 days (Days 0-41) post vaccination]

    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

41. Number of Subjects With Any Unsolicited Adverse Events (AEs) - Second Analysis [Within 41 days (Days 0-40) post vaccination]

    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

42. Number of Subjects With Any Unsolicited Adverse Events (AEs) [Within 84 days (Days 0-83) post vaccination]

    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

43. Number of Subjects With Any Medically-attended Adverse Events (MAEs) - Preliminary Analysis [Within 21 days (Days 0-20) post vaccination]

    MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

44. Number of Subjects With Any Medically-attended Adverse Events (MAEs) - First Analysis [Within 41 days (Days 0-40) post vaccination]

    MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

45. Number of Subjects With Any Medically-attended Adverse Events (MAEs) - Second Analysis [Within 42 days (Days 0-41) post vaccination]

    MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

46. Number of Subjects With Any Medically-attended Adverse Events (MAEs) [Within 182 days (Days 0-181) post vaccination]

    MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

47. Number of Subjects With Any Medically-attended Adverse Events (MAEs) [Throughout the entire study period (Day 0 - Day 385)]

    MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

48. Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) - Preliminary Analysis [Within 21 days (Days 0-20) post vaccination]

    Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

49. Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) - First Analysis [Within 42 days (Days 0-41) post vaccination]

    Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

50. Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) - Second Analysis [Within 42 days (Days 0-41) post vaccination]

    Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

51. Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) [Within 182 days (Days 0-181) post vaccination]

    Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

52. Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) [Throughout the entire study period (Day 0 - Day 385)]

    Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

53. Number of Subjects With Serious Adverse Events (SAEs) - Preliminary Analysis [Within 21 days (Days 0-20) post vaccination]

    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

54. Number of Subjects With Serious Adverse Events (SAEs) - First Analysis [Within 42 days (Days 0-41) post vaccination]

    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

55. Number of Subjects With Serious Adverse Events (SAEs) - Second Analysis [Within 42 days (Day 0-41) post vaccination]

    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

56. Number of Subjects With Serious Adverse Events (SAEs) [Within 182 days (Days 0-181) post vaccination]

    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

57. Number of Subjects With Serious Adverse Events (SAEs) [Throughout the entire study period (Day 0 - Day 385)]

    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 8 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Male or female children 6 months to less than 9 years of age at the time of the first vaccination.

• Written informed consent obtained from the subject's parent/ legally acceptable representative (LAR); written informed assent obtained from the subject if appropriate.

• Good general health as established by medical history and clinical examination before entering into the study.

• Safety laboratory test results within the parameters specified in the protocol.

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

• Subjects who the investigator believes that their parent(s)/ LAR can and will comply with the requirements of the protocol.

• Female subjects of non-childbearing potential (pre-menarche) may be enrolled in the study.

Exclusion Criteria:

• Previous vaccination with an H1N1v-like virus vaccine or a medical history of physician-confirmed infection with an H1N1v-like virus.

• Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject or parent(s)/ LAR(s) unable/unlikely to provide accurate safety reports.

• Presence of a temperature >= 38.0ºC (>=100.4ºF) by any route or method, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.

• 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 study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed.

• Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.

• Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin are eligible if no such doses are given in the 24 hours before a study vaccination. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.

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

• Administration of any licensed vaccine within 4 weeks before the first dose of study vaccine, with the exception of seasonal influenza vaccine.

• Planned administration of any vaccine not foreseen by the study protocol between Day 0 and the Day 42 phlebotomy, including seasonal influenza vaccine. Routine childhood vaccinations are exempted if they cannot be delayed, but they must not be administered on the same day as the H1N1 vaccine candidate.

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

• Any known or suspected allergy to any constituent of influenza vaccines a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.

• Child in care.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Conway	Arkansas	United States	72034
2	GSK Investigational Site	Little Rock	Arkansas	United States	72202
3	GSK Investigational Site	Frisco	California	United States	94102
4	GSK Investigational Site	Sacramento	California	United States	95816
5	GSK Investigational Site	Arkansas City	Kansas	United States	67005
6	GSK Investigational Site	Wichita	Kansas	United States	67205
7	GSK Investigational Site	Bardstown	Kentucky	United States	40004
8	GSK Investigational Site	Metairie	Louisiana	United States	70006
9	GSK Investigational Site	Saint Paul	Minnesota	United States	55108
10	GSK Investigational Site	Omaha	Nebraska	United States	68134
11	GSK Investigational Site	Cleveland	Ohio	United States	44121
12	GSK Investigational Site	Kingsport	Tennessee	United States	37660
13	GSK Investigational Site	Austin	Texas	United States	78705
14	GSK Investigational Site	Fort Worth	Texas	United States	76135
15	GSK Investigational Site	San Angelo	Texas	United States	76904
16	GSK Investigational Site	Orem	Utah	United States	84057
17	GSK Investigational Site	S. Jordan	Utah	United States	84095
18	GSK Investigational Site	Coquitlam	British Columbia	Canada	V3K 3P4
19	GSK Investigational Site	Winnipeg	Manitoba	Canada	R3A 1M3
20	GSK Investigational Site	Saint John's	Newfoundland and Labrador	Canada	A1A 3R5
21	GSK Investigational Site	Halifax	Nova Scotia	Canada	B3K 6R8
22	GSK Investigational Site	Brampton	Ontario	Canada	L6T 0G1
23	GSK Investigational Site	Hamilton	Ontario	Canada	L8L 5G8
24	GSK Investigational Site	Newmarket	Ontario	Canada	L3Y 5G8
25	GSK Investigational Site	Sudbury	Ontario	Canada	P3E 1H5
26	GSK Investigational Site	Toronto	Ontario	Canada	M5G 1N8
27	GSK Investigational Site	Toronto	Ontario	Canada	M9V 4B4
28	GSK Investigational Site	Montreal	Quebec	Canada	H3T 1C5
29	GSK Investigational Site	Quebec City	Quebec	Canada	G1V 4T3
30	GSK Investigational Site	Sherbrooke	Quebec	Canada	J1H 1Z1

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

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00976820
• Other Study ID Numbers: 113482
• First Posted: Sep 14, 2009
• Last Update Posted: Dec 12, 2017
• Last Verified: Jul 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: influenza infection; Influenza Vaccines; GSK Bio's influenza vaccine GSK2340273A; GSK Bio's influenza vaccine GSK2340274A
• Additional relevant MeSH terms: Influenza, Human

Study Results

Participant Flow

Pre-assignment Detail	Out of the 323 subjects originally enrolled in the study, 1 subject was not included in the Total Vaccinated Cohort.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh [for children under (<) 12 months of age]. The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Period Title: Overall Study
STARTED	67	128	64	63
COMPLETED	59	108	60	56
NOT COMPLETED	8	20	4	7

Baseline Characteristics

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group	Total
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Total of all reporting groups
Overall Participants	67	128	64	63	322
Age (Months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Months]	53.6 (31.6)	47.4 (28.6)	50.3 (29.0)	54.4 (30.4)	50.6 (29.7)
Sex: Female, Male (Count of Participants)
Female	27 40.3%	58 45.3%	33 51.6%	30 47.6%	148 46%
Male	40 59.7%	70 54.7%	31 48.4%	33 52.4%	174 54%
Race/Ethnicity, Customized (Count of Participants)
African heritage/African American	1 1.5%	7 5.5%	1 1.6%	1 1.6%	10 3.1%
American Indian or Alaskan native	1 1.5%	6 4.7%	1 1.6%	2 3.2%	10 3.1%
Asian - Central/South Asian heritage	14 20.9%	16 12.5%	16 25%	14 22.2%	60 18.6%
Asian - East Asian heritage	2 3%	4 3.1%	0 0%	2 3.2%	8 2.5%
Asian - South East Asian heritage	3 4.5%	1 0.8%	2 3.1%	2 3.2%	8 2.5%
White - Arabic/North African heritage	0 0%	3 2.3%	0 0%	1 1.6%	4 1.2%
White - Caucasian/European heritage	46 68.7%	86 67.2%	44 68.8%	38 60.3%	214 66.5%
Not specified	0 0%	5 3.9%	0 0%	3 4.8%	8 2.5%

Outcome Measures

1. Primary Outcome

Title	Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
Description	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer lower than (<) 10 and a post-vaccination reciprocal HI titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Time Frame	At Day 21

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	63	55	58	60
Count of Participants [Participants]	60 89.6%	53 41.4%	45 70.3%	36 57.1%

2. Primary Outcome

Title	Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
Description	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Time Frame	At Day 21

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	57	47	55	57
Count of Participants [Participants]	54 80.6%	45 35.2%	41 64.1%	34 54%

3. Primary Outcome

Title	Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
Description	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Time Frame	At Day 21

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	59	101	54	57
Count of Participants [Participants]	56 83.6%	98 76.6%	41 64.1%	34 54%

4. Primary Outcome

Title	Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
Description	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Time Frame	At Day 42

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	43	40	46	44
Count of Participants [Participants]	43 64.2%	39 30.5%	46 71.9%	38 60.3%

5. Primary Outcome

Title	Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
Description	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Time Frame	At Day 42

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	44	84	46	44
Count of Participants [Participants]	44 65.7%	83 64.8%	46 71.9%	38 60.3%

6. Primary Outcome

Title	Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
Description	A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time Frame	At Day 0

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort at Day 21, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	66	59	61	62
Count of Participants [Participants]	13 19.4%	3 2.3%	12 18.8%	15 23.8%

7. Primary Outcome

Title	Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
Description	A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time Frame	At Day 21

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort at Day 21, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	63	56	59	60
Count of Participants [Participants]	62 92.5%	55 43%	46 71.9%	39 61.9%

8. Primary Outcome

Title	Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
Description	A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time Frame	At Day 0

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	57	49	55	58
Count of Participants [Participants]	12 17.9%	2 1.6%	12 18.8%	14 22.2%

9. Primary Outcome

Title	Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
Description	A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time Frame	At Day 21

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	57	49	55	57
Count of Participants [Participants]	56 83.6%	48 37.5%	42 65.6%	37 58.7%

10. Primary Outcome

Title	Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
Description	A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time Frame	At Day 0

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	59	102	54	58
Count of Participants [Participants]	12 17.9%	24 18.8%	12 18.8%	14 22.2%

11. Primary Outcome

Title	Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
Description	A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time Frame	At Day 21

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	59	103	54	57
Count of Participants [Participants]	58 86.6%	102 79.7%	42 65.6%	37 58.7%

12. Primary Outcome

Title	Number of Seroprotected Subjects Against Flu A/CAL/7/09 Strain - First Analysis
Description	A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time Frame	At Day 0

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	43	40	46	44
Count of Participants [Participants]	8 11.9%	1 0.8%	9 14.1%	9 14.3%

13. Primary Outcome

Title	Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
Description	A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time Frame	At Day 42

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	43	42	46	44
Count of Participants [Participants]	43 64.2%	42 32.8%	46 71.9%	41 65.1%

14. Primary Outcome

Title	Number of Seroprotected Subjects Against Flu A/CAL/7/09 Strain - Second Analysis
Description	A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time Frame	At Day 0

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	44	84	46	44
Count of Participants [Participants]	8 11.9%	20 15.6%	9 14.1%	9 14.3%

15. Primary Outcome

Title	Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
Description	A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time Frame	At Day 42

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	44	87	46	44
Count of Participants [Participants]	44 65.7%	87 68%	46 71.9%	41 65.1%

16. Primary Outcome

Title	Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
Description	SCF 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 21

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	63	55	58	60
Geometric Mean (95% Confidence Interval) [Fold change]	38.6	39.2	14.4	7.8

17. Primary Outcome

Title	Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - First Analysis
Description	SCF 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 21

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	57	47	55	57
Geometric Mean (95% Confidence Interval) [Fold change]	35.9	40.8	13.2	7.6

18. Primary Outcome

Title	Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
Description	SCF 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 21

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	59	101	54	57
Geometric Mean (95% Confidence Interval) [Fold change]	36.2	33.6	13.8	7.6

19. Primary Outcome

Title	Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - First Analysis
Description	SCF 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 42

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	43	40	46	44
Geometric Mean (95% Confidence Interval) [Fold change]	155.3	217.2	44.2	24.1

20. Primary Outcome

Title	Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
Description	SCF 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 42

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	44	84	46	44
Geometric Mean (95% Confidence Interval) [Fold change]	157.1	151.6	44.2	24.1

21. Secondary Outcome

Title	Number of Seropositive Subjects for HI Antibodies - Preliminary Analysis
Description	A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.
Time Frame	At Day 0 (PRE) and at Day 21

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	66	59	61	62
Flu A/CAL/7/09, PRE	17 25.4%	4 3.1%	13 20.3%	15 23.8%
Flu A/CAL/7/09, D21	63 94%	56 43.8%	57 89.1%	56 88.9%

22. Secondary Outcome

Title	Number of Seropositive Subjects for HI Antibodies - First Analysis
Description	A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.
Time Frame	At Day 0 (PRE) and at Day 21

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	57	49	55	58
Flu A/CAL/7/09, PRE	15 22.4%	3 2.3%	13 20.3%	14 22.2%
Flu A/CAL/7/09, D21	57 85.1%	49 38.3%	53 82.8%	54 85.7%

23. Secondary Outcome

Title	Number of Seropositive Subjects for HI Antibodies - Second Analysis
Description	A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.
Time Frame	At Day 0 (PRE) and at Day 21

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	59	103	54	58
Flu A/CAL/7/09, PRE	15 22.4%	27 21.1%	13 20.3%	14 22.2%
Flu A/CAL/7/09, D21	59 88.1%	103 80.5%	53 82.8%	54 85.7%

24. Secondary Outcome

Title	Number of Seropositive Subjects for HI Antibodies - First Analysis
Description	A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.
Time Frame	At Day 0 (PRE) and at Day 42

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	43	42	46	44
Flu A/CAL/7/09, PRE	10 14.9%	2 1.6%	10 15.6%	9 14.3%
Flu A/CAL/7/09, D42	43 64.2%	42 32.8%	46 71.9%	44 69.8%

25. Secondary Outcome

Title	Number of Seropositive Subjects for HI Antibodies - Second Analysis
Description	A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.
Time Frame	At Day 0 (PRE) and at Day 42

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	44	87	46	44
Flu A/CAL/7/09, PRE	10 14.9%	23 18%	10 15.6%	9 14.3%
Flu A/CAL/7/09, D42	44 65.7%	87 68%	46 71.9%	44 69.8%

26. Secondary Outcome

Title	Number of Seropositive Subjects for HI Antibodies
Description	A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.
Time Frame	At Day 0 (PRE) and at Day 182

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 182, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	54	84	47	52
Flu A/CAL/7/09, PRE	13 19.4%	18 14.1%	13 20.3%	12 19%
Flu A/CAL/7/09, D182	54 80.6%	84 65.6%	45 70.3%	50 79.4%

27. Secondary Outcome

Title	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
Description	Titers are presented as geometric mean titers (GMTs) and measured in titers.
Time Frame	At Day 0 (PRE) and at Day 21

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	66	59	61	62
Flu A/CAL/7/09, PRE	10.3	6.2	9.8	10.9
Flu A/CAL/7/09, D21	387.9	253.0	141.4	82.7

28. Secondary Outcome

Title	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - First Analysis
Description	Titers are presented as geometric mean titers (GMTs) and measured in titers.
Time Frame	At Day 0 (PRE) and at Day 21

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	57	49	55	58
Flu A/CAL/7/09, PRE	10.8	6.1	10.5	10.9
Flu A/CAL/7/09, D21	386.4	270.1	138.4	83.4

29. Secondary Outcome

Title	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Second Analysis
Description	Titers are presented as geometric mean titers (GMTs) and measured in titers.
Time Frame	At Day 0 (PRE) and at Day 21

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	59	103	54	58
Flu A/CAL/7/09, PRE	10.5	10.8	10.7	10.9
Flu A/CAL/7/09, D21	379.4	377.3	147.2	83.4

30. Secondary Outcome

Title	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - First Analysis
Description	Titers are presented as geometric mean titers (GMTs) and measured in titers.
Time Frame	At Day 0 (PRE) and at Day 42

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	43	42	46	44
Flu A/CAL/7/09, PRE	9.3	5.7	9.3	9.5
Flu A/CAL/7/09, D42	1444.4	1238.5	413.5	228.0

31. Secondary Outcome

Title	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Second Analysis
Description	Titers are presented as geometric mean titers (GMTs) and measured in titers.
Time Frame	At Day 0 (PRE) and at Day 42

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	44	87	46	44
Flu A/CAL/7/09, PRE	9.2	11.1	9.3	9.5
Flu A/CAL/7/09, D42	1440.5	1671.6	413.5	228.0

32. Secondary Outcome

Title	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain
Description	Titers are presented as geometric mean titers (GMTs) and measured in titers.
Time Frame	At Day 0 (PRE) and at Day 182

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 182, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	54	84	47	52
Flu A/CAL/7/09, PRE	9.6	10.0	11.9	10.6
Flu A/CAL/7/09, D182	296.2	267.9	122.7	82.8

33. Secondary Outcome

Title	Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain
Description	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer lower than (<) 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Time Frame	At Day 182

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 182, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	54	82	47	52
Count of Participants [Participants]	50 74.6%	78 60.9%	35 54.7%	34 54%

34. Secondary Outcome

Title	Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain
Description	A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Time Frame	At Day 0 (PRE) and at Day 182

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 182, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	54	84	47	52
Flu A/CAL/7/09, PRE	10 14.9%	16 12.5%	12 18.8%	12 19%
Flu A/CAL/7/09, D182	53 79.1%	84 65.6%	43 67.2%	43 68.3%

35. Secondary Outcome

Title	Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain
Description	SCF 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 182

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 182, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	54	82	47	52
Geometric Mean (95% Confidence Interval) [Fold change]	31.0	26.6	10.3	7.8

36. Secondary Outcome

Title	Number of Seropositive Subjects for Neutralizing Antibodies Against Flu A/Neth/602/09 Influenza Strain
Description	A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:8. The vaccine strain assessed was Flu A/Neth/602/09 H1N1.
Time Frame	At Day 0 (PRE) and at Day 21

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	52	84	44	55
Flu A/Neth/602/09, PRE	25 37.3%	30 23.4%	17 26.6%	20 31.7%
Flu A/Neth/602/09, D21	51 76.1%	82 64.1%	39 60.9%	35 55.6%

37. Secondary Outcome

Title	Titers for Neutralizing Antibodies Against the Flu A/Neth/602/09 Influenza Strain
Description	Titers are presented as geometric mean titers (GMTs) and measured in titers.
Time Frame	At Day 0 (PRE) and at Day 21

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	52	84	44	55
Flu A/Neth/602/09, PRE	19.3	13.8	15.0	15.3
Flu A/Neth/602/09, D21	427.6	296.1	231.1	138.3

38. Secondary Outcome

Title	Number of Seropositive Subjects for Neutralizing Antibodies Against Flu A/Neth/602/09 Influenza Strain
Description	A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:8. The vaccine strain assessed was Flu A/Neth/602/09 H1N1.
Time Frame	At Day 0 (PRE) and at Day 42

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	40	68	36	42
Flu A/Neth/602/09, PRE	18 26.9%	26 20.3%	13 20.3%	13 20.6%
Flu A/Neth/602/09, D42	34 50.7%	63 49.2%	35 54.7%	33 52.4%

39. Secondary Outcome

Title	Titers for Neutralizing Antibodies Against the Flu A/Neth/602/09 Influenza Strain
Description	Titers are presented as geometric mean titers (GMTs) and measured in titers.
Time Frame	At Day 0 (PRE) and at Day 42

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	40	68	36	42
Flu A/Neth/602/09, PRE	16.7	15.0	12.0	13.6
Flu A/Neth/602/09, D42	1389.3	1786.9	428.4	146.1

40. Secondary Outcome

Title	Number of Subjects With Vaccine Responses for Neutralizing Antibody Concentrations
Description	Vaccine responses are defined as the incidence rate of vaccinated subjects with at least a 4-fold increase in post vaccination reciprocal titer relative to that prior to first vaccination. The vaccine strain assessed was Flu A/Neth/602/09 H1N1.
Time Frame	At Day 0 (PRE) and at Day 21

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	45	70	37	43
Count of Participants [Participants]	41 61.2%	57 44.5%	27 42.2%	24 38.1%

41. Secondary Outcome

Title	Number of Subjects With Vaccine Responses for Neutralizing Antibody Concentrations
Description	Vaccine response was defined as at least a 4-fold increase in post vaccination reciprocal titer relative to that prior to first vaccination. The vaccine strain assessed was Flu A/Neth/602/09.
Time Frame	At Day 0 (PRE) and at Day 42

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	32	54	30	34
Count of Participants [Participants]	31 46.3%	54 42.2%	26 40.6%	23 36.5%

42. Secondary Outcome

Title	Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Preliminary Analysis
Description	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time Frame	During the 7-day (Days 0-6) post-vaccination period

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 6M-5Y Group	Arepanrix/F1 6Y-9Y Group	Arepanrix/F2 6M-5Y Group	Arepanrix/F2 6Y-9Y Group	GSK2340273A/F1 6M-5Y Group	GSK2340273A/F1 6Y-9Y Group	GSK2340273A/F2 6M-5Y Group	GSK2340273A/F2 6Y-9Y Group
Arm/Group Description	Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	47	18	48	12	45	17	44	18
Any Pain	27 40.3%	14 10.9%	26 40.6%	9 14.3%	18 5.6%	12 NaN	15 NaN	10 NaN
Grade 3 Pain	4 6%	1 0.8%	0 0%	0 0%	0 0%	1 NaN	0 NaN	0 NaN
Any Redness	5 7.5%	4 3.1%	4 6.3%	2 3.2%	1 0.3%	0 NaN	1 NaN	1 NaN
Grade 3 Redness	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN
Any Swelling	1 1.5%	2 1.6%	1 1.6%	1 1.6%	1 0.3%	0 NaN	1 NaN	0 NaN
Grade 3 Swelling	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN

43. Secondary Outcome

Title	Number of Subjects With Any and Grade 3 Solicited Local Symptoms - First Analysis
Description	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time Frame	During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 6M-5Y Group	Arepanrix/F1 6Y-9Y Group	Arepanrix/F1 Out Group	Arepanrix/F2 6M-5Y Group	Arepanrix/F2 6Y-9Y Group	GSK2340273A/F1 6M-5Y Group	GSK2340273A/F1 6Y-9Y Group	GSK2340273A/F2 6M-5Y Group	GSK2340273A/F2 6Y-9Y Group
Arm/Group Description	Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, out of age interval, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	47	18	1	49	12	46	17	44	18
Any Pain, Dose 1	27 40.3%	14 10.9%	1 1.6%	26 41.3%	9 2.8%	19 NaN	12 NaN	15 NaN	10 NaN
Grade 3 Pain, Dose 1	4 6%	1 0.8%	0 0%	0 0%	0 0%	1 NaN	1 NaN	0 NaN	0 NaN
Any Redness, Dose 1	5 7.5%	4 3.1%	0 0%	4 6.3%	2 0.6%	1 NaN	0 NaN	1 NaN	1 NaN
Grade 3 Redness, Dose 1	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN
Any Swelling, Dose 1	1 1.5%	2 1.6%	0 0%	1 1.6%	1 0.3%	1 NaN	0 NaN	1 NaN	0 NaN
Grade 3 Swelling, Dose 1	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN
Any Pain, Dose 2	22 32.8%	13 10.2%	0 0%	25 39.7%	7 2.2%	11 NaN	8 NaN	9 NaN	7 NaN
Grade 3 Pain, Dose 2	4 6%	0 0%	0 0%	1 1.6%	2 0.6%	0 NaN	0 NaN	0 NaN	1 NaN
Any Redness, Dose 2	5 7.5%	1 0.8%	0 0%	3 4.8%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN
Grade 3 Redness, Dose 2	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN
Any Swelling, Dose 2	1 1.5%	1 0.8%	0 0%	2 3.2%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN
Grade 3 Swelling, Dose 2	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN
Any Pain, Across doses	35 52.2%	15 11.7%	1 1.6%	33 52.4%	9 2.8%	22 NaN	12 NaN	18 NaN	12 NaN
Grade 3 Pain, Across doses	7 10.4%	1 0.8%	0 0%	1 1.6%	2 0.6%	1 NaN	1 NaN	0 NaN	1 NaN
Any Redness, Across doses	7 10.4%	4 3.1%	0 0%	6 9.5%	2 0.6%	1 NaN	0 NaN	1 NaN	1 NaN
Grade 3 Redness, Across doses	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN
Any Swelling, Across doses	2 3%	2 1.6%	0 0%	3 4.8%	1 0.3%	1 NaN	0 NaN	1 NaN	0 NaN
Grade 3 Swelling, Across doses	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN

44. Secondary Outcome

Title	Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Second Analysis
Description	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time Frame	During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 6M-35M Group	Arepanrix/F1 3Y-5Y Group	Arepanrix/F1 6Y-9Y Group	Arepanrix/F1 Out Group	Arepanrix/F2 6M-35M Group	Arepanrix/F2 3Y-5Y Group	Arepanrix/F2 6Y-9Y Group	GSK2340273A/F1 6M-35M Group	GSK2340273A/F1 3Y-5Y Group	GSK2340273A/F1 6Y-9Y Group	GSK2340273A/F2 6M-35M Group	GSK2340273A/F2 3Y-6Y Group	GSK2340273A/F2 6Y-9Y Group
Arm/Group Description	Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 3 years (Y) - 5 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, out of age interval, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 3 years (Y) - 5 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 3 years (Y) - 5 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	22	25	18	1	46	53	26	24	22	17	23	21	18
Any Pain, Dose 1	12 17.9%	15 11.7%	14 21.9%	1 1.6%	20 6.2%	34 NaN	22 NaN	10 NaN	9 NaN	12 NaN	8 NaN	7 NaN	10 NaN
Grade 3 Pain, Dose 1	2 3%	2 1.6%	1 1.6%	0 0%	1 0.3%	3 NaN	2 NaN	1 NaN	0 NaN	1 NaN	0 NaN	0 NaN	0 NaN
Any Redness, Dose 1	2 3%	3 2.3%	4 6.3%	0 0%	4 1.2%	4 NaN	2 NaN	1 NaN	0 NaN	0 NaN	0 NaN	1 NaN	1 NaN
Grade 3 Redness, Dose 1	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Any Swelling, Dose 1	0 0%	1 0.8%	2 3.1%	0 0%	3 0.9%	2 NaN	1 NaN	1 NaN	0 NaN	0 NaN	0 NaN	1 NaN	0 NaN
Grade 3 Swelling, Dose 1	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Any Pain, Dose 2	12 17.9%	10 7.8%	13 20.3%	0 0%	18 5.6%	35 NaN	19 NaN	5 NaN	6 NaN	8 NaN	4 NaN	5 NaN	7 NaN
Grade 3 Pain, Dose 2	3 4.5%	1 0.8%	0 0%	0 0%	3 0.9%	2 NaN	3 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	1 NaN
Any Redness, Dose 2	2 3%	3 2.3%	1 1.6%	0 0%	1 0.3%	2 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Grade 3 Redness, Dose 2	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Any Swelling, Dose 2	0 0%	1 0.8%	1 1.6%	0 0%	1 0.3%	3 NaN	2 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Grade 3 Swelling, Dose 2	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Any Pain, Across Doses	16 23.9%	19 14.8%	15 23.4%	1 1.6%	25 7.8%	44 NaN	22 NaN	11 NaN	11 NaN	12 NaN	9 NaN	9 NaN	12 NaN
Grade 3 Pain, Across Doses	4 6%	3 2.3%	1 1.6%	0 0%	3 0.9%	5 NaN	5 NaN	1 NaN	0 NaN	1 NaN	0 NaN	0 NaN	1 NaN
Any Redness, Across Doses	3 4.5%	4 3.1%	4 6.3%	0 0%	5 1.6%	5 NaN	2 NaN	1 NaN	0 NaN	0 NaN	0 NaN	1 NaN	1 NaN
Grade 3 Redness, Across Doses	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Any Swelling, Across Doses	0 0%	2 1.6%	2 3.1%	0 0%	4 1.2%	4 NaN	3 NaN	1 NaN	0 NaN	0 NaN	0 NaN	1 NaN	0 NaN
Grade 3 Swelling, Across Doses	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN

45. Secondary Outcome

Title	Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Description	Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 loss of appetite= not eating at all. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame	During the 7-day (Days 0-6) post-vaccination period

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 6M-5Y Group	Arepanrix/F2 6M-5Y Group	GSK2340273A/F1 6M-5Y Group	GSK2340273A/F2 6M-5Y Group
Arm/Group Description	Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	47	48	45	44
Any Drowsiness	11 16.4%	11 8.6%	8 12.5%	9 14.3%
Grade 3 Drowsiness	2 3%	1 0.8%	0 0%	0 0%
Related Drowsiness	5 7.5%	8 6.3%	5 7.8%	7 11.1%
Any Irritability	22 32.8%	18 14.1%	14 21.9%	8 12.7%
Grade 3 Irritability	3 4.5%	3 2.3%	0 0%	0 0%
Related Irritability	19 28.4%	15 11.7%	12 18.8%	8 12.7%
Any Loss of appetite	16 23.9%	17 13.3%	6 9.4%	9 14.3%
Grade 3 Loss of appetite	1 1.5%	1 0.8%	0 0%	1 1.6%
Related Loss of appetite	9 13.4%	12 9.4%	3 4.7%	8 12.7%
Any Temperature (Axillary)	8 11.9%	6 4.7%	2 3.1%	1 1.6%
Grade 3 Temperature (Axillary)	1 1.5%	0 0%	0 0%	0 0%
Related Temperature (Axillary)	6 9%	3 2.3%	1 1.6%	1 1.6%

46. Secondary Outcome

Title	Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Description	Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating, temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame	During the 7-day (Days 0-6) post-vaccination period

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 6Y-9Y Group	Arepanrix/F2 6Y-9Y Group	GSK2340273A/F1 6Y-9Y Group	GSK2340273A/F2 6Y-9Y Group
Arm/Group Description	Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	18	12	17	18
Any Fatigue	3 4.5%	4 3.1%	4 6.3%	4 6.3%
Grade 3 Fatigue	0 0%	0 0%	1 1.6%	0 0%
Related Fatigue	2 3%	3 2.3%	4 6.3%	3 4.8%
Any Gastro-intestinal symptoms	1 1.5%	2 1.6%	3 4.7%	2 3.2%
Grade 3 Gastro-intestinal symptoms	0 0%	0 0%	0 0%	0 0%
Related Gastro-intestinal symptoms	0 0%	1 0.8%	3 4.7%	0 0%
Any Headache	4 6%	4 3.1%	2 3.1%	2 3.2%
Grade 3 Headache	0 0%	0 0%	0 0%	0 0%
Related Headache	3 4.5%	2 1.6%	1 1.6%	2 3.2%
Any Joint pain at other location	0 0%	0 0%	2 3.1%	1 1.6%
Grade 3 Joint pain at other location	0 0%	0 0%	0 0%	0 0%
Related Joint pain at other location	0 0%	0 0%	2 3.1%	0 0%
Any Muscle aches	4 6%	2 1.6%	3 4.7%	1 1.6%
Grade 3 Muscle aches	0 0%	0 0%	0 0%	0 0%
Related Muscle aches	4 6%	2 1.6%	3 4.7%	1 1.6%
Any Shivering	0 0%	0 0%	1 1.6%	0 0%
Grade 3 Shivering	0 0%	0 0%	0 0%	0 0%
Related Shivering	0 0%	0 0%	1 1.6%	0 0%
Any Sweating	1 1.5%	1 0.8%	2 3.1%	1 1.6%
Grade 3 Sweating	0 0%	0 0%	0 0%	0 0%
Related Sweating	1 1.5%	0 0%	2 3.1%	0 0%
Any Temperature (Axillary)	4 6%	2 1.6%	1 1.6%	0 0%
Grade 3 Temperature (Axillary)	0 0%	0 0%	0 0%	0 0%
Related Temperature (Axillary)	3 4.5%	2 1.6%	1 1.6%	0 0%

47. Secondary Outcome

Title	Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Description	Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame	During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 6M-5Y Group	Arepanrix/F2 6M-5Y Group	GSK2340273A/F1 6M-5Y Group	GSK2340273A/F2 6M-5Y Group
Arm/Group Description	Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	47	49	46	44
Any Drowsiness, Dose 1	11 16.4%	11 8.6%	8 12.5%	9 14.3%
Grade 3 Drowsiness, Dose 1	2 3%	1 0.8%	0 0%	0 0%
Related Drowsiness, Dose 1	5 7.5%	8 6.3%	5 7.8%	7 11.1%
Any Irritability, Dose 1	22 32.8%	18 14.1%	15 23.4%	8 12.7%
Grade 3 Irritability, Dose 1	3 4.5%	3 2.3%	1 1.6%	0 0%
Related Irritability, Dose 1	19 28.4%	15 11.7%	12 18.8%	8 12.7%
Any Loss of appetite, Dose 1	16 23.9%	17 13.3%	6 9.4%	9 14.3%
Grade 3 Loss of appetite, Dose 1	1 1.5%	1 0.8%	0 0%	1 1.6%
Related Loss of appetite, Dose 1	9 13.4%	12 9.4%	3 4.7%	8 12.7%
Any Temperature (Axillary), Dose 1	9 13.4%	6 4.7%	2 3.1%	1 1.6%
Grade 3 Temperature (Axillary), Dose 1	1 1.5%	0 0%	0 0%	0 0%
Related Temperature (Axillary), Dose 1	8 11.9%	3 2.3%	1 1.6%	1 1.6%
Any Drowsiness, Dose 2	13 19.4%	6 4.7%	7 10.9%	7 11.1%
Grade 3 Drowsiness, Dose 2	5 7.5%	0 0%	0 0%	0 0%
Related Drowsiness, Dose 2	9 13.4%	2 1.6%	5 7.8%	7 11.1%
Any Irritability, Dose 2	19 28.4%	12 9.4%	13 20.3%	11 17.5%
Grade 3 Irritability, Dose 2	3 4.5%	1 0.8%	2 3.1%	2 3.2%
Related Irritability, Dose 2	18 26.9%	11 8.6%	12 18.8%	11 17.5%
Any Loss of appetite, Dose 2	18 26.9%	10 7.8%	7 10.9%	5 7.9%
Grade 3 Loss of appetite, Dose 2	1 1.5%	2 1.6%	0 0%	0 0%
Related Loss of appetite, Dose 2	15 22.4%	8 6.3%	5 7.8%	5 7.9%
Any Temperature (Axillary), Dose 2	13 19.4%	7 5.5%	3 4.7%	3 4.8%
Grade 3 Temperature (Axillary), Dose 2	5 7.5%	0 0%	0 0%	0 0%
Related Temperature (Axillary), Dose 2	11 16.4%	6 4.7%	2 3.1%	0 0%
Any Drowsiness, Across doses	17 25.4%	15 11.7%	13 20.3%	14 22.2%
Grade 3 Drowsiness, Across doses	6 9%	1 0.8%	0 0%	0 0%
Related Drowsiness, Across doses	10 14.9%	9 7%	9 14.1%	12 19%
Any Irritability, Across doses	28 41.8%	22 17.2%	21 32.8%	17 27%
Grade 3 Irritability, Across doses	6 9%	4 3.1%	3 4.7%	2 3.2%
Related Irritability, Across doses	25 37.3%	20 15.6%	17 26.6%	17 27%
Any Loss of appetite, Across doses	25 37.3%	23 18%	11 17.2%	11 17.5%
Grade 3 Loss of appetite, Across doses	2 3%	3 2.3%	0 0%	1 1.6%
Related Loss of appetite, Across doses	17 25.4%	17 13.3%	7 10.9%	10 15.9%
Any Temperature (Axillary), Across doses	19 28.4%	11 8.6%	4 6.3%	4 6.3%
Grade 3 Temperature (Axillary), Across doses	6 9%	0 0%	0 0%	0 0%
Related Temperature (Axillary), Across doses	16 23.9%	8 6.3%	2 3.1%	1 1.6%

48. Secondary Outcome

Title	Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Description	Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, and shivering, sweating, temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (° C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame	During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 6Y-9Y Group	Arepanrix/F2 6Y-9Y Group	GSK2340273A/F1 6Y-9Y Group	GSK2340273A/F2 6Y-9Y Group
Arm/Group Description	Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	18	12	17	18
Any Fatigue, Dose 1	3 4.5%	4 3.1%	4 6.3%	4 6.3%
Grade 3 Fatigue, Dose 1	0 0%	0 0%	1 1.6%	0 0%
Related Fatigue, Dose 1	2 3%	3 2.3%	4 6.3%	3 4.8%
Any Gastrointestinal symptoms, Dose 1	1 1.5%	2 1.6%	3 4.7%	2 3.2%
Grade 3 Gastrointestinal symptoms, Dose 1	0 0%	0 0%	1 1.6%	0 0%
Related Gastrointestinal symptoms, Dose 1	0 0%	1 0.8%	3 4.7%	0 0%
Any Headache, Dose 1	4 6%	4 3.1%	2 3.1%	2 3.2%
Grade 3 Headache, Dose 1	0 0%	0 0%	0 0%	0 0%
Related Headache, Dose 1	3 4.5%	2 1.6%	1 1.6%	2 3.2%
Any Joint pain at other location, Dose 1	0 0%	0 0%	2 3.1%	1 1.6%
Grade 3 Joint pain at other location, Dose 1	0 0%	0 0%	0 0%	0 0%
Related Joint pain at other location, Dose 1	0 0%	0 0%	2 3.1%	0 0%
Any Muscle aches, Dose 1	4 6%	2 1.6%	3 4.7%	1 1.6%
Grade 3 Muscle aches, Dose 1	0 0%	0 0%	0 0%	0 0%
Related Muscle aches, Dose 1	4 6%	2 1.6%	3 4.7%	1 1.6%
Any Shivering, Dose 1	0 0%	0 0%	1 1.6%	0 0%
Grade 3 Shivering, Dose 1	0 0%	0 0%	0 0%	0 0%
Related Shivering, Dose 1	0 0%	0 0%	1 1.6%	0 0%
Any Sweating, Dose 1	1 1.5%	1 0.8%	2 3.1%	1 1.6%
Grade 3 Sweating, Dose 1	0 0%	0 0%	0 0%	0 0%
Related Sweating, Dose 1	1 1.5%	0 0%	2 3.1%	0 0%
Any Temperature (Axillary), Dose 1	5 7.5%	2 1.6%	1 1.6%	0 0%
Grade 3 Temperature (Axillary), Dose 1	0 0%	0 0%	0 0%	0 0%
Related Temperature (Axillary), Dose 1	3 4.5%	2 1.6%	1 1.6%	0 0%
Any Fatigue, Dose 2	3 4.5%	3 2.3%	3 4.7%	4 6.3%
Grade 3 Fatigue, Dose 2	0 0%	1 0.8%	0 0%	0 0%
Related Fatigue, Dose 2	3 4.5%	2 1.6%	3 4.7%	3 4.8%
Any Gastrointestinal symptoms, Dose 2	0 0%	2 1.6%	1 1.6%	5 7.9%
Grade 3 Gastrointestinal symptoms, Dose 2	0 0%	0 0%	0 0%	1 1.6%
Related Gastrointestinal symptoms, Dose 2	0 0%	2 1.6%	1 1.6%	4 6.3%
Any Headache, Dose 2	8 11.9%	3 2.3%	2 3.1%	4 6.3%
Grade 3 Headache, Dose 2	0 0%	0 0%	0 0%	1 1.6%
Related Headache, Dose 2	8 11.9%	3 2.3%	2 3.1%	3 4.8%
Any Joint pain at other location, Dose 2	2 3%	4 3.1%	0 0%	1 1.6%
Grade 3 Joint pain at other location, Dose 2	0 0%	1 0.8%	0 0%	0 0%
Related Joint pain at other location, Dose 2	2 3%	4 3.1%	0 0%	0 0%
Any Muscle aches, Dose 2	7 10.4%	2 1.6%	1 1.6%	2 3.2%
Grade 3 Muscle aches, Dose 2	0 0%	1 0.8%	0 0%	0 0%
Related Muscle aches, Dose 2	7 10.4%	2 1.6%	1 1.6%	1 1.6%
Any Shivering, Dose 2	4 6%	2 1.6%	2 3.1%	1 1.6%
Grade 3 Shivering, Dose 2	0 0%	0 0%	0 0%	0 0%
Related Shivering, Dose 2	4 6%	2 1.6%	2 3.1%	0 0%
Any Sweating, Dose 2	1 1.5%	1 0.8%	0 0%	2 3.2%
Grade 3 Sweating, Dose 2	0 0%	0 0%	0 0%	0 0%
Related Sweating, Dose 2	1 1.5%	1 0.8%	0 0%	1 1.6%
Any Temperature (Axillary), Dose 2	5 7.5%	2 1.6%	0 0%	2 3.2%
Grade 3 Temperature (Axillary), Dose 2	2 3%	0 0%	0 0%	0 0%
Related Temperature (Axillary), Dose 2	5 7.5%	2 1.6%	0 0%	1 1.6%
Any Fatigue, Across doses	6 9%	5 3.9%	4 6.3%	8 12.7%
Grade 3 Fatigue, Across doses	0 0%	1 0.8%	1 1.6%	0 0%
Related Fatigue, Across doses	5 7.5%	4 3.1%	4 6.3%	6 9.5%
Any Gastrointestinal symptoms, Across doses	1 1.5%	3 2.3%	3 4.7%	7 11.1%
Grade 3 Gastrointestinal symptoms, Across doses	0 0%	0 0%	1 1.6%	1 1.6%
Related Gastrointestinal symptoms, Across doses	0 0%	3 2.3%	3 4.7%	4 6.3%
Any Headache, Across doses	9 13.4%	5 3.9%	4 6.3%	5 7.9%
Grade 3 Headache, Across doses	0 0%	0 0%	0 0%	1 1.6%
Related Headache, Across doses	9 13.4%	4 3.1%	3 4.7%	4 6.3%
Any Joint pain at other location, Across doses	2 3%	4 3.1%	2 3.1%	2 3.2%
Grade 3 Joint pain at other location, Across doses	0 0%	1 0.8%	0 0%	0 0%
Related Joint pain at other location, Across doses	2 3%	4 3.1%	2 3.1%	0 0%
Any Muscle aches, Across doses	8 11.9%	3 2.3%	3 4.7%	3 4.8%
Grade 3 Muscle aches, Across doses	0 0%	1 0.8%	0 0%	0 0%
Related Muscle aches, Across doses	8 11.9%	3 2.3%	3 4.7%	2 3.2%
Any Shivering, Across doses	4 6%	2 1.6%	2 3.1%	1 1.6%
Grade 3 Shivering, Across doses	0 0%	0 0%	0 0%	0 0%
Related Shivering, Across doses	4 6%	2 1.6%	2 3.1%	0 0%
Any Sweating, Across doses	2 3%	1 0.8%	2 3.1%	3 4.8%
Grade 3 Sweating, Across doses	0 0%	0 0%	0 0%	0 0%
Related Sweating, Across doses	2 3%	1 0.8%	2 3.1%	1 1.6%
Any Temperature (Axillary), Across doses	9 13.4%	4 3.1%	1 1.6%	2 3.2%
Grade 3 Temperature (Axillary), Across doses	2 3%	0 0%	0 0%	0 0%
Related Temperature (Axillary), Across doses	7 10.4%	4 3.1%	1 1.6%	1 1.6%

49. Secondary Outcome

Title	Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Description	Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame	During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 6M-35M Group	Arepanrix/F1 3Y-5Y Group	Arepanrix/F2 6M-35M Group	Arepanrix/F2 3Y-5Y Group	GSK2340273A/F1 6M-35M Group	GSK2340273A/F1 3Y-5Y Group	GSK2340273A/F2 6M-35M Group	GSK2340273A/F2 3Y-5Y Group
Arm/Group Description	Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 3 years (Y) - 5 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 3 years (Y) - 5 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 3 years (Y) - 5 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 3 years (Y) - 5 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	22	25	46	53	24	22	23	21
Any Drowsiness, Dose 1	6 9%	5 3.9%	20 31.3%	13 20.6%	4 1.2%	4 NaN	6 NaN	3 NaN
Grade 3 Drowsiness, Dose 1	1 1.5%	1 0.8%	2 3.1%	0 0%	0 0%	0 NaN	0 NaN	0 NaN
Related Drowsiness, Dose 1	3 4.5%	2 1.6%	13 20.3%	4 6.3%	3 0.9%	2 NaN	5 NaN	2 NaN
Any Irritability, Dose 1	14 20.9%	8 6.3%	22 34.4%	14 22.2%	9 2.8%	6 NaN	8 NaN	0 NaN
Grade 3 Irritability, Dose 1	1 1.5%	2 1.6%	6 9.4%	0 0%	1 0.3%	0 NaN	0 NaN	0 NaN
Related Irritability, Dose 1	13 19.4%	6 4.7%	15 23.4%	8 12.7%	8 2.5%	4 NaN	8 NaN	0 NaN
Any Loss of appetite, Dose 1	9 13.4%	7 5.5%	19 29.7%	12 19%	2 0.6%	4 NaN	8 NaN	1 NaN
Grade 3 Loss of appetite, Dose 1	1 1.5%	0 0%	2 3.1%	1 1.6%	0 0%	0 NaN	1 NaN	0 NaN
Related Loss of appetite, Dose 1	6 9%	3 2.3%	12 18.8%	5 7.9%	1 0.3%	2 NaN	7 NaN	1 NaN
Any Temperature (Axillary), Dose 1	5 7.5%	4 3.1%	6 9.4%	9 14.3%	0 0%	2 NaN	0 NaN	1 NaN
Grade 3 Temperature (Axillary), Dose 1	0 0%	1 0.8%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN
Related Temperature (Axillary), Dose 1	4 6%	4 3.1%	1 1.6%	2 3.2%	0 0%	1 NaN	0 NaN	1 NaN
Any Drowsiness, Dose 2	8 11.9%	5 3.9%	9 14.1%	9 14.3%	5 1.6%	2 NaN	5 NaN	2 NaN
Grade 3 Drowsiness, Dose 2	3 4.5%	2 1.6%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN
Related Drowsiness, Dose 2	7 10.4%	2 1.6%	5 7.8%	5 7.9%	4 1.2%	1 NaN	5 NaN	2 NaN
Any Irritability, Dose 2	13 19.4%	6 4.7%	23 35.9%	10 15.9%	10 3.1%	3 NaN	6 NaN	5 NaN
Grade 3 Irritability, Dose 2	2 3%	1 0.8%	1 1.6%	0 0%	1 0.3%	1 NaN	1 NaN	1 NaN
Related Irritability, Dose 2	13 19.4%	5 3.9%	19 29.7%	8 12.7%	9 2.8%	3 NaN	6 NaN	5 NaN
Any Loss of appetite, Dose 2	11 16.4%	7 5.5%	13 20.3%	10 15.9%	7 2.2%	0 NaN	4 NaN	1 NaN
Grade 3 Loss of appetite, Dose 2	0 0%	1 0.8%	1 1.6%	1 1.6%	0 0%	0 NaN	0 NaN	0 NaN
Related Loss of appetite, Dose 2	11 16.4%	4 3.1%	10 15.6%	7 11.1%	5 1.6%	0 NaN	4 NaN	1 NaN
Any Temperature (Axillary), Dose 2	10 14.9%	3 2.3%	6 9.4%	8 12.7%	2 0.6%	1 NaN	1 NaN	2 NaN
Grade 3 Temperature (Axillary), Dose 2	4 6%	1 0.8%	1 1.6%	0 0%	0 0%	0 NaN	0 NaN	0 NaN
Related Temperature (Axillary), Dose 2	9 13.4%	2 1.6%	5 7.8%	5 7.9%	1 0.3%	1 NaN	0 NaN	0 NaN
Any Drowsiness, Across doses	10 14.9%	7 5.5%	23 35.9%	19 30.2%	7 2.2%	6 NaN	9 NaN	5 NaN
Grade 3 Drowsiness, Across doses	4 6%	2 1.6%	2 3.1%	0 0%	0 0%	0 NaN	0 NaN	0 NaN
Related Drowsiness, Across doses	7 10.4%	3 2.3%	16 25%	7 11.1%	6 1.9%	3 NaN	8 NaN	4 NaN
Any Irritability, Across doses	19 28.4%	9 7%	30 46.9%	20 31.7%	14 4.3%	7 NaN	12 NaN	5 NaN
Grade 3 Irritability, Across doses	3 4.5%	3 2.3%	7 10.9%	0 0%	2 0.6%	1 NaN	1 NaN	1 NaN
Related Irritability, Across doses	18 26.9%	7 5.5%	23 35.9%	14 22.2%	12 3.7%	5 NaN	12 NaN	5 NaN
Any Loss of appetite, Across doses	15 22.4%	10 7.8%	26 40.6%	19 30.2%	7 2.2%	4 NaN	9 NaN	2 NaN
Grade 3 Loss of appetite, Across doses	1 1.5%	1 0.8%	3 4.7%	2 3.2%	0 0%	0 NaN	1 NaN	0 NaN
Related Loss of appetite, Across doses	12 17.9%	5 3.9%	19 29.7%	10 15.9%	5 1.6%	2 NaN	8 NaN	2 NaN
Any Temperature (Axillary), Across doses	13 19.4%	6 4.7%	10 15.6%	14 22.2%	2 0.6%	2 NaN	1 NaN	3 NaN
Grade 3 Temperature (Axillary), Across doses	4 6%	2 1.6%	1 1.6%	0 0%	0 0%	0 NaN	0 NaN	0 NaN
Related Temperature (Axillary), Across doses	11 16.4%	5 3.9%	6 9.4%	6 9.5%	1 0.3%	1 NaN	0 NaN	1 NaN

50. Secondary Outcome

Title	Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Description	Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame	During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 6Y-9Y Group	Arepanrix/F2 6Y-9Y Group	GSK2340273A/F1 6Y-9Y Group	GSK2340273A/F2 6Y-9Y Group
Arm/Group Description	Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	18	26	17	18
Any Fatigue, Dose 1	3 4.5%	8 6.3%	4 6.3%	4 6.3%
Grade 3 Fatigue, Dose 1	0 0%	1 0.8%	1 1.6%	0 0%
Related Fatigue, Dose 1	2 3%	4 3.1%	4 6.3%	3 4.8%
Any Gastrointestinal symptoms, Dose 1	1 1.5%	4 3.1%	3 4.7%	2 3.2%
Grade 3 Gastrointestinal symptoms, Dose 1	0 0%	1 0.8%	1 1.6%	0 0%
Related Gastrointestinal symptoms, Dose 1	0 0%	1 0.8%	3 4.7%	0 0%
Any Headache, Dose 1	4 6%	9 7%	2 3.1%	2 3.2%
Grade 3 Headache, Dose 1	0 0%	1 0.8%	0 0%	0 0%
Related Headache, Dose 1	3 4.5%	3 2.3%	1 1.6%	2 3.2%
Any Joint pain at other location, Dose 1	0 0%	5 3.9%	2 3.1%	1 1.6%
Grade 3 Joint pain at other location, Dose 1	0 0%	1 0.8%	0 0%	0 0%
Related Joint pain at other location, Dose 1	0 0%	1 0.8%	2 3.1%	0 0%
Any Muscle aches, Dose 1	4 6%	7 5.5%	3 4.7%	1 1.6%
Grade 3 Muscle aches, Dose 1	0 0%	1 0.8%	0 0%	0 0%
Related Muscle aches, Dose 1	4 6%	5 3.9%	3 4.7%	1 1.6%
Any Shivering, Dose 1	0 0%	2 1.6%	1 1.6%	0 0%
Grade 3 Shivering, Dose 1	0 0%	0 0%	0 0%	0 0%
Related Shivering, Dose 1	0 0%	0 0%	1 1.6%	0 0%
Any Sweating, Dose 1	1 1.5%	2 1.6%	2 3.1%	1 1.6%
Grade 3 Sweating, Dose 1	0 0%	0 0%	0 0%	0 0%
Related Sweating, Dose 1	1 1.5%	0 0%	2 3.1%	0 0%
Any Temperature (Axillary), Dose 1	5 7.5%	6 4.7%	1 1.6%	0 0%
Grade 3 Temperature (Axillary), Dose 1	0 0%	0 0%	0 0%	0 0%
Related Temperature (Axillary), Dose 1	3 4.5%	2 1.6%	1 1.6%	0 0%
Any Fatigue, Dose 2	3 4.5%	7 5.5%	3 4.7%	4 6.3%
Grade 3 Fatigue, Dose 2	0 0%	2 1.6%	0 0%	0 0%
Related Fatigue, Dose 2	3 4.5%	3 2.3%	3 4.7%	3 4.8%
Any Gastrointestinal symptoms, Dose 2	0 0%	6 4.7%	1 1.6%	5 7.9%
Grade 3 Gastrointestinal symptoms, Dose 2	0 0%	1 0.8%	0 0%	1 1.6%
Related Gastrointestinal symptoms, Dose 2	0 0%	2 1.6%	1 1.6%	4 6.3%
Any Headache, Dose 2	8 11.9%	7 5.5%	2 3.1%	4 6.3%
Grade 3 Headache, Dose 2	0 0%	1 0.8%	0 0%	1 1.6%
Related Headache, Dose 2	8 11.9%	4 3.1%	2 3.1%	3 4.8%
Any Joint pain at other location, Dose 2	2 3%	6 4.7%	0 0%	1 1.6%
Grade 3 Joint pain at other location, Dose 2	0 0%	2 1.6%	0 0%	0 0%
Related Joint pain at other location, Dose 2	2 3%	5 3.9%	0 0%	0 0%
Any Muscle aches, Dose 2	7 10.4%	8 6.3%	1 1.6%	2 3.2%
Grade 3 Muscle aches, Dose 2	0 0%	3 2.3%	0 0%	0 0%
Related Muscle aches, Dose 2	7 10.4%	6 4.7%	1 1.6%	1 1.6%
Any Shivering, Dose 2	4 6%	3 2.3%	2 3.1%	1 1.6%
Grade 3 Shivering, Dose 2	0 0%	1 0.8%	0 0%	0 0%
Related Shivering, Dose 2	4 6%	2 1.6%	2 3.1%	0 0%
Any Sweating, Dose 2	1 1.5%	3 2.3%	0 0%	2 3.2%
Grade 3 Sweating, Dose 2	0 0%	1 0.8%	0 0%	0 0%
Related Sweating, Dose 2	1 1.5%	1 0.8%	0 0%	1 1.6%
Any Temperature (Axillary), Dose 2	5 7.5%	6 4.7%	0 0%	2 3.2%
Grade 3 Temperature (Axillary), Dose 2	2 3%	2 1.6%	0 0%	0 0%
Related Temperature (Axillary), Dose 2	5 7.5%	4 3.1%	0 0%	1 1.6%
Any Fatigue, Across doses	6 9%	11 8.6%	4 6.3%	8 12.7%
Grade 3 Fatigue, Across doses	0 0%	2 1.6%	1 1.6%	0 0%
Related Fatigue, Across doses	5 7.5%	6 4.7%	4 6.3%	6 9.5%
Any Gastrointestinal symptoms, Across doses	1 1.5%	8 6.3%	3 4.7%	7 11.1%
Grade 3 Gastrointestinal symptoms, Across doses	0 0%	1 0.8%	1 1.6%	1 1.6%
Related Gastrointestinal symptoms, Across doses	0 0%	3 2.3%	3 4.7%	4 6.3%
Any Headache, Across doses	9 13.4%	12 9.4%	4 6.3%	5 7.9%
Grade 3 Headache, Across doses	0 0%	1 0.8%	0 0%	1 1.6%
Related Headache, Across doses	9 13.4%	6 4.7%	3 4.7%	4 6.3%
Any Joint pain at other location, Across doses	2 3%	10 7.8%	2 3.1%	2 3.2%
Grade 3 Joint pain at other location, Across doses	0 0%	2 1.6%	0 0%	0 0%
Related Joint pain at other location, Across doses	2 3%	6 4.7%	2 3.1%	0 0%
Any Muscle aches, Across doses	8 11.9%	11 8.6%	3 4.7%	3 4.8%
Grade 3 Muscle aches, Across doses	0 0%	3 2.3%	0 0%	0 0%
Related Muscle aches, Across doses	8 11.9%	8 6.3%	3 4.7%	2 3.2%
Any Shivering, Across doses	4 6%	5 3.9%	2 3.1%	1 1.6%
Grade 3 Shivering, Across doses	0 0%	1 0.8%	0 0%	0 0%
Related Shivering, Across doses	4 6%	2 1.6%	2 3.1%	0 0%
Any Sweating, Across doses	2 3%	4 3.1%	2 3.1%	3 4.8%
Grade 3 Sweating, Across doses	0 0%	1 0.8%	0 0%	0 0%
Related Sweating, Across doses	2 3%	1 0.8%	2 3.1%	1 1.6%
Any Temperature (Axillary), Across doses	9 13.4%	9 7%	1 1.6%	2 3.2%
Grade 3 Temperature (Axillary), Across doses	2 3%	2 1.6%	0 0%	0 0%
Related Temperature (Axillary), Across doses	7 10.4%	6 4.7%	1 1.6%	1 1.6%

51. Secondary Outcome

Title	Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
Description	Among haematological parameters assessed were basophils [BAS], eosinophils [EOS], hematocrit [HCT], hemoglobin level [HGB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelet count [PLC], red blood cells [RBC] and white blood cells [WBC]. Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Time Frame	At Day 0 (PRE), at Day 7 and at Day 21

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	66	60	60	61
Unknown	2 3%	6 4.7%	4 6.3%	0 0%
Below	0 0%	0 0%	0 0%	0 0%
Within	35 52.2%	31 24.2%	24 37.5%	28 44.4%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	5 7.5%	4 3.1%	4 6.3%	3 4.8%
Below	0 0%	0 0%	0 0%	0 0%
Within	61 91%	56 43.8%	56 87.5%	58 92.1%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	1 1.5%	3 2.3%	6 9.4%	0 0%
Below	0 0%	0 0%	0 0%	0 0%
Within	64 95.5%	54 42.2%	52 81.3%	61 96.8%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	2 3%	6 4.7%	4 6.3%	0 0%
Below	5 7.5%	1 0.8%	2 3.1%	4 6.3%
Within	28 41.8%	28 21.9%	20 31.3%	20 31.7%
Above	2 3%	2 1.6%	2 3.1%	4 6.3%
Unknown	5 7.5%	4 3.1%	4 6.3%	3 4.8%
Below	7 10.4%	8 6.3%	8 12.5%	6 9.5%
Within	50 74.6%	42 32.8%	46 71.9%	45 71.4%
Above	4 6%	6 4.7%	2 3.1%	7 11.1%
Unknown	1 1.5%	3 2.3%	6 9.4%	0 0%
Below	5 7.5%	6 4.7%	5 7.8%	7 11.1%
Within	54 80.6%	42 32.8%	46 71.9%	51 81%
Above	5 7.5%	6 4.7%	1 1.6%	3 4.8%
Unknown	2 3%	6 4.7%	4 6.3%	0 0%
Below	2 3%	3 2.3%	0 0%	3 4.8%
Within	31 46.3%	24 18.8%	22 34.4%	24 38.1%
Above	2 3%	4 3.1%	2 3.1%	1 1.6%
Unknown	5 7.5%	4 3.1%	4 6.3%	3 4.8%
Below	6 9%	7 5.5%	4 6.3%	6 9.5%
Within	52 77.6%	47 36.7%	48 75%	49 77.8%
Above	3 4.5%	2 1.6%	4 6.3%	3 4.8%
Unknown	1 1.5%	3 2.3%	6 9.4%	0 0%
Below	7 10.4%	10 7.8%	7 10.9%	7 11.1%
Within	54 80.6%	41 32%	42 65.6%	53 84.1%
Above	3 4.5%	3 2.3%	3 4.7%	1 1.6%
Unknown	2 3%	6 4.7%	4 6.3%	0 0%
Below	1 1.5%	2 1.6%	0 0%	3 4.8%
Within	31 46.3%	25 19.5%	22 34.4%	23 36.5%
Above	3 4.5%	4 3.1%	2 3.1%	2 3.2%
Unknown	5 7.5%	3 2.3%	4 6.3%	3 4.8%
Below	4 6%	5 3.9%	1 1.6%	2 3.2%
Within	55 82.1%	50 39.1%	51 79.7%	52 82.5%
Above	2 3%	2 1.6%	4 6.3%	4 6.3%
Unknown	1 1.5%	3 2.3%	6 9.4%	0 0%
Below	5 7.5%	3 2.3%	3 4.7%	3 4.8%
Within	55 82.1%	48 37.5%	46 71.9%	56 88.9%
Above	4 6%	3 2.3%	3 4.7%	2 3.2%
Unknown	2 3%	6 4.7%	4 6.3%	0 0%
Below	0 0%	0 0%	1 1.6%	0 0%
Within	27 40.3%	23 18%	17 26.6%	22 34.9%
Above	8 11.9%	8 6.3%	6 9.4%	6 9.5%
Unknown	5 7.5%	4 3.1%	4 6.3%	3 4.8%
Below	1 1.5%	2 1.6%	0 0%	0 0%
Within	38 56.7%	28 21.9%	33 51.6%	44 69.8%
Above	22 32.8%	26 20.3%	23 35.9%	14 22.2%
Unknown	1 1.5%	3 2.3%	6 9.4%	0 0%
Below	0 0%	1 0.8%	0 0%	1 1.6%
Within	43 64.2%	27 21.1%	35 54.7%	38 60.3%
Above	21 31.3%	26 20.3%	17 26.6%	22 34.9%
Unknown	2 3%	6 4.7%	4 6.3%	0 0%
Below	4 6%	5 3.9%	3 4.7%	5 7.9%
Within	31 46.3%	26 20.3%	21 32.8%	22 34.9%
Above	0 0%	0 0%	0 0%	1 1.6%
Unknown	5 7.5%	4 3.1%	4 6.3%	3 4.8%
Below	13 19.4%	10 7.8%	11 17.2%	7 11.1%
Within	48 71.6%	46 35.9%	44 68.8%	51 81%
Above	0 0%	0 0%	1 1.6%	0 0%
Unknown	1 1.5%	3 2.3%	6 9.4%	0 0%
Below	19 28.4%	8 6.3%	10 15.6%	13 20.6%
Within	45 67.2%	46 35.9%	42 65.6%	48 76.2%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	2 3%	6 4.7%	4 6.3%	0 0%
Below	3 4.5%	2 1.6%	0 0%	3 4.8%
Within	31 46.3%	27 21.1%	21 32.8%	25 39.7%
Above	1 1.5%	2 1.6%	3 4.7%	0 0%
Unknown	5 7.5%	4 3.1%	4 6.3%	3 4.8%
Below	10 14.9%	3 2.3%	2 3.1%	6 9.5%
Within	50 74.6%	52 40.6%	54 84.4%	50 79.4%
Above	1 1.5%	1 0.8%	0 0%	2 3.2%
Unknown	1 1.5%	3 2.3%	6 9.4%	0 0%
Below	1 1.5%	3 2.3%	3 4.7%	2 3.2%
Within	62 92.5%	51 39.8%	49 76.6%	59 93.7%
Above	1 1.5%	0 0%	0 0%	0 0%
Unknown	2 3%	7 5.5%	5 7.8%	1 1.6%
Below	0 0%	0 0%	0 0%	0 0%
Within	33 49.3%	26 20.3%	20 31.3%	27 42.9%
Above	2 3%	4 3.1%	3 4.7%	0 0%
Unknown	6 9%	3 2.3%	4 6.3%	3 4.8%
Below	0 0%	0 0%	1 1.6%	0 0%
Within	51 76.1%	49 38.3%	50 78.1%	51 81%
Above	9 13.4%	8 6.3%	5 7.8%	7 11.1%
Unknown	2 3%	4 3.1%	6 9.4%	0 0%
Below	0 0%	1 0.8%	0 0%	0 0%
Within	57 85.1%	43 33.6%	51 79.7%	57 90.5%
Above	6 9%	9 7%	1 1.6%	4 6.3%
Unknown	2 3%	6 4.7%	4 6.3%	0 0%
Below	0 0%	1 0.8%	0 0%	2 3.2%
Within	34 50.7%	29 22.7%	23 35.9%	25 39.7%
Above	1 1.5%	1 0.8%	1 1.6%	1 1.6%
Unknown	5 7.5%	4 3.1%	4 6.3%	3 4.8%
Below	2 3%	3 2.3%	1 1.6%	1 1.6%
Within	56 83.6%	52 40.6%	54 84.4%	54 85.7%
Above	3 4.5%	1 0.8%	1 1.6%	3 4.8%
Unknown	1 1.5%	3 2.3%	6 9.4%	0 0%
Below	1 1.5%	3 2.3%	2 3.1%	1 1.6%
Within	62 92.5%	51 39.8%	48 75%	57 90.5%
Above	1 1.5%	0 0%	2 3.1%	3 4.8%
Unknown	2 3%	6 4.7%	4 6.3%	0 0%
Below	1 1.5%	0 0%	0 0%	2 3.2%
Within	33 49.3%	30 23.4%	22 34.4%	26 41.3%
Above	1 1.5%	1 0.8%	2 3.1%	0 0%
Unknown	5 7.5%	4 3.1%	4 6.3%	3 4.8%
Below	6 9%	2 1.6%	1 1.6%	1 1.6%
Within	54 80.6%	53 41.4%	55 85.9%	56 88.9%
Above	1 1.5%	1 0.8%	0 0%	1 1.6%
Unknown	1 1.5%	3 2.3%	6 9.4%	0 0%
Below	2 3%	1 0.8%	0 0%	1 1.6%
Within	61 91%	53 41.4%	52 81.3%	60 95.2%
Above	1 1.5%	0 0%	0 0%	0 0%

52. Secondary Outcome

Title	Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
Description	Biochemical parameters assessed for lab abnormalities were alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin [BLR], bilirubin conjugated/direct [BCD], creatinine [CRE] and blood urea nitrogen [BUN]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Time Frame	At Day 0 (PRE), at Day 7 and at Day 21

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	66	60	60	61
Unkown	0 0%	2 1.6%	2 3.1%	0 0%
Below	0 0%	0 0%	0 0%	0 0%
Within	37 55.2%	35 27.3%	27 42.2%	28 44.4%
Above	0 0%	0 0%	0 0%	0 0%
Unkown	1 1.5%	1 0.8%	0 0%	1 1.6%
Below	0 0%	0 0%	0 0%	0 0%
Within	64 95.5%	59 46.1%	59 92.2%	59 93.7%
Above	1 1.5%	0 0%	1 1.6%	1 1.6%
Unkown	2 3%	0 0%	4 6.3%	0 0%
Below	0 0%	0 0%	0 0%	0 0%
Within	63 94%	57 44.5%	54 84.4%	61 96.8%
Above	0 0%	0 0%	0 0%	0 0%
Unkown	3 4.5%	5 3.9%	3 4.7%	0 0%
Below	0 0%	0 0%	0 0%	0 0%
Within	34 50.7%	32 25%	26 40.6%	28 44.4%
Above	0 0%	0 0%	0 0%	0 0%
Unkown	1 1.5%	3 2.3%	0 0%	1 1.6%
Below	0 0%	0 0%	0 0%	0 0%
Within	63 94%	57 44.5%	57 89.1%	58 92.1%
Above	2 3%	0 0%	3 4.7%	2 3.2%
Unkown	4 6%	0 0%	4 6.3%	1 1.6%
Below	0 0%	0 0%	0 0%	0 0%
Within	61 91%	56 43.8%	52 81.3%	60 95.2%
Above	0 0%	1 0.8%	2 3.1%	0 0%
Unkown	0 0%	2 1.6%	2 3.1%	0 0%
Below	0 0%	0 0%	0 0%	0 0%
Within	37 55.2%	35 27.3%	27 42.2%	28 44.4%
Above	0 0%	0 0%	0 0%	0 0%
Unkown	1 1.5%	1 0.8%	0 0%	1 1.6%
Below	0 0%	0 0%	0 0%	0 0%
Within	65 97%	59 46.1%	60 93.8%	60 95.2%
Above	0 0%	0 0%	0 0%	0 0%
Unkown	2 3%	0 0%	4 6.3%	0 0%
Below	0 0%	0 0%	0 0%	0 0%
Within	63 94%	57 44.5%	54 84.4%	61 96.8%
Above	0 0%	0 0%	0 0%	0 0%
Unkown	0 0%	2 1.6%	2 3.1%	0 0%
Below	0 0%	0 0%	0 0%	0 0%
Within	37 55.2%	35 27.3%	27 42.2%	28 44.4%
Above	0 0%	0 0%	0 0%	0 0%
Unkown	1 1.5%	1 0.8%	0 0%	1 1.6%
Below	0 0%	0 0%	0 0%	0 0%
Within	65 97%	59 46.1%	60 93.8%	60 95.2%
Above	0 0%	0 0%	0 0%	0 0%
Unkown	2 3%	0 0%	4 6.3%	0 0%
Below	0 0%	0 0%	0 0%	0 0%
Within	63 94%	57 44.5%	54 84.4%	61 96.8%
Above	0 0%	0 0%	0 0%	0 0%
Unkown	0 0%	2 1.6%	2 3.1%	0 0%
Below	13 19.4%	15 11.7%	10 15.6%	7 11.1%
Within	24 35.8%	20 15.6%	17 26.6%	21 33.3%
Above	0 0%	0 0%	0 0%	0 0%
Unkown	1 1.5%	1 0.8%	0 0%	1 1.6%
Below	18 26.9%	23 18%	19 29.7%	17 27%
Within	47 70.1%	36 28.1%	41 64.1%	43 68.3%
Above	0 0%	0 0%	0 0%	0 0%
Unkown	2 3%	0 0%	4 6.3%	0 0%
Below	22 32.8%	23 18%	15 23.4%	17 27%
Within	41 61.2%	34 26.6%	39 60.9%	44 69.8%
Above	0 0%	0 0%	0 0%	0 0%
Unkown	0 0%	2 1.6%	2 3.1%	0 0%
Below	1 1.5%	0 0%	0 0%	0 0%
Within	35 52.2%	33 25.8%	23 35.9%	25 39.7%
Above	1 1.5%	2 1.6%	4 6.3%	3 4.8%
Unkown	1 1.5%	1 0.8%	0 0%	1 1.6%
Below	0 0%	0 0%	0 0%	1 1.6%
Within	62 92.5%	55 43%	51 79.7%	51 81%
Above	3 4.5%	4 3.1%	9 14.1%	8 12.7%
Unkown	2 3%	0 0%	4 6.3%	0 0%
Below	0 0%	0 0%	0 0%	0 0%
Within	59 88.1%	54 42.2%	48 75%	52 82.5%
Above	4 6%	3 2.3%	6 9.4%	9 14.3%

53. Secondary Outcome

Title	Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
Description	Among haematological parameters assessed were basophils [BAS], eosinophils [EOS], hematocrit [HCT], hemoglobin level [HGB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelet count [PLC], red blood cells [RBC] and white blood cells [WBC]. Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Time Frame	At Day 0 (PRE), at Day 7, at Day 21 and at Day 42

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	66	63	63	63
Unknown	1 1.5%	3 2.3%	7 10.9%	2 3.2%
Below	0 0%	0 0%	0 0%	0 0%
Within	65 97%	60 46.9%	56 87.5%	61 96.8%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	5 7.5%	4 3.1%	4 6.3%	3 4.8%
Below	0 0%	0 0%	0 0%	0 0%
Within	61 91%	56 43.8%	56 87.5%	58 92.1%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	1 1.5%	3 2.3%	6 9.4%	0 0%
Below	0 0%	0 0%	0 0%	0 0%
Within	64 95.5%	54 42.2%	53 82.8%	61 96.8%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	3 4.5%	2 1.6%	1 1.6%	1 1.6%
Below	0 0%	0 0%	0 0%	0 0%
Within	55 82.1%	54 42.2%	59 92.2%	57 90.5%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	4 6%	2 1.6%	6 9.4%	1 1.6%
Below	12 17.9%	5 3.9%	7 10.9%	6 9.5%
Within	46 68.7%	53 41.4%	45 70.3%	51 81%
Above	4 6%	3 2.3%	5 7.8%	5 7.9%
Unknown	5 7.5%	4 3.1%	4 6.3%	3 4.8%
Below	7 10.4%	8 6.3%	8 12.5%	6 9.5%
Within	50 74.6%	42 32.8%	46 71.9%	45 71.4%
Above	4 6%	6 4.7%	2 3.1%	7 11.1%
Unknown	1 1.5%	3 2.3%	6 9.4%	0 0%
Below	5 7.5%	6 4.7%	5 7.8%	7 11.1%
Within	54 80.6%	42 32.8%	47 73.4%	51 81%
Above	5 7.5%	6 4.7%	1 1.6%	3 4.8%
Unknown	3 4.5%	2 1.6%	1 1.6%	1 1.6%
Below	4 6%	3 2.3%	5 7.8%	3 4.8%
Within	42 62.7%	46 35.9%	50 78.1%	47 74.6%
Above	9 13.4%	5 3.9%	4 6.3%	7 11.1%
Unknown	5 7.5%	5 3.9%	6 9.4%	2 3.2%
Below	5 7.5%	8 6.3%	4 6.3%	5 7.9%
Within	53 79.1%	44 34.4%	48 75%	52 82.5%
Above	3 4.5%	6 4.7%	5 7.8%	4 6.3%
Unknown	5 7.5%	4 3.1%	4 6.3%	3 4.8%
Below	6 9%	7 5.5%	4 6.3%	6 9.5%
Within	52 77.6%	47 36.7%	48 75%	49 77.8%
Above	3 4.5%	2 1.6%	4 6.3%	3 4.8%
Unknown	1 1.5%	3 2.3%	6 9.4%	0 0%
Below	7 10.4%	10 7.8%	7 10.9%	7 11.1%
Within	54 80.6%	41 32%	43 67.2%	53 84.1%
Above	3 4.5%	3 2.3%	3 4.7%	1 1.6%
Unknown	3 4.5%	2 1.6%	1 1.6%	1 1.6%
Below	9 13.4%	12 9.4%	5 7.8%	10 15.9%
Within	45 67.2%	41 32%	48 75%	46 73%
Above	1 1.5%	1 0.8%	6 9.4%	1 1.6%
Unknown	3 4.5%	6 4.7%	4 6.3%	2 3.2%
Below	1 1.5%	5 3.9%	3 4.7%	3 4.8%
Within	58 86.6%	45 35.2%	52 81.3%	55 87.3%
Above	4 6%	7 5.5%	4 6.3%	3 4.8%
Unknown	5 7.5%	3 2.3%	4 6.3%	3 4.8%
Below	4 6%	5 3.9%	1 1.6%	2 3.2%
Within	55 82.1%	50 39.1%	51 79.7%	52 82.5%
Above	2 3%	2 1.6%	4 6.3%	4 6.3%
Unknown	1 1.5%	3 2.3%	6 9.4%	0 0%
Below	5 7.5%	3 2.3%	3 4.7%	3 4.8%
Within	55 82.1%	48 37.5%	47 73.4%	56 88.9%
Above	4 6%	3 2.3%	3 4.7%	2 3.2%
Unknown	3 4.5%	2 1.6%	1 1.6%	1 1.6%
Below	2 3%	8 6.3%	4 6.3%	4 6.3%
Within	49 73.1%	43 33.6%	49 76.6%	50 79.4%
Above	4 6%	3 2.3%	6 9.4%	3 4.8%
Unknown	2 3%	4 3.1%	6 9.4%	2 3.2%
Below	0 0%	0 0%	1 1.6%	0 0%
Within	46 68.7%	38 29.7%	35 54.7%	43 68.3%
Above	18 26.9%	21 16.4%	21 32.8%	18 28.6%
Unknown	5 7.5%	4 3.1%	4 6.3%	3 4.8%
Below	1 1.5%	2 1.6%	0 0%	0 0%
Within	38 56.7%	28 21.9%	33 51.6%	44 69.8%
Above	22 32.8%	26 20.3%	23 35.9%	14 22.2%
Unknown	1 1.5%	3 2.3%	6 9.4%	0 0%
Below	0 0%	1 0.8%	0 0%	1 1.6%
Within	43 64.2%	27 21.1%	36 56.3%	38 60.3%
Above	21 31.3%	26 20.3%	17 26.6%	22 34.9%
Unknown	3 4.5%	2 1.6%	1 1.6%	1 1.6%
Below	1 1.5%	1 0.8%	0 0%	0 0%
Within	36 53.7%	31 24.2%	36 56.3%	40 63.5%
Above	18 26.9%	22 17.2%	23 35.9%	17 27%
Unknown	4 6%	5 3.9%	6 9.4%	1 1.6%
Below	10 14.9%	10 7.8%	4 6.3%	15 23.8%
Within	52 77.6%	48 37.5%	53 82.8%	46 73%
Above	0 0%	0 0%	0 0%	1 1.6%
Unknown	5 7.5%	4 3.1%	4 6.3%	3 4.8%
Below	13 19.4%	10 7.8%	11 17.2%	7 11.1%
Within	48 71.6%	46 35.9%	44 68.8%	51 81%
Above	0 0%	0 0%	1 1.6%	0 0%
Unknown	1 1.5%	3 2.3%	6 9.4%	0 0%
Below	19 28.4%	8 6.3%	10 15.6%	13 20.6%
Within	45 67.2%	46 35.9%	43 67.2%	48 76.2%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	3 4.5%	2 1.6%	1 1.6%	1 1.6%
Below	13 19.4%	17 13.3%	21 32.8%	16 25.4%
Within	41 61.2%	37 28.9%	38 59.4%	41 65.1%
Above	1 1.5%	0 0%	0 0%	0 0%
Unknown	5 7.5%	4 3.1%	4 6.3%	1 1.6%
Below	5 7.5%	6 4.7%	4 6.3%	6 9.5%
Within	54 80.6%	52 40.6%	51 79.7%	56 88.9%
Above	2 3%	1 0.8%	4 6.3%	0 0%
Unknown	5 7.5%	4 3.1%	4 6.3%	3 4.8%
Below	10 14.9%	3 2.3%	2 3.1%	6 9.5%
Within	50 74.6%	52 40.6%	54 84.4%	50 79.4%
Above	1 1.5%	1 0.8%	0 0%	2 3.2%
Unknown	1 1.5%	3 2.3%	6 9.4%	0 0%
Below	1 1.5%	3 2.3%	3 4.7%	2 3.2%
Within	62 92.5%	51 39.8%	50 78.1%	59 93.7%
Above	1 1.5%	0 0%	0 0%	0 0%
Unknown	3 4.5%	2 1.6%	1 1.6%	1 1.6%
Below	5 7.5%	5 3.9%	10 15.6%	13 20.6%
Within	50 74.6%	48 37.5%	48 75%	40 63.5%
Above	0 0%	1 0.8%	1 1.6%	4 6.3%
Unknown	4 6%	8 6.3%	8 12.5%	3 4.8%
Below	0 0%	0 0%	1 1.6%	0 0%
Within	51 76.1%	49 38.3%	48 75%	56 88.9%
Above	11 16.4%	6 4.7%	6 9.4%	4 6.3%
Unknown	6 9%	3 2.3%	4 6.3%	3 4.8%
Below	0 0%	0 0%	1 1.6%	0 0%
Within	51 76.1%	49 38.3%	50 78.1%	51 81%
Above	9 13.4%	8 6.3%	5 7.8%	7 11.1%
Unknown	2 3%	4 3.1%	6 9.4%	0 0%
Below	0 0%	1 0.8%	0 0%	0 0%
Within	57 85.1%	43 33.6%	52 81.3%	57 90.5%
Above	6 9%	9 7%	1 1.6%	4 6.3%
Unknown	3 4.5%	3 2.3%	1 1.6%	2 3.2%
Below	0 0%	0 0%	0 0%	1 1.6%
Within	50 74.6%	47 36.7%	59 92.2%	53 84.1%
Above	5 7.5%	6 4.7%	0 0%	2 3.2%
Unknown	4 6%	4 3.1%	5 7.8%	2 3.2%
Below	1 1.5%	4 3.1%	0 0%	3 4.8%
Within	59 88.1%	54 42.2%	56 87.5%	55 87.3%
Above	2 3%	1 0.8%	2 3.1%	3 4.8%
Unknown	5 7.5%	4 3.1%	4 6.3%	3 4.8%
Below	2 3%	3 2.3%	1 1.6%	1 1.6%
Within	56 83.6%	52 40.6%	54 84.4%	54 85.7%
Above	3 4.5%	1 0.8%	1 1.6%	3 4.8%
Unknown	1 1.5%	3 2.3%	6 9.4%	0 0%
Below	1 1.5%	3 2.3%	2 3.1%	1 1.6%
Within	62 92.5%	51 39.8%	49 76.6%	57 90.5%
Above	1 1.5%	0 0%	2 3.1%	3 4.8%
Unknown	3 4.5%	2 1.6%	1 1.6%	1 1.6%
Below	1 1.5%	2 1.6%	2 3.1%	3 4.8%
Within	51 76.1%	52 40.6%	55 85.9%	52 82.5%
Above	3 4.5%	0 0%	2 3.1%	2 3.2%
Unknown	6 9%	5 3.9%	6 9.4%	2 3.2%
Below	3 4.5%	0 0%	1 1.6%	2 3.2%
Within	55 82.1%	57 44.5%	54 84.4%	59 93.7%
Above	2 3%	1 0.8%	2 3.1%	0 0%
Unknown	5 7.5%	4 3.1%	4 6.3%	3 4.8%
Below	6 9%	2 1.6%	1 1.6%	1 1.6%
Within	54 80.6%	53 41.4%	55 85.9%	56 88.9%
Above	1 1.5%	1 0.8%	0 0%	1 1.6%
Unknown	1 1.5%	3 2.3%	6 9.4%	0 0%
Below	2 3%	1 0.8%	0 0%	1 1.6%
Within	61 91%	53 41.4%	53 82.8%	60 95.2%
Above	1 1.5%	0 0%	0 0%	0 0%
Unknown	3 4.5%	2 1.6%	1 1.6%	1 1.6%
Below	3 4.5%	3 2.3%	2 3.1%	5 7.9%
Within	52 77.6%	51 39.8%	56 87.5%	50 79.4%
Above	0 0%	0 0%	1 1.6%	2 3.2%

54. Secondary Outcome

Title	Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
Description	Biochemical parameters assessed for lab abnormalities were alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin [BLR], bilirubin conjugated/direct [BCD], creatinine [CRE] and blood urea nitrogen [BUN]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Time Frame	At Day 0 (PRE), at Day 7, at Day 21 and at Day 42

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	66	63	63	63
Unknown	2 3%	2 1.6%	3 4.7%	0 0%
Below	0 0%	0 0%	0 0%	0 0%
Within	64 95.5%	61 47.7%	59 92.2%	63 100%
Above	0 0%	0 0%	1 1.6%	0 0%
Unknown	1 1.5%	1 0.8%	0 0%	1 1.6%
Below	0 0%	0 0%	0 0%	0 0%
Within	64 95.5%	59 46.1%	59 92.2%	59 93.7%
Above	1 1.5%	0 0%	1 1.6%	1 1.6%
Unknown	2 3%	0 0%	4 6.3%	0 0%
Below	0 0%	0 0%	0 0%	0 0%
Within	63 94%	57 44.5%	55 85.9%	61 96.8%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	3 4.5%	2 1.6%	0 0%	1 1.6%
Below	0 0%	0 0%	0 0%	0 0%
Within	55 82.1%	53 41.4%	59 92.2%	56 88.9%
Above	0 0%	1 0.8%	1 1.6%	1 1.6%
Unknown	5 7.5%	6 4.7%	3 4.7%	0 0%
Below	0 0%	0 0%	0 0%	0 0%
Within	61 91%	57 44.5%	59 92.2%	63 100%
Above	0 0%	0 0%	1 1.6%	0 0%
Unknown	1 1.5%	3 2.3%	0 0%	1 1.6%
Below	0 0%	0 0%	0 0%	0 0%
Within	63 94%	57 44.5%	57 89.1%	58 92.1%
Above	2 3%	0 0%	3 4.7%	2 3.2%
Unknown	4 6%	0 0%	4 6.3%	1 1.6%
Below	0 0%	0 0%	0 0%	0 0%
Within	61 91%	56 43.8%	53 82.8%	60 95.2%
Above	0 0%	1 0.8%	2 3.1%	0 0%
Unknown	4 6%	2 1.6%	0 0%	1 1.6%
Below	0 0%	0 0%	0 0%	0 0%
Within	54 80.6%	53 41.4%	57 89.1%	57 90.5%
Above	0 0%	1 0.8%	3 4.7%	0 0%
Unknown	2 3%	1 0.8%	3 4.7%	0 0%
Below	0 0%	0 0%	0 0%	0 0%
Within	64 95.5%	62 48.4%	60 93.8%	63 100%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	1 1.5%	1 0.8%	0 0%	1 1.6%
Below	0 0%	0 0%	0 0%	0 0%
Within	65 97%	59 46.1%	60 93.8%	60 95.2%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	2 3%	0 0%	4 6.3%	0 0%
Below	0 0%	0 0%	0 0%	0 0%
Within	63 94%	57 44.5%	55 85.9%	61 96.8%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	3 4.5%	2 1.6%	0 0%	1 1.6%
Below	0 0%	0 0%	0 0%	0 0%
Within	55 82.1%	53 41.4%	60 93.8%	57 90.5%
Above	0 0%	1 0.8%	0 0%	0 0%
Unknown	2 3%	2 1.6%	3 4.7%	0 0%
Below	0 0%	0 0%	0 0%	0 0%
Within	64 95.5%	61 47.7%	60 93.8%	63 100%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	1 1.5%	1 0.8%	0 0%	1 1.6%
Below	0 0%	0 0%	0 0%	0 0%
Within	65 97%	59 46.1%	60 93.8%	60 95.2%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	2 3%	0 0%	4 6.3%	0 0%
Below	0 0%	0 0%	0 0%	0 0%
Within	63 94%	57 44.5%	55 85.9%	61 96.8%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	3 4.5%	2 1.6%	0 0%	1 1.6%
Below	0 0%	0 0%	0 0%	0 0%
Within	55 82.1%	54 42.2%	60 93.8%	57 90.5%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	2 3%	2 1.6%	3 4.7%	0 0%
Below	19 28.4%	22 17.2%	17 26.6%	15 23.8%
Within	45 67.2%	39 30.5%	43 67.2%	48 76.2%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	1 1.5%	1 0.8%	0 0%	1 1.6%
Below	18 26.9%	23 18%	19 29.7%	17 27%
Within	47 70.1%	36 28.1%	41 64.1%	43 68.3%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	2 3%	0 0%	4 6.3%	0 0%
Below	22 32.8%	23 18%	15 23.4%	17 27%
Within	41 61.2%	34 26.6%	40 62.5%	44 69.8%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	3 4.5%	2 1.6%	0 0%	1 1.6%
Below	18 26.9%	20 15.6%	16 25%	13 20.6%
Within	37 55.2%	34 26.6%	44 68.8%	44 69.8%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	2 3%	2 1.6%	3 4.7%	0 0%
Below	2 3%	0 0%	0 0%	0 0%
Within	58 86.6%	55 43%	55 85.9%	58 92.1%
Above	4 6%	6 4.7%	5 7.8%	5 7.9%
Unknown	1 1.5%	1 0.8%	0 0%	1 1.6%
Below	0 0%	0 0%	0 0%	1 1.6%
Within	62 92.5%	55 43%	51 79.7%	51 81%
Above	3 4.5%	4 3.1%	9 14.1%	8 12.7%
Unknown	2 3%	0 0%	4 6.3%	0 0%
Below	0 0%	0 0%	0 0%	0 0%
Within	59 88.1%	54 42.2%	49 76.6%	52 82.5%
Above	4 6%	3 2.3%	6 9.4%	9 14.3%
Unknown	3 4.5%	2 1.6%	0 0%	1 1.6%
Below	1 1.5%	0 0%	0 0%	0 0%
Within	49 73.1%	49 38.3%	54 84.4%	50 79.4%
Above	5 7.5%	5 3.9%	6 9.4%	7 11.1%

55. Secondary Outcome

Title	Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
Description	Among haematological parameters assessed were basophils [BAS], eosinophils [EOS], hematocrit [HCT], hemoglobin level [HGB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelet count [PLC], red blood cells [RBC] and white blood cells [WBC], Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Time Frame	At Day 0 (PRE), at Day 7 and at Day 21

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	66	126	63	63
Unknown	1 1.5%	5 3.9%	3 4.7%	1 1.6%
Below	0 0%	0 0%	0 0%	0 0%
Within	65 97%	121 94.5%	60 93.8%	62 98.4%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	5 7.5%	5 3.9%	4 6.3%	3 4.8%
Below	0 0%	0 0%	0 0%	0 0%
Within	61 91%	115 89.8%	56 87.5%	58 92.1%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	1 1.5%	4 3.1%	6 9.4%	0 0%
Below	0 0%	0 0%	0 0%	0 0%
Within	64 95.5%	112 87.5%	53 82.8%	61 96.8%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	3 4.5%	5 3.9%	1 1.6%	1 1.6%
Below	0 0%	0 0%	0 0%	0 0%
Within	55 82.1%	109 85.2%	59 92.2%	57 90.5%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	1 1.5%	5 3.9%	3 4.7%	1 1.6%
Below	12 17.9%	11 8.6%	7 10.9%	6 9.5%
Within	49 73.1%	100 78.1%	48 75%	51 81%
Above	4 6%	10 7.8%	5 7.8%	5 7.9%
Unknown	5 7.5%	5 3.9%	4 6.3%	3 4.8%
Below	7 10.4%	20 15.6%	8 12.5%	6 9.5%
Within	50 74.6%	84 65.6%	46 71.9%	45 71.4%
Above	4 6%	11 8.6%	2 3.1%	7 11.1%
Unknown	1 1.5%	4 3.1%	6 9.4%	0 0%
Below	5 7.5%	14 10.9%	5 7.8%	7 11.1%
Within	54 80.6%	90 70.3%	47 73.4%	51 81%
Above	5 7.5%	8 6.3%	1 1.6%	3 4.8%
Unknown	3 4.5%	5 3.9%	1 1.6%	1 1.6%
Below	4 6%	8 6.3%	5 7.8%	3 4.8%
Within	42 62.7%	94 73.4%	50 78.1%	47 74.6%
Above	9 13.4%	7 5.5%	4 6.3%	7 11.1%
Unknown	1 1.5%	6 4.7%	3 4.7%	1 1.6%
Below	5 7.5%	22 17.2%	5 7.8%	6 9.5%
Within	56 83.6%	90 70.3%	50 78.1%	52 82.5%
Above	4 6%	8 6.3%	5 7.8%	4 6.3%
Unknown	5 7.5%	5 3.9%	4 6.3%	3 4.8%
Below	6 9%	26 20.3%	4 6.3%	6 9.5%
Within	52 77.6%	82 64.1%	48 75%	49 77.8%
Above	3 4.5%	7 5.5%	4 6.3%	3 4.8%
Unknown	1 1.5%	4 3.1%	6 9.4%	0 0%
Below	7 10.4%	32 25%	7 10.9%	7 11.1%
Within	54 80.6%	77 60.2%	43 67.2%	53 84.1%
Above	3 4.5%	3 2.3%	3 4.7%	1 1.6%
Unknown	3 4.5%	6 4.7%	1 1.6%	1 1.6%
Below	9 13.4%	24 18.8%	5 7.8%	10 15.9%
Within	45 67.2%	80 62.5%	48 75%	46 73%
Above	1 1.5%	4 3.1%	6 9.4%	1 1.6%
Unknown	1 1.5%	5 3.9%	3 4.7%	1 1.6%
Below	1 1.5%	15 11.7%	3 4.7%	4 6.3%
Within	59 88.1%	96 75%	53 82.8%	55 87.3%
Above	5 7.5%	10 7.8%	4 6.3%	3 4.8%
Unknown	5 7.5%	4 3.1%	4 6.3%	3 4.8%
Below	4 6%	9 7%	1 1.6%	2 3.2%
Within	55 82.1%	98 76.6%	51 79.7%	52 82.5%
Above	2 3%	9 7%	4 6.3%	4 6.3%
Unknown	1 1.5%	4 3.1%	6 9.4%	0 0%
Below	5 7.5%	10 7.8%	3 4.7%	3 4.8%
Within	55 82.1%	97 75.8%	47 73.4%	56 88.9%
Above	4 6%	5 3.9%	3 4.7%	2 3.2%
Unknown	3 4.5%	5 3.9%	1 1.6%	1 1.6%
Below	2 3%	13 10.2%	4 6.3%	4 6.3%
Within	49 73.1%	90 70.3%	49 76.6%	50 79.4%
Above	4 6%	6 4.7%	6 9.4%	3 4.8%
Unknown	1 1.5%	5 3.9%	3 4.7%	1 1.6%
Below	0 0%	1 0.8%	1 1.6%	0 0%
Within	47 70.1%	83 64.8%	37 57.8%	44 69.8%
Above	18 26.9%	37 28.9%	22 34.4%	18 28.6%
Unknown	5 7.5%	5 3.9%	4 6.3%	3 4.8%
Below	1 1.5%	3 2.3%	0 0%	0 0%
Within	38 56.7%	73 57%	33 51.6%	44 69.8%
Above	22 32.8%	39 30.5%	23 35.9%	14 22.2%
Unknown	1 1.5%	4 3.1%	6 9.4%	0 0%
Below	0 0%	2 1.6%	0 0%	1 1.6%
Within	43 64.2%	72 56.3%	36 56.3%	38 60.3%
Above	21 31.3%	38 29.7%	17 26.6%	22 34.9%
Unknown	3 4.5%	5 3.9%	1 1.6%	1 1.6%
Below	1 1.5%	3 2.3%	0 0%	0 0%
Within	36 53.7%	75 58.6%	36 56.3%	40 63.5%
Above	18 26.9%	31 24.2%	23 35.9%	17 27%
Unknown	1 1.5%	5 3.9%	3 4.7%	1 1.6%
Below	12 17.9%	26 20.3%	7 10.9%	15 23.8%
Within	53 79.1%	95 74.2%	53 82.8%	46 73%
Above	0 0%	0 0%	0 0%	1 1.6%
Unknown	5 7.5%	5 3.9%	4 6.3%	3 4.8%
Below	13 19.4%	19 14.8%	11 17.2%	7 11.1%
Within	48 71.6%	96 75%	44 68.8%	51 81%
Above	0 0%	0 0%	1 1.6%	0 0%
Unknown	1 1.5%	4 3.1%	6 9.4%	0 0%
Below	19 28.4%	18 14.1%	10 15.6%	13 20.6%
Within	45 67.2%	94 73.4%	43 67.2%	48 76.2%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	3 4.5%	5 3.9%	1 1.6%	1 1.6%
Below	13 19.4%	22 17.2%	21 32.8%	16 25.4%
Within	41 61.2%	87 68%	38 59.4%	41 65.1%
Above	1 1.5%	0 0%	0 0%	0 0%
Unknown	1 1.5%	5 3.9%	3 4.7%	1 1.6%
Below	6 9%	9 7%	4 6.3%	6 9.5%
Within	57 85.1%	109 85.2%	52 81.3%	56 88.9%
Above	2 3%	3 2.3%	4 6.3%	0 0%
Unknown	5 7.5%	5 3.9%	4 6.3%	3 4.8%
Below	10 14.9%	4 3.1%	2 3.1%	6 9.5%
Within	50 74.6%	109 85.2%	54 84.4%	50 79.4%
Above	1 1.5%	2 1.6%	0 0%	2 3.2%
Unknown	1 1.5%	4 3.1%	6 9.4%	0 0%
Below	1 1.5%	10 7.8%	3 4.7%	2 3.2%
Within	62 92.5%	100 78.1%	50 78.1%	59 93.7%
Above	1 1.5%	2 1.6%	0 0%	0 0%
Unknown	3 4.5%	5 3.9%	1 1.6%	1 1.6%
Below	5 7.5%	12 9.4%	10 15.6%	13 20.6%
Within	50 74.6%	96 75%	48 75%	40 63.5%
Above	0 0%	1 0.8%	1 1.6%	4 6.3%
Unknown	1 1.5%	6 4.7%	5 7.8%	2 3.2%
Below	0 0%	1 0.8%	1 1.6%	0 0%
Within	54 80.6%	107 83.6%	51 79.7%	57 90.5%
Above	11 16.4%	12 9.4%	6 9.4%	4 6.3%
Unknown	6 9%	5 3.9%	4 6.3%	3 4.8%
Below	0 0%	0 0%	1 1.6%	0 0%
Within	51 76.1%	95 74.2%	50 78.1%	51 81%
Above	9 13.4%	20 15.6%	5 7.8%	7 11.1%
Unknown	2 3%	7 5.5%	6 9.4%	0 0%
Below	0 0%	2 1.6%	0 0%	0 0%
Within	57 85.1%	89 69.5%	52 81.3%	57 90.5%
Above	6 9%	18 14.1%	1 1.6%	4 6.3%
Unknown	3 4.5%	6 4.7%	1 1.6%	2 3.2%
Below	0 0%	0 0%	0 0%	1 1.6%
Within	50 74.6%	93 72.7%	59 92.2%	53 84.1%
Above	5 7.5%	15 11.7%	0 0%	2 3.2%
Unknown	1 1.5%	6 4.7%	3 4.7%	1 1.6%
Below	1 1.5%	6 4.7%	0 0%	3 4.8%
Within	62 92.5%	113 88.3%	58 90.6%	56 88.9%
Above	2 3%	1 0.8%	2 3.1%	3 4.8%
Unknown	5 7.5%	5 3.9%	4 6.3%	3 4.8%
Below	2 3%	4 3.1%	1 1.6%	1 1.6%
Within	56 83.6%	110 85.9%	54 84.4%	54 85.7%
Above	3 4.5%	1 0.8%	1 1.6%	3 4.8%
Unknown	1 1.5%	4 3.1%	6 9.4%	0 0%
Below	1 1.5%	5 3.9%	2 3.1%	1 1.6%
Within	62 92.5%	107 83.6%	49 76.6%	57 90.5%
Above	1 1.5%	0 0%	2 3.1%	3 4.8%
Unknown	3 4.5%	6 4.7%	1 1.6%	1 1.6%
Below	1 1.5%	4 3.1%	2 3.1%	3 4.8%
Within	51 76.1%	103 80.5%	55 85.9%	52 82.5%
Above	3 4.5%	1 0.8%	2 3.1%	2 3.2%
Unknown	1 1.5%	5 3.9%	3 4.7%	1 1.6%
Below	4 6%	0 0%	1 1.6%	2 3.2%
Within	59 88.1%	118 92.2%	57 89.1%	60 95.2%
Above	2 3%	3 2.3%	2 3.1%	0 0%
Unknown	5 7.5%	5 3.9%	4 6.3%	3 4.8%
Below	6 9%	3 2.3%	1 1.6%	1 1.6%
Within	54 80.6%	110 85.9%	55 85.9%	56 88.9%
Above	1 1.5%	2 1.6%	0 0%	1 1.6%
Unknown	1 1.5%	4 3.1%	6 9.4%	0 0%
Below	2 3%	4 3.1%	0 0%	1 1.6%
Within	61 91%	107 83.6%	53 82.8%	60 95.2%
Above	1 1.5%	1 0.8%	0 0%	0 0%
Unknown	3 4.5%	5 3.9%	1 1.6%	1 1.6%
Below	3 4.5%	7 5.5%	2 3.1%	5 7.9%
Within	52 77.6%	102 79.7%	56 87.5%	50 79.4%
Above	0 0%	0 0%	1 1.6%	2 3.2%

56. Secondary Outcome

Title	Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
Description	Biochemical parameters assessed for lab abnormalities were alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin [BLR], bilirubin conjugated/direct [BCD], creatinine [CRE] and blood urea nitrogen [BUN]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Time Frame	At Day 0 (PRE), at Day 7, at Day 21 and at Day 42

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	66	126	63	63
Unknown	2 3%	2 1.6%	3 4.7%	0 0%
Below	0 0%	0 0%	0 0%	0 0%
Within	64 95.5%	124 96.9%	59 92.2%	63 100%
Above	0 0%	0 0%	1 1.6%	0 0%
Unknown	1 1.5%	2 1.6%	0 0%	1 1.6%
Below	0 0%	0 0%	0 0%	0 0%
Within	64 95.5%	118 92.2%	59 92.2%	59 93.7%
Above	1 1.5%	0 0%	1 1.6%	1 1.6%
Unknown	2 3%	0 0%	4 6.3%	0 0%
Below	0 0%	0 0%	0 0%	0 0%
Within	63 94%	115 89.8%	55 85.9%	61 96.8%
Above	0 0%	1 0.8%	0 0%	0 0%
Unknown	3 4.5%	3 2.3%	0 0%	1 1.6%
Below	0 0%	0 0%	0 0%	0 0%
Within	55 82.1%	110 85.9%	59 92.2%	56 88.9%
Above	0 0%	1 0.8%	1 1.6%	1 1.6%
Unknown	4 6%	4 3.1%	3 4.7%	0 0%
Below	0 0%	0 0%	0 0%	0 0%
Within	62 92.5%	117 91.4%	59 92.2%	63 100%
Above	0 0%	5 3.9%	1 1.6%	0 0%
Unknown	1 1.5%	4 3.1%	0 0%	1 1.6%
Below	0 0%	0 0%	0 0%	0 0%
Within	63 94%	113 88.3%	57 89.1%	58 92.1%
Above	2 3%	3 2.3%	3 4.7%	2 3.2%
Unknown	4 6%	1 0.8%	4 6.3%	1 1.6%
Below	0 0%	0 0%	0 0%	0 0%
Within	61 91%	112 87.5%	53 82.8%	60 95.2%
Above	0 0%	3 2.3%	2 3.1%	0 0%
Unknown	4 6%	3 2.3%	0 0%	1 1.6%
Below	0 0%	0 0%	0 0%	0 0%
Within	54 80.6%	105 82%	57 89.1%	57 90.5%
Above	0 0%	6 4.7%	3 4.7%	0 0%
Unknown	2 3%	2 1.6%	3 4.7%	0 0%
Below	0 0%	0 0%	0 0%	0 0%
Within	64 95.5%	124 96.9%	60 93.8%	63 100%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	1 1.5%	2 1.6%	0 0%	1 1.6%
Below	0 0%	0 0%	0 0%	0 0%
Within	65 97%	118 92.2%	60 93.8%	60 95.2%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	2 3%	0 0%	4 6.3%	0 0%
Below	0 0%	0 0%	0 0%	0 0%
Within	63 94%	116 90.6%	55 85.9%	61 96.8%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	3 4.5%	3 2.3%	0 0%	1 1.6%
Below	0 0%	0 0%	0 0%	0 0%
Within	55 82.1%	110 85.9%	60 93.8%	57 90.5%
Above	0 0%	1 0.8%	0 0%	0 0%
Unknown	2 3%	2 1.6%	3 4.7%	0 0%
Below	0 0%	0 0%	0 0%	0 0%
Within	64 95.5%	124 96.9%	60 93.8%	63 100%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	1 1.5%	2 1.6%	0 0%	1 1.6%
Below	0 0%	0 0%	0 0%	0 0%
Within	65 97%	118 92.2%	60 93.8%	60 95.2%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	2 3%	0 0%	4 6.3%	0 0%
Below	0 0%	0 0%	0 0%	0 0%
Within	63 94%	116 90.6%	55 85.9%	61 96.8%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	3 4.5%	3 2.3%	0 0%	1 1.6%
Below	0 0%	0 0%	0 0%	0 0%
Within	55 82.1%	111 86.7%	60 93.8%	57 90.5%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	2 3%	2 1.6%	3 4.7%	0 0%
Below	19 28.4%	38 29.7%	17 26.6%	15 23.8%
Within	45 67.2%	86 67.2%	43 67.2%	48 76.2%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	1 1.5%	2 1.6%	0 0%	1 1.6%
Below	18 26.9%	38 29.7%	19 29.7%	17 27%
Within	47 70.1%	80 62.5%	41 64.1%	43 68.3%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	2 3%	0 0%	4 6.3%	0 0%
Below	22 32.8%	40 31.3%	15 23.4%	17 27%
Within	41 61.2%	76 59.4%	40 62.5%	44 69.8%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	3 4.5%	3 2.3%	0 0%	1 1.6%
Below	18 26.9%	37 28.9%	16 25%	13 20.6%
Within	37 55.2%	74 57.8%	44 68.8%	44 69.8%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	2 3%	2 1.6%	3 4.7%	0 0%
Below	2 3%	4 3.1%	0 0%	0 0%
Within	58 86.6%	110 85.9%	56 87.5%	58 92.1%
Above	4 6%	10 7.8%	4 6.3%	5 7.9%
Unknown	1 1.5%	2 1.6%	0 0%	1 1.6%
Below	0 0%	1 0.8%	0 0%	1 1.6%
Within	62 92.5%	110 85.9%	51 79.7%	51 81%
Above	3 4.5%	7 5.5%	9 14.1%	8 12.7%
Unknown	2 3%	0 0%	4 6.3%	0 0%
Below	0 0%	4 3.1%	0 0%	0 0%
Within	59 88.1%	107 83.6%	49 76.6%	52 82.5%
Above	4 6%	5 3.9%	6 9.4%	9 14.3%
Unknown	3 4.5%	3 2.3%	0 0%	1 1.6%
Below	1 1.5%	4 3.1%	0 0%	0 0%
Within	49 73.1%	96 75%	54 84.4%	50 79.4%
Above	5 7.5%	11 8.6%	6 9.4%	7 11.1%

57. Secondary Outcome

Title	Number of Subjects With Haematological Laboratory Abnormalities
Description	Among haematological parameters assessed were basophils [BAS], eosinophils [EOS], hematocrit [HCT], hemoglobin level [HGB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelet count [PLC], red blood cells [RBC] and white blood cells [WBC]. Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Time Frame	At Day 182

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	59	108	53	56
Unknown	5 7.5%	8 6.3%	2 3.1%	3 4.8%
Below	0 0%	0 0%	0 0%	0 0%
Within	54 80.6%	100 78.1%	51 79.7%	53 84.1%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	5 7.5%	8 6.3%	2 3.1%	3 4.8%
Below	6 9%	10 7.8%	8 12.5%	3 4.8%
Within	43 64.2%	83 64.8%	39 60.9%	47 74.6%
Above	5 7.5%	7 5.5%	4 6.3%	3 4.8%
Unknown	5 7.5%	9 7%	3 4.7%	3 4.8%
Below	8 11.9%	17 13.3%	5 7.8%	7 11.1%
Within	43 64.2%	70 54.7%	42 65.6%	43 68.3%
Above	3 4.5%	12 9.4%	3 4.7%	3 4.8%
Unknown	5 7.5%	8 6.3%	2 3.1%	3 4.8%
Below	1 1.5%	8 6.3%	3 4.7%	4 6.3%
Within	50 74.6%	79 61.7%	44 68.8%	45 71.4%
Above	3 4.5%	13 10.2%	4 6.3%	4 6.3%
Unknown	5 7.5%	8 6.3%	2 3.1%	3 4.8%
Below	1 1.5%	0 0%	0 0%	0 0%
Within	40 59.7%	72 56.3%	37 57.8%	41 65.1%
Above	13 19.4%	28 21.9%	14 21.9%	12 19%
Unknown	5 7.5%	8 6.3%	2 3.1%	3 4.8%
Below	18 26.9%	18 14.1%	12 18.8%	13 20.6%
Within	35 52.2%	82 64.1%	39 60.9%	40 63.5%
Above	1 1.5%	0 0%	0 0%	0 0%
Unknown	5 7.5%	8 6.3%	2 3.1%	3 4.8%
Below	4 6%	8 6.3%	5 7.8%	1 1.6%
Within	48 71.6%	92 71.9%	43 67.2%	51 81%
Above	2 3%	0 0%	3 4.7%	1 1.6%
Unknown	6 9%	9 7%	2 3.1%	3 4.8%
Below	0 0%	1 0.8%	0 0%	0 0%
Within	48 71.6%	92 71.9%	51 79.7%	52 82.5%
Above	5 7.5%	6 4.7%	0 0%	1 1.6%
Unknown	5 7.5%	9 7%	3 4.7%	3 4.8%
Below	2 3%	6 4.7%	3 4.7%	1 1.6%
Within	51 76.1%	91 71.1%	47 73.4%	51 81%
Above	1 1.5%	2 1.6%	0 0%	1 1.6%
Unknown	5 7.5%	8 6.3%	2 3.1%	3 4.8%
Below	5 7.5%	2 1.6%	2 3.1%	1 1.6%
Within	49 73.1%	98 76.6%	47 73.4%	51 81%
Above	0 0%	0 0%	2 3.1%	1 1.6%

58. Secondary Outcome

Title	Number of Subjects With Biochemical Laboratory Abnormalities
Description	Biochemical parameters assessed for lab abnormalities were alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin [BLR], bilirubin conjugated/direct [BCD], creatinine [CRE] and blood urea nitrogen [BUN]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Time Frame	At Day 182

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	59	108	53	56
Unknown	1 1.5%	1 0.8%	1 1.6%	1 1.6%
Below	0 0%	0 0%	0 0%	0 0%
Within	58 86.6%	107 83.6%	51 79.7%	54 85.7%
Above	0 0%	0 0%	1 1.6%	1 1.6%
Unknown	1 1.5%	1 0.8%	1 1.6%	2 3.2%
Below	0 0%	0 0%	0 0%	0 0%
Within	57 85.1%	106 82.8%	50 78.1%	53 84.1%
Above	1 1.5%	1 0.8%	2 3.1%	1 1.6%
Unknown	1 1.5%	1 0.8%	1 1.6%	1 1.6%
Below	0 0%	0 0%	0 0%	0 0%
Within	58 86.6%	107 83.6%	52 81.3%	55 87.3%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	1 1.5%	1 0.8%	1 1.6%	1 1.6%
Below	0 0%	0 0%	0 0%	0 0%
Within	58 86.6%	106 82.8%	52 81.3%	55 87.3%
Above	0 0%	1 0.8%	0 0%	0 0%
Unknown	1 1.5%	1 0.8%	1 1.6%	1 1.6%
Below	18 26.9%	35 27.3%	16 25%	18 28.6%
Within	40 59.7%	72 56.3%	36 56.3%	37 58.7%
Above	0 0%	0 0%	0 0%	0 0%
Unknown	1 1.5%	1 0.8%	1 1.6%	1 1.6%
Below	3 4.5%	2 1.6%	1 1.6%	0 0%
Within	51 76.1%	99 77.3%	48 75%	53 84.1%
Above	4 6%	6 4.7%	3 4.7%	2 3.2%

59. Secondary Outcome

Title	Number of Subjects With Any Unsolicited Adverse Events (AEs) - Preliminary Analysis
Description	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time Frame	Within 21 days (Days 0-20) post vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	67	64	64	63
Count of Participants [Participants]	17 25.4%	20 15.6%	16 25%	14 22.2%

60. Secondary Outcome

Title	Number of Subjects With Any Unsolicited Adverse Events (AEs) - First Analysis
Description	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time Frame	Within 42 days (Days 0-41) post vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	67	64	64	63
Count of Participants [Participants]	33 49.3%	35 27.3%	25 39.1%	23 36.5%

61. Secondary Outcome

Title	Number of Subjects With Any Unsolicited Adverse Events (AEs) - Second Analysis
Description	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time Frame	Within 41 days (Days 0-40) post vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	67	128	64	63
Count of Participants [Participants]	34 50.7%	65 50.8%	24 37.5%	23 36.5%

62. Secondary Outcome

Title	Number of Subjects With Any Unsolicited Adverse Events (AEs)
Description	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time Frame	Within 84 days (Days 0-83) post vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	67	128	64	63
Count of Participants [Participants]	36 53.7%	76 59.4%	30 46.9%	32 50.8%

63. Secondary Outcome

Title	Number of Subjects With Any Medically-attended Adverse Events (MAEs) - Preliminary Analysis
Description	MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Time Frame	Within 21 days (Days 0-20) post vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	67	64	64	63
Count of Participants [Participants]	7 10.4%	5 3.9%	3 4.7%	4 6.3%

64. Secondary Outcome

Title	Number of Subjects With Any Medically-attended Adverse Events (MAEs) - First Analysis
Description	MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Time Frame	Within 41 days (Days 0-40) post vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	67	64	64	63
Count of Participants [Participants]	18 26.9%	14 10.9%	8 12.5%	9 14.3%

65. Secondary Outcome

Title	Number of Subjects With Any Medically-attended Adverse Events (MAEs) - Second Analysis
Description	MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Time Frame	Within 42 days (Days 0-41) post vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	67	128	64	63
Count of Participants [Participants]	18 26.9%	31 24.2%	8 12.5%	9 14.3%

66. Secondary Outcome

Title	Number of Subjects With Any Medically-attended Adverse Events (MAEs)
Description	MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Time Frame	Within 182 days (Days 0-181) post vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	67	128	64	63
Count of Participants [Participants]	32 47.8%	62 48.4%	24 37.5%	25 39.7%

67. Secondary Outcome

Title	Number of Subjects With Any Medically-attended Adverse Events (MAEs)
Description	MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Time Frame	Throughout the entire study period (Day 0 - Day 385)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	67	128	64	63
Count of Participants [Participants]	39 58.2%	87 68%	39 60.9%	34 54%

68. Secondary Outcome

Title	Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) - Preliminary Analysis
Description	Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time Frame	Within 21 days (Days 0-20) post vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	67	64	64	63
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%

69. Secondary Outcome

Title	Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) - First Analysis
Description	Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time Frame	Within 42 days (Days 0-41) post vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	67	64	64	63
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%

70. Secondary Outcome

Title	Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) - Second Analysis
Description	Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time Frame	Within 42 days (Days 0-41) post vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	67	128	64	63
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%

71. Secondary Outcome

Title	Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)
Description	Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time Frame	Within 182 days (Days 0-181) post vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	67	128	64	63
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%

72. Secondary Outcome

Title	Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)
Description	Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time Frame	Throughout the entire study period (Day 0 - Day 385)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	67	128	64	63
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%

73. Secondary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs) - Preliminary Analysis
Description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame	Within 21 days (Days 0-20) post vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	67	64	64	63
Count of Participants [Participants]	1 1.5%	0 0%	0 0%	0 0%

74. Secondary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs) - First Analysis
Description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame	Within 42 days (Days 0-41) post vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	67	64	64	63
Count of Participants [Participants]	1 1.5%	0 0%	0 0%	0 0%

75. Secondary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs) - Second Analysis
Description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame	Within 42 days (Day 0-41) post vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	67	128	64	63
Count of Participants [Participants]	1 1.5%	0 0%	0 0%	0 0%

76. Secondary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs)
Description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame	Within 182 days (Days 0-181) post vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	67	128	64	63
Count of Participants [Participants]	1 1.5%	2 1.6%	0 0%	0 0%

77. Secondary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs)
Description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame	Throughout the entire study period (Day 0 - Day 385)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.

Arm/Group Title	Arepanrix/F1 Group	Arepanrix/F2 Group	GSK2340273A/F1 Group	GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).	Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
Measure Participants	67	128	64	63
Count of Participants [Participants]	2 3%	2 1.6%	0 0%	0 0%

Adverse Events

Time Frame	Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
Arm/Group Title	Arepanrix/F1 Group		Arepanrix/F2 Group		GSK2340273A/F1 Group		GSK2340273A/F2 Group
Arm/Group Description	Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).		Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).		Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).		Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children < 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children < 12 months of age).
All Cause Mortality
	Arepanrix/F1 Group		Arepanrix/F2 Group		GSK2340273A/F1 Group		GSK2340273A/F2 Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/67 (0%)		0/128 (0%)		0/64 (0%)		0/63 (0%)
Serious Adverse Events
	Arepanrix/F1 Group		Arepanrix/F2 Group		GSK2340273A/F1 Group		GSK2340273A/F2 Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/67 (3%)		2/128 (1.6%)		0/64 (0%)		0/63 (0%)
Infections and infestations
Appendiceal abscess	0/67 (0%)	0	1/128 (0.8%)	2	0/64 (0%)	0	0/63 (0%)	0
Tonsillitis	1/67 (1.5%)	1	0/128 (0%)	0	0/64 (0%)	0	0/63 (0%)	0
Nervous system disorders
Convulsion	1/67 (1.5%)	1	1/128 (0.8%)	1	0/64 (0%)	0	0/63 (0%)	0
Other (Not Including Serious) Adverse Events
	Arepanrix/F1 Group		Arepanrix/F2 Group		GSK2340273A/F1 Group		GSK2340273A/F2 Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	61/67 (91%)		125/128 (97.7%)		54/64 (84.4%)		55/63 (87.3%)
Gastrointestinal disorders
Gastrointestinal disorder	1/67 (1.5%)	1	8/128 (6.3%)	10	3/64 (4.7%)	4	7/63 (11.1%)	7
Vomiting	4/67 (6%)	4	6/128 (4.7%)	6	2/64 (3.1%)	2	6/63 (9.5%)	7
General disorders
Chills	4/67 (6%)	4	5/128 (3.9%)	5	2/64 (3.1%)	3	2/63 (3.2%)	2
Fatigue	6/67 (9%)	6	11/128 (8.6%)	15	4/64 (6.3%)	7	8/63 (12.7%)	8
Pain	51/67 (76.1%)	77	91/128 (71.1%)	148	34/64 (53.1%)	50	30/63 (47.6%)	41
Pyrexia	32/67 (47.8%)	36	41/128 (32%)	50	11/64 (17.2%)	12	10/63 (15.9%)	11
Swelling	7/67 (10.4%)	9	15/128 (11.7%)	17	1/64 (1.6%)	1	1/63 (1.6%)	1
Infections and infestations
Nasopharyngitis	4/67 (6%)	5	10/128 (7.8%)	11	4/64 (6.3%)	6	6/63 (9.5%)	8
Otitis media	2/67 (3%)	2	8/128 (6.3%)	10	2/64 (3.1%)	2	3/63 (4.8%)	4
Upper respiratory tract infection	5/67 (7.5%)	6	12/128 (9.4%)	12	4/64 (6.3%)	4	2/63 (3.2%)	2
Metabolism and nutrition disorders
Decreased appetite	27/67 (40.3%)	36	45/128 (35.2%)	54	12/64 (18.8%)	14	11/63 (17.5%)	14
Musculoskeletal and connective tissue disorders
Arthralgia	2/67 (3%)	2	11/128 (8.6%)	12	2/64 (3.1%)	2	2/63 (3.2%)	2
Myalgia	8/67 (11.9%)	11	11/128 (8.6%)	15	3/64 (4.7%)	4	3/63 (4.8%)	3
Nervous system disorders
Headache	11/67 (16.4%)	15	15/128 (11.7%)	19	4/64 (6.3%)	4	6/63 (9.5%)	8
Somnolence	17/67 (25.4%)	24	42/128 (32.8%)	51	13/64 (20.3%)	15	14/63 (22.2%)	16
Psychiatric disorders
Irritability	28/67 (41.8%)	41	50/128 (39.1%)	69	21/64 (32.8%)	28	17/63 (27%)	19
Respiratory, thoracic and mediastinal disorders
Cough	3/67 (4.5%)	3	20/128 (15.6%)	23	6/64 (9.4%)	7	6/63 (9.5%)	6
Skin and subcutaneous tissue disorders
Erythema	14/67 (20.9%)	18	13/128 (10.2%)	14	1/64 (1.6%)	1	2/63 (3.2%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.