Trial Outcomes & Findings for Evaluate Safety & Immunogenicity of a Pandemic Influenza Vaccine (GSK1562902A) in Children (NCT NCT00502593)

Last Updated: 2018-10-25

Results Overview

Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

138 participants

Primary outcome timeframe

At Day 0

Results posted on

2018-10-25

Participant Flow

138 subjects were enrolled as part of the first 107066/Phase A part of this NCT00502593 study. This first part was then followed by a second and third part (Phases B \[study 108498\] and C \[study 108500\] during which 134 and 133 subjects were enrolled, respectively. Duration of the study was of 24 months for all subjects.

For safety reasons, subjects in each group were enrolled in a staggered manner, with enrolment taking place sequentially into 2 age strata, '6-9 years' 1st, and '3-5 years' next.

Participant milestones

Participant milestones
Measure	GSK1562902A-A Lot 1 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Overall Study STARTED	51	18	51	18	51	17	49	17	49	17	49	18
Overall Study COMPLETED	48	16	41	14	47	17	44	17	43	17	47	18
Overall Study NOT COMPLETED	3	2	10	4	4	0	5	0	6	0	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK1562902A-A Lot 1 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Overall Study Withdrawn unspecified reason	1	1	3	1	2	2	0	0
Overall Study Withdrawal by Subject	0	0	6	2	2	3	3	1
Overall Study Lost to Follow-up	2	1	1	1	0	0	3	1

Baseline Characteristics

Evaluate Safety & Immunogenicity of a Pandemic Influenza Vaccine (GSK1562902A) in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK1562902A -A Lot 1 3-5Y Group n=51 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=18 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=51 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group n=51 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group n=49 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group n=49 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group n=49 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Total n=405 Participants Total of all reporting groups
Age, Continuous	3.9 Years STANDARD_DEVIATION 0.84 • n=5 Participants	3.6 Years STANDARD_DEVIATION 0.70 • n=7 Participants	7.6 Years STANDARD_DEVIATION 1.06 • n=5 Participants	7.6 Years STANDARD_DEVIATION 1.38 • n=4 Participants	4.2 Years STANDARD_DEVIATION 0.85 • n=21 Participants	4.4 Years STANDARD_DEVIATION 0.79 • n=8 Participants	7.3 Years STANDARD_DEVIATION 1.28 • n=8 Participants	7.2 Years STANDARD_DEVIATION 1.20 • n=24 Participants	4.2 Years STANDARD_DEVIATION 0.85 • n=42 Participants	3.9 Years STANDARD_DEVIATION 0.93 • n=42 Participants	7.0 Years STANDARD_DEVIATION 1.06 • n=42 Participants	7.4 Years STANDARD_DEVIATION 0.98 • n=42 Participants	6.1 Years STANDARD_DEVIATION 0.92 • n=36 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	9 Participants n=7 Participants	24 Participants n=5 Participants	7 Participants n=4 Participants	25 Participants n=21 Participants	10 Participants n=8 Participants	19 Participants n=8 Participants	3 Participants n=24 Participants	22 Participants n=42 Participants	11 Participants n=42 Participants	18 Participants n=42 Participants	9 Participants n=42 Participants	182 Participants n=36 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	9 Participants n=7 Participants	27 Participants n=5 Participants	11 Participants n=4 Participants	26 Participants n=21 Participants	7 Participants n=8 Participants	30 Participants n=8 Participants	14 Participants n=24 Participants	27 Participants n=42 Participants	6 Participants n=42 Participants	31 Participants n=42 Participants	9 Participants n=42 Participants	223 Participants n=36 Participants

PRIMARY outcome

Timeframe: At Day 0

Population: The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=49 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=15 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=43 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=15 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group n=42 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group n=16 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group n=45 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group n=44 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group n=15 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group n=43 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group n=13 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/VIET	NA Titer Data was not computed (titers below cut-off value for titer calculation)	NA Titer Data was not computed (titers below cut-off value for titer calculation)	NA Titer Data was not computed (titers below cut-off value for titer calculation)	NA Titer Data was not computed (titers below cut-off value for titer calculation)	5.1 Titer Interval 4.9 to 5.4	NA Titer Data was not computed (titers below cut-off value for titer calculation)	NA Titer Data was not computed (titers below cut-off value for titer calculation)	NA Titer Data was not computed (titers below cut-off value for titer calculation)	NA Titer Data was not computed (titers below cut-off value for titer calculation)	NA Titer Data was not computed (titers below cut-off value for titer calculation)	NA Titer Data was not computed (titers below cut-off value for titer calculation)	NA Titer Data was not computed (titers below cut-off value for titer calculation)
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/INDO	NA Titer Data was not computed (titers below cut-off value for titer calculation)	NA Titer Data was not computed (titers below cut-off value for titer calculation)	NA Titer Data was not computed (titers below cut-off value for titer calculation)	NA Titer Data was not computed (titers below cut-off value for titer calculation)	NA Titer Data was not computed (titers below cut-off value for titer calculation)	NA Titer Data was not computed (titers below cut-off value for titer calculation)	NA Titer Data was not computed (titers below cut-off value for titer calculation)	NA Titer Data was not computed (titers below cut-off value for titer calculation)	NA Titer Data was not computed (titers below cut-off value for titer calculation)	NA Titer Data was not computed (titers below cut-off value for titer calculation)	NA Titer Data was not computed (titers below cut-off value for titer calculation)	NA Titer Data was not computed (titers below cut-off value for titer calculation)

PRIMARY outcome

Timeframe: At Day 21

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=49 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=15 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=43 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=15 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group n=41 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group n=16 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group n=45 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group n=43 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group n=15 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group n=30 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group n=9 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/VIET	8.7 Titer Interval 6.2 to 12.3	NA Titer Data was not computed (titers below cut-off value for titer calculation)	12.1 Titer Interval 8.4 to 17.5	NA Titer Data was not computed (titers below cut-off value for titer calculation)	22.7 Titer Interval 14.6 to 35.3	NA Titer Data was not computed (titers below cut-off value for titer calculation)	23.7 Titer Interval 14.3 to 39.1	NA Titer Data was not computed (titers below cut-off value for titer calculation)	25.0 Titer Interval 16.0 to 39.3	5.7 Titer Interval 4.3 to 7.7	27.3 Titer Interval 16.2 to 46.0	NA Titer Data was not computed (titers below cut-off value for titer calculation)
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/INDO	5.2 Titer Interval 4.9 to 5.6	NA Titer Data was not computed (titers below cut-off value for titer calculation)	5.2 Titer Interval 4.8 to 5.8	NA Titer Data was not computed (titers below cut-off value for titer calculation)	5.5 Titer Interval 4.9 to 6.2	NA Titer Data was not computed (titers below cut-off value for titer calculation)	5.3 Titer Interval 4.9 to 5.8	NA Titer Data was not computed (titers below cut-off value for titer calculation)	7.7 Titer Interval 6.0 to 9.8	NA Titer Data was not computed (titers below cut-off value for titer calculation)	6.0 Titer Interval 5.0 to 7.2	NA Titer Data was not computed (titers below cut-off value for titer calculation)

PRIMARY outcome

Timeframe: At Day 42

Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=49 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=15 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=43 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=15 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group n=42 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group n=16 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group n=45 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group n=44 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group n=15 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group n=43 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group n=13 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/VIET	392.7 Titer Interval 280.4 to 550.2	NA Titer Data was not computed (titers below cut-off value for titer calculation)	540.3 Titer Interval 424.5 to 687.7	NA Titer Data was not computed (titers below cut-off value for titer calculation)	678.1 Titer Interval 475.7 to 966.6	NA Titer Data was not computed (titers below cut-off value for titer calculation)	615.8 Titer Interval 429.0 to 884.0	NA Titer Data was not computed (titers below cut-off value for titer calculation)	956.4 Titer Interval 769.2 to 1189.3	NA Titer Data was not computed (titers below cut-off value for titer calculation)	883.5 Titer Interval 737.3 to 1058.6	NA Titer Data was not computed (titers below cut-off value for titer calculation)
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/INDO	53.5 Titer Interval 35.0 to 81.7	NA Titer Data was not computed (titers below cut-off value for titer calculation)	60.8 Titer Interval 38.7 to 95.5	NA Titer Data was not computed (titers below cut-off value for titer calculation)	73.7 Titer Interval 45.2 to 120.3	NA Titer Data was not computed (titers below cut-off value for titer calculation)	64.9 Titer Interval 38.7 to 108.9	NA Titer Data was not computed (titers below cut-off value for titer calculation)	167.9 Titer Interval 121.7 to 231.5	NA Titer Data was not computed (titers below cut-off value for titer calculation)	92.5 Titer Interval 59.3 to 144.2	NA Titer Data was not computed (titers below cut-off value for titer calculation)

PRIMARY outcome

Timeframe: At Month 6

Population: The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=50 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=15 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=44 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=14 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group n=47 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group n=16 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group n=45 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group n=29 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group n=11 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group n=41 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group n=16 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/INDO	6.9 Titer Interval 5.6 to 8.4	NA Titer Data was not computed (titers below cut-off value for titer calculation)	6.6 Titer Interval 5.2 to 8.4	NA Titer Data was not computed (titers below cut-off value for titer calculation)	21.7 Titer Interval 14.3 to 33.0	NA Titer Data was not computed (titers below cut-off value for titer calculation)	11.9 Titer Interval 8.4 to 16.9	NA Titer Data was not computed (titers below cut-off value for titer calculation)	42.5 Titer Interval 23.7 to 76.3	NA Titer Data was not computed (titers below cut-off value for titer calculation)	36.8 Titer Interval 22.3 to 60.6	NA Titer Data was not computed (titers below cut-off value for titer calculation)
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/VIET	29.3 Titer Interval 19.2 to 44.6	5.9 Titer Interval 4.2 to 8.3	33.4 Titer Interval 21.2 to 52.7	NA Titer Data was not computed (titers below cut-off value for titer calculation)	46.3 Titer Interval 29.8 to 72.0	NA Titer Data was not computed (titers below cut-off value for titer calculation)	43.2 Titer Interval 27.9 to 66.8	NA Titer Data was not computed (titers below cut-off value for titer calculation)	80.0 Titer Interval 47.0 to 136.4	NA Titer Data was not computed (titers below cut-off value for titer calculation)	61.5 Titer Interval 38.9 to 97.3	NA Titer Data was not computed (titers below cut-off value for titer calculation)

PRIMARY outcome

Timeframe: At Month 12

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=47 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=14 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=37 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=14 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group n=40 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group n=16 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group n=43 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group n=16 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group n=27 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group n=10 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group n=35 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group n=13 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/VIET	13.9 Titer Interval 9.7 to 20.0	NA Titer Data was not computed (titers below cut-off value for titer calculation)	12.0 Titer Interval 8.0 to 18.1	5.8 Titer Interval 4.2 to 8.0	19.8 Titer Interval 13.6 to 28.8	5.2 Titer Interval 4.8 to 5.7	22.4 Titer Interval 15.4 to 32.5	5.2 Titer Interval 4.8 to 5.7	23.9 Titer Interval 15.1 to 37.8	NA Titer Data was not computed (titers below cut-off value for titer calculation)	27.7 Titer Interval 19.1 to 40.4	5.4 Titer Interval 4.6 to 6.4
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/INDO	13.0 Titer Interval 9.1 to 18.7	NA Titer Data was not computed (titers below cut-off value for titer calculation)	10.5 Titer Interval 7.0 to 15.8	5.5 Titer Interval 4.5 to 6.8	16.4 Titer Interval 11.4 to 23.5	5.9 Titer Interval 4.5 to 7.9	15.0 Titer Interval 11.1 to 20.1	6.5 Titer Interval 5.2 to 8.2	18.5 Titer Interval 11.5 to 29.9	NA Titer Data was not computed (titers below cut-off value for titer calculation)	20.4 Titer Interval 13.4 to 31.1	NA Titer Data was not computed (titers below cut-off value for titer calculation)

PRIMARY outcome

Timeframe: At Month 24

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=47 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=13 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=37 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=11 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group n=39 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group n=16 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group n=42 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group n=16 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group n=26 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group n=10 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group n=34 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group n=13 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/INDO	10.1 Titer Interval 7.7 to 13.4	NA Titer Data was not computed (titers below cut-off value for titer calculation)	7.7 Titer Interval 5.9 to 10.0	NA Titer Data was not computed (titers below cut-off value for titer calculation)	22.7 Titer Interval 15.2 to 33.7	5.3 Titer Interval 4.6 to 6.1	8.7 Titer Interval 7.0 to 10.8	NA Titer Data was not computed (titers below cut-off value for titer calculation)	27.5 Titer Interval 16.1 to 47.0	NA Titer Data was not computed (titers below cut-off value for titer calculation)	18.2 Titer Interval 12.1 to 27.6	NA Titer Data was not computed (titers below cut-off value for titer calculation)
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/VIET	14.9 Titer Interval 10.3 to 21.5	NA Titer Data was not computed (titers below cut-off value for titer calculation)	13.2 Titer Interval 9.1 to 19.2	NA Titer Data was not computed (titers below cut-off value for titer calculation)	52.2 Titer Interval 33.6 to 81.1	6.8 Titer Interval 4.7 to 9.7	20.1 Titer Interval 13.9 to 29.3	NA Titer Data was not computed (titers below cut-off value for titer calculation)	55.8 Titer Interval 33.2 to 93.8	6.6 Titer Interval 3.5 to 12.4	36.5 Titer Interval 24.8 to 53.8	6.2 Titer Interval 3.9 to 9.8

PRIMARY outcome

Timeframe: At Day 21

A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer below (\<) 1:10 and a post-vaccination HI antibody titer above than or equal to (≥)1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=49 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=15 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=43 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=15 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group n=41 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group n=16 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group n=45 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group n=43 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group n=15 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group n=30 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group n=9 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease A/VIET	6 Participants	0 Participants	13 Participants	0 Participants	20 Participants	0 Participants	19 Participants	0 Participants	20 Participants	1 Participants	17 Participants	0 Participants
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease A/INDO	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: At Day 42

A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer \< 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=49 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=15 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=43 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=15 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group n=42 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group n=16 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group n=45 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group n=44 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group n=15 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group n=43 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group n=13 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease A/VIET	47 Participants	0 Participants	43 Participants	0 Participants	41 Participants	0 Participants	44 Participants	0 Participants	44 Participants	0 Participants	43 Participants	0 Participants
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease A/INDO	35 Participants	0 Participants	32 Participants	0 Participants	32 Participants	0 Participants	31 Participants	0 Participants	42 Participants	0 Participants	34 Participants	0 Participants

PRIMARY outcome

Timeframe: At Month 6

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=50 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=15 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=41 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=14 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group n=47 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group n=16 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group n=45 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group n=29 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group n=11 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group n=41 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group n=16 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease A/INDO	3 Participants	0 Participants	1 Participants	0 Participants	23 Participants	0 Participants	12 Participants	0 Participants	20 Participants	0 Participants	25 Participants	0 Participants
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease A/VIET	28 Participants	1 Participants	25 Participants	0 Participants	32 Participants	0 Participants	31 Participants	0 Participants	24 Participants	0 Participants	32 Participants	0 Participants

PRIMARY outcome

Timeframe: At Month 12

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=47 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=14 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=37 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=14 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group n=40 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group n=16 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group n=43 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group n=16 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group n=27 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group n=10 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group n=35 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group n=13 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease A/VIET	18 Participants	0 Participants	8 Participants	1 Participants	17 Participants	0 Participants	20 Participants	0 Participants	13 Participants	0 Participants	22 Participants	0 Participants
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease A/INDO	17 Participants	0 Participants	6 Participants	0 Participants	16 Participants	1 Participants	7 Participants	0 Participants	12 Participants	0 Participants	15 Participants	0 Participants

PRIMARY outcome

Timeframe: At Month 24

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=47 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=13 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=35 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=11 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group n=39 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group n=16 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group n=42 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group n=16 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group n=26 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group n=10 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group n=34 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group n=13 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease A/VIET	18 Participants	0 Participants	8 Participants	0 Participants	30 Participants	1 Participants	18 Participants	0 Participants	19 Participants	1 Participants	23 Participants	1 Participants
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease A/INDO	5 Participants	0 Participants	3 Participants	0 Participants	19 Participants	0 Participants	2 Participants	0 Participants	14 Participants	0 Participants	10 Participants	0 Participants

PRIMARY outcome

Timeframe: At Day 21

The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=49 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=15 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=43 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=15 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group n=41 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group n=16 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group n=45 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group n=43 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group n=15 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group n=30 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group n=9 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/VIET	1.7 Fold Interval 1.2 to 2.5	NA Fold Data was not computed (titers below cut-off value for titer calculation)	2.4 Fold Interval 1.7 to 3.5	NA Fold Data was not computed (titers below cut-off value for titer calculation)	4.4 Fold Interval 2.9 to 6.8	NA Fold Data was not computed (titers below cut-off value for titer calculation)	4.7 Fold Interval 2.9 to 7.8	NA Fold Data was not computed (titers below cut-off value for titer calculation)	5.0 Fold Interval 3.2 to 7.9	1.1 Fold Interval 0.9 to 1.5	5.5 Fold Interval 3.2 to 9.2	NA Fold Data was not computed (titers below cut-off value for titer calculation)
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/INDO	NA Fold Data was not computed (titers below cut-off value for titer calculation)	NA Fold Data was not computed (titers below cut-off value for titer calculation)	NA Fold Data was not computed (titers below cut-off value for titer calculation)	NA Fold Data was not computed (titers below cut-off value for titer calculation)	1.1 Fold Interval 1.0 to 1.2	NA Fold Data was not computed (titers below cut-off value for titer calculation)	1.1 Fold Interval 1.0 to 1.2	NA Fold Data was not computed (titers below cut-off value for titer calculation)	1.5 Fold Interval 1.2 to 2.0	NA Fold Data was not computed (titers below cut-off value for titer calculation)	1.2 Fold Interval 1.0 to 1.4	NA Fold Data was not computed (titers below cut-off value for titer calculation)

PRIMARY outcome

Timeframe: At Day 42

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=49 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=15 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=43 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=15 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group n=42 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group n=16 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group n=45 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group n=44 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group n=15 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group n=43 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group n=13 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/VIET	78.5 Fold Interval 56.1 to 110.0	NA Fold Data was not computed (titers below cut-off value for titer calculation)	108.1 Fold Interval 84.9 to 137.5	NA Fold Data was not computed (titers below cut-off value for titer calculation)	132.3 Fold Interval 91.8 to 190.7	NA Fold Data was not computed (titers below cut-off value for titer calculation)	123.2 Fold Interval 85.8 to 176.8	NA Fold Data was not computed (titers below cut-off value for titer calculation)	191.3 Fold Interval 153.8 to 237.9	NA Fold Data was not computed (titers below cut-off value for titer calculation)	176.7 Fold Interval 147.5 to 211.7	NA Fold Data was not computed (titers below cut-off value for titer calculation)
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/INDO	10.7 Fold Interval 7.0 to 16.3	NA Fold Data was not computed (titers below cut-off value for titer calculation)	12.2 Fold Interval 7.7 to 19.1	NA Fold Data was not computed (titers below cut-off value for titer calculation)	14.7 Fold Interval 9.0 to 24.1	NA Fold Data was not computed (titers below cut-off value for titer calculation)	13.0 Fold Interval 7.7 to 21.8	NA Fold Data was not computed (titers below cut-off value for titer calculation)	33.6 Fold Interval 24.3 to 46.3	NA Fold Data was not computed (titers below cut-off value for titer calculation)	18.5 Fold Interval 11.9 to 28.8	NA Fold Data was not computed (titers below cut-off value for titer calculation)

PRIMARY outcome

Timeframe: At Month 6

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=50 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=15 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=41 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=14 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group n=47 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group n=16 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group n=45 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group n=29 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group n=11 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group n=41 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group n=16 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/INDO	1.4 Fold Interval 1.1 to 1.7	NA Fold Data was not computed (titers below cut-off value for titer calculation)	1.2 Fold Interval 1.0 to 1.5	1.2 Fold Interval 1.0 to 1.5	4.3 Fold Interval 2.9 to 6.6	1.1 Fold Interval 0.9 to 1.4	2.4 Fold Interval 1.7 to 3.4	NA Fold Data was not computed (titers below cut-off value for titer calculation)	8.5 Fold Interval 4.7 to 15.3	NA Fold Data was not computed (titers below cut-off value for titer calculation)	7.4 Fold Interval 4.5 to 12.1	NA Fold Data was not computed (titers below cut-off value for titer calculation)
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/VIET	5.9 Fold Interval 3.8 to 8.9	1.2 Fold Interval 0.8 to 1.7	6.1 Fold Interval 3.8 to 9.7	NA Fold Data was not computed (titers below cut-off value for titer calculation)	9.1 Fold Interval 5.8 to 14.1	NA Fold Data was not computed (titers below cut-off value for titer calculation)	8.6 Fold Interval 5.6 to 13.4	NA Fold Data was not computed (titers below cut-off value for titer calculation)	16.0 Fold Interval 9.4 to 27.3	NA Fold Data was not computed (titers below cut-off value for titer calculation)	12.3 Fold Interval 7.8 to 19.5	NA Fold Data was not computed (titers below cut-off value for titer calculation)

PRIMARY outcome

Timeframe: At Month 12

The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO).

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=47 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=14 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=35 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=14 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group n=40 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group n=16 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group n=43 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group n=16 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group n=27 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group n=10 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group n=35 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group n=13 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/VIET	2.8 Fold Interval 1.9 to 4.0	NA Fold Data was not computed (titers below cut-off value for titer calculation)	2.2 Fold Interval 1.5 to 3.3	1.2 Fold Interval 0.8 to 1.6	4.0 Fold Interval 2.7 to 5.8	1.0 Fold Interval 1.0 to 1.1	4.5 Fold Interval 3.1 to 6.5	1.0 Fold Interval 1.0 to 1.1	4.8 Fold Interval 3.0 to 7.6	NA Fold Data was not computed (titers below cut-off value for titer calculation)	5.5 Fold Interval 3.8 to 8.1	1.1 Fold Interval 0.9 to 1.3
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/INDO	2.6 Fold Interval 1.8 to 3.7	NA Fold Data was not computed (titers below cut-off value for titer calculation)	1.9 Fold Interval 1.3 to 2.8	1.1 Fold Interval 0.9 to 1.4	3.3 Fold Interval 2.3 to 4.7	1.2 Fold Interval 0.9 to 1.6	3.0 Fold Interval 2.2 to 4.0	1.3 Fold Interval 1.0 to 1.6	3.7 Fold Interval 2.3 to 6.0	NA Fold Data was not computed (titers below cut-off value for titer calculation)	4.1 Fold Interval 2.7 to 6.2	NA Fold Data was not computed (titers below cut-off value for titer calculation)

PRIMARY outcome

Timeframe: At Month 24

The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO).

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=47 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=13 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=35 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=11 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group n=39 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group n=16 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group n=42 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group n=16 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group n=26 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group n=10 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group n=34 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group n=13 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/VIET	3.0 Fold Interval 2.1 to 4.3	NA Fold Data was not computed (titers below cut-off value for titer calculation)	2.5 Fold Interval 1.7 to 3.6	NA Fold Data was not computed (titers below cut-off value for titer calculation)	10.4 Fold Interval 6.7 to 16.2	1.4 Fold Interval 0.9 to 1.9	4.0 Fold Interval 2.8 to 5.9	NA Fold Data was not computed (titers below cut-off value for titer calculation)	11.2 Fold Interval 6.6 to 18.8	1.3 Fold Interval 0.7 to 2.5	7.3 Fold Interval 5.0 to 10.8	1.2 Fold Interval 0.8 to 2.0
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease A/INDO	2.0 Fold Interval 1.5 to 2.7	NA Fold Data was not computed (titers below cut-off value for titer calculation)	1.5 Fold Interval 1.1 to 1.9	NA Fold Data was not computed (titers below cut-off value for titer calculation)	4.5 Fold Interval 3.0 to 6.7	1.1 Fold Interval 0.9 to 1.2	1.7 Fold Interval 1.4 to 2.2	NA Fold Data was not computed (titers below cut-off value for titer calculation)	5.5 Fold Interval 3.2 to 9.4	NA Fold Data was not computed (titers below cut-off value for titer calculation)	3.6 Fold Interval 2.4 to 5.5	NA Fold Data was not computed (titers below cut-off value for titer calculation)

PRIMARY outcome

Timeframe: At Day 0

A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=49 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=15 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=43 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=15 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group n=45 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group n=42 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group n=16 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group n=44 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group n=15 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group n=43 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group n=13 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease A/VIET	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease A/INDO	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At Day 21

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=49 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=15 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=43 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=15 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group n=41 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group n=16 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group n=45 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group n=43 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group n=15 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group n=30 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group n=9 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease A/VIET	6 Participants	0 Participants	13 Participants	0 Participants	20 Participants	0 Participants	19 Participants	0 Participants	20 Participants	1 Participants	17 Participants	0 Participants
Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease A/INDO	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: At Day 42

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=49 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=15 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=43 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=15 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group n=42 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group n=16 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group n=45 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group n=44 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group n=15 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group n=43 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group n=13 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease A/VIET	47 Participants	0 Participants	43 Participants	0 Participants	41 Participants	0 Participants	44 Participants	0 Participants	44 Participants	0 Participants	43 Participants	0 Participants
Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease A/INDO	35 Participants	0 Participants	32 Participants	0 Participants	32 Participants	0 Participants	31 Participants	0 Participants	42 Participants	0 Participants	34 Participants	0 Participants

PRIMARY outcome

Timeframe: At Month 6

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=50 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=15 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=44 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=14 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group n=47 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group n=16 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group n=45 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group n=29 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group n=11 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group n=41 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group n=16 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease A/VIET	28 Participants	1 Participants	28 Participants	0 Participants	33 Participants	0 Participants	31 Participants	0 Participants	24 Participants	0 Participants	32 Participants	0 Participants
Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease A/INDO	3 Participants	0 Participants	2 Participants	0 Participants	23 Participants	0 Participants	12 Participants	0 Participants	20 Participants	0 Participants	25 Participants	0 Participants

PRIMARY outcome

Timeframe: At Month 12

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=47 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=14 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=37 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=14 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group n=40 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group n=16 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group n=43 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group n=16 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group n=27 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group n=10 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group n=35 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group n=13 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease A/INDO	17 Participants	0 Participants	7 Participants	0 Participants	16 Participants	1 Participants	7 Participants	0 Participants	12 Participants	0 Participants	15 Participants	0 Participants
Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease A/VIET	18 Participants	0 Participants	9 Participants	1 Participants	17 Participants	0 Participants	20 Participants	0 Participants	13 Participants	0 Participants	22 Participants	0 Participants

PRIMARY outcome

Timeframe: At Month 24

A seroprotected subject was defined as a vaccinated subject with a serum HI antibody titer ≥ 1:40, a level of HI antibody that has been viewed as correlating with protection against influenza. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=47 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=13 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=37 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=11 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group n=39 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group n=16 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group n=42 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group n=16 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group n=26 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group n=10 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group n=34 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group n=13 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease A/INDO	5 Participants	0 Participants	4 Participants	0 Participants	19 Participants	0 Participants	2 Participants	0 Participants	14 Participants	0 Participants	10 Participants	0 Participants
Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease A/VIET	18 Participants	0 Participants	9 Participants	0 Participants	30 Participants	1 Participants	18 Participants	0 Participants	19 Participants	1 Participants	23 Participants	1 Participants

PRIMARY outcome

Timeframe: During the 7 day follow-up period after each vaccination

Population: The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.

Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal activities. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling larger than (\>) 100 millimeters (mm). All solicited local symptoms were considered to be related to study vaccination. This outcome presents results from subjects participating in Phase A of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=51 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=18 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=51 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms Ecchymosis >50mm	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms Any pain	31 Participants	7 Participants	44 Participants	12 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms Grade 3 pain	2 Participants	0 Participants	5 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms Any redness	10 Participants	2 Participants	12 Participants	5 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms Swelling >50mm	1 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms Any swelling	10 Participants	1 Participants	14 Participants	7 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms Any ecchymosis	9 Participants	3 Participants	3 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms Any induration	7 Participants	1 Participants	12 Participants	6 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms Induration >50mm	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms Redness >50mm	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: During the 7-day follow-up period after each vaccination

Population: The analysis was based on theTotal Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=49 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=49 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms Any ecchymosis	4 Participants	0 Participants	0 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms Ecchymosys >50mm	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms Any induration	14 Participants	0 Participants	10 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms Induration >50mm	1 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms Any pain	37 Participants	7 Participants	44 Participants	15 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms Grade 3 pain	5 Participants	0 Participants	3 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms Any redness	16 Participants	2 Participants	6 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms Redness >50mm	1 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms Swelling >50mm	2 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms Any swelling	18 Participants	2 Participants	14 Participants	3 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) follow-up period after any vaccination

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.

Assessed solicited general symptoms were drowsiness, fever (axillary temperature above or equal (≥) 37.5°C), irritability, loss of appetite, shivering, sweating and vomiting. Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = general symptom that prevented normal activity. Grade 3 temperature = axillary temperature \> 39.0°C. Related = symptom assessed as causally related to study vaccination. This outcome presents results for subjects aged between 3 and 5 years participating in Phases A, B and C of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=51 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=18 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=51 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group n=49 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 shivering	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related vomiting	3 Participants	0 Participants	2 Participants	0 Participants	3 Participants	1 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any shivering	1 Participants	0 Participants	4 Participants	1 Participants	10 Participants	1 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 vomiting	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related fever (Axillary)	6 Participants	0 Participants	5 Participants	1 Participants	17 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any drowsiness	7 Participants	1 Participants	9 Participants	1 Participants	12 Participants	1 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any irritability	9 Participants	1 Participants	13 Participants	2 Participants	18 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 drowsiness	1 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related drowsiness	6 Participants	1 Participants	6 Participants	0 Participants	12 Participants	1 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fever (Axillary) >=37.5 deg C	8 Participants	0 Participants	10 Participants	2 Participants	18 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fever >39degC (Axillary)	2 Participants	0 Participants	0 Participants	1 Participants	5 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 irritability	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related irritability	7 Participants	1 Participants	9 Participants	1 Participants	15 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any loss of appetite	12 Participants	1 Participants	8 Participants	1 Participants	15 Participants	1 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 loss of appetite	3 Participants	0 Participants	1 Participants	0 Participants	5 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related loss of appetite	4 Participants	1 Participants	5 Participants	1 Participants	13 Participants	1 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related shivering	1 Participants	0 Participants	2 Participants	0 Participants	9 Participants	1 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any sweating	4 Participants	0 Participants	1 Participants	0 Participants	4 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any vomiting	7 Participants	0 Participants	6 Participants	0 Participants	6 Participants	1 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 sweating	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related sweating	2 Participants	0 Participants	1 Participants	0 Participants	3 Participants	0 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) follow-up period after any vaccination

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.

Solicited general symptoms were arthralgia, fatigue, headache, muscle aches, shivering and fever, assessed as oral temperature above or equal (≥) 37.0 degrees Celsius (°C). Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = general symptom that prevented normal activity, everyday activities, or required intervention of a physician/healthcare provider. Grade 3 fever= oral temperature ≥ 39.0°C. Related = symptom assessed as causally related to study vaccination. This outcome presents results related to subjects aged 6 to 9 years participating in the study phases A, B and C.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=51 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=18 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=49 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group n=49 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group n=18 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any fatigue	7 Participants	1 Participants	6 Participants	1 Participants	11 Participants	2 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related fatigue	7 Participants	1 Participants	6 Participants	1 Participants	11 Participants	2 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fever >=37.5 deg C	7 Participants	3 Participants	3 Participants	0 Participants	18 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any headache	20 Participants	5 Participants	11 Participants	2 Participants	25 Participants	3 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any arthralgia	6 Participants	3 Participants	7 Participants	0 Participants	9 Participants	2 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 arthralgia	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related arthralgia	6 Participants	3 Participants	7 Participants	0 Participants	7 Participants	2 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 fatigue	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fever >39.0 deg C	0 Participants	1 Participants	1 Participants	0 Participants	7 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related fever	6 Participants	2 Participants	1 Participants	0 Participants	17 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any gastrointestinal symptoms	9 Participants	5 Participants	4 Participants	5 Participants	16 Participants	5 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 gastrointestinal symptoms	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related gastrointestinal symptoms	8 Participants	4 Participants	2 Participants	2 Participants	13 Participants	3 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 headache	2 Participants	0 Participants	2 Participants	0 Participants	3 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related headache	16 Participants	3 Participants	8 Participants	2 Participants	22 Participants	3 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any myalgia	10 Participants	3 Participants	11 Participants	2 Participants	13 Participants	2 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 myalgia	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related myalgia	9 Participants	3 Participants	11 Participants	1 Participants	11 Participants	2 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any shivering	3 Participants	1 Participants	7 Participants	0 Participants	13 Participants	3 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering	3 Participants	1 Participants	5 Participants	0 Participants	13 Participants	2 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any sweating	3 Participants	2 Participants	3 Participants	2 Participants	6 Participants	1 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 sweating	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related sweating	3 Participants	2 Participants	1 Participants	1 Participants	6 Participants	1 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: During the 7-day follow-up period after each vaccination

Population: The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=51 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=49 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms Induration >50mm	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms Any ecchymosis	4 Participants	0 Participants	4 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms Ecchymosis >50mm	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms Any induration	4 Participants	1 Participants	6 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms Any pain	27 Participants	3 Participants	36 Participants	9 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms Grade 3 pain	5 Participants	0 Participants	3 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms Any redness	6 Participants	4 Participants	6 Participants	3 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms Redness >50mm	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms Any swelling	9 Participants	2 Participants	10 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms Swelling >50mm	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: During the entire study (Day 0 to Month 24)

Population: The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any SAE regardless of intensity or relationship to vaccination.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=51 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=18 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=51 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group n=51 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group n=49 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group n=49 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group n=49 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Serious Adverse Events (SAEs)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: During a 21 day follow-up period after the first vaccination, during a 30-day follow-up period after the second vaccination

Population: The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.

An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event. Grade 3 AE = AE that prevented normal activity, everyday activities, or required intervention of a physician/healthcare provider. Related = symptom assessed as causally related to study vaccination.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=51 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=18 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=51 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group n=51 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group n=49 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group n=49 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group n=49 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events Subjects with any AE(s)	29 Participants	12 Participants	10 Participants	5 Participants	28 Participants	9 Participants	19 Participants	6 Participants	26 Participants	8 Participants	27 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events Subjects with any Grade 3 AE(s)	4 Participants	1 Participants	1 Participants	0 Participants	3 Participants	0 Participants	0 Participants	1 Participants	3 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events Subjects with any related AE(s)	6 Participants	2 Participants	2 Participants	1 Participants	3 Participants	1 Participants	4 Participants	1 Participants	9 Participants	0 Participants	3 Participants	1 Participants

PRIMARY outcome

Timeframe: At Days 21 and 42 and Months 6, 12 and 24

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.

Changes from baseline are categorised as below, within(normal), or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT for subjects participating in Phase A of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=50 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=49 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Unknown, Month 12,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Normal, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Normal, Month 12,Normal	45 Participants	17 Participants	41 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Normal, Month 12,Above	1 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Unknown,Day 21,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Unknown,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Unknown,Day 21,Normal	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Unknown,Day 21,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Normal,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Normal,Day 21,Normal	47 Participants	16 Participants	44 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Normal,Day 21,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Normal,Day 21,Unknown	1 Participants	1 Participants	4 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Unknown,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Unknown,Day 42,Normal	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Unknown,Day 42,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Unknown,Day 42,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Normal,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Normal,Day 42,Normal	48 Participants	15 Participants	45 Participants	15 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Normal,Day 42,Above	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Normal,Day 42,Unknown	1 Participants	1 Participants	4 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Unknown, Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Unknown, Month 6,Normal	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Unknown, Month 6,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Unknown, Month 6,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Normal, Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Normal, Month 6,Normal	47 Participants	15 Participants	42 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Normal, Month 6,Above	1 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Normal, Month 6,Unknown	1 Participants	2 Participants	4 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Unknown, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Unknown, Month 12,Normal	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Unknown, Month 12,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Normal, Month 12,Unknown	3 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Unknown, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Unknown, Month 24,Normal	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Unknown, Month 24,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Unknown, Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Normal, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Normal, Month 24,Normal	46 Participants	16 Participants	40 Participants	13 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Normal, Month 24,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ALT,Normal, Month 24,Unknown	0 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 21 and 42 and Months 6, 12 and 24

Population: The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.

Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for AST for subjects participating in Phase A of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=50 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=49 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Above,Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Unknown,Day 21,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Normal,Day 21,Above	4 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Above,Day 21,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Above,Day 42,Above	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Normal, Month 6,Normal	42 Participants	14 Participants	42 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Normal, Month 6,Above	2 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Above,Month 6,Normal	3 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Above, Month 6,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Unknown, Month 12,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Normal, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Normal, Month 12,Normal	41 Participants	16 Participants	42 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Normal, Month 12,Unknown	2 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Unknown, Month 24,Normal	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Unknown, Month 24,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Unknown, Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Normal,Month 24,Unknown	0 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Above,Month 24,Above	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Normal,Day 21,Unknown	1 Participants	1 Participants	4 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Above,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Above,Day 21,Normal	2 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Above,Day 21,Above	2 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Unknown,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Unknown,Day 42,Normal	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Unknown,Day 42,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Unknown,Day 42,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Normal,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Normal,Day 42,Normal	42 Participants	13 Participants	45 Participants	15 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Normal,Day 42,Above	2 Participants	2 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Normal,Day 42,Unknown	1 Participants	2 Participants	4 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Above,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Above,Day 42,Normal	3 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Above,Day 42,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Unknown, Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Unknown, Month 6,Normal	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Unknown, Month 6,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Unknown, Month 6,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Normal, Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Normal, Month 6,Unknown	1 Participants	2 Participants	4 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Above, Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Above, Month 6,Above	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Unknown, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Normal,Month 24,Above	2 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Unknown, Month 12,Normal	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Unknown, Month 12,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Normal, Month 12,Above	2 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Above, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Above, Month 12,Normal	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Above, Month 12,Above	2 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Above, Month 12,Unknown	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Unknown, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Normal,Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Normal,Month 24,Normal	41 Participants	16 Participants	40 Participants	13 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Above,Month 24,Normal	2 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Above,Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Unknown,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Unknown,Day 21,Normal	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Unknown,Day 21,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Normal,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A AST,Normal,Day 21,Normal	39 Participants	16 Participants	44 Participants	16 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 21 and 42 and Months 6, 12 and 24

Population: The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.

Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for BUN for subjects participating in Phase A of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=50 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=49 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Unknown, Day 21, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Unknown, Day 21, Above	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Unknown, Day 21, Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Normal, Day 21, Below	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Normal, Day 21, Normal	43 Participants	14 Participants	38 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Above, Day 21, Above	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Above, Day 21, Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Unknown, Day 42, Normal	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Unknown, Day 42, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Normal, Day 42, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Normal, Day 42, Normal	40 Participants	16 Participants	38 Participants	12 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Normal, Day 42,Above	6 Participants	0 Participants	6 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Normal, Month 6,Above	3 Participants	1 Participants	4 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Unknown, Month 12,Normal	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Unknown, Month 12,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Normal, Month 12,Above	3 Participants	1 Participants	0 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Above, Month 12,Normal	0 Participants	0 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Unknown, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Normal, Month 24,Unknown	0 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Above, Day 42, Normal	1 Participants	0 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Unknown, Day 21, Normal	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Normal, Day 21, Above	2 Participants	1 Participants	5 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Normal, Day 21, Unknown	1 Participants	1 Participants	4 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Above, Day 21, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Above, Day 21, Normal	1 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Unknown, Day 42, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Unknown, Day 42, Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Normal, Day 42, Unknown	1 Participants	1 Participants	4 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Above, Day 42, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Above, Day 42, Above	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Above, Day 42, Unknkwn	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Unknown, Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Unknown, Month 6,Normal	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Unknown, Month 6,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Unknown, Month 6,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Normal, Month 6,Below	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Normal, Month 6,Normal	43 Participants	13 Participants	38 Participants	14 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Normal, Month 6,Unknown	1 Participants	2 Participants	4 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Above, Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Above,Month 6,Normal	2 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Above, Month 6,Above	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Above, Month 6,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Unknown, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Unknown, Month 12,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Normal, Month 12,Below	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Normal, Month 12,Normal	41 Participants	16 Participants	40 Participants	13 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Normal, Month 12,Unknown	3 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Above, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Above, Month 12,Above	2 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Above, Month 12,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Unknown, Month 24,Normal	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Unknown, Month 24,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Unknown, Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Normal, Month 24,Below	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Normal, Month 24,Normal	42 Participants	16 Participants	37 Participants	11 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Normal, Month 24,Above	2 Participants	0 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Above, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Above, Month 24,Normal	2 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Above, Month 24,Above	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A BUN,Above, Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 21 and 42 and Months 6, 12 and 24

Population: The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.

Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CPK for subjects participating in Phase A of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=50 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=49 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Unknown, Day 42,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK, Above, Day 21, Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Unknown, Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Unknown, Day 21,Normal	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Normal, Day 21, Above	2 Participants	0 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK, Above, Day 21, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK, Above, Day 21, Normal	1 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK, Above, Day 21, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Unknown, Day 42,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Normal, Day 42, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Normal, Day 42, Unknown	1 Participants	1 Participants	4 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK, Above, Day 42, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK, Above, Day 42, Normal	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK, Above, Day 42, Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Unknown, Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Unknown, Month 6,Normal	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Unknown, Month 6,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Unknown, Month 6,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Normal, Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Normal, Month 6,Normal	45 Participants	13 Participants	38 Participants	15 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Normal, Month 6,Above	2 Participants	1 Participants	5 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Normal, Month 6,Unknown	1 Participants	2 Participants	4 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Above, Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Above,Month 6,Normal	1 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Above, Month 6,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Above, Month 6,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Unknown, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Unknown, Month 12,Normal	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Unknown, Month 12,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Unknown, Month 12,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Normal, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Normal, Month 12,Normal	43 Participants	14 Participants	40 Participants	15 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Normal, Month 12,Above	2 Participants	2 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Normal, Month 12,Unknown	3 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Above, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Above, Month 12,Normal	1 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Above, Month 12,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Above, Month 12,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Unknown, Month 24,Normal	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Unknown, Month 24,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Unknown, Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Normal, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Normal, Month 24,Normal	45 Participants	14 Participants	36 Participants	12 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Normal, Month 24,Unknown	0 Participants	0 Participants	3 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Above, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Above, Month 24,Normal	1 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Unknown, Day 21,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Unknown, Day 21,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Normal, Day 21, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Normal, Day 21, Normal	44 Participants	15 Participants	42 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Normal, Day 21, Unknown	1 Participants	1 Participants	4 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Unknown, Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Unknown, Day 42,Normal	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Normal, Day 42, Normal	46 Participants	14 Participants	42 Participants	14 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Normal, Day 42, Above	2 Participants	1 Participants	3 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK, Above, Day 42, Above	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Unknown, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Normal, Month 24,Above	0 Participants	1 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Above, Month 24,Above	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A CPK,Above, Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 21 and 42 and Months 6, 12 and 24

Population: The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.

Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CREA for subjects participating in Phase A of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=50 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=49 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA, Unknown, Day 21, Normal	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA, Unknown, Day 21, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA, Unknown, Day 21, Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA, Normal, Day 21, Normal	47 Participants	16 Participants	42 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA, Normal, Day 21, Above	0 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA, Normal, Day 21, Unknown	1 Participants	1 Participants	4 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA, Unknown, Day 42, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA, Unknown, Day 42, Normal	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA, Unknown, Day 42, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA, Unknown, Day 42, Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA, Normal, Day 42, Normal	48 Participants	16 Participants	43 Participants	15 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA, Normal, Day 42, Unknown	1 Participants	1 Participants	4 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA,Unknown, Month 6,Normal	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA,Unknown, Month 6,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA,Unknown, Month 6,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA,Normal, Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA,Normal, Month 6,Normal	48 Participants	15 Participants	43 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA,Normal, Month 6,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA,Normal, Month 6,Unknown	1 Participants	2 Participants	4 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA,Unknown, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA,Unknown, Month 12,Normal	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA,Unknown, Month 12,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA,Unknown, Month 12,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA,Normal, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA,Normal, Month 12,Normal	46 Participants	17 Participants	42 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA,Normal, Month 12,Unknown	3 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA,Unknown, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA,Unknown, Month 24,Normal	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA,Unknown, Month 24,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA,Unknown, Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA,Normal, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA,Normal, Month 24,Normal	46 Participants	16 Participants	39 Participants	13 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA,Normal, Month 24,Above	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA, Normal, Day 42, Above	0 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA,Unknown, Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA,Normal, Month 12,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA, Unknown, Day 21, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA, Normal, Day 21, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA, Normal, Day 42, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A CREA,Normal, Month 24,Unknown	0 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 21 and 42 and Months 6, 12 and 24

Population: The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.

Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for LDH for subjects participating in Phase A of the study

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=50 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=49 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH, Unknown, Day 21, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH, Unknown, Day 21, Normal	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH, Unknown, Day 21, Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH, Normal, Day 21, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH, Normal, Day 21, Normal	36 Participants	8 Participants	40 Participants	14 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH, Normal, Day 21, Unknown	1 Participants	1 Participants	4 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH, Above, Day 21, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH, Above, Day 21, Normal	5 Participants	2 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH, Unknown, Day 42, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH, Above, Day 21, Above	4 Participants	3 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH, Unknown, Day 42, Normal	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH, Unknown, Day 42, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH, Unknown, Day 42, Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH, Normal, Day 42, Above	7 Participants	4 Participants	4 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH, Normal, Day 42, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH, Normal, Day 42, Normal	32 Participants	6 Participants	41 Participants	14 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH, Normal, Day 42, Unknown	1 Participants	2 Participants	3 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH, Above, Day 42, Above	4 Participants	2 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH, Above, Day 42, Below	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH, Above, Day 42, Normal	5 Participants	3 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH, Above, Day 42, Unknow	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Unknown, Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Unknown, Month 6,Normal	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Unknown, Month 6,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Unknown, Month 6,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Normal, Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Normal, Month 6,Normal	31 Participants	7 Participants	38 Participants	13 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Normal, Month 6,Above	8 Participants	3 Participants	4 Participants	3 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Above, Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Above,Month 6,Normal	5 Participants	4 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Above, Month 6,Above	4 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Unknown, Month 12,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Normal, Month 12,Above	4 Participants	4 Participants	1 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Unknown, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Unknown, Month 24,Normal	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Unknown, Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Normal, Month 24,Normal	35 Participants	8 Participants	36 Participants	11 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Above, Month 24,Above	2 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Above, Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Normal, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Normal, Month 12,Normal	33 Participants	8 Participants	40 Participants	14 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Normal, Month 12,Unknown	3 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Above, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Above, Month 12,Normal	6 Participants	4 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Above, Month 12,Above	3 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH, Unknown, Day 21, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Above, Month 12,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Unknown, Month 24,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Normal, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Normal, Month 24,Above	3 Participants	3 Participants	3 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Normal, Month 24,Unknown	0 Participants	0 Participants	3 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Above, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Above, Month 24,Normal	6 Participants	5 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH, Normal, Day 21, Above	2 Participants	3 Participants	3 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH, Above, Day 21, Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Normal, Month 6,Unknown	1 Participants	2 Participants	4 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Above, Month 6,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Unknown, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Unknown, Month 12,Normal	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A LDH,Unknown, Month 12,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 21 and 42 and Months 6, 12 and 24

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.

Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT for subjects participating in Phase B of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=49 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=16 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=46 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=16 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Unknown,Day 21,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Normal,Day 21,Above	1 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Normal,Day 21,Unknown	3 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Above,Day 21,Normal	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Above,Day 21,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Above,Day 21,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Unknown,Day 42,Normal	0 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Unknown,Day 42,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Normal,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Normal,Day 42,Normal	46 Participants	16 Participants	44 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Normal,Day 42,Above	1 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Normal,Day 42,Unknown	2 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Above,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Normal,Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Normal,Month 6,Normal	48 Participants	16 Participants	44 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Above,Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Above,Month 6,Normal	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Unknown, Month 12,Normal	0 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Normal, Month 12,Normal	44 Participants	16 Participants	44 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Normal, Month 24,Normal	44 Participants	16 Participants	43 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Unknown,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Unknown,Day 21,Normal	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Unknown,Day 21,Above	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Normal,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Normal,Day 21,Normal	44 Participants	16 Participants	44 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Above,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Unknown,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Unknown,Day 42,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Above,Day 42,Normal	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Above,Day 42,Above	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Above,Day 42,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Unknown,Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Unknown,Month 6,Normal	0 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Unknown,Month 6,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Unknown,Month 6,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Normal,Month 6,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Normal,Month 6,Unknown	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Above, Month 6,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Above, Month 6,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Unknown, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Unknown, Month 12,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Unknown, Month 12,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Normal, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Normal, Month 12,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Normal, Month 12,Unknown	2 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Above, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Above,Month 12,Normal	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Above, Month 12,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Above, Month 12,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Unknown, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Unknown, Month 24,Normal	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Unknown, Month 24,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Unknown, Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Normal, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Normal, Month 24,Above	1 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Normal, Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Above, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Above, Month 24,Normal	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Above, Month 24,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ALT,Above, Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 21, and 42, and at Months 6, 12 and 24

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=47 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=15 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=43 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=16 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Normal,Day 21,Above	3 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Above,Day 21,Unknown	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Unknown,Day 42,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Normal,Day 42,Above	5 Participants	2 Participants	3 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Unknown, Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Above, Month 6,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Above, Month 6,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Unknown, Month 12,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Normal, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Normal, Month 12,Normal	44 Participants	15 Participants	41 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Above, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Above, Month 12,Unknown	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Unknown, Month 24,Normal	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Unknown, Month 24,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Unknown, Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Normal, Month 24,Normal	44 Participants	15 Participants	41 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Above, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Above, Month 24,Above	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Above, Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Unknown,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Unknown,Day 21,Normal	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Unknown,Day 21,Above	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Unknown,Day 21,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Normal,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Normal,Day 21,Normal	40 Participants	15 Participants	41 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Normal,Day 21,Unknown	3 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Above,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Above,Day 21,Normal	1 Participants	1 Participants	3 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Above,Day 21,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Unknown,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Unknown,Day 42,Normal	0 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Unknown,Day 42,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Normal,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Normal,Day 42,Normal	40 Participants	13 Participants	40 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Normal,Day 42,Unknown	2 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Above,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Above,Day 42,Normal	2 Participants	1 Participants	3 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Above,Day 42,Above	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Above,Day 42,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Unknown, Month 6,Normal	0 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Unknown, Month 6,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Unknown, Month 6,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Normal, Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Above,Month 12,Normal	0 Participants	1 Participants	3 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Normal, Month 6,Normal	45 Participants	14 Participants	40 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Normal, Month 6,Above	2 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Normal, Month 6,Unknown	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Above, Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Above,Month 6,Normal	2 Participants	1 Participants	3 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Above, Month 12,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Unknown, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Unknown, Month 12,Normal	0 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Unknown, Month 12,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Normal, Month 12,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Normal, Month 12,Unknown	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Unknown, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Normal, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Normal, Month 24,Above	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Normal, Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B AST,Above, Month 24,Normal	0 Participants	1 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 21, and 42, and at Months 6, 12 and 24

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.

Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for BUN for subjects participating in Phase B of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=49 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=47 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Unknown,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Unknown,Day 21,Above	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Normal,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Normal,Day 21,Above	6 Participants	1 Participants	3 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Above,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Above,Day 21,Above	1 Participants	1 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Above,Day 21,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Normal,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Normal,Day 42,Normal	38 Participants	12 Participants	39 Participants	11 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Unknown, Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Unknown, Month 6,Normal	0 Participants	1 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Normal, Month 6,Above	3 Participants	2 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Above,Month 6,Normal	4 Participants	1 Participants	5 Participants	3 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Above, Month 6,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Unknown, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Unknown, Month 12,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Unknown, Month 12,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Normal, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Normal, Month 12,Above	4 Participants	2 Participants	1 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Above,Month 12,Normal	3 Participants	2 Participants	5 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Above, Month 12,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Unknown, Month 24,Normal	0 Participants	1 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Unknown, Month 24,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Normal, Month 24,Normal	36 Participants	11 Participants	39 Participants	13 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Normal, Month 24,Above	5 Participants	3 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Above, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Unknown, Month 6,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Normal, Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Normal, Month 6,Normal	42 Participants	12 Participants	39 Participants	13 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Normal, Month 12,Normal	36 Participants	12 Participants	38 Participants	11 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Normal, Month 12,Unknown	2 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Above, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Above, Month 12,Above	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Unknown, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Unknown, Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Normal, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Normal, Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Above, Month 24,Normal	4 Participants	1 Participants	2 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Above, Month 24,Above	0 Participants	1 Participants	3 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Above, Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Unknown,Day 21,Normal	0 Participants	0 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Unknown,Day 21,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Normal,Day 21,Normal	35 Participants	13 Participants	37 Participants	12 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Normal,Day 21,Unknown	3 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Above,Day 21,Normal	3 Participants	1 Participants	5 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Unknown,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Unknown,Day 42,Normal	0 Participants	1 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Unknown,Day 42,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Unknown,Day 42,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Normal,Day 42,Above	6 Participants	2 Participants	2 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Normal,Day 42,Unknown	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Above,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Above,Day 42,Normal	2 Participants	1 Participants	3 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Above,Day 42,Above	1 Participants	1 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Above,Day 42,Unknown	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Unknown, Month 6,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Normal, Month 6,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Above, Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Above, Month 6,Above	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B BUN,Unknown, Month 12,Normal	0 Participants	1 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 21, and 42, and at Months 6, 12 and 24

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.

Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CPK for subjects participating in Phase B of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=49 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=47 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Unknown,Day 21,Normal	0 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Unknown,Day 21,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Normal,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Normal,Day 21,Normal	46 Participants	16 Participants	43 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Normal,Day 21,Unknown	2 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Above,Day 21,Above	1 Participants	0 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Above,Day 21,Unknown	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Unknown,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Unknown,Day 42,Normal	0 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Unknown,Day 42,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Unknown,Day 42,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Normal,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Above,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Above,Day 42,Normal	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Above,Day 42,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Unknown, Month 6,Normal	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Normal, Month 6,Above	1 Participants	3 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Normal, Month 6,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Above,Month 6,Normal	1 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Unknown, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Unknown, Month 12,Normal	0 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Unknown, Month 12,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Normal, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Normal, Month 12,Unknown	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Unknown, Month 24,Normal	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Unknown, Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Above, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Unknown,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Unknown,Day 21,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Normal,Day 21,Above	2 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Above,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Above,Day 21,Normal	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Normal,Day 42,Normal	43 Participants	16 Participants	42 Participants	14 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Normal,Day 42,Above	2 Participants	2 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Normal,Day 42,Unknown	2 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Above,Day 42,Above	2 Participants	0 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Unknown, Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Unknown, Month 6,Above	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Unknown, Month 6,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Normal, Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Normal, Month 6,Normal	46 Participants	13 Participants	42 Participants	15 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Above, Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Above, Month 6,Above	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Above, Month 6,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Unknown, Month 12,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Normal, Month 12,Normal	39 Participants	13 Participants	42 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Normal, Month 12,Above	4 Participants	3 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Above, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Above,Month 12,Normal	0 Participants	0 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Above, Month 12,Above	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Above, Month 12,Unknown	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Unknown, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Unknown, Month 24,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Normal, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Normal, Month 24,Normal	43 Participants	14 Participants	41 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Normal, Month 24,Above	1 Participants	2 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Normal, Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Above, Month 24,Normal	1 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Above, Month 24,Above	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B CPK,Above, Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 21, and 42, and at Months 6, 12 and 24

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.

Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CREA for subjects participating in Phase B of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=49 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=46 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Normal,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Normal,Day 21,Above	1 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Above,Day 21,Unknow	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Normal,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Normal,Day 42,Above	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Above,Day 42,Normal	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Above,Day 42,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Normal, Month 6,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Above, Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Above, Month 6,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Unknown, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Normal, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Above, Month 24,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Unknown,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Unknown,Day 21,Normal	0 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Unknown,Day 21,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Unknown,Day 21,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Normal,Day 21,Normal	44 Participants	16 Participants	43 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Normal,Day 21,Unknown	3 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Above,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Above,Day 21,Normal	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Above,Day 21,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Unknown,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Unknown,Day 42,Normal	0 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Unknown,Day 42,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Unknown,Day 42,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Normal,Day 42,Normal	46 Participants	16 Participants	45 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Normal,Day 42,Unknown	2 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Above,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Above,Day 42,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Unknown, Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Unknown, Month 6,Normal	0 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Unknown, Month 6,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Unknown, Month 6,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Normal, Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Normal, Month 6,Normal	49 Participants	16 Participants	42 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Normal, Month 6,Above	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Above, Month 6,Normal	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Above, Month 6,Above	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Unknown, Month 12,Normal	0 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Unknown, Month 12,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Unknown, Month 12,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Normal, Month 12,Normal	44 Participants	16 Participants	42 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Normal, Month 12,Above	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Normal, Month 12,Unknown	2 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Above, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Above,Month 12,Normal	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Above, Month 12,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Above, Month 12,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Unknown, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Unknown, Month 24,Normal	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Unknown, Month 24,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Unknown, Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Normal, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Normal, Month 24,Normal	45 Participants	16 Participants	43 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Normal, Month 24,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Normal, Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Above, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Above, Month 24,Normal	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B CREA,Above, Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 21, and 42, and at Months 6, 12 and 24

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.

Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for LDH for subjects participating in Phase B of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=49 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=47 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Normal, Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Normal, Month 6,Above	6 Participants	5 Participants	3 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Normal, Month 6,Unknown	1 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Above, Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Normal, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Normal, Month 12,Unknown	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Above, Month 12,Above	0 Participants	0 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Above, Month 12,Unknown	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Unknown, Month 24,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Unknown, Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Normal, Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Above, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Unknown, Month 12,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Normal, Month 12,Normal	32 Participants	10 Participants	36 Participants	15 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Unknown,Day 42,Normal	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Unknown,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Unknown,Day 21,Normal	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Unknown,Day 21,Above	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Unknown,Day 21,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Normal,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Normal,Day 21,Normal	33 Participants	13 Participants	38 Participants	15 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Normal,Day 21,Above	7 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Normal,Day 21,Unknown	3 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Above,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Above,Day 21,Normal	2 Participants	1 Participants	3 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Above,Day 21,Above	2 Participants	1 Participants	4 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Above,Day 21,Unknown	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Unknown,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Unknown,Day 42,Above	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Unknown,Day 42,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Normal,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Normal,Day 42,Normal	33 Participants	9 Participants	37 Participants	14 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Normal,Day 42,Above	9 Participants	5 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Normal,Day 42,Unknown	2 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Above,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Above,Day 42,Normal	2 Participants	1 Participants	3 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Above,Day 42,Above	3 Participants	1 Participants	4 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Above,Day 42,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Unknown, Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Unknown, Month 6,Normal	0 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Unknown, Month 6,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Unknown, Month 6,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Normal, Month 6,Normal	37 Participants	9 Participants	34 Participants	14 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Normal, Month 12,Above	9 Participants	4 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Above, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Above,Month 12,Normal	3 Participants	2 Participants	5 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Above,Month 6,Normal	3 Participants	2 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Above, Month 6,Above	2 Participants	0 Participants	4 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Above, Month 6,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Unknown, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Unknown, Month 24,Normal	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Normal, Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Normal, Month 24,Normal	40 Participants	13 Participants	37 Participants	15 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Normal, Month 24,Above	2 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Above, Month 24,Normal	3 Participants	2 Participants	4 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Above, Month 24,Above	0 Participants	0 Participants	2 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Above, Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Unknown, Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Unknown, Month 12,Normal	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B LDH,Unknown, Month 12,Above	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 21, and 42, and at Months 6, 12 and 24

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.

Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT for subjects participating in Phase C of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=48 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=48 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Unknown, Day 21, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Unknown, Day 21, Unknown	2 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Normal, Day 21, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Normal, Day 21, Normal	41 Participants	12 Participants	40 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Above, Day 21, Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Unknown, Day 21, Normal	3 Participants	0 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Unknown, Day 21, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Normal, Day 21, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Normal, Day 21, Unknown	1 Participants	3 Participants	4 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Above, Day 21, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Above, Day 21, Normal	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Above, Day 21, Above	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Unknown, Day 42, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Unknown, Day 42, Normal	5 Participants	2 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Unknown, Day 42, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Unknown, Day 42, Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Normal, Day 42, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Normal, Day 42, Normal	40 Participants	14 Participants	43 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Normal, Day 42, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Normal, Day 42, Unknown	2 Participants	1 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Above, Day 42, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Above, Day 42, Normal	1 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Above, Day 42, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Above, Day 42, Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Unknown, Month 6, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Unknown, Month 6, Normal	4 Participants	2 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Unknown, Month 6, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Unknown, Month 6, Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Normal , Month 6, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Normal , Month 6, Normal	36 Participants	13 Participants	41 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Normal , Month 6, Above	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Normal , Month 6, Unknown	4 Participants	1 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Above, Month 6, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Above, Month 6, Normal	1 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Above, Month 6, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Above, Month 6, Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Unknown, Month 12, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Unknown, Month 12, Normal	3 Participants	2 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Unknown, Month 12, Above	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Unknown, Month 12, Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Normal , Month 12, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Normal , Month 12, Normal	38 Participants	15 Participants	41 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Normal , Month 12, Above	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Normal , Month 12, Unknown	2 Participants	0 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Above, Month 12, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Above, Month 12, Normal	1 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Above, Month 12, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Above, Month 12, Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Unknown, Month 24, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Unknown, Month 24, Normal	2 Participants	2 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Unknown, Month 24, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Unknown, Month 24, Unknown	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Normal , Month 24, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Normal , Month 24, Normal	36 Participants	15 Participants	41 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Normal , Month 24, Above	2 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Normal , Month 24, Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Above, Month 24, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Above, Month 24, Normal	1 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Above, Month 24, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ALT, Above, Month 24, Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 21, and 42, and at Months 6, 12 and 24

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=48 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=48 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Above, Month 12, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Unknown, Day 42, Normal	5 Participants	2 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Unknown, Month 12, Above	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Unknown, Month 12, Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Normal, Month 12, Normal	36 Participants	12 Participants	37 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Normal, Month 12, Above	0 Participants	0 Participants	4 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Normal, Month 12, Unknown	3 Participants	0 Participants	3 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Above, Month 12, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Above, Month 12, Normal	2 Participants	3 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Unknown, Month 24, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Unknown, Month 24, Normal	2 Participants	2 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Unknown, Month 24, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Above, Month 12, Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Normal, Day 42, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Unknown, Day 21, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Unknown, Day 21, Normal	3 Participants	0 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Unknown, Day 21, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Unknown, Day 21, Unknown	2 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Normal, Day 21, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Normal, Day 21, Normal	39 Participants	10 Participants	40 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Normal, Day 21, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Normal, Day 21, Unknown	1 Participants	2 Participants	4 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Above, Day 21, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Above, Day 21, Normal	2 Participants	2 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Above, Day 21, Above	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Above, Day 21, Unknown	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Unknown, Day 42, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Unknown, Day 42, Above	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Unknown, Day 42, Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Normal, Day 42, Normal	36 Participants	11 Participants	41 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Normal, Day 42, Above	2 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Normal, Day 42, Unknown	2 Participants	1 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Above, Day 42, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Above, Day 42, Normal	3 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Above, Day 42, Above	0 Participants	2 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Above, Day 42, Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Unknown, Month 6, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Unknown, Month 6, Normal	3 Participants	2 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Unknown, Month 6, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Unknown, Month 6, Unknown	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Normal, Month 6, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Normal, Month 6, Normal	34 Participants	9 Participants	40 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Normal, Month 6, Above	1 Participants	2 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Normal, Month 6, Unknown	4 Participants	1 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Above, Month 6, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Above, Month 6, Normal	2 Participants	3 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Above, Month 6, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Above, Month 6, Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Unknown, Month 12, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Unknown, Month 12, Normal	3 Participants	2 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Unknown, Month 24, Unknown	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Normal, Month 24, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Normal, Month 12, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Normal, Month 24, Normal	34 Participants	12 Participants	42 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Normal, Month 24, Above	3 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Normal, Month 24, Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Above, Month 24, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Above, Month 24, Normal	2 Participants	3 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Above, Month 24, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C AST, Above, Month 24, Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 21, and 42, and at Months 6, 12 and 24

Population: The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.

Changes from baseline are categorised as below, within(normal), or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for BUN for subjects participating in Phase C of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=48 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=48 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Below,Day 21,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Below,Month 12,Normal	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Unknown,Day 21,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Unknown,Day 21,Unknown	2 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Below,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Below,Day 21,Normal	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Below,Day 21,Unknown	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Normal,Day 21,Below	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Normal,Day 21,Normal	37 Participants	9 Participants	41 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Normal,Day 21,Above	2 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Normal,Day 21,Unknown	1 Participants	2 Participants	4 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Above,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Above,Day 21,Normal	2 Participants	3 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Above,Day 21,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Unknown,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Unknown,Day 21,Normal	3 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Normal,Day 42,Below	0 Participants	0 Participants	3 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Normal,Day 42,Normal	37 Participants	11 Participants	38 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Normal,Day 42, Above	2 Participants	0 Participants	3 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Normal,Day 42,Unknown	2 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Above,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Above,Day 42,Normal	1 Participants	2 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Above,Day 42,Above	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Above,Day 42,Unknown	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Unknown,Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Unknown,Month 6,Normal	4 Participants	2 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Unknown,Month 6,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Above,Day 21,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Unknown,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Unknown,Month 6,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Unknown,Day 42,Normal	5 Participants	2 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Below,Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Unknown,Day 42,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Below,Month 6,Normal	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Below,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Unknown,Day 42,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Below,Month 6,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Below,Month 6,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Normal,Month 6,Below	0 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Below,Day 42,Normal	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Normal,Month 6,Normal	34 Participants	10 Participants	35 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Below,Day 42,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Normal,Month 6,Above	1 Participants	0 Participants	5 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Below,Day 42,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Normal,Month 6,Unknown	4 Participants	1 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Above,Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Above,Month 6,Normal	2 Participants	2 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Above,Month 6,Above	0 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Normal,Month12,Above	1 Participants	1 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Above,Month 6,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Unknown,Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Unknown,Month 12,Normal	3 Participants	2 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Unknown,Month 12,Above	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Unknown,Month 12,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Below,Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Below,Month 12,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Below,Month 12,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Normal,Month12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Normal,Month12,Normal	36 Participants	10 Participants	41 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Normal,Month12,Unknown	2 Participants	0 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Above,Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Above,Month 12,Normal	2 Participants	2 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Above,Month 12,Above	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Above,Month 12,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Unknown,Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Unknown,Month 24,Normal	2 Participants	2 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Unknown,Month 24,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Unknown,Month 24,Unknown	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Below,Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Below,Month 24,Normal	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Below,Month 24,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Below,Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Normal,Month 24,Below	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Normal,Month 24,Normal	35 Participants	9 Participants	39 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Normal,Month 24,Above	2 Participants	2 Participants	4 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Normal,Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Above,Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Above,Month 24,Normal	2 Participants	3 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Above,Month 24,Above	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C BUN,Above,Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 21, and 42, and at Months 6, 12 and 24

Population: The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.

Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CREA for subjects participating in Phase C of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=48 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=48 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Normal,Day 21,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Unknown,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Unknown,Day 21,Normal	3 Participants	0 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Unknown,Day 21,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Unknown,Day 21,Unknown	2 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Normal,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Normal,Day 21,Normal	42 Participants	12 Participants	41 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Normal,Day 21,Unknown	1 Participants	3 Participants	4 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Unknown,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Unknown,Day 42,Normal	5 Participants	2 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Unknown,Day 42,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Unknown,Day 42,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Normal,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Normal,Day 42,Normal	41 Participants	14 Participants	44 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Normal,Day 42,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Normal,Day 42,Unknown	2 Participants	1 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Unknown,Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Unknown,Month 6,Normal	4 Participants	2 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Unknown,Month 6,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Unknown,Month 6,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Normal,Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Normal,Month 6,Normal	37 Participants	14 Participants	42 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Normal,Month 6,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Normal,Month 6,Unknown	4 Participants	1 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Unknown,Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Unknown,Month 12,Normal	3 Participants	2 Participants	3 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Unknown,Month 12,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Unknown,Month 12,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Normal,Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Normal,Month 12,Normal	39 Participants	15 Participants	43 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Normal,Month 12,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Normal,Month 12,Unknown	2 Participants	0 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Unknown,Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Unknown,Month 24,Normal	2 Participants	2 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Unknown,Month 24,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Unknown,Month 24,Unknown	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Normal,Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Normal,Month 24,Normal	39 Participants	15 Participants	44 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Normal,Month 24,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C CREA,Normal,Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 21, and 42, and at Months 6, 12 and 24

Population: The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.

Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CPK for subjects participating in Phase C of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=48 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=48 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Normal,Day 21,Above	2 Participants	0 Participants	0 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Normal,Day 21,Unknown	1 Participants	3 Participants	4 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Above,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Above,Day 21,Above	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Unknown,Day 42,Above	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Normal,Day 42,Unknown	2 Participants	1 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Above,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Above,Month 6,Normal	0 Participants	1 Participants	3 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Above,Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Above,Month 12,Normal	1 Participants	1 Participants	4 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Above,Month 12,Above	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Above,Month 12,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Unknown,Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Unknown,Month 24,Normal	2 Participants	2 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Above,Month 6,Above	1 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Above,Month 6,Unknown	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Normal,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Normal,Day 21,Normal	39 Participants	10 Participants	37 Participants	14 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Above,Day 21,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Unknown,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Unknown,Day 42,Normal	5 Participants	1 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Unknown,Day 42,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Normal,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Normal,Day 42,Normal	39 Participants	11 Participants	40 Participants	15 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Normal,Day 42,Above	1 Participants	1 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Above,Day 42,Normal	0 Participants	1 Participants	4 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Above,Day 42,Above	1 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Above,Day 42,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Unknown,Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Unknown,Month 6,Normal	3 Participants	2 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Unknown,Month 6,Above	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Unknown,Month 6,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Normal,Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Normal,Month 6,Normal	34 Participants	12 Participants	36 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Normal,Month 6,Above	2 Participants	0 Participants	3 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Normal,Month 6,Unknown	4 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Above,Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Unknown,Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Unknown,Month 12,Normal	2 Participants	2 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Unknown,Month 12,Above	1 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Unknown,Month 12,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Normal,Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Normal,Month 12,Normal	35 Participants	12 Participants	36 Participants	14 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Normal,Month 12,Above	3 Participants	1 Participants	3 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Normal,Month 12,Unknown	2 Participants	0 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Unknown,Month 24,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Unknown,Month 24,Unknown	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Normal,Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Normal,Month 24,Normal	36 Participants	12 Participants	38 Participants	14 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Normal,Month 24,Above	2 Participants	1 Participants	2 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Normal,Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Above,Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Above,Month 24,Normal	1 Participants	1 Participants	3 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Above,Month 24,Above	0 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Above,Month 24,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Above,Day 21,Normal	1 Participants	1 Participants	4 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Unknown,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Unknown,Day 21,Normal	3 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Unknown,Day 21,Above	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK,Unknown,Day 21,Unknown	2 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 21, and 42, and at Months 6, 12 and 24

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.

Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for LDH for subjects participating in Phase C of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=48 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=48 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Above, Month 24, Above	5 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Above, Month 24, Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH,Normal,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH,Above,Day 21,Above	2 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH,Above,Day 21,Unknown	1 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH,Unknown,Day 42,Normal	4 Participants	0 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH,Unknown,Day 42,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Unknown, Month 12, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Normal, Month 12, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Above, Month 12, Unknown	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Normal, Month 24, Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Above, Month 24, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Above, Month 24, Normal	2 Participants	2 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH,Unknown,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH,Unknown,Day 21,Normal	2 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH,Unknown,Day 21,Above	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH,Unknown,Day 21,Unknown	2 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH,Unknown,Day 42,Above	1 Participants	2 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH,Normal,Day 21,Normal	31 Participants	9 Participants	37 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH,Normal,Day 21,Above	4 Participants	1 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH,Normal,Day 21,Unknown	0 Participants	2 Participants	4 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH,Above,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH,Above,Day 21,Normal	5 Participants	2 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH,Unknown,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH,Normal,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH,Normal,Day 42,Normal	29 Participants	7 Participants	39 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH,Normal,Day 42,Above	4 Participants	4 Participants	3 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH,Normal,Day 42,Unknown	2 Participants	1 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH,Above,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH,Above,Day 42,Normal	2 Participants	1 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH,Above,Day 42,Above	6 Participants	2 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH,Above,Day 42,Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Unknown, Month 6, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Unknown, Month 6, Normal	2 Participants	0 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH,Unknown, Month 6, Above	1 Participants	2 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Unknown, Month 6, Unknown	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Normal, Month 6, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Normal, Month 6, Normal	28 Participants	8 Participants	37 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Normal, Month 6, Above	2 Participants	3 Participants	3 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Normal, Month 6, Unknown	4 Participants	1 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Above, Month 6, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Above, Month 6, Normal	2 Participants	2 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Above, Month 6, Above	5 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Above, Month 6, Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Unknown, Month 12, Normal	3 Participants	2 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Unknown, Month 12, Above	0 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Unknown, Month 12, Unknown	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Normal, Month 12, Normal	26 Participants	9 Participants	34 Participants	14 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Normal, Month 12, Above	6 Participants	3 Participants	6 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Normal, Month 12, Unknwon	2 Participants	0 Participants	3 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Above, Month 12, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Above, Month 12, Normal	1 Participants	1 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Above, Month 12, Above	5 Participants	2 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Unknown, Month 24, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Unknown, Month 24, Normal	2 Participants	2 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Unknown, Month 24, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Unknown, Month 24, Unknown	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Normal, Month 24, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Normal, Month 24, Normal	24 Participants	10 Participants	40 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Normal, Month 24, Above	8 Participants	2 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 0, 21, and 42, and at Months 6, 12 and 24

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.

Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents ALT results for subjects participating in Phase A of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=52 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=18 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=53 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase A ALT, Day 0, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase A ALT, Day 0, Normal	50 Participants	18 Participants	51 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase A ALT, Day 0, Above	2 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase A ALT, Day 21, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase A ALT, Day 21, Normal	48 Participants	16 Participants	44 Participants	18 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase A ALT, Day 21, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase A ALT, Day 42, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase A ALT, Day 42, Normal	49 Participants	15 Participants	45 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase A ALT, Day 42, Above	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase A ALT, Month 6, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase A ALT, Month 6, Normal	48 Participants	15 Participants	42 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase A ALT, Month 6, Above	1 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase A ALT, Month 12, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase A ALT, Month 12, Normal	46 Participants	17 Participants	41 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase A ALT, Month 24, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase A ALT, Month 24, Normal	47 Participants	16 Participants	40 Participants	14 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase A ALT, Month 24, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase A ALT, Month 12, Above	1 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 0, 21, and 42, and at Months 6, 12 and 24

Population: The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.

Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results for subjects participating in Phase A of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=52 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=18 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=53 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase A AST, Day 0, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase A AST, Day 0, Normal	46 Participants	18 Participants	51 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase A AST, Day 0, Above	6 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase A AST, Day 21, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase A AST, Day 21, Normal	42 Participants	16 Participants	44 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase A AST, Day 21, Above	6 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase A AST, Day 42, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase A AST, Day 42, Above	3 Participants	2 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase A AST, Month 6, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase A AST, Month 6, Normal	46 Participants	14 Participants	42 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase A AST, Month 12, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase A AST, Month 12, Normal	43 Participants	16 Participants	42 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase A AST, Month 12, Above	4 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase A AST, Month 24, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase A AST, Month 24, Normal	44 Participants	16 Participants	40 Participants	14 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase A AST, Day 42, Normal	46 Participants	13 Participants	45 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase A AST, Month 6, Above	3 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase A AST, Month 24, Above	3 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 0, 21, and 42, and at Months 6, 12 and 24

Population: The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.

Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents BUN results for subjects participating in Phase A of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=53 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=18 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=53 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase A BUN, Month 24, Below	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase A BUN, Month 24, Normal	45 Participants	16 Participants	38 Participants	12 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase A BUN, Day 0, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase A BUN, Day 0, Normal	50 Participants	18 Participants	52 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase A BUN, Day 0, Above	2 Participants	0 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase A BUN, Day 21, Below	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase A BUN, Day 21, Normal	45 Participants	14 Participants	39 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase A BUN, Day 21, Above	3 Participants	1 Participants	5 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase A BUN, Day 42, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase A BUN, Day 42, Normal	42 Participants	16 Participants	39 Participants	14 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase A BUN, Day 42, Above	7 Participants	0 Participants	6 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase A BUN, Month 6, Below	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase A BUN, Month 6, Normal	46 Participants	13 Participants	39 Participants	15 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase A BUN, Month 6, Above	3 Participants	1 Participants	4 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase A BUN, Month 12, Below	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase A BUN, Month 12, Normal	42 Participants	16 Participants	41 Participants	15 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase A BUN, Month 24, Above	2 Participants	0 Participants	1 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase A BUN, Month 12, Above	5 Participants	1 Participants	0 Participants	2 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 0, 21, and 42, and at Months 6, 12 and 24

Population: The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.

Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CREA results, for subjects participating in Phase A of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=52 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=18 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=53 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase A CREA, Day 0, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase A CREA, Day 21, Above	0 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase A CREA, Month 6, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase A CREA, Month 12, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase A CREA, Month 12, Normal	47 Participants	17 Participants	42 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase A CREA, Month 24, Normal	47 Participants	16 Participants	39 Participants	14 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase A CREA, Month 6, Normal	49 Participants	15 Participants	43 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase A CREA, Month 6, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase A CREA, Month 12, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase A CREA, Month 24, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase A CREA, Month 24, Above	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase A CREA, Day 0, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase A CREA, Day 0, Normal	52 Participants	18 Participants	53 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase A CREA, Day 21, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase A CREA, Day 21, Normal	48 Participants	16 Participants	42 Participants	18 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase A CREA, Day 42, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase A CREA, Day 42, Normal	49 Participants	16 Participants	43 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase A CREA, Day 42, Above	0 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 0, 21, and 42, and at Months 6, 12 and 24

Population: The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.

Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CPK results for subjects participating in Phase A of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=52 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=18 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=53 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase A CPK, Day 0, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase A CPK, Day 21, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase A CPK, Day 42, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase A CPK, Day 42, Normal	47 Participants	14 Participants	42 Participants	15 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase A CPK, Month 6, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase A CPK, Month 6, Normal	47 Participants	14 Participants	38 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase A CPK, Month 12, Normal	45 Participants	15 Participants	40 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase A CPK, Month 24, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase A CPK, Month 12, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase A CPK, Day 0, Normal	51 Participants	17 Participants	51 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase A CPK, Day 0, Above	1 Participants	1 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase A CPK, Day 21, Normal	46 Participants	16 Participants	42 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase A CPK, Day 21, Above	2 Participants	0 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase A CPK, Day 42, Above	2 Participants	2 Participants	3 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase A CPK, Month 24, Normal	47 Participants	15 Participants	36 Participants	13 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase A CPK, Month 24, Above	0 Participants	1 Participants	3 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase A CPK, Month 6, Above	2 Participants	1 Participants	5 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase A CPK, Month 12, Above	2 Participants	2 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 0, 21, and 42, and at Months 6, 12 and 24

Population: The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.

Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents LDH results for subjects participating in Phase A of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=52 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=18 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=53 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase A LDH, Day 0, Normal	41 Participants	12 Participants	52 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase A LDH, Day 0, Above	11 Participants	6 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase A LDH, Day 21, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase A LDH, Day 21, Normal	42 Participants	10 Participants	41 Participants	15 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase A LDH, Day 21, Above	6 Participants	6 Participants	3 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase A LDH, Day 42, Above	11 Participants	6 Participants	4 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase A LDH, Month 6, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase A LDH, Month 6, Normal	37 Participants	11 Participants	39 Participants	14 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase A LDH, Month 6, Above	12 Participants	4 Participants	4 Participants	3 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase A LDH, Month 12, Normal	40 Participants	12 Participants	41 Participants	15 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase A LDH, Day 0, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase A LDH, Day 42, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase A LDH, Day 42, Normal	38 Participants	9 Participants	42 Participants	15 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase A LDH, Month 12, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase A LDH, Month 12, Above	7 Participants	5 Participants	1 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase A LDH, Month 24, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase A LDH, Month 24, Normal	42 Participants	13 Participants	36 Participants	12 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase A LDH, Month 24, Above	5 Participants	3 Participants	3 Participants	2 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 0, 21, and 42, and at Months 6, 12 and 24

Population: The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.

Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results, for subjects participating to Phase B of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=51 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=48 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase B ALT, Day 42, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase B ALT, Month 12, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase B ALT, Month 24, Normal	44 Participants	17 Participants	43 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase B ALT, Day 0, Above	1 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase B ALT, Day 21, Normal	44 Participants	16 Participants	45 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase B ALT, Day 21, Above	1 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase B ALT, Day 42, Normal	46 Participants	17 Participants	45 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase B ALT, Day 42, Above	1 Participants	0 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase B ALT, Month 6, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase B ALT, Month 6, Normal	41 Participants	16 Participants	43 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase B ALT, Month 6, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase B ALT, Day 0, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase B ALT, Day 0, Normal	50 Participants	16 Participants	48 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase B ALT, Month 12, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase B ALT, Month 12, Normal	44 Participants	17 Participants	45 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase B ALT, Month 24, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase B ALT, Day 21, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase B ALT, Month 24, Above	1 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 0, 21, and 42, and at Months 6, 12 and 24

Population: The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.

Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results, for subjects participating to Phase B of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=51 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=48 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Aspartate Aminotransferase (AST) in Study Phase B AST, Day 0, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Aspartate Aminotransferase (AST) in Study Phase B AST, Day 42, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Aspartate Aminotransferase (AST) in Study Phase B AST, Day 42, Normal	42 Participants	15 Participants	44 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Aspartate Aminotransferase (AST) in Study Phase B AST, Day 0, Normal	48 Participants	15 Participants	45 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Aspartate Aminotransferase (AST) in Study Phase B AST, Day 0, Above	3 Participants	1 Participants	3 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Aspartate Aminotransferase (AST) in Study Phase B AST, Day 21, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Aspartate Aminotransferase (AST) in Study Phase B AST, Day 21, Normal	41 Participants	16 Participants	45 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Aspartate Aminotransferase (AST) in Study Phase B AST, Day 21, Above	3 Participants	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Aspartate Aminotransferase (AST) in Study Phase B AST, Day 42, Above	5 Participants	2 Participants	3 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Aspartate Aminotransferase (AST) in Study Phase B AST, Month 6, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Aspartate Aminotransferase (AST) in Study Phase B AST, Month 6, Above	2 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Aspartate Aminotransferase (AST) in Study Phase B AST, Month 6, Normal	40 Participants	15 Participants	42 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Aspartate Aminotransferase (AST) in Study Phase B AST, Month 12, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Aspartate Aminotransferase (AST) in Study Phase B AST, Month 12, Normal	44 Participants	17 Participants	45 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Aspartate Aminotransferase (AST) in Study Phase B AST, Month 12, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Aspartate Aminotransferase (AST) in Study Phase B AST, Month 24, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Aspartate Aminotransferase (AST) in Study Phase B AST, Month 24, Normal	44 Participants	17 Participants	43 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Aspartate Aminotransferase (AST) in Study Phase B AST, Month 24, Above	1 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 0, 21 and 42 and at Month 6, 12 and 24

Population: The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.

Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CREA results, for subjects participating in Phase B of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=51 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=48 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase B CREA, Day 21, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase B CREA, Month 6, Above	0 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase B CREA, Month 24, Normal	45 Participants	17 Participants	44 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase B CREA, Day 21, Above	1 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase B CREA, Day 0, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase B CREA, Day 42, Above	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase B CREA, Month 6, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase B CREA, Month 6, Normal	42 Participants	16 Participants	41 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase B CREA, Month 12, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase B CREA, Month 12, Normal	44 Participants	17 Participants	44 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase B CREA, Month 12, Above	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase B CREA, Day 0, Normal	51 Participants	16 Participants	47 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase B CREA, Day 0, Above	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase B CREA, Day 21, Normal	44 Participants	17 Participants	45 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase B CREA, Month 24, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase B CREA, Day 42, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase B CREA, Month 24, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase B CREA, Day 42, Normal	46 Participants	17 Participants	47 Participants	17 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 0, 21, and 42, and at Months 6, 12 and 24

Population: The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.

Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents LDH results, for subjects participating to Phase B of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=51 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=48 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase B LDH, Day 0, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase B LDH, Day 0, Normal	46 Participants	14 Participants	41 Participants	15 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase B LDH, Day 0, Above	5 Participants	2 Participants	7 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase B LDH, Day 21, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase B LDH, Day 21, Above	9 Participants	3 Participants	4 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase B LDH, Day 42, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase B LDH, Day 42, Normal	35 Participants	10 Participants	41 Participants	14 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase B LDH, Day 42, Above	12 Participants	7 Participants	6 Participants	3 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase B LDH, Month 6, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase B LDH, Month 6, Normal	35 Participants	11 Participants	36 Participants	15 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase B LDH, Month 12, Above	9 Participants	5 Participants	3 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase B LDH, Month 24, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase B LDH, Month 24, Normal	43 Participants	16 Participants	41 Participants	15 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase B LDH, Month 24, Above	2 Participants	1 Participants	3 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase B LDH, Day 21, Normal	35 Participants	14 Participants	42 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase B LDH, Month 6, Above	6 Participants	5 Participants	6 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase B LDH, Month 12, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase B LDH, Month 12, Normal	35 Participants	12 Participants	42 Participants	16 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 0, 21, and 42, and at Months 6, 12 and 24

Population: The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.

Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents BUN results, for subjects participating to Phase B of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=51 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=48 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase B BUN, Day 0, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase B BUN, Day 0, Normal	47 Participants	14 Participants	43 Participants	13 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase B BUN, Day 0, Above	4 Participants	2 Participants	5 Participants	3 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase B BUN, Day 21, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase B BUN, Day 21, Normal	38 Participants	14 Participants	43 Participants	15 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase B BUN, Day 21, Above	7 Participants	3 Participants	3 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase B BUN, Day 42, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase B BUN, Day 42, Normal	40 Participants	14 Participants	43 Participants	14 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase B BUN, Day 42, Above	7 Participants	3 Participants	4 Participants	3 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase B BUN, Month 6, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase B BUN, Month 6, Normal	42 Participants	13 Participants	43 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase B BUN, Month 6, Above	0 Participants	3 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase B BUN, Month 12, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase B BUN, Month 12, Normal	39 Participants	15 Participants	44 Participants	14 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase B BUN, Month 12, Above	5 Participants	2 Participants	1 Participants	3 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase B BUN, Month 24, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase B BUN, Month 24, Normal	40 Participants	13 Participants	41 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase B BUN, Month 24, Above	5 Participants	4 Participants	3 Participants	1 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 0, 21 and 42 and at Months 6, 12 and 24

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.

Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents BUN results, for subjects participating to Phase C of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=46 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=47 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase C BUN, Month 12, Normal	41 Participants	15 Participants	43 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase C BUN, Month 24, Below	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase C BUN, Day 0, Below	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase C BUN, Day 0, Normal	42 Participants	11 Participants	46 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase C BUN, Day 0, Above	2 Participants	3 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase C BUN, Day 21, Below	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase C BUN, Day 21, Normal	42 Participants	12 Participants	42 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase C BUN, Day 21, Above	2 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase C BUN, Day 42, Below	0 Participants	0 Participants	3 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase C BUN, Day 42, Normal	43 Participants	16 Participants	40 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase C BUN, Day 42, Above	3 Participants	0 Participants	3 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase C BUN, Month 6, Below	0 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase C BUN, Month 6, Normal	40 Participants	15 Participants	36 Participants	18 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase C BUN, Month 6, Above	1 Participants	1 Participants	6 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase C BUN, Month 12, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase C BUN, Month 12, Above	1 Participants	2 Participants	3 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase C BUN, Month 24, Normal	39 Participants	15 Participants	40 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase C BUN, Month 24, Above	2 Participants	2 Participants	5 Participants	1 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 0, 21, and 42, and at Months 6, 12 and 24

Population: The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.

Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents ALT results, for subjects participating to Phase C of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=46 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=46 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase C ALT,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase C ALT, Month 6, Above	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase C ALT,Day 0,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase C ALT, Day 0,Normal	43 Participants	15 Participants	45 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase C ALT,Day 0,Above	1 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase C ALT,Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase C ALT,Day 21,Normal	44 Participants	12 Participants	42 Participants	18 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase C ALT,Day 21,Above	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase C ALT,Day 42,Normal	46 Participants	16 Participants	46 Participants	18 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase C ALT,Day 42,Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase C ALT, Month 6, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase C ALT, Month 6, Normal	41 Participants	15 Participants	44 Participants	18 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase C ALT,Month12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase C ALT,Month 12,Normal	42 Participants	17 Participants	44 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase C ALT,Month 12,Above	0 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase C ALT,Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase C ALT,Month 24,Normal	39 Participants	17 Participants	44 Participants	18 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase C ALT,Month 24,Above	2 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 0, 21, and 42, and at Months 6, 12 and 24

Population: The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.

Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CPK results, for subjects participating to Phase B of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=51 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=48 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase B CPK, Day 0, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase B CPK, Day 0, Normal	49 Participants	16 Participants	46 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase B CPK, Day 0, Above	2 Participants	0 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase B CPK, Day 21, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase B CPK, Day 21, Normal	42 Participants	16 Participants	45 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase B CPK, Day 21, Above	3 Participants	1 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase B CPK, Day 42, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase B CPK, Day 42, Normal	43 Participants	15 Participants	44 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase B CPK, Day 42, Above	4 Participants	2 Participants	3 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase B CPK, Month 6, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase B CPK, Month 6, Normal	40 Participants	13 Participants	41 Participants	15 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase B CPK, Month 6, Above	2 Participants	3 Participants	2 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase B CPK, Month 12, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase B CPK, Month 12, Normal	39 Participants	14 Participants	44 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase B CPK, Month 12, Above	5 Participants	3 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase B CPK, Month 24, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase B CPK, Month 24, Normal	44 Participants	15 Participants	42 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase B CPK, Month 24, Above	1 Participants	2 Participants	2 Participants	1 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 0, 21, and 42, and at Months 6, 12 and 24

Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results, for subjects participating to Phase C of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=46 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=46 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase C AST,Month 12,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase C AST,Month 12,Normal	41 Participants	17 Participants	40 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase C AST,Month 12,Above	0 Participants	0 Participants	5 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase C AST,Month 24,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase C AST,Month 24,Normal	38 Participants	17 Participants	45 Participants	18 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase C AST,Month 24,Above	3 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase C AST,Day 0,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase C AST,Day 0,Normal	41 Participants	12 Participants	45 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase C AST,Day 0,Above	3 Participants	3 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase C AST, Day 21,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase C AST,Day 21,Normal	44 Participants	12 Participants	42 Participants	18 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase C AST,Day 21,Above	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase C AST,Day 42,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase C AST,Day 42,Normal	44 Participants	14 Participants	43 Participants	18 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase C AST,Day 42,Above	2 Participants	2 Participants	3 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase C AST,Month 6,Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase C AST, Month 6, Normal	39 Participants	14 Participants	43 Participants	18 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase C AST, Month 6, Above	1 Participants	2 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 0, 21, and 42, and at Months 6, 12 and 24

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.

Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CPK results, for subjects participating to Phase C of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=46 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=46 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK, Month 6, Normal	37 Participants	15 Participants	41 Participants	18 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK, Month 12, Above	4 Participants	2 Participants	4 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK, Month 24, Above	2 Participants	2 Participants	3 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK, Day 0, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK, Day 0, Normal	43 Participants	13 Participants	42 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK, Day 0, Above	1 Participants	2 Participants	4 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK, Day 21, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK, Day 21, Normal	43 Participants	11 Participants	41 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK, Day 21, Above	2 Participants	1 Participants	1 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK, Day 42, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK, Day 42, Normal	44 Participants	13 Participants	46 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK, Day 42, Above	2 Participants	3 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK, Month 6, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK, Month 6, Above	4 Participants	1 Participants	3 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK, Month 12, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK, Month 12, Normal	38 Participants	15 Participants	42 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK, Month 24, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase C CPK, Month 24, Normal	39 Participants	15 Participants	43 Participants	16 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 0, 21 and 42 and at Months 6, 12 and 24

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.

Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CREA results, for subjects participating to Phase C of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=46 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=46 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase C CREA, Day 0, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase C CREA, Month 6, Normal	41 Participants	16 Participants	44 Participants	18 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase C CREA, Month 6, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase C CREA, Month 12, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase C CREA, Month 12, Normal	42 Participants	17 Participants	46 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase C CREA, Month 12, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase C CREA, Month 24, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase C CREA, Month 24, Normal	41 Participants	17 Participants	46 Participants	18 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase C CREA, Month 24, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase C CREA, Day 0, Normal	44 Participants	15 Participants	46 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase C CREA, Day 0, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase C CREA, Day 21, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase C CREA, Day 21, Normal	45 Participants	12 Participants	42 Participants	18 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase C CREA, Day 21, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase C CREA, Day 42, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase C CREA, Day 42, Normal	46 Participants	16 Participants	46 Participants	18 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase C CREA, Day 42, Above	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase C CREA, Month 6, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 0, 21 and 42 and at Months 6, 12 and 24

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.

Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents LDH results, for subjects participating to Phase C of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=46 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=47 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Month 6, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Day 0, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Day 21, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Day 21, Normal	38 Participants	11 Participants	39 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Day 21, Above	7 Participants	1 Participants	3 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Day 42, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Day 42, Normal	35 Participants	8 Participants	42 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Day 42, Above	11 Participants	8 Participants	4 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Month 6, Normal	32 Participants	10 Participants	40 Participants	18 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Month 6, Above	8 Participants	6 Participants	4 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Month 12, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Month 12, Normal	30 Participants	12 Participants	36 Participants	15 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Month 12, Above	11 Participants	5 Participants	9 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Month 24, Below	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Month 24, Normal	28 Participants	14 Participants	43 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Day 0, Normal	36 Participants	12 Participants	44 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Day 0, Above	8 Participants	3 Participants	3 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase C LDH, Month 24, Above	13 Participants	3 Participants	3 Participants	1 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Days 0, 21 and 42

Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The influenza strain assessed was A/Vietnam/1194/04 (A/VIET).Results presented are for subjects participating in Phase A of the study

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=48 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=15 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=43 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=15 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease A/VIET, Day 42	1044.4 Titer Interval 845.4 to 1290.3	158.4 Titer Interval 76.5 to 327.8	1155.1 Titer Interval 920.9 to 1448.7	104.5 Titer Interval 51.2 to 213.3	—	—	—	—	—	—	—	—
Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease A/VIET, Day 0	31.0 Titer Interval 21.8 to 44.0	29.0 Titer Interval 15.2 to 55.2	32.2 Titer Interval 23.1 to 44.9	18.2 Titer Interval 12.2 to 27.3	—	—	—	—	—	—	—	—
Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease A/VIET, Day 21	173.5 Titer Interval 123.3 to 244.0	98.2 Titer Interval 52.4 to 184.1	177.5 Titer Interval 127.0 to 248.0	97.2 Titer Interval 46.3 to 204.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Days 0, 21 and 42

Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The influenza strain assessed was A/Vietnam/1194/04 (A/VIET). Results presented are for subjects participating in Phase B of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=42 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=16 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=45 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease A/VIET, Day 0	65.5 Titer Interval 47.3 to 90.7	48.8 Titer Interval 29.7 to 80.2	46.2 Titer Interval 33.2 to 64.2	25.6 Titer Interval 17.3 to 37.8	—	—	—	—	—	—	—	—
Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease A/VIET, Day 21	344.7 Titer Interval 260.9 to 455.3	124.9 Titer Interval 60.7 to 257.2	461.7 Titer Interval 376.2 to 566.5	148.3 Titer Interval 81.2 to 271.1	—	—	—	—	—	—	—	—
Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease A/VIET, Day 42	1553.2 Titer Interval 1105.9 to 2181.5	86.9 Titer Interval 42.5 to 177.6	1519.4 Titer Interval 1229.9 to 1877.0	154.6 Titer Interval 97.9 to 244.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Days 0, 21 and 42

Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The influenza strain assessed was A/Vietnam/1194/04 (A/VIET). Results presented are for subjects participating in Phase C of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=42 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=15 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=43 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=13 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease A/VIET, Day 0	37.3 Titer Interval 23.9 to 58.1	35.5 Titer Interval 17.3 to 72.8	25.6 Titer Interval 18.6 to 35.3	27.1 Titer Interval 13.3 to 55.4	—	—	—	—	—	—	—	—
Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease A/VIET, Day 21	473.8 Titer Interval 351.2 to 639.3	111.3 Titer Interval 52.7 to 234.9	313.5 Titer Interval 193.3 to 508.4	190.1 Titer Interval 57.6 to 628.2	—	—	—	—	—	—	—	—
Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease A/VIET, Day 42	4578.3 Titer Interval 3786.6 to 5535.6	102.3 Titer Interval 45.9 to 228.2	3032.5 Titer Interval 2431.8 to 3781.6	77.6 Titer Interval 31.3 to 192.7	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Days 21 and 42

Population: The analysis was based on the According to protocol (ATP) cohort for immunogenicity, which included all subjects meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria and no major deviation from protocol, for whom immunogenicity data for at least one antigen were available.

A seroconverted subject as regards to serum neutralizing antibodies against influenza disease was a subject with a minimum 4-fold increase in serum neutralizing antibody titer at post-vaccination. The flu strain assessed was A/Vietnam/1194/2004 (A/VIET). This outcome presents results for subjects participating to Phase A of the study.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=46 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=14 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=43 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=15 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies A/VIET, Day 21	31 Participants	6 Participants	28 Participants	10 Participants	—	—	—	—	—	—	—	—
Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies A/VIET, Day 42	43 Participants	8 Participants	42 Participants	10 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Days 21 and 42

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=42 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=16 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=45 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies A/VIET, Day 21	25 Participants	6 Participants	35 Participants	11 Participants	—	—	—	—	—	—	—	—
Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies A/VIET, Day 42	40 Participants	2 Participants	42 Participants	11 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Days 21 and 42

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=38 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=15 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=42 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=13 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies A/VIET, Day 21	29 Participants	7 Participants	23 Participants	3 Participants	—	—	—	—	—	—	—	—
Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies A/VIET, Day 42	37 Participants	6 Participants	42 Participants	5 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Months 6, 12 and 24

Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO) strains. Results presented are for subjects participating in Phase A of the study. Subjects participating to Phases B and C of the study were not analysed at these persistence time points for this outcome.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=49 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=14 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=40 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=14 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Titers for Serum Neutralizing Antibodies Against 2 Strains of Influenza Disease A/VIET, Month 6	781.2 Titer Interval 641.5 to 951.5	208.5 Titer Interval 108.6 to 400.3	756.1 Titer Interval 624.5 to 915.5	482.3 Titer Interval 313.4 to 742.3	—	—	—	—	—	—	—	—
Titers for Serum Neutralizing Antibodies Against 2 Strains of Influenza Disease A/VIET, Month 12	238.9 Titer Interval 186.1 to 306.6	35.4 Titer Interval 16.7 to 74.9	179.4 Titer Interval 126.1 to 255.3	27.6 Titer Interval 13.4 to 56.9	—	—	—	—	—	—	—	—
Titers for Serum Neutralizing Antibodies Against 2 Strains of Influenza Disease A/VIET, Month 24	302.5 Titer Interval 231.0 to 396.0	39.4 Titer Interval 16.3 to 95.5	234.5 Titer Interval 177.1 to 310.6	46.6 Titer Interval 18.4 to 118.3	—	—	—	—	—	—	—	—
Titers for Serum Neutralizing Antibodies Against 2 Strains of Influenza Disease A/INDO, Month 6	113.8 Titer Interval 87.2 to 148.6	17.0 Titer Interval 11.1 to 26.1	106.8 Titer Interval 82.6 to 138.0	16.9 Titer Interval 11.1 to 25.8	—	—	—	—	—	—	—	—
Titers for Serum Neutralizing Antibodies Against 2 Strains of Influenza Disease A/INDO, Month 24	188.5 Titer Interval 144.6 to 245.7	31.8 Titer Interval 14.6 to 69.3	146.0 Titer Interval 111.7 to 190.8	20.5 Titer Interval 11.6 to 36.3	—	—	—	—	—	—	—	—
Titers for Serum Neutralizing Antibodies Against 2 Strains of Influenza Disease A/INDO, Month 12	170.8 Titer Interval 132.7 to 220.0	18.2 Titer Interval 11.4 to 29.1	139.7 Titer Interval 105.8 to 184.6	21.9 Titer Interval 12.2 to 39.2	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Months 6, 12 and 24.

A seroconverted subject as regards to neutralizing antibody response was a subject with a minimum 4-fold increase in neutralizing antibody titer at post-vaccination. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO) strains. Results presented are for subjects participating in Phase A of the study. Subjects participating to Phases B and C of the study were not analysed at these persistence time points for this outcome.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=47 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=13 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=40 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=14 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease as Regards to Neutralizing Antibody Response A/VIET, Month 6	41 Participants	9 Participants	38 Participants	13 Participants	—	—	—	—	—	—	—	—
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease as Regards to Neutralizing Antibody Response A/VIET, Month 24	36 Participants	3 Participants	23 Participants	4 Participants	—	—	—	—	—	—	—	—
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease as Regards to Neutralizing Antibody Response A/INDO, Month 6	34 Participants	0 Participants	31 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease as Regards to Neutralizing Antibody Response A/INDO, Month 24	40 Participants	3 Participants	33 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease as Regards to Neutralizing Antibody Response A/VIET, Month 12	37 Participants	3 Participants	23 Participants	3 Participants	—	—	—	—	—	—	—	—
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease as Regards to Neutralizing Antibody Response A/INDO, Month 12	37 Participants	1 Participants	31 Participants	2 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Throughout the entire study period, from Day 0 to Month 24

Population: The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.

AESIs are adverse events such as clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. AESIs assessed included neuroinflammatory disorders such as cranial nerve disorders, multiple sclerosis,transverse myelitis, Guillain-Barré syndromeor neuritis), musculoskeletal disorders (such as systemic lupus erythematosus, cutaneous lupus, polymyositis, rheumatoid arthritis, reactive arthritis, psoriatic arthropathy, or undifferentiated spondyloarthropathy), gastrointestinal disorders (such as Crohn's disease, ulcerative colitis, ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, Addison's disease). skin disorders (such as psoriasis, vitiligo, Raynaud's phenomenon, or autoimmune bullous skin diseases), and other conditions as autoimmune hemolytic anemia, thrombocytopenias, antiphospholipid syndrome, vasculitis, autoimmune hepatitis, or sarcoidosis.

Outcome measures

Outcome measures
Measure	GSK1562902A-A Lot 1 3-5Y Group n=51 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=18 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=51 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group n=51 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group n=49 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group n=17 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group n=49 Participants Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group n=17 Participants Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group n=49 Participants Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group n=18 Participants Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Number of Subjects With Adverse Events of Specific Interest (AESIs)	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

GSK1562902A -A Lot 1 3-5Y Group

Serious events: 0 serious events

Other events: 42 other events

Deaths: 0 deaths

Fluarix-A 3-5Y Group

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

GSK1562902A-A Lot 1 6-9Y Group

Serious events: 0 serious events

Other events: 48 other events

Deaths: 0 deaths

Fluarix-A 6-9Y Group

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

GSK1562902A-B Lot 2 3-5Y Group

Serious events: 1 serious events

Other events: 42 other events

Deaths: 0 deaths

Fluarix-B 3-5Y Group

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

GSK1562902A-B Lot 2 6-9Y Group

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

Fluarix-B 6-9Y Group

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

GSK1562902A-C Lot 3 3-5Y Group

Serious events: 2 serious events

Other events: 43 other events

Deaths: 0 deaths

Fluarix-C 3-5Y Group

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

GSK1562902A-C Lot 3 6-9Y Group

Serious events: 1 serious events

Other events: 46 other events

Deaths: 0 deaths

Fluarix-C 6-9Y Group

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GSK1562902A -A Lot 1 3-5Y Group n=51 participants at risk Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=18 participants at risk Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=51 participants at risk Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 participants at risk Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group n=51 participants at risk Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group n=17 participants at risk Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group n=49 participants at risk Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group n=17 participants at risk Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group n=49 participants at risk Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group n=17 participants at risk Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group n=49 participants at risk Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group n=18 participants at risk Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	2.0% 1/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Investigations Transaminases increased	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	2.0% 1/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Injury, poisoning and procedural complications Wound	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	2.0% 1/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Infections and infestations Gastroenteritis	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	2.0% 1/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Injury, poisoning and procedural complications Traumatic brain injury	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	2.0% 1/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.

Other adverse events

Other adverse events
Measure	GSK1562902A -A Lot 1 3-5Y Group n=51 participants at risk Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 3-5Y Group n=18 participants at risk Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-A Lot 1 6-9Y Group n=51 participants at risk Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-A 6-9Y Group n=18 participants at risk Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 3-5Y Group n=51 participants at risk Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 3-5Y Group n=17 participants at risk Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-B Lot 2 6-9Y Group n=49 participants at risk Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-B 6-9Y Group n=17 participants at risk Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 3-5Y Group n=49 participants at risk Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 3-5Y Group n=17 participants at risk Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	GSK1562902A-C Lot 3 6-9Y Group n=49 participants at risk Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.	Fluarix-C 6-9Y Group n=18 participants at risk Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Infections and infestations Pharyngitis	5.9% 3/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	11.1% 2/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	11.8% 6/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	11.8% 2/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	6.1% 3/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	6.1% 3/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	2.0% 1/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Infections and infestations Upper respiratory tract infection	21.6% 11/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	16.7% 3/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	3.9% 2/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	7.8% 4/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	6.1% 3/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	20.4% 10/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	11.8% 2/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	12.2% 6/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Gastrointestinal disorders Abdominal pain	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
General disorders Injection site reaction	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Gastrointestinal disorders Vomiting	2.0% 1/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Infections and infestations Bronchitis	3.9% 2/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	11.1% 2/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Infections and infestations Folliculitis	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Infections and infestations Gastroenteritis	9.8% 5/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	17.6% 3/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	6.1% 3/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Infections and infestations Impetigo	2.0% 1/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Infections and infestations Myringitis	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Musculoskeletal and connective tissue disorders Torticollis	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Respiratory, thoracic and mediastinal disorders Cough	11.8% 6/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	27.8% 5/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	8.2% 4/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Skin and subcutaneous tissue disorders Rash	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Respiratory, thoracic and mediastinal disorders Herpangina	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Respiratory, thoracic and mediastinal disorders Laryngitis	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 3/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 3/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Infections and infestations Scarlet fever	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
General disorders Pyrexia	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Infections and infestations Acute tonsillitis	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Infections and infestations Tonsillitis	5.9% 3/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	3.9% 2/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	17.6% 3/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	8.2% 4/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	11.8% 2/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	6.1% 3/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Gastrointestinal disorders Nausea	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Injury, poisoning and procedural complications Tooth injury	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Nervous system disorders Headache	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	6.1% 3/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Eye disorders Conjunctivitis	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Infections and infestations Otitis media acute	5.9% 3/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Skin and subcutaneous tissue disorders Acne	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Nervous system disorders Dizziness	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Investigations Hepatic enzyme increased	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Investigations Transaminases increased	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Infections and infestations Varicella	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	2.0% 1/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Injury, poisoning and procedural complications Contusion	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Gastrointestinal disorders Diarrhoea	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
General disorders Influenza like illness	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	6.1% 3/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Skin and subcutaneous tissue disorders Pityriasis rosea	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Psychiatric disorders Tic	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Infections and infestations Tooth abscess	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
General disorders Ecchymosis	17.6% 9/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	16.7% 3/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 3/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	11.1% 2/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	7.8% 4/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	8.2% 4/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	8.2% 4/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	11.1% 2/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
General disorders Induration	13.7% 7/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	23.5% 12/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	33.3% 6/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	7.8% 4/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	12.2% 6/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	28.6% 14/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	20.4% 10/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
General disorders Pain	60.8% 31/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	38.9% 7/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	86.3% 44/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	66.7% 12/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	52.9% 27/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	17.6% 3/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	73.5% 36/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	52.9% 9/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	75.5% 37/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	41.2% 7/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	89.8% 44/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	83.3% 15/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
General disorders Redness	19.6% 10/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	11.1% 2/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	23.5% 12/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	27.8% 5/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	11.8% 6/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	23.5% 4/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	12.2% 6/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	17.6% 3/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	32.7% 16/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	11.8% 2/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	12.2% 6/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
General disorders Swelling	19.6% 10/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	27.5% 14/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	38.9% 7/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	17.6% 9/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	11.8% 2/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	20.4% 10/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	11.8% 2/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	36.7% 18/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	11.8% 2/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	28.6% 14/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	16.7% 3/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
General disorders Drowsiness	13.7% 7/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	17.6% 9/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	24.5% 12/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
General disorders Fever (axillary temperature >=37.5°C)	15.7% 8/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	19.6% 10/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	11.8% 2/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	36.7% 18/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
General disorders Irritability	17.6% 9/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	25.5% 13/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	11.8% 2/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	36.7% 18/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
General disorders Loss of appetite	23.5% 12/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	15.7% 8/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	30.6% 15/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
General disorders Shivering	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 3/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	14.3% 7/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	26.5% 13/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	16.7% 3/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
General disorders Sweating	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 3/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	11.1% 2/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	6.1% 3/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	11.8% 2/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	12.2% 6/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
General disorders Vomiting	13.7% 7/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	11.8% 6/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	12.2% 6/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
General disorders Arthralgia	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	11.8% 6/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	16.7% 3/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	14.3% 7/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	18.4% 9/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	11.1% 2/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
General disorders Fatigue	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	13.7% 7/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.6% 1/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	12.2% 6/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	5.9% 1/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	22.4% 11/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	11.1% 2/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
General disorders Fever (axillary temperature >= 37.5°C)	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	13.7% 7/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	16.7% 3/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	6.1% 3/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	36.7% 18/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
General disorders Gastrointestinal symptoms	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	17.6% 9/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	27.8% 5/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	8.2% 4/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	29.4% 5/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	32.7% 16/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	27.8% 5/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
General disorders Headache	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	39.2% 20/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	27.8% 5/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	22.4% 11/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	11.8% 2/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	51.0% 25/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	16.7% 3/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.
General disorders Myalgia	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	19.6% 10/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	16.7% 3/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/51 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	22.4% 11/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	11.8% 2/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	0.00% 0/17 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	26.5% 13/49 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.	11.1% 2/18 • Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

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