Trial Outcomes & Findings for Monovalent H5N1 Vaccine GSK1557484A in Children 6 Months to < 18 Years of Age (NCT NCT01310413)

NCT ID: NCT01310413

Last Updated: 2021-11-01

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 842 participants
• Primary outcome timeframe: At Day 42.
• Results posted on: 2021-11-01

Participant Flow

The study included a first 385-days Blinded Phase (all subjects), followed by a 385-days Unblinded Phase. In this phase, subjects who received the placebo in the Blinded Phase were offered, after completing the Blinded Phase, 2 doses of Influenza A (H5N1) Virus monovalent vaccine administered for Dose 1 within a short delay of Day 385 (Day U0).

A total of 842 subjects were enrolled in the study in its Blinded Phase part. This number was later amended down to 838, following corrections for wrong subject number allocation and randomization errors.

Participant milestones

Measure	Influenza A (H5N1) Adjuvanted 6-<36M Group Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 6-<36M Group Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo/Influenza A (H5N1) Adjuvanted Group Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-\<36M, Placebo 3-\<9Y or Placebo 9-\<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-\<36M, Placebo 3-\<9Y and Placebo 9-\<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non-dominant arm and Dose 2 in the deltoid region of the dominant arm.
Day 0 to Day 385 STARTED	199	198	210	75	76	80	0
Day 0 to Day 385 COMPLETED	172	190	203	67	73	77	0
Day 0 to Day 385 NOT COMPLETED	27	8	7	8	3	3	0
From Day U0 to Day U385 STARTED	0	0	0	0	0	0	155
From Day U0 to Day U385 COMPLETED	0	0	0	0	0	0	152
From Day U0 to Day U385 NOT COMPLETED	0	0	0	0	0	0	3

Reasons for withdrawal

Measure	Influenza A (H5N1) Adjuvanted 6-<36M Group Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 6-<36M Group Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo/Influenza A (H5N1) Adjuvanted Group Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-\<36M, Placebo 3-\<9Y or Placebo 9-\<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-\<36M, Placebo 3-\<9Y and Placebo 9-\<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non-dominant arm and Dose 2 in the deltoid region of the dominant arm.
Day 0 to Day 385 Withdrawal by Subject	5	2	0	2	1	1	0
Day 0 to Day 385 Lost to Follow-up	18	3	3	5	1	2	0
Day 0 to Day 385 Migrated/moved from study area	3	3	1	1	1	0	0
Day 0 to Day 385 Other	1	0	3	0	0	0	0
From Day U0 to Day U385 Withdrawal by Subject	0	0	0	0	0	0	1
From Day U0 to Day U385 Lost to Follow-up	0	0	0	0	0	0	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Influenza A (H5N1) Adjuvanted 6-<36M Group n=199 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 3-<9Y Group n=198 Participants Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 9-<18Y Group n=210 Participants Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 6-<36M Group n=75 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 3-<9Y Group n=76 Participants Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 9-<18Y Group n=80 Participants Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Total n=838 Participants Total of all reporting groups
Age, Continuous	21.7 Months STANDARD_DEVIATION 8.17 • n=5 Participants	70.5 Months STANDARD_DEVIATION 21.71 • n=7 Participants	160.8 Months STANDARD_DEVIATION 28.21 • n=5 Participants	22.6 Months STANDARD_DEVIATION 8.17 • n=4 Participants	65.2 Months STANDARD_DEVIATION 20.2 • n=21 Participants	156.0 Months STANDARD_DEVIATION 31.29 • n=8 Participants	84.9 Months STANDARD_DEVIATION 61.40 • n=8 Participants
Sex: Female, Male Female	92 Participants n=5 Participants	90 Participants n=7 Participants	103 Participants n=5 Participants	39 Participants n=4 Participants	35 Participants n=21 Participants	42 Participants n=8 Participants	401 Participants n=8 Participants
Sex: Female, Male Male	107 Participants n=5 Participants	108 Participants n=7 Participants	107 Participants n=5 Participants	36 Participants n=4 Participants	41 Participants n=21 Participants	38 Participants n=8 Participants	437 Participants n=8 Participants

PRIMARY outcome

Timeframe: At Day 42.

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: At Days 0 and 21

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

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

Outcome measures

Measure	Influenza A (H5N1) Adjuvanted 6-<36M Group n=182 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 3-<9Y Group n=184 Participants Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 9-<18Y Group n=204 Participants Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 6-<36M Group n=67 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 3-<9Y Group n=71 Participants Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 9-<18Y Group n=76 Participants Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain. A/INDO, Day 0 [N=182;184;204;67;71;76]	5.3 Titer Interval 5.1 to 5.5	5.6 Titer Interval 5.3 to 5.9	5.7 Titer Interval 5.4 to 6.1	5.3 Titer Interval 5.0 to 5.7	5.6 Titer Interval 5.1 to 6.0	5.4 Titer Interval 5.1 to 5.8
Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain. A/INDO, Day 21 [N=179;184;204;67;70;76]	38.7 Titer Interval 33.9 to 44.2	44.6 Titer Interval 39.2 to 50.9	35.3 Titer Interval 31.7 to 39.5	5.2 Titer Interval 5.0 to 5.4	5.4 Titer Interval 5.0 to 5.7	5.4 Titer Interval 5.1 to 5.7

SECONDARY outcome

Timeframe: At Days 0 and 21

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: At Days 21 and 42

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

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

As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.

Outcome measures

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

SECONDARY outcome

Timeframe: At Days 21 and 42

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

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

Outcome measures

Measure	Influenza A (H5N1) Adjuvanted 6-<36M Group n=179 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 3-<9Y Group n=185 Participants Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 9-<18Y Group n=204 Participants Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 6-<36M Group n=67 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 3-<9Y Group n=71 Participants Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 9-<18Y Group n=76 Participants Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain. A/INDO, Day 21 [N=179;183;204;67;70;76]	7.3 Ratio Interval 6.4 to 8.4	8.0 Ratio Interval 7.0 to 9.1	6.2 Ratio Interval 5.5 to 6.9	1.0 Ratio Interval 0.9 to 1.0	1.0 Ratio Interval 0.9 to 1.0	1.0 Ratio Interval 0.9 to 1.1
Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain. A/INDO, Day 42 [N=175;184;203;64;71;76]	148.5 Ratio Interval 134.5 to 164.1	96.9 Ratio Interval 85.3 to 110.1	72.4 Ratio Interval 63.9 to 82.0	1.0 Ratio Interval 0.9 to 1.0	1.0 Ratio Interval 0.9 to 1.0	1.1 Ratio Interval 1.0 to 1.2

SECONDARY outcome

Timeframe: At Day 0 and Day 182.

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

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

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

Outcome measures

Measure	Influenza A (H5N1) Adjuvanted 6-<36M Group n=107 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 3-<9Y Group n=101 Participants Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 9-<18Y Group n=100 Participants Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 6-<36M Group n=36 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 3-<9Y Group n=37 Participants Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 9-<18Y Group n=35 Participants Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain. A/INDO, Day 0 [N=107;101;100;36;37;35]	5.1 Titre Interval 5.0 to 5.2	5.2 Titre Interval 5.0 to 5.4	5.6 Titre Interval 5.2 to 6.0	5.3 Titre Interval 4.9 to 5.7	5.2 Titre Interval 4.8 to 5.8	5.4 Titre Interval 4.8 to 6.0
Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain. A/INDO, Day 182 [N=84;89;87;29;34;31]	90.6 Titre Interval 78.1 to 105.0	57.4 Titre Interval 50.8 to 64.9	50.2 Titre Interval 43.3 to 58.2	5.0 Titre Interval 5.0 to 5.0	5.4 Titre Interval 4.9 to 6.0	5.4 Titre Interval 4.9 to 5.9

SECONDARY outcome

Timeframe: At Day 0 and Day 182

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

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

As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.

Outcome measures

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

SECONDARY outcome

Timeframe: At Day 42.

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

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

As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.

Outcome measures

Measure	Influenza A (H5N1) Adjuvanted 6-<36M Group n=175 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 3-<9Y Group n=185 Participants Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 9-<18Y Group n=203 Participants Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 6-<36M Group n=64 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 3-<9Y Group n=71 Participants Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 9-<18Y Group n=76 Participants Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain	777.1 Titer Interval 705.6 to 855.9	543.8 Titer Interval 484.9 to 609.8	416.2 Titer Interval 371.5 to 466.2	5.1 Titer Interval 4.9 to 5.3	5.4 Titer Interval 5.0 to 5.7	5.8 Titer Interval 5.3 to 6.3

SECONDARY outcome

Timeframe: At Day 182

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: At Day 182

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

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

Outcome measures

Measure	Influenza A (H5N1) Adjuvanted 6-<36M Group n=84 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 3-<9Y Group n=89 Participants Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 9-<18Y Group n=87 Participants Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 6-<36M Group n=29 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 3-<9Y Group n=34 Participants Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 9-<18Y Group n=31 Participants Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.	17.8 Ratio Interval 15.3 to 20.8	11.0 Ratio Interval 9.7 to 12.4	8.8 Ratio Interval 7.5 to 10.4	1.0 Ratio Interval 0.9 to 1.0	1.1 Ratio Interval 1.0 to 1.2	1.0 Ratio Interval 0.9 to 1.2

SECONDARY outcome

Timeframe: At Day 0 and Day 385

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

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

As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.

Outcome measures

Measure	Influenza A (H5N1) Adjuvanted 6-<36M Group n=182 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 3-<9Y Group n=184 Participants Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 9-<18Y Group n=204 Participants Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 6-<36M Group n=67 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 3-<9Y Group n=71 Participants Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 9-<18Y Group n=76 Participants Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain. A/INDO, Day 0 [N=182;184;204;67;71;76]	5.3 Titer Interval 5.1 to 5.5	5.6 Titer Interval 5.3 to 5.9	5.7 Titer Interval 5.4 to 6.1	5.3 Titer Interval 5.0 to 5.7	5.6 Titer Interval 5.1 to 6.0	5.4 Titer Interval 5.1 to 5.8
Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain. A/INDO, Day 385 [N=63;85;95;26;34;36]	65.6 Titer Interval 55.9 to 76.9	32.8 Titer Interval 28.1 to 38.4	21.6 Titer Interval 18.6 to 25.1	5.1 Titer Interval 4.9 to 5.4	5.4 Titer Interval 4.9 to 5.8	5.3 Titer Interval 4.8 to 5.9

SECONDARY outcome

Timeframe: At Day 0 and Day 385

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

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

As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.

Outcome measures

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

SECONDARY outcome

Timeframe: At Day 385

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: At Day 385.

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

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

Outcome measures

Measure	Influenza A (H5N1) Adjuvanted 6-<36M Group n=63 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 3-<9Y Group n=85 Participants Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 9-<18Y Group n=95 Participants Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 6-<36M Group n=26 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 3-<9Y Group n=34 Participants Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 9-<18Y Group n=36 Participants Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.	12.1 Fold increase Interval 10.3 to 14.2	5.5 Fold increase Interval 4.7 to 6.6	3.6 Fold increase Interval 3.1 to 4.3	1.0 Fold increase Interval 0.9 to 1.1	0.9 Fold increase Interval 0.8 to 1.0	1.0 Fold increase Interval 0.8 to 1.1

SECONDARY outcome

Timeframe: At Days 0, 42, 182 and 385

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

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

Outcome measures

Measure	Influenza A (H5N1) Adjuvanted 6-<36M Group n=36 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 3-<9Y Group n=39 Participants Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 9-<18Y Group n=40 Participants Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 6-<36M Group n=10 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 3-<9Y Group n=11 Participants Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 9-<18Y Group n=11 Participants Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Microneutralization (MN) Antibody Titers Against the H5N1 A/Indonesia and H5N1 A/Vietnam Virus Strains. A/INDO, Day 182 [N=33;39;33;10;10;9]	216.82 Titer Interval 162.03 to 290.14	130.32 Titer Interval 107.3 to 158.26	104.18 Titer Interval 86.95 to 124.82	16.11 Titer Interval 11.73 to 22.13	14.00 Titer Interval 14.0 to 14.0	17.67 Titer Interval 12.08 to 25.86
Microneutralization (MN) Antibody Titers Against the H5N1 A/Indonesia and H5N1 A/Vietnam Virus Strains. A/INDO, Day 385 [N=25;33;37;8;11;9]	166.64 Titer Interval 135.9 to 204.32	108.59 Titer Interval 87.88 to 134.19	82.26 Titer Interval 67.27 to 100.59	15.27 Titer Interval 12.44 to 18.74	14.91 Titer Interval 12.96 to 17.16	16.33 Titer Interval 12.91 to 20.66
Microneutralization (MN) Antibody Titers Against the H5N1 A/Indonesia and H5N1 A/Vietnam Virus Strains. A/VIET, Day 0 [N=36;36;40;7;10;11]	14.83 Titer Interval 13.89 to 15.84	19.84 Titer Interval 16.82 to 23.4	24.88 Titer Interval 20.75 to 29.85	17.11 Titer Interval 10.47 to 27.95	16.08 Titer Interval 13.05 to 19.82	20.47 Titer Interval 14.82 to 28.26
Microneutralization (MN) Antibody Titers Against the H5N1 A/Indonesia and H5N1 A/Vietnam Virus Strains. A/VIET, Day 42 [N=34;37;40;6;10;11]	68.18 Titer Interval 58.05 to 80.07	71.15 Titer Interval 61.62 to 82.15	65.25 Titer Interval 57.03 to 74.64	17.69 Titer Interval 9.69 to 32.28	19.87 Titer Interval 12.97 to 30.43	28.14 Titer Interval 19.53 to 40.54
Microneutralization (MN) Antibody Titers Against the H5N1 A/Indonesia and H5N1 A/Vietnam Virus Strains. A/VIET, Day 182 [N=33;39;33;10;10;9]	48.77 Titer Interval 36.56 to 65.06	44.11 Titer Interval 36.19 to 53.77	61.67 Titer Interval 51.38 to 74.01	19.82 Titer Interval 12.22 to 32.14	17.24 Titer Interval 13.56 to 21.9	24.14 Titer Interval 14.29 to 40.78
Microneutralization (MN) Antibody Titers Against the H5N1 A/Indonesia and H5N1 A/Vietnam Virus Strains. A/VIET, Day 385 [N=25;33;37;8;11;9]	59.83 Titer Interval 48.09 to 74.43	38.62 Titer Interval 30.6 to 48.73	47.73 Titer Interval 38.76 to 58.79	14.00 Titer Interval 14.0 to 14.0	18.07 Titer Interval 12.34 to 26.47	35.42 Titer Interval 19.45 to 64.49
Microneutralization (MN) Antibody Titers Against the H5N1 A/Indonesia and H5N1 A/Vietnam Virus Strains. A/INDO, Day 0 [N=36;37;40;7;10;11]	14.00 Titer Interval 14.0 to 14.0	15.67 Titer Interval 14.37 to 17.08	15.54 Titer Interval 14.13 to 17.09	15.46 Titer Interval 12.13 to 19.7	14.00 Titer Interval 14.0 to 14.0	14.91 Titer Interval 12.96 to 17.16
Microneutralization (MN) Antibody Titers Against the H5N1 A/Indonesia and H5N1 A/Vietnam Virus Strains. A/INDO, Day 42 [N=34;37;40;6;10;11]	855.62 Titer Interval 597.88 to 1224.47	657.60 Titer Interval 453.13 to 954.33	380.62 Titer Interval 277.43 to 522.2	14.00 Titer Interval 14.0 to 14.0	14.00 Titer Interval 14.0 to 14.0	14.91 Titer Interval 12.96 to 17.16

SECONDARY outcome

Timeframe: At Days 0 and 42

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

Outcome measures

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

SECONDARY outcome

Timeframe: At Day 42

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 1)

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: During the 7-day (Days U0-U6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 2)

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

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

Outcome measures

Measure	Influenza A (H5N1) Adjuvanted 6-<36M Group n=154 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 6-<36M Group Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Number of Subjects Reporting Solicited Local Symptoms. Any Redness	6 Subject	—	—	—	—	—
Number of Subjects Reporting Solicited Local Symptoms. Any Pain	111 Subject	—	—	—	—	—
Number of Subjects Reporting Solicited Local Symptoms. Grade 3 Pain	8 Subject	—	—	—	—	—
Number of Subjects Reporting Solicited Local Symptoms. Grade 3 Redness	0 Subject	—	—	—	—	—
Number of Subjects Reporting Solicited Local Symptoms. Any Swelling	5 Subject	—	—	—	—	—
Number of Subjects Reporting Solicited Local Symptoms. Grade 3 Swelling	0 Subject	—	—	—	—	—

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 1)

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: During the 7-day (Days U0-U6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 2)

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

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

Outcome measures

Measure	Influenza A (H5N1) Adjuvanted 6-<36M Group n=79 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 6-<36M Group Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms. Any Drowsiness	23 Subject	—	—	—	—	—
Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms. Grade 3 Drowsiness	1 Subject	—	—	—	—	—
Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms. Related Drowsiness	17 Subject	—	—	—	—	—
Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms. Any Irritability/Fussiness	28 Subject	—	—	—	—	—
Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms. Grade 3 Irritability/Fussiness	1 Subject	—	—	—	—	—
Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms. Related Irritability/Fussiness	23 Subject	—	—	—	—	—
Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms. Any Loss of appetite	18 Subject	—	—	—	—	—
Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms. Grade 3 Loss of appetite	0 Subject	—	—	—	—	—
Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms. Related Loss of appetite	13 Subject	—	—	—	—	—
Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms. Any Fever	4 Subject	—	—	—	—	—
Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms. Grade 3 Fever	2 Subject	—	—	—	—	—
Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms. Related Fever	3 Subject	—	—	—	—	—

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 1)

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: During the 7-day (Days U0-U6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 2)

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

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

Outcome measures

Measure	Influenza A (H5N1) Adjuvanted 6-<36M Group n=75 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 6-<36M Group Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms. Any Gastrointestinal	7 Subject	—	—	—	—	—
Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms. Any Fatigue	18 Subject	—	—	—	—	—
Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms. Grade 3 Fatigue	1 Subject	—	—	—	—	—
Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms. Related Fatigue	13 Subject	—	—	—	—	—
Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms. Grade 3 Gastrointestinal	0 Subject	—	—	—	—	—
Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms. Related Gastrointestinal	5 Subject	—	—	—	—	—
Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms. Any Headache	24 Subject	—	—	—	—	—
Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms. Grade 3 Headache	1 Subject	—	—	—	—	—
Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms. Related Headache	20 Subject	—	—	—	—	—
Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms. Any Increased Sweating	5 Subject	—	—	—	—	—
Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms. Grade 3 Increased Sweating	0 Subject	—	—	—	—	—
Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms. Related Increased Sweating	3 Subject	—	—	—	—	—
Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms. Any Joint Pain	14 Subject	—	—	—	—	—
Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms. Grade 3 Joint Pain	0 Subject	—	—	—	—	—
Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms. Related Joint Pain	12 Subject	—	—	—	—	—
Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms. Any Muscle Aches	34 Subject	—	—	—	—	—
Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms. Grade 3 Muscle Aches	0 Subject	—	—	—	—	—
Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms. Related Muscle Aches	28 Subject	—	—	—	—	—
Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms. Any Shivering (Chills)	7 Subject	—	—	—	—	—
Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms. Grade 3 Shivering (Chills)	2 Subject	—	—	—	—	—
Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms. Related Shivering (Chills)	4 Subject	—	—	—	—	—
Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms. Any Fever	1 Subject	—	—	—	—	—
Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms. Grade 3 Fever	0 Subject	—	—	—	—	—
Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms. Related Fever	0 Subject	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 0 up to Day 385

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

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

Outcome measures

Measure	Influenza A (H5N1) Adjuvanted 6-<36M Group n=607 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 3-<9Y Group n=231 Participants Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 6-<36M Group Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Number of Subjects With Medically-attended Adverse Events (MAEs)	189 Subject	77 Subject	—	—	—	—

SECONDARY outcome

Timeframe: From Day U0 up to Day U385

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

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

Outcome measures

Measure	Influenza A (H5N1) Adjuvanted 6-<36M Group n=155 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 6-<36M Group Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Number of Subjects With Medically-attended Adverse Events (MAEs)	36 Subject	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 0 up to Day 385

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

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

Outcome measures

Measure	Influenza A (H5N1) Adjuvanted 6-<36M Group n=607 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 3-<9Y Group n=231 Participants Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 6-<36M Group Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)	1 Subject	1 Subject	—	—	—	—

SECONDARY outcome

Timeframe: From Day U0 to Day U385

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

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

Outcome measures

Measure	Influenza A (H5N1) Adjuvanted 6-<36M Group n=155 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 6-<36M Group Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)	0 Subject	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 0 up to Day 385

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

Outcome measures

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

SECONDARY outcome

Timeframe: From Day U0 to Day U385

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

Outcome measures

Measure	Influenza A (H5N1) Adjuvanted 6-<36M Group n=155 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 6-<36M Group Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Number of Subjects Reporting Pregnancies, and Outcomes of These Reported Pregnancies	0 Subject	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day 0 up to Day 385

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: From Day 0 up to Day 385

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: From Day 0 up to Day 385

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

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

Outcome measures

Measure	Influenza A (H5N1) Adjuvanted 6-<36M Group n=607 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 3-<9Y Group n=231 Participants Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 6-<36M Group Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) BUN, Day 385 Within [N=251,104]	237 Subject	100 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) BUN, Day 385 Above [N=251,104]	4 Subject	2 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) BUN, Day 385 Below [N=251,104]	3 Subject	2 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) BUN, PRE Below [N=606,231]	13 Subject	4 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) BUN, PRE Within [N=606,231]	553 Subject	218 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) BUN, PRE Above [N=606,231]	25 Subject	5 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) BUN, Day 42 Unknown [N=583,220]	17 Subject	4 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) BUN, Day 42 Below [N=583,220]	11 Subject	3 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) BUN, Day 42 Within [N=583,220]	531 Subject	209 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) BUN, Day 42 Above [N=583,220]	24 Subject	4 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) BUN, Day 182 Unknown [N=304,110]	6 Subject	0 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) BUN, Day 182 Below [N=304,110]	8 Subject	2 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) BUN, Day 182 Within [N=304,110]	281 Subject	105 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) BUN, Day 182 Above [N=304,110]	9 Subject	3 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) BUN, Day 385 Unknown [N=251,104]	7 Subject	0 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) CREA, Day 385 Within [N=251,104]	191 Subject	80 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) CREA, Day 385 Above [N=251,104]	3 Subject	0 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) BUN, PRE Unknown [N=606,231]	15 Subject	4 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) CREA, PRE Unknown [N=606,231]	15 Subject	4 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) CREA, PRE Below [N=606, 231]	142 Subject	61 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) CREA, PRE Within [N=606, 231]	447 Subject	165 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) CREA, PRE Above [N=606, 231]	2 Subject	1 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) CREA, Day 42 Unknown [N=583,220]	17 Subject	4 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) CREA, Day 42 Below [N=583,220]	130 Subject	48 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) CREA, Day 42 Within [N=583,220]	432 Subject	166 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) CREA, Day 42 Above [N=583,220]	4 Subject	2 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) CREA, Day 182 Unknown [N=304,110]	6 Subject	1 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) CREA, Day 182 Below [N=304,110]	66 Subject	26 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) CREA, Day 182 Within [N=304,110]	231 Subject	83 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) CREA, Day 182 Above [N=304,110]	1 Subject	0 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) CREA, Day 385 Unknown [N=251,104]	6 Subject	0 Subject	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN) CREA, Day 385 Below [N=251,104]	51 Subject	24 Subject	—	—	—	—

SECONDARY outcome

Timeframe: From Day 0 up to Day 385

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: From Day 0 up to Day 385

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: From Day 0 up to Day 385

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: From Day 0 up to Day 385

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: From Day 0 up to Day 385

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: During the 21-day (Days 0-20) post-vaccination period following Dose 1 of vaccine/placebo

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

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

Outcome measures

Measure	Influenza A (H5N1) Adjuvanted 6-<36M Group n=607 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 3-<9Y Group n=231 Participants Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 6-<36M Group Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).	153 Subject	63 Subject	—	—	—	—

SECONDARY outcome

Timeframe: During the 21-day (Days 21-41) post-vaccination period following Dose 2 of vaccine/placebo

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

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

Outcome measures

Measure	Influenza A (H5N1) Adjuvanted 6-<36M Group n=593 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 3-<9Y Group n=224 Participants Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 6-<36M Group Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).	135 Subject	54 Subject	—	—	—	—

SECONDARY outcome

Timeframe: During the 42-day (Days 0-41) post-vaccination period following Dose 1 of vaccine/placebo

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

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

Outcome measures

Measure	Influenza A (H5N1) Adjuvanted 6-<36M Group n=607 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 3-<9Y Group n=231 Participants Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 6-<36M Group Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).	243 Subject	97 Subject	—	—	—	—

SECONDARY outcome

Timeframe: From Day 0 up to Day 385

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

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

Outcome measures

Measure	Influenza A (H5N1) Adjuvanted 6-<36M Group n=607 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 3-<9Y Group n=231 Participants Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 6-<36M Group Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Number of Subjects Reporting Serious Adverse Events (SAEs)	8 Subject	4 Subject	—	—	—	—

SECONDARY outcome

Timeframe: During the 21-day (Days U0-U20) post-vaccination period following Dose 1 of Influenza A (H5N1) Virus monovalent vaccine

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

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

Outcome measures

Measure	Influenza A (H5N1) Adjuvanted 6-<36M Group n=155 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 6-<36M Group Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).	21 Subject	—	—	—	—	—

SECONDARY outcome

Timeframe: During the 21-day (Days U21-U41) post-vaccination period following Dose 2 of Influenza A (H5N1) Virus monovalent vaccine

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

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

Outcome measures

Measure	Influenza A (H5N1) Adjuvanted 6-<36M Group n=155 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 6-<36M Group Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).	27 Subject	—	—	—	—	—

SECONDARY outcome

Timeframe: During the 42-day (Days U0-U41) post-vaccination period following Dose 1 of Influenza A (H5N1) Virus monovalent vaccine

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

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

Outcome measures

Measure	Influenza A (H5N1) Adjuvanted 6-<36M Group n=155 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 6-<36M Group Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).	41 Subject	—	—	—	—	—

SECONDARY outcome

Timeframe: From Day U0 up to Day U385

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

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

Outcome measures

Measure	Influenza A (H5N1) Adjuvanted 6-<36M Group n=155 Participants Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Influenza A (H5N1) Adjuvanted 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 6-<36M Group Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 3-<9Y Group Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo 9-<18Y Group Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Number of Subjects Reporting Serious Adverse Events (SAEs)	2 Subject	—	—	—	—	—

Adverse Events

Influenza A (H5N1) Adjuvanted Group

Serious events: 8 serious events

Other events: 502 other events

Deaths: 0 deaths

Placebo Group

Serious events: 4 serious events

Other events: 189 other events

Deaths: 0 deaths

Placebo/Influenza A (H5N1) Adjuvanted Group

Serious events: 2 serious events

Other events: 124 other events

Deaths: 0 deaths

Serious adverse events

Measure	Influenza A (H5N1) Adjuvanted Group n=607 participants at risk This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-\<36M, Influenza A (H5N1) adjuvanted 3≤9Y and Influenza A (H5N1) adjuvanted 9≤18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (≥12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo Group n=231 participants at risk This group results from the pooling of the Placebo 6-\<36M, Placebo 3-\<9Y and Placebo 9≤18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (≥) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo/Influenza A (H5N1) Adjuvanted Group n=155 participants at risk Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6≤36M, Placebo 3≤9Y or Placebo 9≤18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6≤36M, Placebo 3≤9Y and Placebo 9≤18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non-dominant arm and Dose 2 in the deltoid region of the dominant arm.
Infections and infestations Infectious mononucleosis	0.33% 2/607 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/231 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/155 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.16% 1/607 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/231 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/155 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/607 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.43% 1/231 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/155 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.16% 1/607 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/231 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/155 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Metabolism and nutrition disorders Dehydration	0.16% 1/607 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/231 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/155 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Nervous system disorders Febrile convulsion	0.16% 1/607 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/231 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/155 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Infections and infestations Influenza	0.16% 1/607 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/231 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/155 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Gastrointestinal disorders Inguinal hernia	0.16% 1/607 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/231 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/155 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/607 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.43% 1/231 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/155 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Infections and infestations Pneumonia	0.16% 1/607 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/231 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/155 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Injury, poisoning and procedural complications Skeletal injury	0.16% 1/607 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/231 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/155 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Psychiatric disorders Suicidal ideation	0.00% 0/607 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.43% 1/231 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/155 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/607 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.43% 1/231 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/155 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Infections and infestations Upper respiratory tract infection	0.16% 1/607 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/231 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/155 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Infections and infestations Scarlet fever	0.00% 0/607 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/231 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.65% 1/155 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Injury, poisoning and procedural complications Wound	0.00% 0/607 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/231 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.65% 1/155 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.

Other adverse events

Measure	Influenza A (H5N1) Adjuvanted Group n=607 participants at risk This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-\<36M, Influenza A (H5N1) adjuvanted 3≤9Y and Influenza A (H5N1) adjuvanted 9≤18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (≥12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo Group n=231 participants at risk This group results from the pooling of the Placebo 6-\<36M, Placebo 3-\<9Y and Placebo 9≤18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (≥) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).	Placebo/Influenza A (H5N1) Adjuvanted Group n=155 participants at risk Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6≤36M, Placebo 3≤9Y or Placebo 9≤18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6≤36M, Placebo 3≤9Y and Placebo 9≤18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non-dominant arm and Dose 2 in the deltoid region of the dominant arm.
General disorders Pain	67.2% 405/603 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	30.1% 69/229 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	72.1% 111/154 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Swelling	6.8% 41/603 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.44% 1/229 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	3.2% 5/154 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Drowsiness	34.4% 101/294 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	23.8% 29/122 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	29.1% 23/79 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Irritability/fussiness	43.5% 128/294 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	32.8% 40/122 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	35.4% 28/79 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Loss of appetite	26.9% 79/294 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	23.8% 29/122 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	22.8% 18/79 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Fever (axillary temperature >= 38.0°C)	6.1% 19/309 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	2.8% 3/107 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	1.3% 1/75 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Fatigue	28.8% 89/309 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	17.8% 19/107 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	24.0% 18/75 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Gastrointestinal disorders	13.9% 43/309 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	16.8% 18/107 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	9.3% 7/75 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Headache	32.4% 100/309 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	16.8% 18/107 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	32.0% 24/75 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Joint pain at other location	16.2% 50/309 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	8.4% 9/107 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	18.7% 14/75 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Muscle aches	39.8% 123/309 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	15.9% 17/107 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	45.3% 34/75 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Shivering	8.1% 25/309 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	6.5% 7/107 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	9.3% 7/75 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Sweating	8.1% 25/309 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	3.7% 4/107 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	6.7% 5/75 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Respiratory, thoracic and mediastinal disorders Cough	5.9% 36/607 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	7.4% 17/231 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	5.8% 9/155 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Infections and infestations Nasopharyngitis	4.8% 29/607 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	7.8% 18/231 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	6.5% 10/155 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	4.4% 27/607 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	5.6% 13/231 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	1.9% 3/155 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Gastrointestinal disorders Diarrhoea	2.1% 13/607 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	5.2% 12/231 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	1.9% 3/155 • Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration. For the systematically assessed other (non-serious) adverse events, number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.

Additional Information

GSK Response Center

GlaxoSmithKline

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Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER