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Clinical Trial Results:
A phase II, randomized, open, partially controlled study to evaluate the safety and immunogenicity of different formulations of a pandemic influenza vaccine candidate (split virus formulation adjuvanted with AS03) given following a two-administration schedule (21 days apart) in children between 3 and 9 years of age.

Summary
EudraCT number	2006-001168-22
Trial protocol	GB ES
Global end of trial date	04 Dec 2009

Results information
Results version number	v2(current)
This version publication date	06 Jun 2022
First version publication date	20 Mar 2015
Other versions	v1
Version creation reason	Correction of full data set Correction of full data set and alingment between registries.

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

107066 , 108498, 108500

ISRCTN number

US NCT number

NCT00502593

WHO universal trial number (UTN)

Sponsor organisation name

GlaxoSmithKline Biologicals

Sponsor organisation address

Rue de l’Institut 89, Rixensart, Belgium, B-1330

Public contact

Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com

Scientific contact

Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

14 Oct 2010

Is this the analysis of the primary completion data?

Yes

Primary completion date

04 Dec 2009

Global end of trial reached?

Yes

Global end of trial date

04 Dec 2009

Was the trial ended prematurely?

Main objective of the trial

•To evaluate the humoral immune response induced by the H5N1 vaccine candidate in terms of anti-haemagglutinin antibody titer. •To evaluate the safety and reactogenicity of the H5N1 vaccine candidate in terms of solicited local and general adverse events, unsolicited adverse events and serious adverse events.

Protection of trial subjects

As with all injectable vaccines, appropriate medical treatment was always readily available in case of anaphylactic reactions following the administration of the vaccine. For this reason, the vaccinee remained under medical supervision for 30 minutes after vaccination.

Background therapy

Evidence for comparator

Actual start date of recruitment

23 Jul 2007

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Spain: 405

Worldwide total number of subjects

405

EEA total number of subjects

405

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

405

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

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.

Screening details

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.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

GSK1562902A–A Lot 1 3-5Y Group

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Biological: Pandemic Influenza Vaccine (GSK1562902A)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

2 doses, intramuscular injection on Days 0 and 21, 3 different formulations are tested.

Fluarix–A 3-5Y Group

Arm description

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.

Arm type

Active comparator

Investigational medicinal product name

Biological: Fluarix

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

2 doses, intramuscular injection on Days 0 and 21.

GSK1562902A–A Lot 1 6-9Y Group

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Biological: Pandemic Influenza Vaccine (GSK1562902A)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

2 doses, intramuscular injection on Days 0 and 21, 3 different formulations are tested.

Fluarix–A 6-9Y Group

Arm description

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.

Arm type

Active comparator

Investigational medicinal product name

Biological: Fluarix

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

2 doses, intramuscular injection on Days 0 and 21.

GSK1562902A–B Lot 2 3-5Y Group

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Biological: Pandemic Influenza Vaccine (GSK1562902A)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

2 doses, intramuscular injection on Days 0 and 21, 3 different formulations are tested.

Fluarix–B 3-5Y Group

Arm description

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.

Arm type

Active comparator

Investigational medicinal product name

Biological: Fluarix

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

2 doses, intramuscular injection on Days 0 and 21.

GSK1562902A–B Lot 2 6-9Y Group

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Biological: Pandemic Influenza Vaccine (GSK1562902A)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

2 doses, intramuscular injection on Days 0 and 21, 3 different formulations are tested.

Fluarix–B 6-9Y Group

Arm description

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.

Arm type

Active comparator

Investigational medicinal product name

Biological: Fluarix

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

2 doses, intramuscular injection on Days 0 and 21.

GSK1562902A–C Lot 3 3-5Y Group

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Biological: Pandemic Influenza Vaccine (GSK1562902A)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

2 doses, intramuscular injection on Days 0 and 21, 3 different formulations are tested.

Fluarix–C 3-5Y Group

Arm description

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.

Arm type

Active comparator

Investigational medicinal product name

Biological: Fluarix

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

2 doses, intramuscular injection on Days 0 and 21.

GSK1562902A–C Lot 3 6-9Y Group

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Biological: Pandemic Influenza Vaccine (GSK1562902A)

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

2 doses, intramuscular injection on Days 0 and 21, 3 different formulations are tested.

Fluarix–C 6-9Y Group

Arm description

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.

Arm type

Active comparator

Investigational medicinal product name

Biological: Fluarix

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

2 doses, intramuscular injection on Days 0 and 21.

Number of subjects in period 1	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Started	51	18	51	18	51	17	49	17	49	17	49	18
Completed	48	16	41	14	47	17	44	17	43	17	47	18
Not completed	3	2	10	4	4	0	5	0	6	0	2	0
Withdrawn unspecified reason	1	1	3	1	2	-	2	-	-	-	-	-
Consent withdrawn by subject	-	-	6	2	2	-	3	-	3	-	1	-
Lost to follow-up	2	1	1	1	-	-	-	-	3	-	1	-

Baseline characteristics

Top of page

Reporting group title

GSK1562902A–A Lot 1 3-5Y Group

Reporting group description

Reporting group title

Fluarix–A 3-5Y Group

Reporting group description

Reporting group title

GSK1562902A–A Lot 1 6-9Y Group

Reporting group description

Reporting group title

Fluarix–A 6-9Y Group

Reporting group description

Reporting group title

GSK1562902A–B Lot 2 3-5Y Group

Reporting group description

Reporting group title

Fluarix–B 3-5Y Group

Reporting group description

Reporting group title

GSK1562902A–B Lot 2 6-9Y Group

Reporting group description

Reporting group title

Fluarix–B 6-9Y Group

Reporting group description

Reporting group title

GSK1562902A–C Lot 3 3-5Y Group

Reporting group description

Reporting group title

Fluarix–C 3-5Y Group

Reporting group description

Reporting group title

GSK1562902A–C Lot 3 6-9Y Group

Reporting group description

Reporting group title

Fluarix–C 6-9Y Group

Reporting group description

Reporting group values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group	Total
Number of subjects	51	18	51	18	51	17	49	17	49	17	49	18	405
Age categorical
Units: Subjects
Children (2-11 years)	51	18	51	18	51	17	49	17	49	17	49	18	405
Age continuous
Units: years
geometric mean (standard deviation)	3.9 ( 0.84 )	3.6 ( 0.7 )	7.6 ( 1.06 )	7.6 ( 1.38 )	4.2 ( 0.85 )	4.4 ( 0.79 )	7.3 ( 1.28 )	7.2 ( 1.2 )	4.2 ( 0.85 )	3.9 ( 0.93 )	7 ( 1.06 )	7.4 ( 0.98 )	-
Gender categorical
Units: Subjects
Female	25	9	24	7	25	10	19	3	22	11	18	9	182
Male	26	9	27	11	26	7	30	14	27	6	31	9	223

End points

Top of page

Reporting group title

GSK1562902A–A Lot 1 3-5Y Group

Reporting group description

Reporting group title

Fluarix–A 3-5Y Group

Reporting group description

Reporting group title

GSK1562902A–A Lot 1 6-9Y Group

Reporting group description

Reporting group title

Fluarix–A 6-9Y Group

Reporting group description

Reporting group title

GSK1562902A–B Lot 2 3-5Y Group

Reporting group description

Reporting group title

Fluarix–B 3-5Y Group

Reporting group description

Reporting group title

GSK1562902A–B Lot 2 6-9Y Group

Reporting group description

Reporting group title

Fluarix–B 6-9Y Group

Reporting group description

Reporting group title

GSK1562902A–C Lot 3 3-5Y Group

Reporting group description

Reporting group title

Fluarix–C 3-5Y Group

Reporting group description

Reporting group title

GSK1562902A–C Lot 3 6-9Y Group

Reporting group description

Reporting group title

Fluarix–C 6-9Y Group

Reporting group description

Primary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

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End point title

Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease ^[1]

End point description

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.

End point type

Primary

End point timeframe

At Day 0

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

GSK1562902A–A Lot 1 3-5Y Group

Fluarix–A 3-5Y Group

GSK1562902A–A Lot 1 6-9Y Group

Fluarix–A 6-9Y Group

GSK1562902A–B Lot 2 3-5Y Group

Fluarix–B 3-5Y Group

GSK1562902A–B Lot 2 6-9Y Group

Fluarix–B 6-9Y Group

GSK1562902A–C Lot 3 3-5Y Group

Fluarix–C 3-5Y Group

GSK1562902A–C Lot 3 6-9Y Group

Fluarix–C 6-9Y Group

Number of subjects analysed

49 ^[2]

15 ^[3]

43 ^[4]

15 ^[5]

42 ^[6]

16 ^[7]

45 ^[8]

17 ^[9]

44 ^[10]

15 ^[11]

43 ^[12]

13 ^[13]

Units: units: Titer

geometric mean (confidence interval 95%)

A/VIET

0 (0 to 0)

5.1 (4.9 to 5.4)

0 (0 to 0)

A/INDO

0 (0 to 0)

Notes
[2] - The data was not computed for titers below the cut-off value for titer calculation.
[3] - The data was not computed for titers below the cut-off value for titer calculation.
[4] - The data was not computed for titers below the cut-off value for titer calculation.
[5] - The data was not computed for titers below the cut-off value for titer calculation.
[6] - The data was not computed for titers below the cut-off value for titer calculation.
[7] - The data was not computed for titers below the cut-off value for titer calculation.
[8] - The data was not computed for titers below the cut-off value for titer calculation.
[9] - The data was not computed for titers below the cut-off value for titer calculation.
[10] - The data was not computed for titers below the cut-off value for titer calculation.
[11] - The data was not computed for titers below the cut-off value for titer calculation.
[12] - The data was not computed for titers below the cut-off value for titer calculation.
[13] - The data was not computed for titers below the cut-off value for titer calculation.

No statistical analyses for this end point

Primary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Top of page

End point title

Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease ^[14]

End point description

End point type

Primary

End point timeframe

At Day 21

Notes
[14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

GSK1562902A–A Lot 1 3-5Y Group

Fluarix–A 3-5Y Group

GSK1562902A–A Lot 1 6-9Y Group

Fluarix–A 6-9Y Group

GSK1562902A–B Lot 2 3-5Y Group

Fluarix–B 3-5Y Group

GSK1562902A–B Lot 2 6-9Y Group

Fluarix–B 6-9Y Group

GSK1562902A–C Lot 3 3-5Y Group

Fluarix–C 3-5Y Group

GSK1562902A–C Lot 3 6-9Y Group

Fluarix–C 6-9Y Group

Number of subjects analysed

15 ^[15]

15 ^[16]

16 ^[17]

17 ^[18]

15 ^[19]

9 ^[20]

Units: units: Titer

geometric mean (confidence interval 95%)

A/VIET

8.7 (6.2 to 12.3)

0 (0 to 0)

12.1 (8.4 to 17.5)

0 (0 to 0)

22.7 (14.6 to 35.3)

0 (0 to 0)

23.7 (14.3 to 39.1)

0 (0 to 0)

25 (16 to 39.3)

5.7 (4.3 to 7.7)

27.3 (16.2 to 46)

0 (0 to 0)

A/INDO

5.2 (4.9 to 5.6)

0 (0 to 0)

5.2 (4.8 to 5.8)

0 (0 to 0)

5.5 (4.9 to 6.2)

0 (0 to 0)

5.3 (4.9 to 5.8)

0 (0 to 0)

7.7 (6 to 9.8)

0 (0 to 0)

6 (5 to 7.2)

0 (0 to 0)

Notes
[15] - The data was not computed for titers below the cut-off value for titer calculation.
[16] - The data was not computed for titers below the cut-off value for titer calculation.
[17] - The data was not computed for titers below the cut-off value for titer calculation.
[18] - The data was not computed for titers below the cut-off value for titer calculation.
[19] - The data was not computed for titers below the cut-off value for titer calculation.
[20] - The data was not computed for titers below the cut-off value for titer calculation.

No statistical analyses for this end point

Primary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Top of page

End point title

Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease ^[21]

End point description

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.

End point type

Primary

End point timeframe

At Day 42

Notes
[21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

GSK1562902A–A Lot 1 3-5Y Group

Fluarix–A 3-5Y Group

GSK1562902A–A Lot 1 6-9Y Group

Fluarix–A 6-9Y Group

GSK1562902A–B Lot 2 3-5Y Group

Fluarix–B 3-5Y Group

GSK1562902A–B Lot 2 6-9Y Group

Fluarix–B 6-9Y Group

GSK1562902A–C Lot 3 3-5Y Group

Fluarix–C 3-5Y Group

GSK1562902A–C Lot 3 6-9Y Group

Fluarix–C 6-9Y Group

Number of subjects analysed

15 ^[22]

15 ^[23]

16 ^[24]

17 ^[25]

15 ^[26]

13 ^[27]

Units: units: Titer

geometric mean (confidence interval 95%)

A/VIET

392.7 (280.4 to 550.2)

0 (0 to 0)

540.3 (424.5 to 687.7)

0 (0 to 0)

678.1 (475.7 to 966.6)

0 (0 to 0)

615.8 (429 to 884)

0 (0 to 0)

956.4 (769.2 to 1189.3)

0 (0 to 0)

883.5 (737.3 to 1058.6)

0 (0 to 0)

A/INDO

53.5 (35 to 81.7)

0 (0 to 0)

60.8 (38.7 to 95.5)

0 (0 to 0)

73.7 (45.2 to 120.3)

0 (0 to 0)

64.9 (38.7 to 108.9)

0 (0 to 0)

167.9 (121.7 to 231.5)

0 (0 to 0)

92.5 (59.3 to 144.2)

0 (0 to 0)

Notes
[22] - The data was not computed for titers below the cut-off value for titer calculation.
[23] - The data was not computed for titers below the cut-off value for titer calculation.
[24] - The data was not computed for titers below the cut-off value for titer calculation.
[25] - The data was not computed for titers below the cut-off value for titer calculation.
[26] - The data was not computed for titers below the cut-off value for titer calculation.
[27] - The data was not computed for titers below the cut-off value for titer calculation.

No statistical analyses for this end point

Primary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Top of page

End point title

Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease ^[28]

End point description

End point type

Primary

End point timeframe

At Month 6

Notes
[28] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

GSK1562902A–A Lot 1 3-5Y Group

Fluarix–A 3-5Y Group

GSK1562902A–A Lot 1 6-9Y Group

Fluarix–A 6-9Y Group

GSK1562902A–B Lot 2 3-5Y Group

Fluarix–B 3-5Y Group

GSK1562902A–B Lot 2 6-9Y Group

Fluarix–B 6-9Y Group

GSK1562902A–C Lot 3 3-5Y Group

Fluarix–C 3-5Y Group

GSK1562902A–C Lot 3 6-9Y Group

Fluarix–C 6-9Y Group

Number of subjects analysed

15 ^[29]

14 ^[30]

16 ^[31]

17 ^[32]

11 ^[33]

16 ^[34]

Units: units: Titer

geometric mean (confidence interval 95%)

A/VIET

29.3 (19.2 to 44.6)

5.9 (4.2 to 8.3)

33.4 (21.2 to 52.7)

0 (0 to 0)

46.3 (29.8 to 72)

0 (0 to 0)

43.2 (27.9 to 66.8)

0 (0 to 0)

80 (47 to 136.4)

0 (0 to 0)

61.5 (38.9 to 97.3)

0 (0 to 0)

A/INDO

6.9 (5.6 to 8.4)

0 (0 to 0)

6.6 (5.2 to 8.4)

0 (0 to 0)

21.7 (14.3 to 33)

0 (0 to 0)

11.9 (8.4 to 16.9)

0 (0 to 0)

42.5 (23.7 to 76.3)

0 (0 to 0)

36.8 (22.3 to 60.6)

0 (0 to 0)

Notes
[29] - The data was not computed for titers below the cut-off value for titer calculation.
[30] - The data was not computed for titers below the cut-off value for titer calculation.
[31] - The data was not computed for titers below the cut-off value for titer calculation.
[32] - The data was not computed for titers below the cut-off value for titer calculation.
[33] - The data was not computed for titers below the cut-off value for titer calculation.
[34] - The data was not computed for titers below the cut-off value for titer calculation.

No statistical analyses for this end point

Primary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Top of page

End point title

Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease ^[35]

End point description

End point type

Primary

End point timeframe

At Month 12

Notes
[35] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

GSK1562902A–A Lot 1 3-5Y Group

Fluarix–A 3-5Y Group

GSK1562902A–A Lot 1 6-9Y Group

Fluarix–A 6-9Y Group

GSK1562902A–B Lot 2 3-5Y Group

Fluarix–B 3-5Y Group

GSK1562902A–B Lot 2 6-9Y Group

Fluarix–B 6-9Y Group

GSK1562902A–C Lot 3 3-5Y Group

Fluarix–C 3-5Y Group

GSK1562902A–C Lot 3 6-9Y Group

Fluarix–C 6-9Y Group

Number of subjects analysed

14 ^[36]

10 ^[37]

13 ^[38]

Units: units: Titer

geometric mean (confidence interval 95%)

A/VIET

13.9 (9.7 to 20)

0 (0 to 0)

12 (8 to 18.1)

5.8 (4.2 to 8)

19.8 (13.6 to 28.8)

5.2 (4.8 to 5.7)

22.4 (15.4 to 32.5)

5.2 (4.8 to 5.7)

23.9 (15.1 to 37.8)

0 (0 to 0)

27.7 (19.1 to 40.4)

5.4 (4.6 to 6.4)

A/INDO

13 (9.1 to 18.7)

0 (0 to 0)

10.5 (7 to 15.8)

5.5 (4.5 to 6.8)

16.4 (11.4 to 23.5)

5.9 (4.5 to 7.9)

15 (11.1 to 20.1)

6.5 (5.2 to 8.2)

18.5 (11.5 to 29.9)

0 (0 to 0)

20.4 (13.4 to 31.1)

0 (0 to 0)

Notes
[36] - The data was not computed for titers below the cut-off value for titer calculation.
[37] - The data was not computed for titers below the cut-off value for titer calculation.
[38] - The data was not computed for titers below the cut-off value for titer calculation.

No statistical analyses for this end point

Primary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Top of page

End point title

Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease ^[39]

End point description

End point type

Primary

End point timeframe

At Month 24

Notes
[39] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

GSK1562902A–A Lot 1 3-5Y Group

Fluarix–A 3-5Y Group

GSK1562902A–A Lot 1 6-9Y Group

Fluarix–A 6-9Y Group

GSK1562902A–B Lot 2 3-5Y Group

Fluarix–B 3-5Y Group

GSK1562902A–B Lot 2 6-9Y Group

Fluarix–B 6-9Y Group

GSK1562902A–C Lot 3 3-5Y Group

Fluarix–C 3-5Y Group

GSK1562902A–C Lot 3 6-9Y Group

Fluarix–C 6-9Y Group

Number of subjects analysed

13 ^[40]

11 ^[41]

16 ^[42]

10 ^[43]

13 ^[44]

Units: units: Titer

geometric mean (confidence interval 95%)

A/VIET

14.9 (10.3 to 21.5)

0 (0 to 0)

13.2 (9.1 to 19.2)

0 (0 to 0)

52.2 (33.6 to 81.1)

6.8 (4.7 to 9.7)

20.1 (13.9 to 29.3)

0 (0 to 0)

55.8 (33.2 to 93.8)

6.6 (3.5 to 12.4)

36.5 (24.8 to 53.8)

6.2 (3.9 to 9.8)

A/INDO

10.1 (7.7 to 13.4)

0 (0 to 0)

7.7 (5.9 to 10)

0 (0 to 0)

22.7 (15.2 to 33.7)

5.3 (4.6 to 6.1)

8.7 (7 to 10.8)

0 (0 to 0)

27.5 (16.1 to 47)

0 (0 to 0)

18.2 (12.1 to 27.6)

0 (0 to 0)

Notes
[40] - The data was not computed for titers below the cut-off value for titer calculation.
[41] - The data was not computed for titers below the cut-off value for titer calculation.
[42] - The data was not computed for titers below the cut-off value for titer calculation.
[43] - The data was not computed for titers below the cut-off value for titer calculation.
[44] - The data was not computed for titers below the cut-off value for titer calculation.

No statistical analyses for this end point

Primary: Number of seroconverted subjects against 2 strains of influenza disease

Top of page

End point title

Number of seroconverted subjects against 2 strains of influenza disease ^[45]

End point description

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).

End point type

Primary

End point timeframe

At Day 21

Notes
[45] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Number of subjects analysed	49	15	43	15	41	16	45	17	43	15	30	9
Units: Subjects
A/VIET	6	0	13	0	20	0	19	0	20	1	17	0
A/INDO	0	0	1	0	0	0	0	0	3	0	1	0

No statistical analyses for this end point

Primary: Number of Seroconverted Subjects Against 2 Strains of Influenza Disease

Top of page

End point title

Number of Seroconverted Subjects Against 2 Strains of Influenza Disease ^[46]

End point description

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).

End point type

Primary

End point timeframe

At Day 42

Notes
[46] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Number of subjects analysed	49	15	43	15	42	16	45	17	44	15	43	13
Units: Subjects
A/VIET	47	0	43	0	41	0	44	0	44	0	43	0
A/INDO	35	0	32	0	32	0	31	0	42	0	34	0

No statistical analyses for this end point

Primary: Number of Seroconverted Subjects Against 2 Strains of Influenza Disease

Top of page

End point title

Number of Seroconverted Subjects Against 2 Strains of Influenza Disease ^[47]

End point description

End point type

Primary

End point timeframe

At Month 6

Notes
[47] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Number of subjects analysed	50	15	41	14	47	16	45	17	29	11	41	16
Units: Subjects
A/VIET	28	1	25	0	32	0	31	0	24	0	32	0
A/INDO	3	0	1	0	23	0	12	0	20	0	25	0

No statistical analyses for this end point

Primary: Number of Seroconverted Subjects Against 2 Strains of Influenza Disease

Top of page

End point title

Number of Seroconverted Subjects Against 2 Strains of Influenza Disease ^[48]

End point description

End point type

Primary

End point timeframe

At Month 12

Notes
[48] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Number of subjects analysed	47	14	37	14	40	16	43	16	27	10	35	13
Units: Subjects
A/VIET	18	0	8	1	17	0	20	0	13	0	22	0
A/INDO	17	0	6	0	16	1	7	0	12	0	15	0

No statistical analyses for this end point

Primary: Number of Seroconverted Subjects Against 2 Strains of Influenza Disease

Top of page

End point title

Number of Seroconverted Subjects Against 2 Strains of Influenza Disease ^[49]

End point description

End point type

Primary

End point timeframe

At Month 24

Notes
[49] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Number of subjects analysed	47	13	35	11	39	16	42	16	26	10	34	13
Units: Subjects
A/VIET	18	0	8	0	30	1	18	0	19	1	23	1
A/INDO	5	0	3	0	19	0	2	0	14	0	10	0

No statistical analyses for this end point

Primary: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Top of page

End point title

Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease ^[50]

End point description

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).

End point type

Primary

End point timeframe

At Day 21

Notes
[50] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

GSK1562902A–A Lot 1 3-5Y Group

Fluarix–A 3-5Y Group

GSK1562902A–A Lot 1 6-9Y Group

Fluarix–A 6-9Y Group

GSK1562902A–B Lot 2 3-5Y Group

Fluarix–B 3-5Y Group

GSK1562902A–B Lot 2 6-9Y Group

Fluarix–B 6-9Y Group

GSK1562902A–C Lot 3 3-5Y Group

Fluarix–C 3-5Y Group

GSK1562902A–C Lot 3 6-9Y Group

Fluarix–C 6-9Y Group

Number of subjects analysed

49 ^[51]

15 ^[52]

43 ^[53]

15 ^[54]

16 ^[55]

17 ^[56]

15 ^[57]

9 ^[58]

Units: units: Fold

geometric mean (confidence interval 95%)

A/VIET

1.7 (1.2 to 2.5)

0 (0 to 0)

2.4 (1.7 to 3.5)

0 (0 to 0)

4.4 (2.9 to 6.8)

0 (0 to 0)

4.7 (2.9 to 7.8)

0 (0 to 0)

5 (3.2 to 7.9)

1.1 (0.9 to 1.5)

5.5 (3.2 to 9.2)

0 (0 to 0)

A/INDO

0 (0 to 0)

1.1 (1 to 1.2)

0 (0 to 0)

1.1 (1 to 1.2)

0 (0 to 0)

1.5 (1.2 to 2)

0 (0 to 0)

1.2 (1 to 1.4)

0 (0 to 0)

Notes
[51] - The data was not computed for titers below the cut-off value for titer calculation.
[52] - The data was not computed for titers below the cut-off value for titer calculation.
[53] - The data was not computed for titers below the cut-off value for titer calculation.
[54] - The data was not computed for titers below the cut-off value for titer calculation.
[55] - The data was not computed for titers below the cut-off value for titer calculation.
[56] - The data was not computed for titers below the cut-off value for titer calculation.
[57] - The data was not computed for titers below the cut-off value for titer calculation.
[58] - The data was not computed for titers below the cut-off value for titer calculation.

No statistical analyses for this end point

Primary: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Top of page

End point title

Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease ^[59]

End point description

End point type

Primary

End point timeframe

At Day 42

Notes
[59] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

GSK1562902A–A Lot 1 3-5Y Group

Fluarix–A 3-5Y Group

GSK1562902A–A Lot 1 6-9Y Group

Fluarix–A 6-9Y Group

GSK1562902A–B Lot 2 3-5Y Group

Fluarix–B 3-5Y Group

GSK1562902A–B Lot 2 6-9Y Group

Fluarix–B 6-9Y Group

GSK1562902A–C Lot 3 3-5Y Group

Fluarix–C 3-5Y Group

GSK1562902A–C Lot 3 6-9Y Group

Fluarix–C 6-9Y Group

Number of subjects analysed

15 ^[60]

15 ^[61]

16 ^[62]

17 ^[63]

15 ^[64]

13 ^[65]

Units: units: Fold

geometric mean (confidence interval 95%)

A/VIET

78.5 (56.1 to 110)

0 (0 to 0)

108.1 (84.9 to 137.5)

0 (0 to 0)

132.3 (91.8 to 190.7)

0 (0 to 0)

123.2 (85.8 to 176.8)

0 (0 to 0)

191.3 (153.8 to 237.9)

0 (0 to 0)

176.7 (147.5 to 211.7)

0 (0 to 0)

A/INDO

10.7 (7 to 16.3)

0 (0 to 0)

12.2 (7.7 to 19.1)

0 (0 to 0)

14.7 (9 to 24.1)

0 (0 to 0)

13 (7.7 to 21.8)

0 (0 to 0)

33.6 (24.3 to 46.3)

0 (0 to 0)

18.5 (11.9 to 28.8)

0 (0 to 0)

Notes
[60] - The data was not computed for titers below the cut-off value for titer calculation.
[61] - The data was not computed for titers below the cut-off value for titer calculation.
[62] - The data was not computed for titers below the cut-off value for titer calculation.
[63] - The data was not computed for titers below the cut-off value for titer calculation.
[64] - The data was not computed for titers below the cut-off value for titer calculation.
[65] - The data was not computed for titers below the cut-off value for titer calculation.

No statistical analyses for this end point

Primary: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Top of page

End point title

Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease ^[66]

End point description

End point type

Primary

End point timeframe

At Month 6

Notes
[66] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

GSK1562902A–A Lot 1 3-5Y Group

Fluarix–A 3-5Y Group

GSK1562902A–A Lot 1 6-9Y Group

Fluarix–A 6-9Y Group

GSK1562902A–B Lot 2 3-5Y Group

Fluarix–B 3-5Y Group

GSK1562902A–B Lot 2 6-9Y Group

Fluarix–B 6-9Y Group

GSK1562902A–C Lot 3 3-5Y Group

Fluarix–C 3-5Y Group

GSK1562902A–C Lot 3 6-9Y Group

Fluarix–C 6-9Y Group

Number of subjects analysed

15 ^[67]

14 ^[68]

16 ^[69]

17 ^[70]

11 ^[71]

16 ^[72]

Units: units: Fold

geometric mean (confidence interval 95%)

A/VIET

5.9 (3.8 to 8.9)

1.2 (0.8 to 1.7)

6.1 (3.8 to 9.7)

0 (0 to 0)

9.1 (5.8 to 14.1)

0 (0 to 0)

8.6 (5.6 to 13.4)

0 (0 to 0)

16 (9.4 to 27.3)

0 (0 to 0)

12.3 (7.8 to 19.5)

0 (0 to 0)

A/INDO

1.4 (1.1 to 1.7)

0 (0 to 0)

1.2 (1 to 1.5)

4.3 (2.9 to 6.6)

1.1 (0.9 to 1.4)

2.4 (1.7 to 3.4)

0 (0 to 0)

8.5 (4.7 to 15.3)

0 (0 to 0)

7.4 (4.5 to 12.1)

0 (0 to 0)

Notes
[67] - The data was not computed for titers below the cut-off value for titer calculation.
[68] - The data was not computed for titers below the cut-off value for titer calculation.
[69] - The data was not computed for titers below the cut-off value for titer calculation.
[70] - The data was not computed for titers below the cut-off value for titer calculation.
[71] - The data was not computed for titers below the cut-off value for titer calculation.
[72] - The data was not computed for titers below the cut-off value for titer calculation.

No statistical analyses for this end point

Primary: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Top of page

End point title

Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease ^[73]

End point description

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).

End point type

Primary

End point timeframe

At Month 12

Notes
[73] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

GSK1562902A–A Lot 1 3-5Y Group

Fluarix–A 3-5Y Group

GSK1562902A–A Lot 1 6-9Y Group

Fluarix–A 6-9Y Group

GSK1562902A–B Lot 2 3-5Y Group

Fluarix–B 3-5Y Group

GSK1562902A–B Lot 2 6-9Y Group

Fluarix–B 6-9Y Group

GSK1562902A–C Lot 3 3-5Y Group

Fluarix–C 3-5Y Group

GSK1562902A–C Lot 3 6-9Y Group

Fluarix–C 6-9Y Group

Number of subjects analysed

14 ^[74]

10 ^[75]

13 ^[76]

Units: units: Fold

geometric mean (confidence interval 95%)

A/VIET (N=47;14;35;14;40;16;43;16;27;10;35;13)

2.8 (1.9 to 4)

0 (0 to 0)

2.2 (1.5 to 3.3)

1.2 (0.8 to 1.6)

4 (2.7 to 5.8)

1 (1 to 1.1)

4.5 (3.1 to 6.5)

1 (1 to 1.1)

4.8 (3 to 7.6)

0 (0 to 0)

5.5 (3.8 to 8.1)

1.1 (0.9 to 1.3)

A/INDO (N=47;14;34;14;40;16;43;16;27;10;35;13)

2.6 (1.8 to 3.7)

0 (0 to 0)

1.9 (1.3 to 2.8)

1.1 (0.9 to 1.4)

3.3 (2.3 to 4.7)

1.2 (0.9 to 1.6)

3 (2.2 to 4)

1.3 (1 to 1.6)

3.7 (2.3 to 6)

0 (0 to 0)

4.1 (2.7 to 6.2)

0 (0 to 0)

Notes
[74] - The data was not computed for titers below the cut-off value for titer calculation.
[75] - The data was not computed for titers below the cut-off value for titer calculation.
[76] - The data was not computed for titers below the cut-off value for titer calculation.

No statistical analyses for this end point

Primary: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Top of page

End point title

Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease ^[77]

End point description

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).

End point type

Primary

End point timeframe

At Month 24

Notes
[77] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

GSK1562902A–A Lot 1 3-5Y Group

Fluarix–A 3-5Y Group

GSK1562902A–A Lot 1 6-9Y Group

Fluarix–A 6-9Y Group

GSK1562902A–B Lot 2 3-5Y Group

Fluarix–B 3-5Y Group

GSK1562902A–B Lot 2 6-9Y Group

Fluarix–B 6-9Y Group

GSK1562902A–C Lot 3 3-5Y Group

Fluarix–C 3-5Y Group

GSK1562902A–C Lot 3 6-9Y Group

Fluarix–C 6-9Y Group

Number of subjects analysed

13 ^[78]

11 ^[79]

16 ^[80]

10 ^[81]

13 ^[82]

Units: units: Fold

geometric mean (confidence interval 95%)

A/VIET

3 (2.1 to 4.3)

0 (0 to 0)

2.5 (1.7 to 3.6)

0 (0 to 0)

10.4 (6.7 to 16.2)

1.4 (0.9 to 1.9)

4 (2.8 to 5.9)

0 (0 to 0)

11.2 (6.6 to 18.8)

1.3 (0.7 to 2.5)

7.3 (5 to 10.8)

1.2 (0.8 to 2)

A/INDO

2 (1.5 to 2.7)

0 (0 to 0)

1.5 (1.1 to 1.9)

0 (0 to 0)

4.5 (3 to 6.7)

1.1 (0.9 to 1.2)

1.7 (1.4 to 2.2)

0 (0 to 0)

5.5 (3.2 to 9.4)

0 (0 to 0)

3.6 (2.4 to 5.5)

0 (0 to 0)

Notes
[78] - The data was not computed for titers below the cut-off value for titer calculation.
[79] - The data was not computed for titers below the cut-off value for titer calculation.
[80] - The data was not computed for titers below the cut-off value for titer calculation.
[81] - The data was not computed for titers below the cut-off value for titer calculation.
[82] - The data was not computed for titers below the cut-off value for titer calculation.

No statistical analyses for this end point

Primary: Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease

Top of page

End point title

Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease ^[83]

End point description

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).

End point type

Primary

End point timeframe

At Day 0

Notes
[83] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Number of subjects analysed	49	15	43	15	45	17	42	16	44	15	43	13
Units: Subjects
A/VIET	0	0	0	0	0	0	0	0	0	0	0	0
A/INDO	0	0	0	0	0	0	0	0	0	0	0	0

No statistical analyses for this end point

Primary: Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease

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End point title

Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease ^[84]

End point description

End point type

Primary

End point timeframe

At Day 21

Notes
[84] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Number of subjects analysed	49	15	43	15	41	16	45	17	43	15	30	9
Units: Subjects
A/VIET	6	0	13	0	20	0	19	0	20	1	17	0
A/INDO	0	0	1	0	0	0	0	0	3	0	1	0

No statistical analyses for this end point

Primary: Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease

Top of page

End point title

Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease ^[85]

End point description

End point type

Primary

End point timeframe

At Day 42

Notes
[85] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Number of subjects analysed	49	15	43	15	42	16	45	17	44	15	43	13
Units: Subjects
A/VIET	47	0	43	0	41	0	44	0	44	0	43	0
A/INDO	35	0	32	0	32	0	31	0	42	0	34	0

No statistical analyses for this end point

Primary: Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease

Top of page

End point title

Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease ^[86]

End point description

End point type

Primary

End point timeframe

At Month 6

Notes
[86] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Number of subjects analysed	50	15	44	14	47	16	45	17	29	11	41	16
Units: Subjects
A/VIET	28	1	28	0	33	0	31	0	24	0	32	0
A/INDO	3	0	2	0	23	0	12	0	20	0	25	0

No statistical analyses for this end point

Primary: Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease

Top of page

End point title

Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease ^[87]

End point description

End point type

Primary

End point timeframe

At Month 12

Notes
[87] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Number of subjects analysed	47	14	37	14	40	16	43	16	27	10	35	13
Units: Subjects
A/VIET (N=47,14,37,14,40,16,43,16,27,10,35,13)	18	0	9	1	17	0	20	0	13	0	22	0
A/INDO (N=47,14,36,14,40,16,43,16,27,10,35,13)	17	0	7	0	16	1	7	0	12	0	15	0

No statistical analyses for this end point

Primary: Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease

Top of page

End point title

Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease ^[88]

End point description

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).

End point type

Primary

End point timeframe

At Month 24

Notes
[88] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Number of subjects analysed	47	13	37	11	39	16	42	16	26	10	34	13
Units: Subjects
A/VIET	18	0	9	0	30	1	18	0	19	1	23	1
A/INDO	5	0	4	0	19	0	2	0	14	0	10	0

No statistical analyses for this end point

Primary: Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms

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End point title

Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms ^[89] ^[90]

End point description

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.

End point type

Primary

End point timeframe

During the 7 day follow-up period after each vaccination

Notes
[89] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[90] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group
Number of subjects analysed	51	18	51	18
Units: Subjects
Any ecchymosis	9	3	3	2
Ecchymosis >50mm	0	0	0	0
Any induration	7	1	12	6
Induration >50mm	1	0	0	1
Any pain	31	7	44	12
Grade 3 pain	2	0	5	0
Any redness	10	2	12	5
Redness >50mm	0	0	0	0
Any swelling	10	1	14	7
Swelling >50mm	1	0	1	0

No statistical analyses for this end point

Primary: Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms

Top of page

End point title

Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms ^[91] ^[92]

End point description

End point type

Primary

End point timeframe

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

Notes
[91] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[92] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Number of subjects analysed	49	17	49	18
Units: Subjects
Any ecchymosis	4	0	0	2
Ecchymosys >50mm	0	0	0	0
Any induration	14	0	10	1
Induration >50mm	1	0	1	0
Any pain	37	7	44	15
Grade 3 pain	5	0	3	0
Any redness	16	2	6	1
Redness >50mm	1	0	2	0
Any swelling	18	2	14	3
Swelling >50mm	2	0	2	0

No statistical analyses for this end point

Primary: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

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End point title

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms ^[93] ^[94]

End point description

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.

End point type

Primary

End point timeframe

During the 7-day (Days 0-6) follow-up period after any vaccination Safety Issue No

Notes
[93] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[94] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group
Number of subjects analysed	51	18	51	17	49	17
Units: Subjects
Any drowsiness	7	1	9	1	12	1
Grade 3 drowsiness	1	0	1	0	2	0
Related drowsiness	6	1	6	0	12	1
Fever (Axillary) >=37.5 deg C	8	0	10	2	18	0
Fever >39degC (Axillary)	2	0	0	1	5	0
Related fever (Axillary)	6	0	5	1	17	0
Any irritability	9	1	13	2	18	0
Grade 3 irritability	0	0	0	0	1	0
Related irritability	7	1	9	1	15	0
Any loss of appetite	12	1	8	1	15	1
Grade 3 loss of appetite	3	0	1	0	5	0
Related loss of appetite	4	1	5	1	13	1
Any shivering	1	0	4	1	10	1
Grade 3 shivering	0	0	0	0	0	0
Related shivering	1	0	2	0	9	1
Any sweating	4	0	1	0	4	0
Grade 3 sweating	0	0	0	0	1	0
Related sweating	2	0	1	0	3	0
Any vomiting	7	0	6	0	6	1
Grade 3 vomiting	0	0	1	0	0	0
Related vomiting	3	0	2	0	3	1

No statistical analyses for this end point

Primary: Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms

Top of page

End point title

Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms ^[95] ^[96]

End point description

End point type

Primary

End point timeframe

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

Notes
[95] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[96] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group
Number of subjects analysed	51	17	49	17
Units: Subjects
Any ecchymosis	4	0	4	1
Ecchymosis >50mm	0	0	0	0
Any induration	4	1	6	1
Induration >50mm	0	0	1	0
Any pain	27	3	36	9
Grade 3 pain	5	0	3	0
Any redness	6	4	6	3
Redness >50mm	1	0	0	0
Any swelling	9	2	10	2
Swelling >50mm	0	0	1	0

No statistical analyses for this end point

Primary: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Top of page

End point title

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms ^[97] ^[98]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[97] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[98] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Number of subjects analysed	51	18	49	17	49	18
Units: Subjects
Any arthralgia	6	3	7	0	9	2
Grade 3 arthralgia	0	0	1	0	0	0
Related arthralgia	6	3	7	0	7	2
Any fatigue	7	1	6	1	11	2
Grade 3 fatigue	0	0	0	0	1	0
Related fatigue	7	1	6	1	11	2
Fever >=37.5 deg C	7	3	3	0	18	0
Fever >39.0 deg C	0	1	1	0	7	0
Related fever	6	2	1	0	17	0
Any gastrointestinal symptoms	9	5	4	5	16	5
Grade 3 gastrointestinal symptoms	1	0	1	0	0	1
Related gastrointestinal symptoms	8	4	2	2	13	3
Any headache	20	5	11	2	25	3
Grade 3 headache	2	0	2	0	3	0
Related headache	16	3	8	2	22	3
Any myalgia	10	3	11	2	13	2
Grade 3 myalgia	1	0	1	0	1	0
Related myalgia	9	3	11	1	11	2
Any shivering	3	1	7	0	13	3
Grade 3 Shivering	0	0	0	0	2	0
Related Shivering	3	1	5	0	13	2
Any sweating	3	2	3	2	6	1
Grade 3 sweating	0	0	0	0	0	0
Related sweating	3	2	1	1	6	1

No statistical analyses for this end point

Primary: Number of Subjects With Serious Adverse Events (SAEs)

Top of page

End point title

Number of Subjects With Serious Adverse Events (SAEs) ^[99]

End point description

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.

End point type

Primary

End point timeframe

During the entire study (Day 0 to Month 24)

Notes
[99] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Number of subjects analysed	51	18	51	18	51	17	49	17	49	17	49	18
Units: Subjects
Any SAE(s)	0	0	0	0	0	1	0	0	2	0	1	0

No statistical analyses for this end point

Primary: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events

Top of page

End point title

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events ^[100]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[100] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Number of subjects analysed	51	18	51	18	51	17	49	17	49	17	49	18
Units: Subjects
Subjects with any AE(s)	29	12	10	5	28	9	19	6	26	8	27	6
Subjects with any Grade 3 AE(s)	4	1	1	0	3	0	0	1	3	0	1	1
Subjects with any related AE(s)	6	2	2	1	3	1	4	1	9	0	3	1

No statistical analyses for this end point

Primary: Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A

Top of page

End point title

Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A ^[101] ^[102]

End point description

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 A of the study.

End point type

Primary

End point timeframe

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

Notes
[101] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[102] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group
Number of subjects analysed	50	17	49	18
Units: Subjects
ALT,Unknown,Day 21,Below[N=1,0,0,1]	0	0	0	0
ALT,Unknown,Day 21,Normal [N=1,0,0,1]	1	0	0	1
ALT,Unknown,Day 21,Above [N=1,0,0,1]	0	0	0	0
ALT,Unknown,Day 21,Unknown [N=1,0,0,1]	0	0	0	0
ALT,Normal,Day 21,Below [N=48,17,48,17]	0	0	0	0
ALT,Normal,Day 21,Normal [N=48,17,48,17]	47	16	44	17
ALT,Normal,Day 21,Above [N=48,17,48,17]	0	0	0	0
ALT,Normal,Day 21,Unknown [N=48,17,48,17]	1	1	4	0
ALT,Unknown,Day 42,Below [N=1,0,0,1]	0	0	0	0
ALT,Unknown,Day 42,Normal [N=1,0,0,1]	1	0	0	1
ALT,Unknown,Day 42,Above [N=1,0,0,1]	0	0	0	0
ALT,Unknown,Day 42,Unknown [N=1,0,0,1]	0	0	0	0
ALT,Normal,Day 42,Below [N=49,17,49,17]	0	0	0	0
ALT,Normal,Day 42,Normal [N=49,17,49,17]	48	15	45	15
ALT,Normal,Day 42,Above [N=49,17,49,17]	0	1	0	0
ALT,Normal,Day 42,Unknown [N=49,17,49,17]	1	1	4	2
ALT,Unknown, Month 6,Below [N=1,0,0,1]	0	0	0	0
ALT,Unknown, Month 6,Normal [N=1,0,0,1]	1	0	0	1
ALT,Unknown, Month 6,Above [N=1,0,0,1]	0	0	0	0
ALT,Unknown, Month 6,Unknown [N=1,0,0,1]	0	0	0	0
ALT,Normal, Month 6,Below [N=49,17,47,16]	0	0	0	0
ALT,Normal, Month 6,Normal [N=49,17,47,16]	47	15	42	16
ALT,Normal, Month 6,Above [N=49,17,47,16]	1	0	1	0
ALT,Normal, Month 6,Unknown [N=49,17,47,16]	1	2	4	0
ALT,Unknown, Month 12,Below[N=1,0,0,1]	0	0	0	0
ALT,Unknown, Month 12,Normal[N=1,0,0,1]	1	0	0	1
ALT,Unknown, Month 12,Unknown[N=1,0,0,1]	0	0	0	0
ALT,Unknown, Month 12,Above[N=1,0,0,1]	0	0	0	0
ALT,Normal, Month 12,Below [N=49,17,44,16]	0	0	0	0
ALT,Normal, Month 12,Normal[N=49,17,44,16]	45	17	41	16
ALT,Normal, Month 12,Above[N=49,17,44,16]	1	0	1	0
ALT,Normal, Month 12,Unknown[N=49,17,44,16]	3	0	2	0
ALT,Unknown, Month 24,Below[N=1,0,0,1]	0	0	0	0
ALT,Unknown, Month 24,Normal[N=1,0,0,1]	1	0	0	1
ALT,Unknown, Month 24,Above[N=1,0,0,1]	0	0	0	0
ALT,Unknown, Month 24,Unknown[N=1,0,0,1]	0	0	0	0
ALT,Normal, Month 24,Below [N=46,16,42,13]	0	0	0	0
ALT,Normal, Month 24,Normal[N=46,16,42,13]	46	16	40	13
ALT,Normal, Month 24,Above[N=46,16,42,13]	0	0	0	0
ALT,Normal, Month 24,Unknown[N=46,16,42,13]	0	0	2	0

No statistical analyses for this end point

Primary: Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A

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End point title

Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A ^[103] ^[104]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[103] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[104] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group
Number of subjects analysed	50	17	49	18
Units: Subjects
AST,Unknown,Day 21,Below [N=1,0,0,1]	0	0	0	0
AST,Unknown,Day 21,Normal [N=1,0,0,1]	1	0	0	1
AST,Unknown,Day 21,Above [N=1,0,0,1]	0	0	0	0
AST,Unknown,Day 21,Unknown [N=1,0,0,1]	0	0	0	0
AST,Normal,Day 21,Below [N=44,17,48,17]	0	0	0	0
AST,Normal,Day 21,Normal [N=44,17,48,17]	39	16	44	16
AST,Normal,Day 21,Above [N=44,17,48,17]	4	0	0	0
AST,Normal,Day21,Unknown [N=44, 17, 48, 17]	1	1	4	1
AST,Above,Day 21,Below [N=4,0,0,0]	0	0	0	0
AST,Above,Day 21,Normal [N=4,0,0,0]	2	0	0	0
AST,Above,Day 21,Above [N=4,0,0,0]	2	0	0	0
AST,Above,Day 21,Unknown [N=4,0,0,0]	0	0	0	0
AST,Unknown,Day 42,Below [N=1,0,0,1]	0	0	0	0
AST,Unknown,Day 42,Normal [N=1,0,0,1]	1	0	0	1
AST,Unknown,Day 42,Above [N=1,0,0,1]	0	0	0	0
AST,Unknown,Day 42,Unknown [N=1,0,0,1]	0	0	0	0
AST,Normal,Day 42,Below [N=45,17,49,17]	0	0	0	0
AST,Normal,Day 42,Normal [N=45,17,49,17]	42	13	45	15
AST,Normal,Day 42,Above [N=45,17,49,17]	2	2	0	0
AST,Normal,Day 42,Unknown [N=45,17,49,17]	1	2	4	2
AST,Above,Day 42,Below [N=4,0,0,0]	0	0	0	0
AST,Above,Day 42,Normal [N=4,0,0,0]	3	0	0	0
AST,Above,Day 42,Above [N=4,0,0,0]	1	0	0	0
AST,Above,Day 42,Unknown [N=4,0,0,0]	0	0	0	0
AST,Unknown, Month 6,Below [N=1,0,0,1]	0	0	0	0
AST,Unknown, Month 6,Normal [N=1,0,0,1]	1	0	0	1
AST,Unknown, Month 6,Above [N=1,0,0,1]	0	0	0	0
AST,Unknown, Month 6,Unknown [N=1,0,0,1]	0	0	0	0
AST,Normal, Month 6,Below [N=45,17,47,16]	0	0	0	0
AST,Normal, Month 6,Normal [N=45,17,47,16]	42	14	42	16
AST,Normal, Month 6,Above [N=45,17,47,16]	2	1	1	0
AST,Normal, Month 6,Unknown [N=45,17,47,16]	1	2	4	0
AST,Above, Month 6,Below [N=4,0,0,0]	0	0	0	0
AST,Above,Month 6,Normal [N=4,0,0,0]	3	0	0	0
AST,Above, Month 6,Above [N=4,0,0,0]	1	0	0	0
AST,Above, Month 6,Unknown [N=4,0,0,0]	0	0	0	0
AST,Unknown, Month 12,Below [N=1,0,0,1]	0	0	0	0
AST,Unknown, Month 12,Normal[N=1,0,0,1]	1	0	0	1
AST,Unknown, Month 12,Above[N=1,0,0,1]	0	0	0	0
AST,Unknown, Month 12,Unknown [N=1,0,0,1]	0	0	0	0
AST,Normal, Month 12,Below [N=45,17,44,16]	0	0	0	0
AST,Normal, Month 12,Normal[N=45,17,44,16]	41	16	42	16
AST,Normal, Month 12,Above[N=45,17,44,16]	2	1	0	0
AST,Normal, Month 12,Unknown[N=45,17,44,16]	2	0	2	0
AST,Above, Month 12,Below [N=4,0,0,0]	0	0	0	0
AST,Above, Month 12,Normal[N=4,0,0,0]	1	0	0	0
AST,Above, Month 12,Above [N=4,0,0,0]	2	0	0	0
AST,Above, Month 12,Unknown[N=4,0,0,0]	1	0	0	0
AST,Unknown, Month 24,Below [N=1,0,0,1]	0	0	0	0
AST,Unknown, Month 24,Normal [N=1,0,0,1]	1	0	0	1
AST,Unknown, Month 24,Above[N=1,0,0,1]	0	0	0	0
AST,Unknown, Month 24,Unknown [N=1,0,0,1]	0	0	0	0
AST,Normal,Month 24,Below [N=43,16,42,13]	0	0	0	0
AST,Normal,Month 24,Normal [N=43,16,42,13]	41	16	40	13
AST,Normal,Month 24,Above [N=43,16,42,13]	2	0	0	0
AST,Normal,Month 24,Unknown [N=43,16,42,13]	0	0	2	0
AST,Above,Month 24,Below [N=3,0,0,0]	0	0	0	0
AST,Above,Month 24,Normal [N=3,0,0,0]	2	0	0	0
AST,Above,Month 24,Above [N=3,0,0,0]	1	0	0	0
AST,Above,Month 24,Unknown [N=3,0,0,0]	0	0	0	0

No statistical analyses for this end point

Primary: Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A

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End point title

Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A ^[105] ^[106]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[105] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[106] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group
Number of subjects analysed	50	17	49	18
Units: Subjects
BUN,Unknown, Day 21, Below [N=1,0,0,1]	0	0	0	0
BUN,Unknown, Day 21, Normal [N=1,0,0,1]	1	0	0	0
BUN,Unknown, Day 21, Above [N=1,0,0,1]	0	0	0	1
BUN,Unknown, Day 21, Unknown [N=1,0,0,1]	0	0	0	0
BUN,Normal, Day 21, Below [N=46,17,47,16]	0	1	0	0
BUN,Normal, Day 21, Normal [N=46,17,47,16]	43	14	38	16
BUN,Normal, Day 21, Above [N=46,17,47,16]	2	1	5	0
BUN,Normal, Day 21, Unknown [N=46,17,47,16]	1	1	4	0
BUN,Above, Day 21, Below [N=2,0,1,1]	0	0	0	0
BUN,Above, Day 21, Normal [N=2,0,1,1]	1	0	1	0
BUN,Above, Day 21, Above [N=2,0,1,1]	1	0	0	1
BUN,Above, Day 21, Unknown [N=2,0,1,1]	0	0	0	0
BUN,Unknown, Day 42, Below [N=1,0,0,1]	0	0	0	0
BUN,Unknown, Day 42, Normal [N=1,0,0,1]	1	0	0	1
BUN,Unknown, Day 42, Above [N=1,0,0,1]	0	0	0	0
BUN,Unknown, Day 42, Unknown [N=1,0,0,1]	0	0	0	0
BUN,Normal, Day 42, Below [N=47,17,48,16]	0	0	0	0
BUN,Normal, Day 42, Normal [N=47,17,48,16]	40	16	38	12
BUN,Normal, Day 42,Above [N=47,17,48,16]	6	0	6	2
BUN,Normal, Day 42, Unknown [N=47,17,48,16]	1	1	4	2
BUN,Above, Day 42, Below [N=2,0,1,1]	0	0	0	0
BUN,Above, Day 42, Normal [N=2,0,1,1]	1	0	1	1
BUN,Above, Day 42, Above [N=2,0,1,1]	1	0	0	0
BUN,Above, Day 42, Unknkwn [N=2,0,1,1]	0	0	0	0
BUN,Unknown, Month 6,Below [N=1,0,0,1]	0	0	0	0
BUN,Unknown, Month 6,Normal [N=1,0,0,1]	1	0	0	1
BUN,Unknown, Month 6,Above [N=1,0,0,1]	0	0	0	0
BUN,Unknown, Month 6,Unknown [N=1,0,0,1]	0	0	0	0
BUN,Normal, Month 6,Below [N=47,17,46,15]	0	1	0	0
BUN,Normal, Month 6,Normal [N=47,17,46,15]	43	13	38	14
BUN,Normal, Month 6,Above [N=47,17,46,15]	3	1	4	1
BUN,Normal, Month 6,Unknown [N=47,17,46,15]	1	2	4	0
BUN,Above, Month 6,Below [N=2,0,1,1]	0	0	0	0
BUN,Above,Month 6,Normal [N=2,0,1,1]	2	0	1	0
BUN,Above, Month 6,Above [N=2,0,1,1]	0	0	0	1
BUN,Above, Month 6,Unknown [N=2,0,1,1]	0	0	0	0
BUN,Unknown, Month 12,Below [N=1,0,0,1]	0	0	0	0
BUN,Unknown, Month 12,Normal[N=1,0,0,1]	1	0	0	1
BUN,Unknown, Month 12,Above [N=1,0,0,1]	0	0	0	0
BUN,Unknown, Month 12,Unknown [N=1,0,0,1]	0	0	0	0
BUN,Normal, Month 12,Below [N=47,17,43,15]	0	0	1	0
BUN,Normal, Month 12,Normal [N=47,17,43,15]	41	16	40	13
BUN,Normal, Month 12,Above [N=47,17,43,15]	3	1	0	2
BUN,Normal, Month 12,Unknown [N=47,17,43,15]	3	0	2	0
BUN,Above, Month 12,Below [N=2,0,1,1]	0	0	0	0
BUN,Above, Month 12,Normal [N=2,0,1,1]	0	0	1	1
BUN,Above, Month 12,Above [N=2,0,1,1]	2	0	0	0
BUN,Above, Month 12,Unknown [N=2,0,1,1]	0	0	0	0
BUN,Unknown, Month 24,Below [N=1,0,0,1]	0	0	0	0
BUN,Unknown, Month 24,Normal [N=1,0,0,1]	1	0	0	1
BUN,Unknown, Month 24,Above [N=1,0,0,1]	0	0	0	0
BUN,Unknown, Month 24,Unknown [N=1,0,0,1]	0	0	0	0
BUN,Normal, Month 24,Below [N=44,16,41,12]	0	0	1	0
BUN,Normal, Month 24,Normal [N=44,16,41,12]	42	16	37	11
BUN,Normal, Month 24,Above [N=44,16,41,12]	2	0	1	1
BUN,Normal, Month 24,Unknown [N=44,16,41,12]	0	0	2	0
BUN,Above, Month 24,Below [N=2,0,1,1]	0	0	0	0
BUN,Above, Month 24,Normal [N=2,0,1,1]	2	0	1	0
BUN,Above, Month 24,Above [N=2,0,1,1]	0	0	0	1
BUN,Above, Month 24,Unknown [N=2,0,1,1]	0	0	0	0

No statistical analyses for this end point

Primary: Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A

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End point title

Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A ^[107] ^[108]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[107] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[108] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group
Number of subjects analysed	50	17	49	18
Units: Subjects
CPK,Unknown, Day 21,Below [N=1,0,0,1]	0	0	0	0
CPK,Unknown, Day 21,Normal [N=1,0,0,1]	1	0	0	1
CPK,Unknown, Day 21,Above [N=1,0,0,1]	0	0	0	0
CPK,Unknown, Day 21,Unknown [N=1,0,0,1]	0	0	0	0
CPK,Normal, Day 21, Below [N=47,16,48,17]	0	0	0	0
CPK,Normal, Day 21, Normal [N=47,16,48,17]	44	15	42	16
CPK,Normal, Day 21, Above [N=47,16,48,17]	2	0	2	1
CPK,Normal, Day 21, Unknown [N=47,16,48,17]	1	1	4	0
CPK, Above, Day 21, Below [N=1,1,0,0]	0	0	0	0
CPK, Above, Day 21, Normal [N=1,1,0,0]	1	1	0	0
CPK, Above, Day 21, Above [N=1,1,0,0]	0	0	0	0
CPK, Above, Day 21, Unknown[N=1,1,0,0]	0	0	0	0
CPK,Unknown, Day 42,Below [N=1,0,0,1]	0	0	0	0
CPK,Unknown, Day 42,Normal [N=1,0,0,1]	1	0	0	1
CPK,Unknown, Day 42,Above [N=1,0,0,1]	0	0	0	0
CPK,Unknown, Day 42,Unknown [N=1,0,0,1]	0	0	0	0
CPK,Normal, Day 42, Below [N=49,16,49,17]	0	0	0	0
CPK,Normal, Day 42, Normal [N=49,16,49,17]	46	14	42	14
CPK,Normal, Day 42, Above [N=49,16,49,17]	2	1	3	1
CPK,Normal, Day 42, Unknown [N=49,16,49,17]	1	1	4	2
CPK, Above, Day 42, Below [N=0,1,0,0]	0	0	0	0
CPK, Above, Day 42, Normal [N=0,1,0,0]	0	1	0	0
CPK, Above, Day 42, Above [N=0,1,0,0]	0	0	1	0
CPK, Above, Day 42, Unknown [N=0,1,0,0]	0	0	0	0
CPK,Unknown, Month 6,Below [N=1,0,0,1]	0	0	0	0
CPK,Unknown, Month 6,Normal [N=1,0,0,1]	1	0	0	1
CPK,Unknown, Month 6,Above [N=1,0,0,1]	0	0	0	0
CPK,Unknown, Month 6,Unknown [N=1,0,0,1]	0	0	0	0
CPK,Normal, Month 6,Below [N=48,16,47,16]	0	0	0	0
CPK,Normal, Month 6,Normal [N=48,16,47,16]	45	13	38	15
CPK,Normal, Month 6,Above [N=48,16,47,16]	2	1	5	1
CPK,Normal, Month 6,Unknown [N=48,16,47,16]	1	2	4	0
CPK,Above, Month 6,Below [N=1,1,0,0]	0	0	0	0
CPK,Above,Month 6,Normal [N=1,1,0,0]	1	1	0	0
CPK,Above, Month 6,Above [N=1,1,0,0]	0	0	0	0
CPK,Above, Month 6,Unknown [N=1,1,0,0]	0	0	0	0
CPK,Unknown, Month 12,Below [N=1,0,0,1]	0	0	0	0
CPK,Unknown, Month 12,Normal [N=1,0,0,1]	1	0	0	1
CPK,Unknown, Month 12,Above [N=1,0,0,1]	0	0	0	0
CPK,Unknown, Month 12,Unknown [N=1,0,0,1]	0	0	0	0
CPK,Normal, Month 12,Below [N=48,16,44,16]	0	0	0	0
CPK,Normal, Month 12,Normal [N=48,16,44,16]	43	14	40	15
CPK,Normal, Month 12,Above [N=48,16,44,16]	2	2	2	1
CPK,Normal, Month 12,Unknown [N=48,16,44,16]	3	0	2	0
CPK,Above, Month 12,Below [N=1,1,0,0]	0	0	0	0
CPK,Above, Month 12,Normal [N=1,1,0,0]	1	1	0	0
CPK,Above, Month 12,Above [N=1,1,0,0]	0	0	0	0
CPK,Above, Month 12,Unknown [N=1,1,0,0]	0	0	0	0
CPK,Unknown, Month 24,Below [N=1,0,0,1]	0	0	0	0
CPK,Unknown, Month 24,Normal [N=1,0,0,1]	1	0	0	1
CPK,Unknown, Month 24,Above [N=1,0,0,1]	0	0	0	0
CPK,Unknown, Month 24,Unknown [N=1,0,0,1]	0	0	0	0
CPK,Normal, Month 24,Below [N=45,15,41,13]	0	0	0	0
CPK,Normal, Month 24,Normal [N=45,15,41,13]	45	14	36	12
CPK,Normal, Month 24,Above [N=45,15,41,13]	0	1	2	1
CPK,Normal, Month 24,Unknown [N=45,15,41,13]	0	0	3	0
CPK,Above, Month 24,Below [N=1,1,1,0]	0	0	0	0
CPK,Above, Month 24,Normal [N=1,1,1,0]	1	1	0	0
CPK,Above, Month 24,Above [N=1,1,1,0]	0	0	1	0
CPK,Above, Month 24,Unknown [N=1,1,1,0]	0	0	0	0

No statistical analyses for this end point

Primary: Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A

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End point title

Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A ^[109] ^[110]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[109] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[110] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group
Number of subjects analysed	50	17	49	18
Units: Subjects
CREA, Unknown, Day 21, Below [N=1,0,0,1]	0	0	0	0
CREA, Unknown, Day 21, Normal [N=1,0,0,1]	1	0	0	1
CREA, Unknown, Day 21, Above [N=1,0,0,1]	0	0	0	0
CREA, Unknown, Day 21, Unknown [N=1,0,0,1]	0	0	0	0
CREA, Normal, Day 21, Below [N=48,17,48,17]	0	0	0	0
CREA, Normal, Day 21, Normal [N=48,17,48,17]	47	16	42	17
CREA, Normal, Day 21, Above [N=48,17,48,17]	0	0	2	0
CREA, Normal, Day 21, Unknown [N=48,17,48,17]	1	1	4	0
CREA, Unknown, Day 42, Below [N=1,0,0,1]	0	0	0	0
CREA, Unknown, Day 42, Normal [N=1,0,0,1]	1	0	0	1
CREA, Unknown, Day 42, Above [N=1,0,0,1]	0	0	0	0
CREA, Unknown, Day 42, Unknown [N=1,0,0,1]	0	0	0	0
CREA, Normal, Day 42, Below [N=49,17,49,17]	0	0	0	0
CREA, Normal, Day 42, Normal [N=49,17,49,17]	48	16	43	15
CREA, Normal, Day 42, Above [N=49,17,49,17]	0	0	2	0
CREA, Normal, Day 42, Unknown [N=49,17,49,17]	1	1	4	2
CREA,Unknown, Month 6,Below [N=1,0,0,1]	0	0	0	0
CREA,Unknown, Month 6,Normal [N=1,0,0,1]	1	0	0	1
CREA,Unknown, Month 6,Above [N=1,0,0,1]	0	0	0	0
CREA,Unknown, Month 6,Unknown [N=1,0,0,1]	0	0	0	0
CREA,Normal, Month 6,Below [N=49,17,47,16]	0	0	0	0
CREA,Normal, Month 6,Normal [N=49,17,47,16]	48	15	43	16
CREA,Normal, Month 6,Above [N=49,17,47,16]	0	0	0	0
CREA,Normal, Month 6,Unknown [N=49,17,47,16]	1	2	4	0
CREA,Unknown, Month 12,Below [N=1,0,0,1]	0	0	0	0
CREA,Unknown, Month 12,Normal [N=1,0,0,1]	1	0	0	1
CREA,Unknown, Month 12,Above [N=1,0,0,1]	0	0	0	0
CREA,Unknown, Month 12,Unknown [N=1,0,0,1]	0	0	0	0
CREA,Normal, Month 12,Below [N=49,17,44,16]	0	0	0	0
CREA,Normal, Month 12,Normal [N=49,17,44,16]	46	17	42	16
CREA,Normal, Month 12,Above [N=49,17,44,16]	0	0	0	0
CREA,Normal, Month 12,Unknown [N=49,17,44,16]	3	0	2	0
CREA,Unknown, Month 24,Below [N=1,0,0,1]	0	0	0	0
CREA,Unknown, Month 24,Normal [N=1,0,0,1]	1	0	0	1
CREA,Unknown, Month 24,Above [N=1,0,0,1]	0	0	0	0
CREA,Unknown, Month 24,Unknown [N=1,0,0,1]	0	0	0	0
CREA,Normal, Month 24,Below [N=46,16,42,13]	0	0	0	0
CREA,Normal, Month 24,Normal [N=46,16,42,13]	46	16	39	13
CREA,Normal, Month 24,Above [N=46,16,42,13]	0	0	1	0
CREA,Normal, Month 24,Unknown [N=46,16,42,13]	0	0	2	0

No statistical analyses for this end point

Primary: Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A

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End point title

Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A ^[111] ^[112]

End point description

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

End point type

Primary

End point timeframe

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

Notes
[111] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[112] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group
Number of subjects analysed	50	17	49	18
Units: Subjects
LDH, Unknown, Day 21, Below [N=1,0,0,1]	0	0	0	0
LDH, Unknown, Day 21, Normal [N=1,0,0,1]	1	0	0	1
LDH, Unknown, Day 21, Above [N=1,0,0,1]	0	0	0	0
LDH, Unknown, Day 21, Unknown [N=1,0,0,1]	0	0	0	0
LDH, Normal, Day 21, Below [N=39,12,47,17]	0	0	0	0
LDH, Normal, Day 21, Normal [N=39,12,47,17]	36	8	40	14
LDH, Normal, Day 21, Above [N=39,12,47,17]	2	3	3	2
LDH, Normal, Day 21, Unknown [N=39,12,47,17]	1	1	4	1
LDH, Above, Day 21, Below [N=9,5,1,0]	0	0	0	0
LDH, Above, Day 21, Normal [N=9,5,1,0]	5	2	1	0
LDH, Above, Day 21, Above [N=9,5,1,0]	4	3	0	0
LDH, Above, Day 21, Unknown [N=9,5,1,0]	0	0	0	0
LDH, Unknown, Day 42, Below [N=1,0,0,1]	0	0	0	0
LDH, Unknown, Day 42, Normal [N=1,0,0,1]	1	0	0	1
LDH, Unknown, Day 42, Above [N=1,0,0,1]	0	0	0	0
LDH, Unknown, Day 42, Unknown [N=1,0,0,1]	0	0	0	0
LDH, Normal, Day 42, Above [N=40,12,48,17]	7	4	4	1
LDH, Normal, Day 42, Below [N=40,12,48,17]	0	0	0	0
LDH, Normal, Day 42, Normal [N=40,12,48,17]	32	6	41	14
LDH, Normal, Day 42, Unknown [N=40,12,48,17]	1	2	3	2
LDH, Above, Day 42, Above [N=9,5,1,0]	4	2	0	0
LDH, Above, Day 42, Below [N=9,5,1,0]	0	0	1	0
LDH, Above, Day 42, Normal [N=9,5,1,0]	5	3	0	0
LDH, Above, Day 42, Unknow [N=9,5,1,0]	0	0	0	0
LDH,Unknown, Month 6,Below [N=1,0,0,1]	0	0	0	0
LDH,Unknown, Month 6,Normal [N=1,0,0,1]	1	0	0	1
LDH,Unknown, Month 6,Above [N=1,0,0,1]	0	0	0	0
LDH,Unknown, Month 6,Unknown [N=1,0,0,1]	0	0	0	0
LDH,Normal, Month 6,Below [N=40,12,46,16]	0	0	0	0
LDH,Normal, Month 6,Normal [N=40,12,46,16]	31	7	38	13
LDH,Normal, Month 6,Above [N=40,12,46,16]	8	3	4	3
LDH,Normal, Month 6,Unknown [N=40,12,46,16]	1	2	4	0
LDH,Above, Month 6,Below [N=9,5,1,0]	0	0	0	0
LDH,Above,Month 6,Normal [N=9,5,1,0]	5	4	1	0
LDH,Above, Month 6,Above [N=9,5,1,0]	4	1	0	0
LDH,Above, Month 6,Unknown [N=9,5,1,0]	0	0	0	0
LDH,Unknown, Month 12,Below [N=1,0,0,1]	0	0	0	0
LDH,Unknown, Month 12,Normal [N=1,0,0,1]	1	0	0	1
LDH,Unknown, Month 12,Above [N=1,0,0,1]	0	0	0	0
LDH,Unknown, Month 12,Unknown [N=1,0,0,1]	0	0	0	0
LDH,Normal, Month 12,Below [N=40,12,43,16]	0	0	0	0
LDH,Normal, Month 12,Normal [N=40,12,43,16]	33	8	40	14
LDH,Normal, Month 12,Above [N=40,12,43,16]	4	4	1	2
LDH,Normal, Month 12,Unknown [N=40,12,43,16]	3	0	2	0
LDH,Above, Month 12,Below [N=9,5,1,0]	0	0	0	0
LDH,Above, Month 12,Normal [N=9,5,1,0]	6	4	1	0
LDH,Above, Month 12,Above [N=9,5,1,0]	3	1	0	0
LDH,Above, Month 12,Unknown [N=9,5,1,0]	0	0	0	0
LDH,Unknown, Month 24,Below [N=1,0,0,1]	0	0	0	0
LDH,Unknown, Month 24,Normal [N=1,0,0,1]	1	0	0	1
LDH,Unknown, Month 24,Above [N=1,0,0,1]	0	0	0	0
LDH,Unknown, Month 24,Unknown [N=1,0,0,1]	0	0	0	0
LDH,Normal, Month 24,Below [N=38,11,42,13]	0	0	0	0
LDH,Normal, Month 24,Normal [N=38,11,42,13]	35	8	36	11
LDH,Normal, Month 24,Above [N=38,11,42,13]	3	3	3	2
LDH,Normal, Month 24,Unknown [N=38,11,42,13]	0	0	3	0
LDH,Above, Month 24,Below [N=8,5,0,0]	0	0	0	0
LDH,Above, Month 24,Normal [N=8,5,0,0]	6	5	0	0
LDH,Above, Month 24,Above [N=8,5,0,0]	2	0	0	0
LDH,Above, Month 24,Unknown [N=8,5,0,0]	0	0	0	0

No statistical analyses for this end point

Primary: Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B

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End point title

Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B ^[113] ^[114]

End point description

End point type

Primary

End point timeframe

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

Notes
[113] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[114] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group
Number of subjects analysed	49	16	46	16
Units: Subjects
ALT,Unknown,Day 21,Below [N=0,1,1,0]	0	0	0	0
ALT,Unknown,Day 21,Normal [N=0,1,1,0]	0	0	1	0
ALT,Unknown,Day 21,Above [N=0,1,1,0]	0	1	0	0
ALT,Unknown,Day 21,Unknown [N=0,1,1,0]	0	0	0	0
ALT,Normal,Day 21,Below [N=48,16,45,16]	0	0	0	0
ALT,Normal,Day 21,Normal [N=48,16,45,16]	44	16	44	16
ALT,Normal,Day 21,Above [N=48,16,45,16]	1	0	1	0
ALT,Normal,Day 21,Unknown [N=48,16,45,16]	3	0	0	0
ALT,Above,Day 21,Below [N=0,0,0,1]	0	0	0	0
ALT,Above,Day 21,Normal [N=0,0,0,1]	0	0	0	1
ALT,Above,Day 21,Above [N=0,0,0,1]	0	0	0	0
ALT,Above,Day 21,Unknown [N=0,0,0,1]	0	0	0	0
ALT,Unknown,Day 42,Below [N=0,1,1,0]	0	0	0	0
ALT,Unknown,Day 42,Normal [N=0,1,1,0]	0	1	1	0
ALT,Unknown,Day 42,Above [N=0,1,1,0]	0	0	0	0
ALT,Unknown,Day 42,Unknown [N=0,1,1,0]	0	0	0	0
ALT,Normal,Day 42,Below [N=49,16,46,16]	0	0	0	0
ALT,Normal,Day 42,Normal [N=49,16,46,16]	46	16	44	16
ALT,Normal,Day 42,Above [N=49,16,46,16]	1	0	2	0
ALT,Normal,Day 42,Unknown [N=49,16,46,16]	2	0	0	0
ALT,Above,Day 42,Below [N=0,0,0,1]	0	0	0	0
ALT,Above,Day 42,Normal [N=0,0,0,1]	0	0	0	0
ALT,Above,Day 42,Above [N=0,0,0,1]	0	0	0	1
ALT,Above,Day 42,Unknown [N=0,0,0,1]	0	0	0	0
ALT,Unknown,Month 6,Below [N=0,1,1,0]	0	0	0	0
ALT,Unknown,Month 6,Normal [N=0,1,1,0]	0	1	1	0
ALT,Unknown,Month 6,Above [N=0,1,1,0]	0	0	0	0
ALT,Unknown,Month 6,Unknown [N=0,1,1,0]	0	0	0	0
ALT,Normal,Month 6,Below [N=49,16,44,16]	0	0	0	0
ALT,Normal,Month 6,Normal [N=49,16,44,16]	48	16	44	16
ALT,Normal,Month 6,Above [N=49,16,44,16]	0	0	0	0
ALT,Normal,Month 6,Unknown [N=49,16,44,16]	1	0	0	0
ALT,Above,Month 6,Below [N=0,0,0,1]	0	0	0	0
ALT,Above,Month 6,Normal [N=0,0,0,1]	0	0	0	1
ALT,Above, Month 6,Above [N=0,0,0,1]	0	0	0	0
ALT,Above, Month 6,Unknown [N=0,0,0,1]	0	0	0	0
ALT,Unknown, Month 12,Below [N=0,1,1,0]	0	0	0	0
ALT,Unknown, Month 12,Normal [N=0,1,1,0]	0	1	1	0
ALT,Unknown, Month 12,Above [N=0,1,1,0]	0	0	0	0
ALT,Unknown, Month 12,Unknown [N=0,1,1,0]	0	0	0	0
ALT,Normal, Month 12,Below [N=46,16,44,16]	0	0	0	0
ALT,Normal, Month 12,Normal [N=46,16,44,16]	44	16	44	16
ALT,Normal, Month 12,Above [N=46,16,44,16]	0	0	0	0
ALT,Normal, Month 12,Unknown [N=46,16,44,16]	2	0	0	0
ALT,Above, Month 12,Below [N=0,0,0,1]	0	0	0	0
ALT,Above,Month 12,Normal [N=0,0,0,1]	0	0	0	1
ALT,Above, Month 12,Above [N=0,0,0,1]	0	0	0	0
ALT,Above, Month 12,Unknown [N=0,0,0,1]	0	0	0	0
ALT,Unknown, Month 24,Below [N=0,1,0,0]	0	0	0	0
ALT,Unknown, Month 24,Normal [N=0,1,0,0]	0	1	0	0
ALT,Unknown, Month 24,Above [N=0,1,0,0]	0	0	0	0
ALT,Unknown, Month 24,Unknown [N=0,1,0,0]	0	0	0	0
ALT,Normal, Month 24,Below [N=45,16,44,16]	0	0	0	0
ALT,Normal, Month 24,Normal [N=45,16,44,16]	44	16	43	16
ALT,Normal, Month 24,Above [N=45,16,44,16]	1	0	1	0
ALT,Normal, Month 24,Unknown [N=45,16,44,16]	0	0	0	0
ALT,Above, Month 24,Below [N=0,0,0,1]	0	0	0	0
ALT,Above, Month 24,Normal [N=0,0,0,1]	0	0	0	1
ALT,Above, Month 24,Above [N=0,0,0,1]	0	0	0	0
ALT,Above, Month 24,Unknown [N=0,0,0,1]	0	0	0	0

No statistical analyses for this end point

Primary: Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B

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End point title

Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B ^[115] ^[116]

End point description

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 B of the study.

End point type

Primary

End point timeframe

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

Notes
[115] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[116] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group
Number of subjects analysed	47	15	43	16
Units: Subjects
AST,Unknown,Day 21,Below [N=0,1,1,0]	0	0	0	0
AST,Unknown,Day 21,Normal [N=0,1,1,0]	0	0	1	0
AST,Unknown,Day 21,Above [N=0,1,1,0]	0	1	0	0
AST,Unknown,Day 21,Unknown [N=0,1,1,0]	0	0	0	0
AST,Normal,Day 21,Below [N=46,15,42,16]	0	0	0	0
AST,Normal,Day 21,Normal [N=46,15,42,16]	40	15	41	16
AST,Normal,Day 21,Above [N=46,15,42,16]	3	0	1	0
AST,Normal,Day 21,Unknown [N=46,15,42,16]	3	0	0	0
AST,Above,Day 21,Below [N=2,1,3,1]	0	0	0	0
AST,Above,Day 21,Normal [N=2,1,3,1]	1	1	3	1
AST,Above,Day 21,Above [N=2,1,3,1]	0	0	0	0
AST,Above,Day 21,Unknown [N=2,1,3,1]	1	0	0	0
AST,Unknown,Day 42,Below [N=0,1,1,0]	0	0	0	0
AST,Unknown,Day 42,Normal [N=0,1,1,0]	0	1	1	0
AST,Unknown,Day 42,Above [N=0,1,1,0]	0	0	0	0
AST,Unknown,Day 42,Unknown [N=0,1,1,0]	0	0	0	0
AST,Normal,Day 42,Below [N=47,15,43,16]	0	0	0	0
AST,Normal,Day 42,Normal [N=47,15,43,16]	40	13	40	16
AST,Normal,Day 42,Above [N=47,15,43,16]	5	2	3	0
AST,Normal,Day 42,Unknown [N=47,15,43,16]	2	0	0	0
AST,Above,Day 42,Below [N=2,1,3,1]	0	0	0	0
AST,Above,Day 42,Normal [N=2,1,3,1]	2	1	3	0
AST,Above,Day 42,Above [N=2,1,3,1]	0	0	0	1
AST,Above,Day 42,Unknown [N=2,1,3,1]	0	0	0	0
AST,Unknown, Month 6,Below [N=0,1,1,0]	0	0	0	0
AST,Unknown, Month 6,Normal [N=0,1,1,0]	0	1	1	0
AST,Unknown, Month 6,Above [N=0,1,1,0]	0	0	0	0
AST,Unknown, Month 6,Unknown [N=0,1,1,0]	0	0	0	0
AST,Normal, Month 6,Below [N=47,15,41,16]	0	0	0	0
AST,Normal, Month 6,Normal [N=47,15,41,16]	45	14	40	16
AST,Normal, Month 6,Above [N=47,15,41,16]	2	1	0	0
AST,Normal, Month 6,Unknown [N=47,15,41,16]	0	0	1	0
AST,Above, Month 6,Below [N=2,1,3,1]	0	0	0	0
AST,Above,Month 6,Normal [N=2,1,3,1]	2	1	3	1
AST,Above, Month 6,Above [N=2,1,3,1]	0	0	0	0
AST,Above, Month 6,Unknown [N=2,1,3,1]	0	0	0	0
AST,Unknown, Month 12,Below [N=0,1,1,0]	0	0	0	0
AST,Unknown, Month 12,Normal [N=0,1,1,0]	0	1	1	0
AST,Unknown, Month 12,Above [N=0,1,1,0]	0	0	0	0
AST,Unknown, Month 12,Unknown [N=0,1,1,0]	0	0	0	0
AST,Normal, Month 12,Below [N=45,15,41,16]	0	0	0	0
AST,Normal, Month 12,Normal [N=45,15,41,16]	44	15	41	16
AST,Normal, Month 12,Above [N=45,15,41,16]	0	0	0	0
AST,Normal, Month 12,Unknown [N=45,15,41,16]	1	0	0	0
AST,Above, Month 12,Below [N=1,1,3,1]	0	0	0	0
AST,Above,Month 12,Normal [N=1,1,3,1]	0	1	3	1
AST,Above, Month 12,Above [N=1,1,3,1]	0	0	0	0
AST,Above, Month 12,Unknown [N=1,1,3,1]	1	0	0	0
AST,Unknown, Month 24,Below [N=0,1,0,0]	0	0	0	0
AST,Unknown, Month 24,Normal [N=0,1,0,0]	0	1	0	0
AST,Unknown, Month 24,Above [N=0,1,0,0]	0	0	0	0
AST,Unknown, Month 24,Unknown [N=0,1,0,0]	0	0	0	0
AST,Normal, Month 24,Below [N=45,15,41,16]	0	0	0	0
AST,Normal, Month 24,Normal [N=45,15,41,16]	44	15	41	16
AST,Normal, Month 24,Above [N=45,15,41,16]	1	0	0	0
AST,Normal, Month 24,Unknown [N=45,15,41,16]	0	0	0	0
AST,Above, Month 24,Below [N=0,1,3,1]	0	0	0	0
AST,Above, Month 24,Normal [N=0,1,3,1]	0	1	2	1
AST,Above, Month 24,Above [N=0,1,3,1]	0	0	1	0
AST,Above, Month 24,Unknown [N=0, 1, 3, 1]	0	0	0	0

No statistical analyses for this end point

Primary: Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B

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End point title

Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B ^[117] ^[118]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[117] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[118] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group
Number of subjects analysed	49	17	47	17
Units: Subjects
BUN,Unknown,Day 21,Below [N=0,1,1,1]	0	0	0	0
BUN,Unknown,Day 21,Normal [N=0,1,1,1]	0	0	1	1
BUN,Unknown,Day 21,Above [N=0,1,1,1]	0	1	0	0
BUN,Unknown,Day 21,Unknown [N=0,1,1,1]	0	0	0	0
BUN,Normal,Day 21,Below [N=44,14,40,13]	0	0	0	0
BUN,Normal,Day 21,Normal [N=44,14,40,13]	35	13	37	12
BUN,Normal,Day 21,Above [N=44,14,40,13]	6	1	3	1
BUN,Normal,Day 21,Unknown [N=44,14,40,13]	3	0	0	0
BUN,Above,Day 21,Below [N=4,2,5,3]	0	0	0	0
BUN,Above,Day 21,Normal [N=4,2,5,3]	3	1	5	2
BUN,Above,Day 21,Above [N=4,2,5,3]	1	1	0	1
BUN,Above,Day 21,Unknown [N=4,2,5,3]	0	0	0	0
BUN,Unknown,Day 42,Below [N=0,1,1,1]	0	0	0	0
BUN,Unknown,Day 42,Normal [N=0,1,1,1]	0	1	1	1
BUN,Unknown,Day 42,Above [N=0,1,1,1]	0	0	0	0
BUN,Unknown,Day 42,Unknown [N=0,1,1,1]	0	0	0	0
BUN,Normal,Day 42,Below [N=45,14,41,13]	0	0	0	0
BUN,Normal,Day 42,Normal [N=45,14,41,13]	38	12	39	11
BUN,Normal,Day 42,Above [N=45,14,41,13]	6	2	2	2
BUN,Normal,Day 42,Unknown [N=45,14,41,13]	1	0	0	0
BUN,Above,Day 42,Below [N=4,2,5,3]	0	0	0	0
BUN,Above,Day 42,Normal [N=4,2,5,3]	2	1	3	2
BUN,Above,Day 42,Above [N=4,2,5,3]	1	1	2	1
BUN,Above,Day 42,Unknown [N=4,2,5,3]	1	0	0	0
BUN,Unknown, Month 6,Below [N=0,1,1,1]	0	0	0	0
BUN,Unknown, Month 6,Normal [N=0,1,1,1]	0	1	1	1
BUN,Unknown, Month 6,Above [N=0,1,1,1]	0	0	0	0
BUN,Unknown, Month 6,Unknown [N=0,1,1,1]	0	0	0	0
BUN,Normal, Month 6,Below [N=45,14,39,13]	0	0	0	0
BUN,Normal, Month 6,Normal [N=45,14,39,13]	42	12	39	13
BUN,Normal, Month 6,Above [N=45,14,39,13]	3	2	0	0
BUN,Normal, Month 6,Unknown [N=45,14,39,13]	0	0	0	0
BUN,Above, Month 6,Below [N=4,2,5,3]	0	0	0	0
BUN,Above,Month 6,Normal [N=4,2,5,3]	4	1	5	3
BUN,Above, Month 6,Above [N=4,2,5,3]	0	1	0	0
BUN,Above, Month 6,Unknown [N=4,2,5,3]	0	0	0	0
BUN,Unknown, Month 12,Below [N=0,1,1,1]	0	0	0	0
BUN,Unknown, Month 12,Normal [N=0,1,1,1]	0	1	1	1
BUN,Unknown, Month 12,Above [N=0,1,1,1]	0	0	0	0
BUN,Unknown, Month 12,Unknown [N=0,1,1,1]	0	0	0	0
BUN,Normal, Month 12,Below [N=42,14,39,13]	0	0	0	0
BUN,Normal, Month 12,Normal [N=42,14,39,13]	36	12	38	11
BUN,Normal, Month 12,Above [N=42,14,39,13]	4	2	1	2
BUN,Normal, Month 12,Unknown [N=42,14,39,13]	2	0	0	0
BUN,Above, Month 12,Below [N=4,2,5,3]	0	0	0	0
BUN,Above,Month 12,Normal [N=4,2,5,3]	3	2	5	2
BUN,Above, Month 12,Above [N=4,2,5,3]	1	0	0	1
BUN,Above, Month 12,Unknown [N=4,2,5,3]	0	0	0	0
BUN,Unknown, Month 24,Below [N=0,1,0,1]	0	0	0	0
BUN,Unknown, Month 24,Normal [N=0,1,0,1]	0	1	0	1
BUN,Unknown, Month 24,Above [N=0,1,0,1]	0	0	0	0
BUN,Unknown, Month 24,Unknown [N=0,1,0,1]	0	0	0	0
BUN,Normal, Month 24,Below [N=41,14,39,13]	0	0	0	0
BUN,Normal, Month 24,Normal [N=41,14,39,13]	36	11	39	13
BUN,Normal, Month 24,Above [N=41,14,39,13]	5	3	0	0
BUN,Normal, Month 24,Unknown [N=41,14,39,13]	0	0	0	0
BUN,Above, Month 24,Below [N=4,2,5,3]	0	0	0	0
BUN,Above, Month 24,Normal [N=4,2,5,3]	4	1	2	2
BUN,Above, Month 24,Above [N=4,2,5,3]	0	1	3	1
BUN,Above, Month 24,Unknown [N=4,2,5,3]	0	0	0	0

No statistical analyses for this end point

Primary: Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B

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End point title

Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B ^[119] ^[120]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[119] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[120] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group
Number of subjects analysed	49	17	47	17
Units: Subjects
CPK,Unknown,Day 21,Below [N=0,1,1,0]	0	0	0	0
CPK,Unknown,Day 21,Normal [N=0,1,1,0]	0	1	1	0
CPK,Unknown,Day 21,Above [N=0,1,1,0]	0	0	0	0
CPK,Unknown,Day 21,Unknown [N=0,1,1,0]	0	0	0	0
CPK,Normal,Day 21,Below [N=46,16,43,16]	0	0	0	0
CPK,Normal,Day 21,Normal [N=46,16,43,16]	46	16	43	16
CPK,Normal,Day 21,Above [N=46,16,43,16]	2	1	0	0
CPK,Normal,Day 21,Unknown [N=46,16,43,16]	2	0	0	0
CPK,Above,Day 21,Below [N=2,0,2,1]	0	0	0	0
CPK,Above,Day 21,Normal [N=2,0,2,1]	0	0	1	0
CPK,Above,Day 21,Above [N=2,0,2,1]	1	0	1	1
CPK,Above,Day 21,Unknown [N=2,0,2,1]	1	0	0	1
CPK,Unknown,Day 42,Below [N=0,1,1,0]	0	0	0	0
CPK,Unknown,Day 42,Normal [N=0,1,1,0]	0	1	1	0
CPK,Unknown,Day 42,Above [N=0,1,1,0]	0	0	0	0
CPK,Unknown,Day 42,Unknown [N=0,1,1,0]	0	0	0	0
CPK,Normal,Day 42,Below [N=47,16,44,16]	0	0	0	0
CPK,Normal,Day 42,Normal [N=47,16,44,16]	43	16	42	14
CPK,Normal,Day 42,Above [N=47,16,44,16]	2	2	2	0
CPK,Normal,Day 42,Unknown [N=47,16,44,16]	2	0	0	0
CPK,Above,Day 42,Below [N=2,0,2,1]	0	0	0	0
CPK,Above,Day 42,Normal [N=2,0,2,1]	0	0	1	0
CPK,Above,Day 42,Above [N=2,0,2,1]	2	0	1	1
CPK,Above,Day 42,Unknown [N=2,0,2,1]	0	0	0	0
CPK,Unknown, Month 6,Below [N=0,1,1,0]	0	0	0	0
CPK,Unknown, Month 6,Normal [N=0,1,1,0]	0	1	0	0
CPK,Unknown, Month 6,Above [N=0,1,1,0]	0	0	1	0
CPK,Unknown, Month 6,Unknown [N=0,1,1,0]	0	0	0	0
CPK,Normal, Month 6,Below [N=47,16,43,16]	0	0	0	0
CPK,Normal, Month 6,Normal [N=47,16,43,16]	46	13	42	15
CPK,Normal, Month 6,Above [N=47,16,43,16]	1	3	1	1
CPK,Normal, Month 6,Unknown [N=47,16,43,16]	0	0	0	0
CPK,Above, Month 6,Below [N=2,0,1,1]	0	0	0	0
CPK,Above,Month 6,Normal [N=2,0,1,1]	1	0	1	0
CPK,Above, Month 6,Above [N=2,0,1,1]	1	0	0	1
CPK,Above, Month 6,Unknown [N=2,0,1,1]	0	0	0	0
CPK,Unknown, Month 12,Below [N=0,1,1,0]	0	0	0	0
CPK,Unknown, Month 12,Normal [N=0,1,1,0]	0	1	1	0
CPK,Unknown, Month 12,Above [N=0,1,1,0]	0	0	0	0
CPK,Unknown, Month 12,Unknown [N=0,1,1,0]	0	0	0	0
CPK,Normal, Month 12,Below [N=44,16,43,16]	0	0	0	0
CPK,Normal, Month 12,Normal [N=44,16,43,16]	39	13	42	16
CPK,Normal, Month 12,Above [N=44,16,43,16]	4	3	1	0
CPK,Normal, Month 12,Unknown [N=44,16,43,16]	1	0	0	0
CPK,Above, Month 12,Below [N=2,0,1,1]	0	0	0	0
CPK,Above,Month 12,Normal [N=2,0,1,1]	0	0	1	1
CPK,Above, Month 12,Above [N=2,0,1,1]	1	0	0	0
CPK,Above, Month 12,Unknown [N=2,0,1,1]	1	0	0	0
CPK,Unknown, Month 24,Below [N=0,1,0,0]	0	0	0	0
CPK,Unknown, Month 24,Normal [N=0,1,0,0]	0	1	0	0
CPK,Unknown, Month 24,Above [N=0,1,0,0]	0	0	0	0
CPK,Unknown, Month 24,Unknown [N=0,1,0,0]	0	0	0	0
CPK,Normal, Month 24,Below [N=44,16,43,16]	0	0	0	0
CPK,Normal, Month 24,Normal [N=44,16,43,16]	43	14	41	16
CPK,Normal, Month 24,Above [N=44,16,43,16]	1	2	2	0
CPK,Normal, Month 24,Unknown [N=44,16,43,16]	0	0	0	0
CPK,Above, Month 24,Below [N=1,0,1,1]	0	0	0	0
CPK,Above, Month 24,Normal [N=1,0,1,1]	1	0	1	0
CPK,Above, Month 24,Above [N=1,0,1,1]	0	0	0	1
CPK,Above, Month 24,Unknown [N=1,0,1,1]	0	0	0	0

No statistical analyses for this end point

Primary: Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B

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End point title

Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B ^[121] ^[122]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[121] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[122] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group
Number of subjects analysed	49	17	46	16
Units: Subjects
CREA,Unknown,Day 21,Below [N=0,1,1,0]	0	0	0	0
CREA,Unknown,Day 21,Normal [N=0,1,1,0]	0	1	1	0
CREA,Unknown,Day 21,Above [N=0,1,1,0]	0	0	0	0
CREA,Unknown,Day 21,Unknown [N=0,1,1,0]	0	0	0	0
CREA,Normal,Day 21,Below [N=48,16,44,17]	0	0	0	0
CREA,Normal,Day 21,Normal [N=48,16,44,17]	44	16	43	17
CREA,Normal,Day 21,Above [N=48,16,44,17]	1	0	1	0
CREA,Normal,Day 21,Unknown [N=48,16,44,17]	3	0	0	0
CREA,Above,Day 21,Below [N=0,0,1,0]	0	0	0	0
CREA,Above,Day 21,Normal [N=0,0,1,0]	0	0	1	0
CREA,Above,Day 21,Above [N=0,0,1,0]	0	0	0	0
CREA,Above,Day 21,Unknow [N=0,0,1,0]	0	0	0	0
CREA,Unknown,Day 42,Below [N=0,1,1,0]	0	0	0	0
CREA,Unknown,Day 42,Normal [N=0,1,1,0]	0	1	1	0
CREA,Unknown,Day 42,Above [N=0,1,1,0]	0	0	0	0
CREA,Unknown,Day 42,Unknown [N=0,1,1,0]	0	0	0	0
CREA,Normal,Day 42,Below [N=49,16,45,17]	0	0	0	0
CREA,Normal,Day 42,Normal [N=49,16,45,17]	46	16	45	17
CREA,Normal,Day 42,Above [N=49,16,45,17]	1	0	0	0
CREA,Normal,Day 42,Unknown [N=49,16,45,17]	2	0	0	0
CREA,Above,Day 42,Below [N=0,0,1,0]	0	0	0	0
CREA,Above,Day 42,Normal [N=0,0,1,0]	0	0	1	0
CREA,Above,Day 42,Above [N=0,0,1,0]	0	0	0	0
CREA,Above,Day 42,Unknown [N=0,0,1,0]	0	0	0	0
CREA,Unknown, Month 6,Below [N=0,1,1,0]	0	0	0	0
CREA,Unknown, Month 6,Normal [N=0,1,1,0]	0	1	1	0
CREA,Unknown, Month 6,Above [N=0,1,1,0]	0	0	0	0
CREA,Unknown, Month 6,Unknown [N=0,1,1,0]	0	0	0	0
CREA,Normal, Month 6,Below [N=49,16,43,17]	0	0	0	0
CREA,Normal, Month 6,Normal [N=49,16,43,17]	49	16	42	17
CREA,Normal, Month 6,Above [N=49,16,43,17]	0	0	1	0
CREA,Normal, Month 6,Unknown [N=49,16,43,17]	0	0	0	0
CREA,Above, Month 6,Below [N=0,0,1,0]	0	0	0	0
CREA,Above, Month 6,Normal [N=0,0,1,0]	0	0	0	0
CREA,Above, Month 6,Above [N=0,0,1,0]	0	0	1	0
CREA,Above, Month 6,Unknown [N=0,0,1,0]	0	0	0	0
CREA,Unknown, Month 12,Below [N=0,1,1,0]	0	0	0	0
CREA,Unknown, Month 12,Normal [N=0,1,1,0]	0	1	1	0
CREA,Unknown, Month 12,Above [N=0,1,1,0]	0	0	0	0
CREA,Unknown, Month 12,Unknown [N=0,1,1,0]	0	0	0	0
CREA,Normal, Month 12,Below [N=46,16,43,17]	0	0	0	0
CREA,Normal, Month 12,Normal [N=46,16,43,17]	44	16	42	17
CREA,Normal, Month 12,Above [N=44,16,43,17]	0	0	1	0
CREA,Normal, Month 12,Unknown [N=44,16,43,17]	2	0	0	0
CREA,Above, Month 12,Below [N=0,0,1,0]	0	0	0	0
CREA,Above,Month 12,Normal [N=0,0,1,0]	0	0	1	0
CREA,Above, Month 12,Above [N=0,0,1,0]	0	0	0	0
CREA,Above, Month 12,Unknown [N=0,0,1,0]	0	0	0	0
CREA,Unknown, Month 24,Below [N=0,1,0,0]	0	0	0	0
CREA,Unknown, Month 24,Normal [N=0,1,0,0]	0	1	0	0
CREA,Unknown, Month 24,Above [N=0,1,0,0]	0	0	0	0
CREA,Unknown, Month 24,Unknown [N=0,1,0,0]	0	0	0	0
CREA,Normal, Month 24,Below [N=45,16,43,17]	0	0	0	0
CREA,Normal, Month 24,Normal [N=45,16,43,17]	45	16	43	17
CREA,Normal, Month 24,Above [N=45,16,43,17]	0	0	0	0
CREA,Normal, Month 24,Unknown [N=45,16,43,17]	0	0	0	0
CREA,Above, Month 24,Below [N=0,0,1,0]	0	0	0	0
CREA,Above, Month 24,Normal [N=0,0,1,0]	0	0	1	0
CREA,Above, Month 24,Above [N=0,0,1,0]	0	0	0	0
CREA,Above, Month 24,Unknown [N=0,0,1,0]	0	0	0	0

No statistical analyses for this end point

Primary: Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B

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End point title

Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B ^[123] ^[124]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[123] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[124] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group
Number of subjects analysed	49	17	47	17
Units: Subjects
LDH,Unknown,Day 21,Below [N=0,1,1,0]	0	0	0	0
LDH,Unknown,Day 21,Normal [N=0,1,1,0]	0	0	1	0
LDH,Unknown,Day 21,Above [N=0,1,1,0]	0	1	0	0
LDH,Unknown,Day 21,Unknown [N=0,1,1,0]	0	0	0	0
LDH,Normal,Day 21,Below [N=43,14,38,15]	0	0	0	0
LDH,Normal,Day 21,Normal [N=43,14,38,15]	33	13	38	15
LDH,Normal,Day 21,Above [N=43,14,38,15]	7	1	0	0
LDH,Normal,Day 21,Unknown [N=43,14,38,15]	3	0	0	0
LDH,Above,Day 21,Below [N=5,2,7,2]	0	0	0	0
LDH,Above,Day 21,Normal [N=5,2,7,2]	2	1	3	1
LDH,Above,Day 21,Above [N=5,2,7,2]	2	1	4	1
LDH,Above,Day 21,Unknown [N=5,2,7,2]	1	0	0	0
LDH,Unknown,Day 42,Below [N=0,1,1,0]	0	0	0	0
LDH,Unknown,Day 42,Normal [N=0,1,1,0]	0	0	1	0
LDH,Unknown,Day 42,Above [N=0,1,1,0]	0	1	0	0
LDH,Unknown,Day 42,Unknown [N=0,1,1,0]	0	0	0	0
LDH,Normal,Day 42,Below [N=44,14,39,15]	0	0	0	0
LDH,Normal,Day 42,Normal [N=44,14,39,15]	33	9	37	14
LDH,Normal,Day 42,Above [N=44,14,39,15]	9	5	2	1
LDH,Normal,Day 42,Unknown [N=44,14,39,15]	2	0	0	0
LDH,Above,Day 42,Below [N=5,2,7,2]	0	0	0	0
LDH,Above,Day 42,Normal [N=5,2,7,2]	2	1	3	0
LDH,Above,Day 42,Above [N=5,2,7,2]	3	1	4	2
LDH,Above,Day 42,Unknown [N=5,2,7,2]	0	0	0	0
LDH,Unknown, Month 6,Below [N=0,1,1,0]	0	0	0	0
LDH,Unknown, Month 6,Normal [N=0,1,1,0]	0	1	1	0
LDH,Unknown, Month 6,Above [N=0,1,1,0]	0	0	0	0
LDH,Unknown, Month 6,Unknown [N=0,1,1,0]	0	0	0	0
LDH,Normal, Month 6,Below [N=44,14,38,15]	0	0	0	0
LDH,Normal, Month 6,Normal [N=44,14,38,15]	37	9	34	14
LDH,Normal, Month 6,Above [N=44,14,38,15]	6	5	3	1
LDH,Normal, Month 6,Unknown [N=44,14,38,15]	1	0	1	0
LDH,Above, Month 6,Below [N=5,2,6,2]	0	0	0	0
LDH,Above,Month 6,Normal [N=5,2,6,2]	3	2	2	1
LDH,Above, Month 6,Above [N=5,2,6,2]	2	0	4	1
LDH,Above, Month 6,Unknown [N=5,2,6,2]	0	0	0	0
LDH,Unknown, Month 12,Below [N=0,1,1,0]	0	0	0	0
LDH,Unknown, Month 12,Normal [N=0,1,1,0]	0	0	1	0
LDH,Unknown, Month 12,Above [N=0,1,1,0]	0	1	0	0
LDH,Unknown, Month 12,Unknown [N=0,1,1,0]	0	0	0	0
LDH,Normal, Month 12,Below [N=42,14,38,15]	0	0	0	0
LDH,Normal, Month 12,Normal [N=42,14,38,15]	32	10	36	15
LDH,Normal, Month 12,Above [N=42,14,38,15]	9	4	2	0
LDH,Normal, Month 12,Unknown [N=42,14,38,15]	1	0	0	0
LDH,Above, Month 12,Below [N=4,2,6,2]	0	0	0	0
LDH,Above,Month 12,Normal [N=4,2,6,2]	3	2	5	1
LDH,Above, Month 12,Above [N=4,2,6,2]	0	0	1	1
LDH,Above, Month 12,Unknown [N=4,2,6,2]	1	0	0	0
LDH,Unknown, Month 24,Below [N=0,1,0,0]	0	0	0	0
LDH,Unknown, Month 24,Normal [N=0,1,0,0]	0	1	0	0
LDH,Unknown, Month 24,Above [N=0,1,0,0]	0	0	0	0
LDH,Unknown, Month 24,Unknown [N=0,1,0,0]	0	0	0	0
LDH,Normal, Month 24,Below [N=42,14,38,15]	0	0	0	0
LDH,Normal, Month 24,Normal [N=42,14,38,15]	40	13	37	15
LDH,Normal, Month 24,Above [N=42,14,38,15]	2	1	1	0
LDH,Normal, Month 24,Unknown [N=42,14,38,15]	0	0	0	0
LDH,Above, Month 24,Below [N=3,2,6,2]	0	0	0	0
LDH,Above, Month 24,Normal [N=3,2,6,2]	3	2	4	0
LDH,Above, Month 24,Above [N=3,2,6,2]	0	0	2	2
LDH,Above, Month 24,Unknown [N=3,2,6,2]	0	0	0	0

No statistical analyses for this end point

Primary: Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C

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End point title

Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C ^[125] ^[126]

End point description

End point type

Primary

End point timeframe

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

Notes
[125] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[126] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Number of subjects analysed	48	17	48	18
Units: Subjects
ALT, Unknown, Day 21, Below [N=5,1,2,1]	0	0	0	0
ALT, Unknown, Day 21, Normal [N=5,1,2,1]	3	0	1	1
ALT, Unknown, Day 21, Above [N=5,1,2,1]	0	0	0	0
ALT, Unknown, Day 21, Unknown [N=5,1,2,1]	2	1	1	0
ALT, Normal, Day 21, Below [N=42,15,44,17]	0	0	0	0
ALT, Normal, Day 21, Normal [N=42,15,44,17]	41	12	40	17
ALT, Normal, Day 21, Above [N=42,15,44,17]	0	0	0	0
ALT, Normal, Day 21, Unknown [N=42,15,44,17]	1	3	4	0
ALT, Above, Day 21, Below [N=1,0,1,0]	0	0	0	0
ALT, Above, Day 21, Normal [N=1,0,1,0]	0	0	1	0
ALT, Above, Day 21, Above [N=1,0,1,0]	1	0	0	0
ALT, Above, Day 21, Unknown [N=1,0,1,0]	0	0	0	0
ALT, Unknown, Day 42, Below [N=5,2,2,1]	0	0	0	0
ALT, Unknown, Day 42, Normal [N=5,2,2,1]	5	2	2	1
ALT, Unknown, Day 42, Above [N=5,2,2,1]	0	0	0	0
ALT, Unknown, Day 42, Unknown [N=5,2,2,1]	0	0	0	0
ALT, Normal, Day 42, Below [N=42,15,45,17]	0	0	0	0
ALT, Normal, Day 42, Normal [N=42,15,45,17]	40	14	43	17
ALT, Normal, Day 42, Above [N=42,15,45,17]	0	0	0	0
ALT, Normal, Day 42, Unknown [N=42,15,45,17]	2	1	2	0
ALT, Above, Day 42, Below [N=1,0,1,0]	0	0	0	0
ALT, Above, Day 42, Normal [N=1,0,1,0]	1	0	1	0
ALT, Above, Day 42, Above [N=1,0,1,0]	0	0	0	0
ALT, Above, Day 42, Unknown [N=1,0,1,0]	0	0	0	0
ALT, Unknown, Month 6, Below [N=4,2,2,1]	0	0	0	0
ALT, Unknown, Month 6, Normal [N=4,2,2,1]	4	2	2	1
ALT, Unknown, Month 6, Above [N=4,2,2,1]	0	0	0	0
ALT, Unknown, Month 6, Unknown [N=4,2,2,1]	0	0	0	0
ALT, Normal , Month 6, Below [N=40,15,43,17]	0	0	0	0
ALT, Normal , Month 6, Normal [N=40,15,43,17]	36	13	41	17
ALT, Normal , Month 6, Above [N=40,15,43,17]	0	1	0	0
ALT, Normal , Month 6, Unknown [N=40,15,43,17]	4	1	2	0
ALT, Above, Month 6, Below [N=1,0,1,0]	0	0	0	0
ALT, Above, Month 6, Normal [N=1,0,1,0]	1	0	1	0
ALT, Above, Month 6, Above [N=1,0,1,0]	0	0	0	0
ALT, Above, Month 6, Unknown [N=1,0,1,0]	0	0	0	0
ALT, Unknown, Month 12, Below [N=3,2,3,1]	0	0	0	0
ALT, Unknown, Month 12, Normal [N=3,2,3,1]	3	2	2	1
ALT, Unknown, Month 12, Above [N=3,2,3,1]	0	0	1	0
ALT, Unknown, Month 12, Unknown [N=3,2,3,1]	0	0	0	0
ALT, Normal , Month 12, Below [N=40,15,44,17]	0	0	0	0
ALT, Normal , Month 12, Normal [N=40,15,44,17]	38	15	41	16
ALT, Normal , Month 12, Above [N=40,15,44,17]	0	0	1	0
ALT, Normal , Month 12, Unknown [N=40,15,44,17]	2	0	2	1
ALT, Above, Month 12, Below [N=1,0,1,0]	0	0	0	0
ALT, Above, Month 12, Normal [N=1,0,1,0]	1	0	1	0
ALT, Above, Month 12, Above [N=1,0,1,0]	0	0	0	0
ALT, Above, Month 12, Unknown [N=1,0,1,0]	0	0	0	0
ALT, Unknown, Month 24, Below [N=3,2,2,1]	0	0	0	0
ALT, Unknown, Month 24, Normal [N=3,2,2,1]	2	2	2	1
ALT, Unknown, Month 24, Above [N=3,2,2,1]	0	0	0	0
ALT, Unknown, Month 24, Unknown [N=3,2,2,1]	1	0	0	0
ALT, Normal , Month 24, Below [N=38,15,43,17]	0	0	0	0
ALT, Normal , Month 24, Normal [N=38,15,43,17]	36	15	41	17
ALT, Normal , Month 24, Above [N=38,15,43,17]	2	0	2	0
ALT, Normal , Month 24, Unknown [N=38,15,43,17]	0	0	0	0
ALT, Above, Month 24, Below [N=1,0,1,0]	0	0	0	0
ALT, Above, Month 24, Normal [N=1,0,1,0]	1	0	1	0
ALT, Above, Month 24, Above [N=1,0,1,0]	0	0	0	0
ALT, Above, Month 24, Unknown [N=1,0,1,0]	0	0	0	0

No statistical analyses for this end point

Primary: Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C

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End point title

Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C ^[127] ^[128]

End point description

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 C of the study.

End point type

Primary

End point timeframe

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

Notes
[127] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[128] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Number of subjects analysed	48	17	48	18
Units: Subjects
AST, Unknown, Day 21, Below [N=5,1,2,1]	0	0	0	0
AST, Unknown, Day 21, Normal [N=5,1,2,1]	3	0	1	1
AST, Unknown, Day 21, Above [N=5,1,2,1]	0	0	0	0
AST, Unknown, Day 21, Unknown [N=5,1,2,1]	2	1	1	0
AST, Normal, Day 21, Below [N=40,12,44,17]	0	0	0	0
AST, Normal, Day 21, Normal [N=40,12,44,17]	39	10	40	17
AST, Normal, Day 21, Above [N=40,12,44,17]	0	0	0	0
AST, Normal, Day 21, Unknown [N=40,12,44,17]	1	2	4	0
AST, Above, Day 21, Below [N=3,3,1,0]	0	0	0	0
AST, Above, Day 21, Normal [N=3,3,1,0]	2	2	1	0
AST, Above, Day 21, Above[N=3,3,1,0]	1	0	0	0
AST, Above, Day 21, Unknown [N=3,3,1,0]	0	1	0	0
AST, Unknown, Day 42, Below [N=5,2,2,1]	0	0	0	0
AST, Unknown, Day 42, Normal [N=5,2,2,1]	5	2	1	1
AST, Unknown, Day 42, Above [N=5,2,2,1]	0	0	1	0
AST, Unknown, Day 42, Unknown [N=5,2,2,1]	0	0	0	0
AST, Normal, Day 42, Below [N=40,12,45,17]	0	0	0	0
AST, Normal, Day 42, Normal [N=40,12,45,17]	36	11	41	17
AST, Normal, Day 42, Above [N=40,12,45,17]	2	0	2	0
AST, Normal, Day 42, Unknown [N=40,12,45,17]	2	1	2	0
AST, Above, Day 42, Below [N=3,3,1,0]	0	0	0	0
AST, Above, Day 42, Normal [N=3,3,1,0]	3	1	1	0
AST, Above, Day 42, Above [N=3,3,1,0]	0	2	0	0
AST, Above, Day 42, Unknown [N=3,3,1,0]	0	0	0	0
AST, Unknown, Month 6, Below [N=4,2,2,1]	0	0	0	0
AST, Unknown, Month 6, Normal [N=4,2,2,1]	3	2	2	1
AST, Unknown, Month 6, Above [N=4,2,2,1]	0	0	0	0
AST, Unknown, Month 6, Unknown [N=4,2,2,1]	1	0	0	0
AST, Normal, Month 6, Below [N=39,12,43,17]	0	0	0	0
AST, Normal, Month 6, Normal [N=39,12,43,17]	34	9	40	17
AST, Normal, Month 6, Above [N=39,12,43,17]	1	2	1	0
AST, Normal, Month 6, Unknown [N=39,12,43,17]	4	1	2	0
AST, Above, Month 6, Below [N=2,3,1,0]	0	0	0	0
AST, Above, Month 6, Normal [N=2,3,1,0]	2	3	1	0
AST, Above, Month 6, Above [N=2,3,1,0]	0	0	0	0
AST, Above, Month 6, Unknown [N=2,3,1,0]	0	0	0	0
AST, Unknown, Month 12, Below [N=3,2,3,1]	0	0	0	0
AST, Unknown, Month 12, Normal [N=3,2,3,1]	3	2	2	1
AST, Unknown, Month 12, Above [N=3,2,3,1]	0	0	1	0
AST, Unknown, Month 12, Unknown [N=3,2,3,1]	0	0	0	0
AST, Normal, Month 12, Below [N=39,12,44,17]	0	0	0	0
AST, Normal, Month 12, Normal [N=39,12,44,17]	36	12	37	16
AST, Normal, Month 12, Above [N=39,12,44,17]	0	0	4	0
AST, Normal, Month 12, Unknown [N=39,12,44,17]	3	0	3	1
AST, Above, Month 12, Below [N=2,3,1,0]	0	0	0	0
AST, Above, Month 12, Normal [N=2,3,1,0]	2	3	1	0
AST, Above, Month 12, Above [N=2,3,1,0]	0	0	0	0
AST, Above, Month 12, Unknown [N=2,3,1,0]	0	0	0	0
AST, Unknown, Month 24, Below [N=3,2,2,1]	0	0	0	0
AST, Unknown, Month 24, Normal [N=3,2,2,1]	2	2	2	1
AST, Unknown, Month 24, Above [N=3,2,2,1]	0	0	0	0
AST, Unknown, Month 24, Unknown [N=3,2,2,1]	1	0	0	0
AST, Normal, Month 24, Below [N=37,12,43,17]	0	0	0	0
AST, Normal, Month 24, Normal [N=37,12,43,17]	34	12	42	17
AST, Normal, Month 24, Above [N=37,12,43,17]	3	0	1	0
AST, Normal, Month 24, Unknown [N=37,12,43,17]	0	0	0	0
AST, Above, Month 24, Below [N=2,3,1,0]	0	0	0	0
AST, Above, Month 24, Normal [N=2,3,1,0]	2	3	1	0
AST, Above, Month 24, Above [N=2,3,1,0]	0	0	0	0
AST, Above, Month 24, Unknown [N=2,3,1,0]	0	0	0	0

No statistical analyses for this end point

Primary: Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C

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End point title

Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C ^[129] ^[130]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[129] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[130] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Number of subjects analysed	48	17	48	18
Units: Subjects
CREA,Unknown,Day 21,Below [N=5,1,2,1]	0	0	0	0
CREA,Unknown,Day 21,Normal [N=5,1,2,1]	3	0	1	1
CREA,Unknown,Day 21,Above [N=5,1,2,1]	0	0	0	0
CREA,Unknown,Day 21,Unknown [N=5,1,2,1]	2	1	1	0
CREA,Normal,Day 21,Below [N=43,15,45,17]	0	0	0	0
CREA,Normal,Day 21,Normal [N=43,15,45,17]	42	12	41	17
CREA,Normal,Day 21,Above [N=43,15,45,17]	0	0	0	0
CREA,Normal,Day 21,Unknown [N=43,15,45,17]	1	3	4	0
CREA,Unknown,Day 42,Below [N=5,2,2,1]	0	0	0	0
CREA,Unknown,Day 42,Normal [N=5,2,2,1]	5	2	2	1
CREA,Unknown,Day 42,Above [N=5,2,2,1]	0	0	0	0
CREA,Unknown,Day 42,Unknown [N=5,2,2,1]	0	0	0	0
CREA,Normal,Day 42,Below [N=43,15,46,17]	0	0	0	0
CREA,Normal,Day 42,Normal [N=43,15,46,17]	41	14	44	17
CREA,Normal,Day 42,Above [N=43,15,46,17]	0	0	0	0
CREA,Normal,Day 42,Unknown [N=43,15,46,17]	2	1	2	0
CREA,Unknown,Month 6,Below [N=4,2,2,1]	0	0	0	0
CREA,Unknown,Month 6,Normal [N=4,2,2,1]	4	2	2	1
CREA,Unknown,Month 6,Above [N=4,2,2,1]	0	0	0	0
CREA,Unknown,Month 6,Unknown [N=4,2,2,1]	0	0	0	0
CREA,Normal,Month 6,Below [N=41,15,44,17]	0	0	0	0
CREA,Normal,Month 6,Normal [N=41,15,44,17]	37	14	42	17
CREA,Normal,Month 6,Above [N=41,15,44,17]	0	0	0	0
CREA,Normal,Month 6,Unknown [N=41,15,44,17]	4	1	2	0
CREA,Unknown,Month 12,Below [N=3,2,3,1]	0	0	0	0
CREA,Unknown,Month 12,Normal [N=3,2,3,1]	3	2	3	1
CREA,Unknown,Month 12,Above [N=3,2,3,1]	0	0	0	0
CREA,Unknown,Month 12,Unknown [N=3,2,3,1]	0	0	0	0
CREA,Normal,Month 12,Below [N=41,15,45,17]	0	0	0	0
CREA,Normal,Month 12,Normal [N=41,15,45,17]	39	15	43	16
CREA,Normal,Month 12,Above [N=41,15,45,17]	0	0	0	0
CREA,Normal,Month 12,Unknown [N=41,15,45,17]	2	0	2	1
CREA,Unknown,Month 24,Below [N=3,2,2,1]	0	0	0	0
CREA,Unknown,Month 24,Normal [N=3,2,2,1]	2	2	2	1
CREA,Unknown,Month 24,Above [N=3,2,2,1]	0	0	0	0
CREA,Unknown,Month 24,Unknown [N=3,2,2,1]	1	0	0	0
CREA,Normal,Month 24,Below [N=39,15,44,17]	0	0	0	0
CREA,Normal,Month 24,Normal [N=39,15,44,17]	39	15	44	17
CREA,Normal,Month 24,Above [N=39,15,44,17]	0	0	0	0
CREA,Normal,Month 24,Unknown [N=39,15,44,17]	0	0	0	0

No statistical analyses for this end point

Primary: Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C

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End point title

Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C ^[131] ^[132]

End point description

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 C of the study.

End point type

Primary

End point timeframe

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

Notes
[131] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[132] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Number of subjects analysed	48	17	48	18
Units: Subjects
BUN,Unknown,Day 21,Below [N=5,1,1,1]	0	0	0	0
BUN,Unknown,Day 21,Normal [N=5,1,1,1]	3	0	0	1
BUN,Unknown,Day 21,Above [N=5,1,1,1]	0	0	0	0
BUN,Unknown,Day 21,Unknown [N=5,1,1,1]	2	1	1	0
BUN,Below,Day 21,Below [N=0,1,0,0]	0	0	0	0
BUN,Below,Day 21,Normal [N=0,1,0,0]	0	0	0	0
BUN,Below,Day 21,Above [N=0,1,0,0]	0	0	0	0
BUN,Below,Day 21,Unknown [N=0,1,0,0]	0	1	0	0
BUN,Normal,Day 21,Below [N=41,11,45,17]	1	0	0	0
BUN,Normal,Day 21,Normal [N=41,11,45,17]	37	9	41	16
BUN,Normal,Day 21,Above [N=41,11,45,17]	2	0	0	1
BUN,Normal,Day 21,Unknown [N=41,11,45,17]	1	2	4	0
BUN,Above,Day 21,Below [N=2,3,1,0]	0	0	0	0
BUN,Above,Day 21,Normal [N=2,3,1,0]	2	3	1	0
BUN,Above,Day 21,Above [N=2,3,1,0]	0	0	0	0
BUN,Above,Day 21,Unknown [N=2,3,1,0]	0	0	0	0
BUN,Unknown,Day 42,Below [N=5,2,1,1]	0	0	0	0
BUN,Unknown,Day 42,Normal [N=5,2,1,1]	5	2	1	1
BUN,Unknown,Day 42,Above [N=5,2,1,1]	0	0	0	0
BUN,Unknown,Day 42,Unknown [N=5,2,1,1]	0	0	0	0
BUN,Below,Day 42,Below [N=0,1,0,0]	0	0	0	0
BUN,Below,Day 42,Normal [N=0,1,0,0]	0	1	0	0
BUN,Below,Day 42,Above [N=0,1,0,0]	0	0	0	0
BUN,Below,Day 42,Unknown [N=0,1,0,0]	0	0	0	0
BUN,Normal,Day 42,Below [N=41,11,46,17]	0	0	3	0
BUN,Normal,Day 42,Normal [N=41,11,46,17]	37	11	38	16
BUN,Normal,Day 42,Above [N=41,11,46,17]	2	0	3	1
BUN,Normal,Day 42,Unknown [N=41,11,46,17]	2	0	2	0
BUN,Above,Day 42,Below [N=2,3,1,0]	0	0	0	0
BUN,Above,Day 42,Normal [N=2,3,1,0]	1	2	1	0
BUN,Above,Day 42,Above [N=2,3,1,0]	1	0	0	0
BUN,Above,Day 42,Unknown [N=2,3,1,0]	0	1	0	0
BUN,Unknown,Month 6,Below [N=4,2,1,1]	0	0	0	0
BUN,Unknown,Month 6,Normal [N=4,2,1,1]	4	2	1	1
BUN,Unknown,Month 6,Above [N=4,2,1,1]	0	0	0	0
BUN,Unknown,Month 6,Unknown [N=4,2,1,1]	0	0	0	0
BUN,Below,Month 6,Below [N=0,1,0,0]	0	0	0	0
BUN,Below,Month 6,Normal [N=0,1,0,0]	0	1	0	0
BUN,Below,Month 6,Above [N=0,1,0,0]	0	0	0	0
BUN,Below,Month 6,Unknown [N=0,1,0,0]	0	0	0	0
BUN,Normal,Month 6,Below [N=39,11,44,17]	0	0	2	0
BUN,Normal,Month 6,Normal [N=39,11,44,17]	34	10	35	17
BUN,Normal,Month 6,Above [N=39,11,44,17]	1	0	5	0
BUN,Normal,Month 6,Unknown [N=39,11,44,17]	4	1	2	0
BUN,Above,Month 6,Below [N=2,3,1,0]	0	0	0	0
BUN,Above,Month 6,Normal [N=2,3,1,0]	2	2	0	0
BUN,Above,Month 6,Above [N=2,3,1,0]	0	1	1	0
BUN,Above,Month 6,Unknown [N=2,3,1,0]	0	0	0	0
BUN,Unknown,Month 12,Below [N=3,2,2,1]	0	0	0	0
BUN,Unknown,Month 12,Normal [N=3,2,2,1]	3	2	1	1
BUN,Unknown,Month 12,Above [N=3,2,2,1]	0	0	1	0
BUN,Unknown,Month 12,Unknown [N=3,2,2,1]	0	0	0	0
BUN,Below,Month 12,Below [N=0,1,0,0]	0	0	0	0
BUN,Below,Month 12,Normal [N=0,1,0,0]	0	1	0	0
BUN,Below,Month 12,Above [N=0,1,0,0]	0	0	0	0
BUN,Below,Month 12,Unknown [N=0,1,0,0]	0	0	0	0
BUN,Normal,Month12,Below [N=39,11,45,17]	0	0	0	0
BUN,Normal,Month12,Normal [N=39,11,45,17]	36	10	41	16
BUN,Normal,Month12,Above [N=39,11,45,17]	1	1	2	0
BUN,Normal,Month12,Unknown [N=39,11,45,17]	2	0	2	1
BUN,Above,Month 12,Below [N=2,3,1,0]	0	0	0	0
BUN,Above,Month 12,Normal [N=2,3,1,0]	2	2	1	0
BUN,Above,Month 12,Above [N=2,3,1,0]	0	1	0	0
BUN,Above,Month 12,Unknown [N=2,3,1,0]	0	0	0	0
BUN,Unknown,Month 24,Below [N=3,2,1,1]	0	0	0	0
BUN,Unknown,Month 24,Normal [N=3,2,1,1]	2	2	1	1
BUN,Unknown,Month 24,Above [N=3,2,1,1]	0	0	0	0
BUN,Unknown,Month 24,Unknown [N=3,2,1,1]	1	0	0	0
BUN,Below,Month 24,Below [N=0,1,0,0]	0	0	0	0
BUN,Below,Month 24,Normal [N=0,1,0,0]	0	1	0	0
BUN,Below,Month 24,Above [N=0,1,0,0]	0	0	0	0
BUN,Below,Month 24,Unknown [N=0,1,0,0]	0	0	0	0
BUN,Normal,Month 24,Below [N=37,11,44,17]	0	0	1	0
BUN,Normal,Month 24,Normal [N=37,11,44,17]	35	9	39	16
BUN,Normal,Month 24,Above [N=37,11,44,17]	2	2	4	1
BUN,Normal,Month 24,Unknown [N=37,11,44,17]	0	0	0	0
BUN,Above,Month 24,Below [N=2,3,1,0]	0	0	0	0
BUN,Above,Month 24,Normal [N=2,3,1,0]	2	3	0	0
BUN,Above,Month 24,Above [N=2,3,1,0]	0	0	1	0
BUN,Above,Month 24,Unknown [N=2,3,1,0]	0	0	0	0

No statistical analyses for this end point

Primary: Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C

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End point title

Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C ^[133] ^[134]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[133] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[134] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Number of subjects analysed	48	17	48	18
Units: Subjects
CPK,Unknown,Day 21,Below [N=5,1,2,1]	0	0	0	0
CPK,Unknown,Day 21,Normal [N=5,1,2,1]	3	0	0	1
CPK,Unknown,Day 21,Above [N=5,1,2,1]	0	0	1	0
CPK,Unknown,Day 21,Unknown [N=5,1,2,1]	2	1	1	0
CPK,Normal,Day 21,Below [N=42,13,41,16]	0	0	0	0
CPK,Normal,Day 21,Normal [N=42,13,41,16]	39	19	37	14
CPK,Normal,Day 21,Above [N=42,13,41,16]	2	0	0	2
CPK,Normal,Day 21,Unknown [N=42,13,41,16]	1	3	4	0
CPK,Above,Day 21,Below [N=1,2,4,1]	0	0	0	0
CPK,Above,Day 21,Normal [N=1,2,4,1]	1	1	4	1
CPK,Above,Day 21,Above [N=1,2,4,1]	0	1	0	0
CPK,Above,Day 21,Unknown [N=1,2,4,1]	0	0	0	0
CPK,Unknown,Day 42,Below [N=5,2,2,1]	0	0	0	0
CPK,Unknown,Day 42,Normal [N=5,2,2,1]	5	1	2	1
CPK,Unknown,Day 42,Above [N=5,2,2,1]	0	1	0	0
CPK,Unknown,Day 42,Unknown [N=5,2,2,1]	0	0	0	0
CPK,Normal,Day 42,Below [N=42,13,42,16]	0	0	0	0
CPK,Normal,Day 42,Normal [N=42,13,42,16]	39	11	40	15
CPK,Normal,Day 42,Above [N=42,13,42,16]	1	1	0	1
CPK,Normal,Day 42,Unknown [N=42,13,42,16]	2	1	2	0
CPK,Above,Day 42,Below [N=1,2,4,1]	0	0	0	0
CPK,Above,Day 42,Normal [N=1,2,4,1]	0	1	4	1
CPK,Above,Day 42,Above [N=1,2,4,1]	1	1	0	0
CPK,Above,Day 42,Unknown [N=1,2,4,1]	0	0	0	0
CPK,Unknown,Month 6,Below [N=4,2,2,1]	0	0	0	0
CPK,Unknown,Month 6,Normal [N=4,2,2,1]	3	2	2	1
CPK,Unknown,Month 6,Above [N=4,2,2,1]	1	0	0	0
CPK,Unknown,Month 6,Unknown [N=4,2,2,1]	0	0	0	0
CPK,Normal,Month 6,Below [N=40,13,40,16]	0	0	0	0
CPK,Normal,Month 6,Normal [N=40,13,40,16]	34	12	36	16
CPK,Normal,Month 6,Above [N=40,13,40,16]	2	0	3	0
CPK,Normal,Month 6,Unknown [N=40,13,40,16]	4	1	1	0
CPK,Above,Month 6,Below [N=1,2,4,1]	0	0	0	0
CPK,Above,Month 6,Normal [N=1,2,4,1]	0	1	3	1
CPK,Above,Month 6,Above [N=1,2,4,1]	1	1	0	0
CPK,Above,Month 6,Unknown [N=1,2,4,1]	0	0	1	0
CPK,Unknown,Month 12,Below [N=3,2,3,1]	0	0	0	0
CPK,Unknown,Month 12,Normal [N=3,2,3,1]	2	2	2	1
CPK,Unknown,Month 12,Above [N=3,2,3,1]	1	0	1	0
CPK,Unknown,Month 12,Unknown [N=3,2,3,1]	0	0	0	0
CPK,Normal,Month 12,Below [N=40,13,41,16]	0	0	0	0
CPK,Normal,Month 12,Normal [N=40,13,41,16]	35	12	36	14
CPK,Normal,Month 12,Above [N=40,13,41,16]	3	1	3	1
CPK,Normal,Month 12,Unknown [N=40,13,41,16]	2	0	2	1
CPK,Above,Month 12,Below [N=1,2,4,1]	0	0	0	0
CPK,Above,Month 12,Normal [N=1,2,4,1]	1	1	4	1
CPK,Above,Month 12,Above [N=1,2,4,1]	0	1	0	0
CPK,Above,Month 12,Unknown [N=1,2,4,1]	0	0	0	0
CPK,Unknown,Month 24,Below [N=3,2,2,1]	0	0	0	0
CPK,Unknown,Month 24,Normal [N=3,2,2,1]	2	2	2	1
CPK,Unknown,Month 24,Above [N=3,2,2,1]	0	0	0	0
CPK,Unknown,Month 24,Unknown [N=3,2,2,1]	1	0	0	0
CPK,Normal,Month 24,Below [N=38,13,40,16]	0	0	0	0
CPK,Normal,Month 24,Normal [N=38,13,40,16]	36	12	38	14
CPK,Normal,Month 24,Above [N=38,13,40,16]	2	1	2	2
CPK,Normal,Month 24,Unknown [N=38,13,40,16]	0	0	0	0
CPK,Above,Month 24,Below [N=1,2,4,1]	0	0	0	0
CPK,Above,Month 24,Normal [N=1,2,4,1]	1	1	3	1
CPK,Above,Month 24,Above [N=1,2,4,1]	0	1	1	0
CPK,Above,Month 24,Unknown [N=1,2,4,1]	0	0	0	0

No statistical analyses for this end point

Primary: Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C

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End point title

Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C ^[135] ^[136]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[135] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[136] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Number of subjects analysed	48	17	48	18
Units: Subjects
LDH,Unknown,Day 21,Below [N=5,1,1,1]	0	0	0	0
LDH,Unknown,Day 21,Normal [N=5,1,1,1]	2	0	0	1
LDH,Unknown,Day 21,Above [N=5,1,1,1]	1	0	0	0
LDH,Unknown,Day 21,Unknown [N=5,1,1,1]	2	1	1	0
LDH,Normal,Day 21,Below [N=35,12,43,17]	0	0	0	0
LDH,Normal,Day 21,Normal [N=35,12,43,17]	31	9	37	16
LDH,Normal,Day 21,Above [N=35,12,43,17]	4	1	2	1
LDH,Normal,Day 21,Unknown [N=35,12,43,17]	0	2	4	0
LDH,Above,Day 21,Below [N=8,3,3,0]	0	0	0	0
LDH,Above,Day 21,Normal [N=8,3,3,0]	5	2	2	0
LDH,Above,Day 21,Above [N=8,3,3,0]	2	0	1	0
LDH,Above,Day 21,Unknown [N=8,3,3,0]	1	1	0	0
LDH,Unknown,Day 42,Below [N=5,2,1,1]	0	0	0	0
LDH,Unknown,Day 42,Normal [N=5,2,1,1]	4	0	1	1
LDH,Unknown,Day 42,Above [N=5,2,1,1]	1	2	0	0
LDH,Unknown,Day 42,Unknown [N=5,2,1,1]	0	0	0	0
LDH,Normal,Day 42,Below [N=35,12,44,17]	0	0	0	0
LDH,Normal,Day 42,Normal [N=35,12,44,17]	29	7	39	16
LDH,Normal,Day 42,Above [N=35,12,44,17]	4	4	3	1
LDH,Normal,Day 42,Unknown [N=35,12,44,17]	2	1	2	0
LDH,Above,Day 42,Below [N=8,3,3,0]	0	0	0	0
LDH,Above,Day 42,Normal [N=8,3,3,0]	2	1	2	0
LDH,Above,Day 42,Above [N=8,3,3,0]	6	2	1	0
LDH,Above,Day 42,Unknown [N=8,3,3,0]	0	0	0	0
LDH, Unknown, Month 6, Below [N=4,2,1,1]	0	0	0	0
LDH, Unknown, Month 6, Normal [N=4,2,1,1]	2	0	1	1
LDH,Unknown, Month 6, Above [N=4,2,1,1]	1	2	0	0
LDH, Unknown, Month 6, Unknown [N=4,2,1,1]	1	0	0	0
LDH, Normal, Month 6, Below [N=34,12,42,17]	0	0	0	0
LDH, Normal, Month 6, Normal [N=34,12,42,17]	28	8	37	17
LDH, Normal, Month 6, Above [N=34,12,42,17]	2	3	3	0
LDH, Normal, Month 6, Unknown [N=34,12,42,17]	4	1	2	0
LDH, Above, Month 6, Below [N=7,3,3,0]	0	0	0	0
LDH, Above, Month 6, Normal [N=7,3,3,0]	2	2	2	0
LDH, Above, Month 6, Above [N=7,3,3,0]	5	1	1	0
LDH, Above, Month 6, Unknown [N=7,3,3,0]	0	0	0	0
LDH, Unknown, Month 12, Below [N=3,2,2,1]	0	0	0	0
LDH, Unknown, Month 12, Normal [N=3,2,2,1]	3	2	0	1
LDH, Unknown, Month 12, Above [N=3,2,2,1]	0	0	2	0
LDH, Unknown, Month 12, Unknown [N=3,2,2,1]	0	0	0	0
LDH, Normal, Month 12, Below [N=34,12,43,17]	0	0	0	0
LDH, Normal, Month 12, Normal [N=34,12,43,17]	26	9	34	14
LDH, Normal, Month 12, Above [N=34,12,43,17]	6	3	6	2
LDH, Normal, Month 12, Unknwon [N=34,12,43,17]	2	0	3	1
LDH, Above, Month 12, Below [N=7,3,3,0]	0	0	0	0
LDH, Above, Month 12, Normal [N=7,3,3,0]	1	1	2	0
LDH, Above, Month 12, Above [N=7,3,3,0]	5	2	1	0
LDH, Above, Month 12, Unknown [N=7,3,3,0]	1	0	0	0
LDH, Unknown, Month 24, Below [N=3,2,1,1]	0	0	0	0
LDH, Unknown, Month 24, Normal [N=3,2,1,1]	2	2	1	1
LDH, Unknown, Month 24, Above [N=3,2,1,1]	0	0	0	0
LDH, Unknown, Month 24, Unknown [N=3,2,1,1]	1	0	0	0
LDH, Normal, Month 24, Below [N=32,12,42,17]	0	0	0	0
LDH, Normal, Month 24, Normal [N=32,12,42,17]	24	10	40	16
LDH, Normal, Month 24, Above [N=32,12,42,17]	8	2	2	1
LDH, Normal, Month 24, Unknown [N=32,12,42,17]	0	0	0	0
LDH, Above, Month 24, Below [N=7,3,3,0]	0	0	0	0
LDH, Above, Month 24, Normal [N=7,3,3,0]	2	2	2	0
LDH, Above, Month 24, Above [N=7,3,3,0]	5	1	1	0
LDH, Above, Month 24, Unknown [N=7,3,3,0]	0	0	0	0

No statistical analyses for this end point

Primary: Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase A

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End point title

Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase A ^[137] ^[138]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[137] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[138] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group
Number of subjects analysed	51	18	51	18
Units: Subjects
ALT, Day 0, Below [N=52,18,53,17]	0	0	0	0
ALT, Day 0, Normal [N=52,18,53,17]	50	18	51	17
ALT, Day 0, Above [N=52,18,53,17]	2	0	2	0
ALT, Day 21, Below [N=48,16,44,18]	0	0	0	0
ALT, Day 21, Normal [N=48,16,44,18]	48	16	44	18
ALT, Day 21, Above [N=48,16,44,18]	0	0	0	0
ALT, Day 42, Below [N=49,16,45,16]	0	0	0	0
ALT, Day 42, Normal [N=49,16,45,16]	49	15	45	16
ALT, Day 42, Above [N=49,16,45,16]	0	1	0	0
ALT, Month 6, Below [N=49,15,43,17]	0	0	0	0
ALT, Month 6, Normal [N=49,15,43,17]	48	15	42	17
ALT, Month 6, Above [N=49,15,43,17]	1	0	1	0
ALT, Month 12, Below [N=47,17,42,17]	0	0	0	0
ALT, Month 12, Normal [N=47,17,42,17]	46	17	41	17
ALT, Month 12, Above [N=47,17,42,17]	1	0	1	0
ALT, Month 24, Below [N=47,16,40,14]	0	0	0	0
ALT, Month 24, Normal [N=47,16,40,14]	47	16	40	14
ALT, Month 24, Above [N=47,16,40,14]	0	0	0	0

No statistical analyses for this end point

Primary: Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase A

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End point title

Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase A ^[139] ^[140]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[139] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[140] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group
Number of subjects analysed	51	17	49	17
Units: Subjects
AST, Day 0, Below [N=52,18,53,17]	0	0	0	0
AST, Day 0, Normal [N=52,18,53,17]	46	18	51	17
AST, Day 0, Above [N=52,18,53,17]	6	0	2	0
AST, Day 21, Below [N=48,16,44,17]	0	0	0	0
AST, Day 21, Normal [N=48,16,44,17]	42	16	44	17
AST, Day 21, Above [N=48,16,44,17]	6	0	0	0
AST, Day 42, Below [N=49,15,45,16]	0	0	0	0
AST, Day 42, Normal [N=49,15,45,16]	46	13	45	16
AST, Day 42, Above [N=49,15,45,16]	3	2	0	0
AST, Month 6, Below [N=49,15,43,17]	0	0	0	0
AST, Month 6, Normal [N=49,15,43,17]	46	14	42	17
AST, Month 6, Above [N=49,15,43,17]	3	1	1	0
AST, Month 12, Below [N=49,15,43,17]	0	0	0	0
AST, Month 12, Normal [N=49,15,43,17]	43	16	42	17
AST, Month 12, Above [N=49,15,43,17]	4	1	0	0
AST, Month 24, Below [N=47,16,40,14]	0	0	0	0
AST, Month 24, Normal [N=47,16,40,14]	44	16	40	14
AST, Month 24, Above [N=47,16,40,14]	3	0	0	0

No statistical analyses for this end point

Primary: Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase A

Top of page

End point title

Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase A ^[141] ^[142]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[141] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[142] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group
Number of subjects analysed	51	18	51	18
Units: Subjects
BUN, Day 0, Below [N=52,18,53,17]	0	0	0	0
BUN, Day 0, Normal [N=52,18,53,17]	50	18	52	16
BUN, Day 0, Above [N=52,18,53,17]	2	0	1	1
BUN, Day 21, Below [N=48,16,44,18]	0	1	0	0
BUN, Day 21, Normal [N=48,16,44,18]	45	14	39	16
BUN, Day 21, Above [N=48,16,44,18]	3	1	5	2
BUN, Day 42, Below [N=49,16,45,16]	0	0	0	0
BUN, Day 42, Normal [N=49,16,45,16]	42	16	39	14
BUN, Day 42, Above [N=49,16,45,16]	7	0	6	2
BUN, Month 6, Below [N=49,15,43,17]	0	1	0	0
BUN, Month 6, Normal [N=49,15,43,17]	46	13	39	15
BUN, Month 6, Above [N=49,15,43,17]	3	1	4	2
BUN, Month 12, Below [N=47,17,42,17]	0	0	1	0
BUN, Month 12, Normal [N=47,17,42,17]	42	16	41	15
BUN, Month 12, Above [N=47,17,42,17]	5	1	0	2
BUN, Month 24, Below [N=47,16,40,14]	0	0	1	0
BUN, Month 24, Normal [N=47,16,40,14]	45	16	38	12
BUN, Month 24, Above [N=47,16,40,14]	2	0	1	2

No statistical analyses for this end point

Primary: Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase A

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End point title

Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase A ^[143] ^[144]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[143] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[144] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group
Number of subjects analysed	51	18	51	18
Units: Subjects
CREA, Day 0, Below [N=52,18,53,17]	0	0	0	0
CREA, Day 0, Normal [N=52,18,53,17]	52	18	53	17
CREA, Day 0, Above [N=52,18,53,17]	0	0	0	0
CREA, Day 21, Below [N=48,16,44,18]	0	0	0	0
CREA, Day 21, Normal [N=48,16,44,18]	48	16	42	18
CREA, Day 21, Above [N=48,16,44,18]	0	0	2	0
CREA, Day 42, Below [N=49,16,45,16]	0	0	0	0
CREA, Day 42, Normal [N=49,16,45,16]	49	16	43	16
CREA, Day 42, Above [N=49,16,45,16]	0	0	2	0
CREA, Month 6, Below [N=49,15,43,17]	0	0	0	0
CREA, Month 6, Normal [N=49,15,43,17]	49	15	43	17
CREA, Month 6, Above [N=49,15,43,17]	0	0	0	0
CREA, Month 12, Below [N=47,17,42,17]	0	0	0	0
CREA, Month 12, Normal [N=47,17,42,17]	47	17	42	17
CREA, Month 12, Above [N=47,17,42,17]	0	0	0	0
CREA, Month 24, Below [N=47,16,40,14]	0	0	0	0
CREA, Month 24, Normal [N=47,16,40,14]	47	16	39	14
CREA, Month 24, Above [N=47,16,40,14]	0	0	1	0

No statistical analyses for this end point

Primary: Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase A

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End point title

Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase A ^[145] ^[146]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[145] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[146] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group
Number of subjects analysed	51	18	51	18
Units: Subjects
CPK, Day 0, Below [N=52,18,53,17]	0	0	0	0
CPK, Day 0, Normal [N=52,18,53,17]	51	17	51	17
CPK, Day 0, Above [N=52,18,53,17]	1	1	2	0
CPK, Day 21, Below [N=48,16,44,18]	0	0	0	0
CPK, Day 21, Normal [N=48,16,44,18]	46	16	42	17
CPK, Day 21, Above [N=48,16,44,18]	2	0	2	1
CPK, Day 42, Below [N=49,16,45,16]	0	0	0	0
CPK, Day 42, Normal [N=49,16,45,16]	47	14	42	15
CPK, Day 42, Above [N=49,16,45,16]	2	2	3	1
CPK, Month 6, Below [N=49,15,43,17]	0	0	0	0
CPK, Month 6, Normal [N=49,15,43,17]	47	14	38	16
CPK, Month 6, Above [N=49,15,43,17]	2	1	5	1
CPK, Month 12, Below [N=47,17,42,17]	0	0	0	0
CPK, Month 12, Normal [N=47,17,42,17]	45	15	40	16
CPK, Month 12, Above [N=47,17,42,17]	2	2	2	1
CPK, Month 24, Below [N=47,16,39,14]	0	0	0	0
CPK, Month 24, Normal [N=47,16,39,14]	47	15	36	13
CPK, Month 24, Above [N=47,16,39,14]	0	1	3	1

No statistical analyses for this end point

Primary: Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase A

Top of page

End point title

Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase A ^[147] ^[148]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[147] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[148] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group
Number of subjects analysed	51	18	51	17
Units: Subjects
LDH, Day 0, Below [N=52,18,53,17]	0	0	0	0
LDH, Day 0, Normal [N=52,18,53,17]	41	12	52	17
LDH, Day 0, Above [N=52,18,53,17]	11	6	1	0
LDH, Day 21, Below [N=48,16,44,17]	0	0	0	0
LDH, Day 21, Normal [N=48,16,44,17]	42	10	41	15
LDH, Day 21, Above [N=48,16,44,17]	6	6	3	2
LDH, Day 42, Below [N=49,15,45,16]	0	0	0	0
LDH, Day 42, Normal [N=49,15,45,16]	38	9	42	15
LDH, Day 42, Above [N=49,15,45,16]	11	6	4	1
LDH, Month 6, Below [N=49,15,43,17]	0	0	0	0
LDH, Month 6, Normal [N=49,15,43,17]	37	11	39	14
LDH, Month 6, Above [N=49,15,43,17]	12	4	4	3
LDH, Month 12, Below [N=47,17,42,17]	0	0	0	0
LDH, Month 12, Normal [N=47,17,42,17]	40	12	41	15
LDH, Month 12, Above [N=47,17,42,17]	7	5	1	2
LDH, Month 24, Below [N=47,16,39,14]	0	0	0	0
LDH, Month 24, Normal [N=47,16,39,14]	42	13	36	12
LDH, Month 24, Above [N=47,16,39,14]	5	3	3	2

No statistical analyses for this end point

Primary: Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase B

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End point title

Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase B ^[149] ^[150]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[149] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[150] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group
Number of subjects analysed	51	17	48	17
Units: Subjects
ALT, Day 0, Below [N=51,16,48,17]	0	0	0	0
ALT, Day 0, Normal [N=51,16,48,17]	50	16	48	16
ALT, Day 0, Above [N=51,16,48,17]	1	0	0	1
ALT, Day 21, Below [N=45,17,46,17]	0	0	0	0
ALT, Day 21, Normal [N=45,17,46,17]	44	16	45	17
ALT, Day 21, Above [N=45,17,46,17]	1	1	1	0
ALT, Day 42, Below [N=47,17,47,17]	0	0	0	0
ALT, Day 42, Normal [N=47,17,47,17]	46	17	45	16
ALT, Day 42, Above [N=47,17,47,17]	1	0	2	1
ALT, Month 6, Below [N=41,16,43,17]	0	0	0	0
ALT, Month 6, Normal [N=41,16,43,17]	41	16	43	17
ALT, Month 6, Above [N=41,16,43,17]	0	0	0	0
ALT, Month 12, Below [N=44,17,45,17]	0	0	0	0
ALT, Month 12, Normal [N=44,17,45,17]	44	17	45	17
ALT, Month 12, Above [N=44,17,45,17]	0	0	0	0
ALT, Month 24, Below [N=45,17,44,17]	0	0	0	0
ALT, Month 24, Normal [N=45,17,44,17]	44	17	43	17
ALT, Month 24, Above [N=45,17,44,17]	1	0	1	0

No statistical analyses for this end point

Primary: Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Aspartate Aminotransferase (AST) in Study Phase B

Top of page

End point title

Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Aspartate Aminotransferase (AST) in Study Phase B ^[151] ^[152]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[151] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[152] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group
Number of subjects analysed	51	16	48	17
Units: Subjects
AST, Day 0, Below [N=51,16,48,17]	0	0	0	0
AST, Day 0, Normal [N=51,16,48,17]	48	15	45	16
AST, Day 0, Above [N=51,16,48,17]	3	1	3	1
AST, Day 21, Below [N=44,17,46,17]	0	0	0	0
AST, Day 21, Normal [N=44,17,46,17]	41	16	45	17
AST, Day 21, Above [N=44,17,46,17]	3	1	1	0
AST, Day 42, Below [N=47,17,47,17]	0	0	0	0
AST, Day 42, Normal [N=47,17,47,17]	42	15	44	16
AST, Day 42, Above [N=47,17,47,17]	5	2	3	1
AST, Month 6, Below [N=42,16,42,17]	0	0	0	0
AST, Month 6, Normal [N=42,16,42,17]	40	15	42	17
AST, Month 6, Above [N=42,16,42,17]	2	1	0	0
AST, Month 12, Below [N=44,17,45,17]	0	0	0	0
AST, Month 12, Normal [N=44,17,45,17]	44	17	45	17
AST, Month 12, Above [N=44,17,45,17]	0	0	0	0
AST, Month 24, Below [N=45,17,44,17]	0	0	0	0
AST, Month 24, Normal [N=45,17,44,17]	44	17	43	17
AST, Month 24, Above [N=45,17,44,17]	1	0	1	0

No statistical analyses for this end point

Primary: Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase B

Top of page

End point title

Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase B ^[153] ^[154]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[153] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[154] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group
Number of subjects analysed	51	17	48	17
Units: Subjects
CREA, Day 0, Below [N=51,16,48,17]	0	0	0	0
CREA, Day 0, Normal [N=51,16,48,17]	51	16	47	17
CREA, Day 0, Above [N=51,16,48,17]	0	0	1	0
CREA, Day 21, Below [N=45,17,46,17]	0	0	0	0
CREA, Day 21, Normal [N=45,17,46,17]	44	17	45	17
CREA, Day 21, Above [N=45,17,46,17]	1	0	1	0
CREA, Day 42, Below [N=47,17,47,17]	0	0	0	0
CREA, Day 42, Normal [N=47,17,47,17]	46	17	47	17
CREA, Day 42, Above [N=47,17,47,17]	1	0	0	0
CREA, Month 6, Below [N=42,16,43,17]	0	0	0	0
CREA, Month 6, Normal [N=42,16,43,17]	42	16	41	17
CREA, Month 6, Above [N=42,16,43,17]	0	0	2	0
CREA, Month 12, Below [N=44,17,45,17]	0	0	0	0
CREA, Month 12, Normal [N=44,17,45,17]	44	17	44	17
CREA, Month 12, Above [N=44,17,45,17]	0	0	1	0
CREA, Month 24, Below [N=44,17,45,17]	0	0	0	0
CREA, Month 24, Normal [N=44,17,45,17]	45	17	44	17
CREA, Month 24, Above [N=44,17,45,17]	0	0	0	0

No statistical analyses for this end point

Primary: Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase B

Top of page

End point title

Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase B ^[155] ^[156]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[155] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[156] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group
Number of subjects analysed	51	17	48	17
Units: Subjects
LDH, Day 0, Below [N=51,16,48,17]	0	0	0	0
LDH, Day 0, Normal [N=51,16,48,17]	46	14	41	15
LDH, Day 0, Above [N=51,16,48,17]	5	2	7	2
LDH, Day 21, Below [N=44,17,46,17]	0	0	0	0
LDH, Day 21, Normal [N=44,17,46,17]	35	14	42	16
LDH, Day 21, Above [N=44,17,46,17]	9	3	4	1
LDH, Day 42, Below [N=47,17,47,17]	0	0	0	0
LDH, Day 42, Normal [N=47,17,47,17]	35	10	41	14
LDH, Day 42, Above [N=47,17,47,17]	12	7	6	3
LDH, Month 6, Below [N=41,16,42,17]	0	0	0	0
LDH, Month 6, Normal [N=41,16,42,17	35	11	36	15
LDH, Month 6, Above [N=41,16,42,17]	6	5	6	2
LDH, Month 12, Below [N=44,17,45,17]	0	0	0	0
LDH, Month 12, Normal [N=44,17,45,17]	35	12	42	16
LDH, Month 12, Above [N=44,17,45,17]	9	5	3	1
LDH, Month 24, Below [N=45,17,44,17]	0	0	0	0
LDH, Month 24, Normal [N=45,17,44,17]	43	16	41	15
LDH, Month 24, Above [N=45,17,44,17]	2	1	3	2

No statistical analyses for this end point

Primary: Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase C

Top of page

End point title

Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase C ^[157] ^[158]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[157] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[158] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Number of subjects analysed	46	17	47	18
Units: Subjects
BUN, Day 0, Below [N=44,15,47,17]	0	1	0	0
BUN, Day 0, Normal [N=44,15,47,17]	42	11	46	17
BUN, Day 0, Above [N=44,15,47,17]	2	3	1	0
BUN, Day 21, Below [N=45,12,42,18]	1	0	0	0
BUN, Day 21, Normal [N=45,12,42,18]	42	12	42	17
BUN, Day 21, Above [N=45,12,42,18]	2	0	0	1
BUN, Day 42, Below [N=46,16,46,18]	0	0	3	0
BUN, Day 42, Normal [N=46,16,46,18]	43	16	40	17
BUN, Day 42, Above [N=46,16,46,18]	3	0	3	1
BUN, Month 6, Below[ N=41,16,44,18]	0	0	2	0
BUN, Month 6, Normal [ N=41,16,44,18]	40	15	36	18
BUN, Month 6, Above [ N=41,16,44,18]	1	1	6	0
BUN, Month 12, Below [N=42,12,46,17]	0	0	0	0
BUN, Month 12, Normal [N=42,12,46,17]	41	15	43	17
BUN, Month 12, Above [N=42,12,46,17]	1	2	3	0
BUN, Month 24, Below [N=41,17,46,18]	0	0	1	0
BUN, Month 24, Normal [N=41,17,46,18]	39	15	40	17
BUN, Month 24, Above [N=41,17,46,18]	2	2	5	1

No statistical analyses for this end point

Primary: Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase B

Top of page

End point title

Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase B ^[159] ^[160]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[159] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[160] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group
Number of subjects analysed	51	17	48	17
Units: Subjects
BUN, Day 0, Below [N=51,16,48,16]	0	0	0	0
BUN, Day 0, Normal [N=51,16,48,16]	47	14	43	13
BUN, Day 0, Above [N=51,16,48,16]	4	2	5	3
BUN, Day 21, Below [N=45,17,46,17]	0	0	0	0
BUN, Day 21, Normal [N=45,17,46,17]	38	14	43	15
BUN, Day 21, Above [N=45,17,46,17]	7	3	3	2
BUN, Day 42, Below [N=47,17,47,17]	0	0	0	0
BUN, Day 42, Normal [N=47,17,47,17]	40	14	43	14
BUN, Day 42, Above [N=47,17,47,17]	7	3	4	3
BUN, Month 6, Below [N=42,16,43,17]	0	0	0	0
BUN, Month 6, Normal [N=42,16,43,17]	42	13	43	17
BUN, Month 6, Above [N=42,16,43,17]	0	3	0	0
BUN, Month 12, Below [N=44,17,45,17]	0	0	0	0
BUN, Month 12, Normal [N=44,17,45,17]	39	15	44	14
BUN, Month 12, Above [N=44,17,45,17]	5	2	1	3
BUN, Month 24, Below [N=45,17,44,17]	0	0	0	0
BUN, Month 24, Normal [N=45,17,44,17]	40	13	41	16
BUN, Month 24, Above [N=45,17,44,17]	5	4	3	1

No statistical analyses for this end point

Primary: Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase C

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End point title

Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase C ^[161] ^[162]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[161] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[162] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Number of subjects analysed	46	17	46	18
Units: Subjects
ALT,Day 0,Below [N=44,15,46,17]	0	0	0	0
ALT, Day 0,Normal [N=44,15,46,17]	43	15	45	17
ALT,Day 0,Above [N=44,15,46,17]	1	0	1	0
ALT,Day 21,Below [N=45,12,42,18]	0	0	0	0
ALT,Day 21,Normal [N=45,12,42,18]	44	12	42	18
ALT,Day 21,Above [N=45,12,42,18]	1	0	0	0
ALT,Day 42,Below [N=46,16,46,18]	0	0	0	0
ALT,Day 42,Normal [N=46,16,46,18]	46	16	46	18
ALT,Day 42,Above [N=46,16,46,18]	0	0	0	0
ALT, Month 6, Below [N=41,16,44,18]	0	0	0	0
ALT, Month 6, Normal [N=41,16,44,18]	41	15	44	18
ALT, Month 6, Above [N=41,16,44,18]	0	1	0	0
ALT,Month12,Below [N=42,17,46,17]	0	0	0	0
ALT,Month 12,Normal [N=42,17,46,17]	42	17	44	17
ALT,Month 12,Above [N=42,17,46,17]	0	0	2	0
ALT,Month 24,Below [N=41,17,46,18]	0	0	0	0
ALT,Month 24,Normal [N=41,17,46,18]	39	17	44	18
ALT,Month 24,Above [N=41,17,46,18]	2	0	2	0

No statistical analyses for this end point

Primary: Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase B

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End point title

Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase B ^[163] ^[164]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[163] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[164] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group
Number of subjects analysed	51	17	48	17
Units: Subjects
CPK, Day 0, Below [N=51,16,48,17]	0	0	0	0
CPK, Day 0, Normal [N=51,16,48,17]	49	16	46	16
CPK, Day 0, Above [N=51,16,48,17]	2	0	2	1
CPK, Day 21, Below [N=45,17,46,17]	0	0	0	0
CPK, Day 21, Normal [N=45,17,46,17]	42	16	45	16
CPK, Day 21, Above [N=45,17,46,17]	3	1	1	1
CPK, Day 42, Below [N=47,17,47,17]	0	0	0	0
CPK, Day 42, Normal [N=47,17,47,17]	43	15	44	16
CPK, Day 42, Above [N=47,17,47,17]	4	2	3	1
CPK, Month 6, Below [42,16,43,17]	0	0	0	0
CPK, Month 6, Normal [42,16,43,17]	40	13	41	15
CPK, Month 6, Above [42,16,43,17]	2	3	2	2
CPK, Month 12, Below [N=44,17,45,17]	0	0	0	0
CPK, Month 12, Normal [N=44,17,45,17]	39	14	44	17
CPK, Month 12, Above [N=44,17,45,17]	5	3	1	0
CPK, Month 24, Below [N=45,17,44,17]	0	0	0	0
CPK, Month 24, Normal [N=45,17,44,17]	44	15	42	16
CPK, Month 24, Above [N=45,17,44,17]	1	2	2	1

No statistical analyses for this end point

Primary: Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase C

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End point title

Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase C ^[165] ^[166]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[165] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[166] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Number of subjects analysed	46	17	46	18
Units: Subjects
AST,Day 0,Below [N=44,15,46,17]	0	0	0	0
AST,Day 0,Normal [N=44,15,46,17	41	12	45	17
AST,Day 0,Above [N=44,15,46,17	3	3	1	0
AST, Day 21,Below [N=45,12,42,18]	0	0	0	0
AST,Day 21,Normal [N=45,12,42,18]	44	12	42	18
AST,Day 21,Above [N=45,12,42,18]	1	0	0	0
AST,Day 42,Below [N=46,16,46,18]	0	0	0	0
AST,Day 42,Normal [N=46,16,46,18]	44	14	43	18
AST,Day 42,Above [N=46,16,46,18]	2	2	3	0
AST,Month 6,Below [N=40,16,44,18]	0	0	0	0
AST, Month 6, Normal [N=40,16,44,18]	39	14	43	18
AST, Month 6, Above [N=40,16,44,18]	1	2	1	0
AST,Month 12,Below [N=41,17,45,17]	0	0	0	0
AST,Month 12,Normal [N=41,17,45,17]	41	17	40	17
AST,Month 12,Above [N=41,17,45,17]	0	0	5	0
AST,Month 24,Below [N=41,17,46,18]	0	0	0	0
AST,Month 24,Normal [N=41,17,46,18]	38	17	45	18
AST,Month 24,Above [N=41,17,46,18]	3	0	1	0

No statistical analyses for this end point

Primary: Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase C

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End point title

Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase C ^[167] ^[168]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[167] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[168] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Number of subjects analysed	46	17	46	18
Units: Subjects
CPK, Day 0, Below [N=44,15,46,17]	0	0	0	0
CPK, Day 0, Normal [N=44,15,46,17]	43	13	42	16
CPK, Day 0, Above [N=44,15,46,17]	1	2	4	1
CPK, Day 21, Below [N=45,12,42,18]	0	0	0	0
CPK, Day 21, Normal [N=45,12,42,18]	43	11	41	16
CPK, Day 21, Above [N=45,12,42,18]	2	1	1	2
CPK, Day 42, Below [N=46,16,46,18]	0	0	0	0
CPK, Day 42, Normal [N=46,16,46,18]	44	13	46	17
CPK, Day 42, Above [N=46,16,46,18]	2	3	0	1
CPK, Month 6, Below [N=41,16,44,18]	0	0	0	0
CPK, Month 6, Normal [N=41,16,44,18	37	15	41	18
CPK, Month 6, Above [N=41,16,44,18	4	1	3	0
CPK, Month 12, Below [N=42,17,46,17]	0	0	0	0
CPK, Month 12, Normal [N=42,17,46,17]	38	15	42	16
CPK, Month 12, Above [N=42,17,46,17]	4	2	4	1
CPK, Month 24, Below [N=41,17,46,18]	0	0	0	0
CPK, Month 24, Normal [N=41,17,46,18]	39	15	43	16
CPK, Month 24, Above [N=41,17,46,18]	2	2	3	2

No statistical analyses for this end point

Primary: Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase C

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End point title

Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase C ^[169] ^[170]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[169] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[170] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Changed Status With Regards to the Biochemical Parameter Blood Creatinine (CREA)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Number of subjects analysed	46	17	46	18
Units: Subjects
CREA, Day 0, Below [N=44,15,46,17]	0	0	0	0
CREA, Day 0, Normal [N=44,15,46,17]	44	15	46	17
CREA, Day 0, Above [N=44,15,46,17]	0	0	0	0
CREA, Day 21, Below [N=45,12,42,18]	0	0	0	0
CREA, Day 21, Normal [N=45,12,42,18]	45	12	42	18
CREA, Day 21, Above [N=45,12,42,18]	0	0	0	0
CREA, Day 42, Below [N=46,16,46,18]	0	0	0	0
CREA, Day 42, Normal [N=46,16,46,18]	46	16	46	18
CREA, Day 42, Above [N=46,16,46,18]	0	0	0	0
CREA, Month 6, Below [N=41,16,44,18]	0	0	0	0
CREA, Month 6, Normal [N=41,16,44,18]	41	16	44	18
CREA, Month 6, Above [N=41,16,44,18]	0	0	0	0
CREA, Month 12, Below [N=42,17,46,17]	0	0	0	0
CREA, Month 12, Normal [N=42,17,46,17]	42	17	46	17
CREA, Month 12, Above [N=42,17,46,17]	0	0	0	0
CREA, Month 24, Below [N=41,17,46,18]	0	0	0	0
CREA, Month 24, Normal [N=41,17,46,18]	41	17	46	18
CREA, Month 24, Above [N=41,17,46,18]	0	0	0	0

No statistical analyses for this end point

Primary: Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase C

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End point title

Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase C ^[171] ^[172]

End point description

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.

End point type

Primary

End point timeframe

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

Notes
[171] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[172] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH)), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Number of subjects analysed	46	17	47	18
Units: Subjects
LDH, Day 0, Below [N=44,15,47,17]	0	0	0	0
LDH, Day 0, Normal [N=44,15,47,17]	36	12	44	17
LDH, Day 0, Above [N=44,15,47,17]	8	3	3	0
LDH, Day 21, Below [N=45,12,42,18]	0	0	0	0
LDH, Day 21, Normal [N=45,12,42,18]	38	11	39	17
LDH, Day 21, Above [N=45,12,42,18]	7	1	3	1
LDH, Day 42, Below [N=46,16,46,18]	0	0	0	0
LDH, Day 42, Normal [N=46,16,46,18]	35	8	42	17
LDH, Day 42, Above [N=46,16,46,18]	11	8	4	1
LDH, Month 6, Below [N=40,16,44,18]	0	0	0	0
LDH, Month 6, Normal [N=40,16,44,18]	32	10	40	18
LDH, Month 6, Above [N=40,16,44,18]	8	6	4	0
LDH, Month 12, Below [N=41,17,45,17]	0	0	0	0
LDH, Month 12, Normal [N=41,17,45,17]	30	12	36	15
LDH, Month 12, Above [N=41,17,45,17]	11	5	9	2
LDH, Month 24, Below [N=41,17,46,18]	0	0	0	0
LDH, Month 24, Normal [N=41,17,46,18]	28	14	43	17
LDH, Month 24, Above [N=41,17,46,18]	13	3	3	1

No statistical analyses for this end point

Secondary: Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease

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End point title

Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease ^[173]

End point description

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

End point type

Secondary

End point timeframe

At Days 0, 21 and 42

Notes
[173] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group
Number of subjects analysed	48	15	43	15
Units: units: Titer
geometric mean (confidence interval 95%)
A/VIET, Day 0 [N=47,14,43,15]	31 (21.8 to 44)	29 (15.2 to 55.2)	32.2 (23.1 to 44.9)	18.2 (12.2 to 27.3)
A/VIET, Day 21 [N=48,15,43,14]	173.5 (123.3 to 244)	98.2 (52.4 to 184.1)	177.5 (127 to 248)	97.2 (46.3 to 204)
A/VIET, Day 42 [N=47,15,42,15]	1044.4 (845.4 to 1290.3)	158.4 (76.5 to 327.8)	1155.1 (920.9 to 1448.7)	104.5 (51.2 to 213.3)

No statistical analyses for this end point

Secondary: Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease

Top of page

End point title

Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease ^[174]

End point description

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.

End point type

Secondary

End point timeframe

At Days 0, 21 and 42

Notes
[174] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group
Number of subjects analysed	42	16	45	17
Units: units: Titer
geometric mean (confidence interval 95%)
A/VIET, Day 0 [N=42,16,45,17]	65.5 (47.3 to 90.7)	48.8 (29.7 to 80.2)	46.2 (33.2 to 64.2)	25.6 (17.3 to 37.8)
A/VIET, Day 21[N=39,16,45,17]	344.7 (260.9 to 455.3)	124.9 (60.7 to 257.2)	461.7 (376.2 to 566.5)	148.3 (81.2 to 271.1)
A/VIET, Day 42 [N=42,16,45,17]	1553.2 (1105.9 to 2181.5)	86.9 (42.5 to 177.6)	1519.4 (1229.9 to 1877)	154.6 (97.9 to 244)

No statistical analyses for this end point

Secondary: Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease

Top of page

End point title

Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease ^[175]

End point description

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.

End point type

Secondary

End point timeframe

At Days 0, 21 and 42

Notes
[175] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Number of subjects analysed	42	15	43	13
Units: units: Titer
geometric mean (confidence interval 95%)
A/VIET, Day 0 [N=40,15,43,13]	37.3 (23.9 to 58.1)	35.5 (17.3 to 72.8)	25.6 (18.6 to 35.3)	27.1 (13.3 to 55.4)
A/VIET, Day 21 [N=40,15,29,8]	473.8 (351.2 to 639.3)	111.3 (52.7 to 234.9)	313.5 (193.3 to 508.4)	190.1 (57.6 to 628.2)
A/VIET, Day 42 [N=42,14,42,13]	4578.3 (3786.6 to 5535.6)	102.3 (45.9 to 228.2)	3032.5 (2431.8 to 3781.6)	77.6 (31.3 to 192.7)

No statistical analyses for this end point

Secondary: Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies

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End point title

Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies ^[176]

End point description

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.

End point type

Secondary

End point timeframe

At Days 21 and 42

Notes
[176] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group
Number of subjects analysed	46	14	43	15
Units: Subjects
A/VIET, Day 21 [N=46,14,43,14]	31	6	28	10
A/VIET, Day 42 [N=45,14,42,15]	43	8	42	10

No statistical analyses for this end point

Secondary: Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies

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End point title

Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies ^[177]

End point description

End point type

Secondary

End point timeframe

At Days 21 and 42

Notes
[177] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Number of subjects analysed	38	15	42	13
Units: Subjects
A/VIET, Day 21 [N=36,15,29,8]	29	7	23	3
A/VIET, Day 42 [N=38,14,42,13]	37	6	42	5

No statistical analyses for this end point

Secondary: Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies

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End point title

Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies ^[178]

End point description

End point type

Secondary

End point timeframe

At Days 21 and 42

Notes
[178] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: There are 3 tables corresponding to the endpoint (Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies), each table representing the result by Phase and the corresponding arms for that phase.

End point values	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group
Number of subjects analysed	42	16	45	17
Units: Subjects
A/VIET, Day 21 [N=39,16,45,17]	25	6	35	11
A/VIET, Day 42 [N=42,16,45,17]	40	2	42	11

No statistical analyses for this end point

Secondary: Number of Seroconverted Subjects Against 2 Strains of Influenza Disease as Regards to Neutralizing Antibody Response

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End point title

Number of Seroconverted Subjects Against 2 Strains of Influenza Disease as Regards to Neutralizing Antibody Response ^[179]

End point description

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.

End point type

Secondary

End point timeframe

At Months 6, 12 and 24.

Notes
[179] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Subjects participating to Phases B and C of the study were not analysed at these persistence time points for this outcome.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group
Number of subjects analysed	47	13	40	14
Units: Subjects
A/VIET, Month 6 [N=47,13,40,14]	41	9	38	13
A/VIET, Month 12 [N=45,13,34,14]	37	3	23	3
A/VIET, Month 24 [N=45,12,36,11	36	3	23	4
A/INDO, Month 6 [N=39,12,35,11]	34	0	31	1
A/INDO, Month 12 [N=43;13;34;14]	37	1	31	2
A/INDO, Month 24 [N=43;12;36;11]	40	3	33	2

No statistical analyses for this end point

Secondary: Titers for Serum Neutralizing Antibodies Against 2 Strains of Influenza Disease

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End point title

Titers for Serum Neutralizing Antibodies Against 2 Strains of Influenza Disease ^[180]

End point description

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.

End point type

Secondary

End point timeframe

At Months 6, 12 and 24

Notes
[180] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Subjects participating to Phases B and C of the study were not analysed at these persistence time points for this outcome.

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group
Number of subjects analysed	49	14	40	14
Units: units: Titer
geometric mean (confidence interval 95%)
A/VIET, Month 6 [N=49,14,40,14]	781.2 (641.5 to 951.5)	208.5 (108.6 to 400.3)	756.1 (624.5 to 915.5)	482.3 (313.4 to 742.3)
A/VIET, Month 12 [N=47,14,36,14]	238.9 (186.1 to 306.6)	35.4 (16.7 to 74.9)	179.4 (126.1 to 255.3)	27.6 (13.4 to 56.9)
A/VIET, Month 24 [N=47,13,38,11]	302.5 (231 to 396)	39.4 (16.3 to 95.5)	234.5 (177.1 to 310.6)	46.6 (18.4 to 118.3)
A/INDO, Month 6 [N=43,13,37,11]	113.8 (87.2 to 148.6)	17 (11.1 to 26.1)	106.8 (82.6 to 138)	16.9 (11.1 to 25.8)
A/INDO, Month 12 [N=47,14,36,14]	170.8 (132.7 to 220)	18.2 (11.4 to 29.1)	139.7 (105.8 to 184.6)	21.9 (12.2 to 39.2)
A/INDO, Month 24 [N=47,13,38,11]	188.5 (144.6 to 245.7)	31.8 (14.6 to 69.3)	146 (111.7 to 190.8)	20.5 (11.6 to 36.3)

No statistical analyses for this end point

Secondary: Number of Subjects With Adverse Events of Specific Interest (AESIs)

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End point title

Number of Subjects With Adverse Events of Specific Interest (AESIs)

End point description

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.

End point type

Secondary

End point timeframe

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

End point values	GSK1562902A–A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	Fluarix–A 6-9Y Group	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Number of subjects analysed	51	18	51	18	51	17	49	17	49	17	49	18
Units: Subjects	1	0	0	1	1	1	0	0	1	0	0	0

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

Reporting group title

GSK1562902A –A Lot 1 3-5Y Group

Reporting group description

Reporting group title

Fluarix–A 3-5Y Group

Reporting group description

Reporting group title

GSK1562902A–A Lot 1 6-9Y Group

Reporting group description

Reporting group title

GSK1562902A–B Lot 2 3-5Y Group

Reporting group description

Reporting group title

Fluarix–A 6-9Y Group

Reporting group description

Reporting group title

Fluarix–B 3-5Y Group

Reporting group description

Reporting group title

GSK1562902A–B Lot 2 6-9Y Group

Reporting group description

Reporting group title

Fluarix–B 6-9Y Group

Reporting group description

Reporting group title

GSK1562902A–C Lot 3 3-5Y Group

Reporting group description

Reporting group title

Fluarix–C 3-5Y Group

Reporting group description

Reporting group title

GSK1562902A–C Lot 3 6-9Y Group

Reporting group description

Reporting group title

Fluarix–C 6-9Y Group

Reporting group description

GSK1562902A –A Lot 1 3-5Y Group

Fluarix–A 3-5Y Group

GSK1562902A–A Lot 1 6-9Y Group

GSK1562902A–B Lot 2 3-5Y Group

Fluarix–A 6-9Y Group

Fluarix–B 3-5Y Group

GSK1562902A–B Lot 2 6-9Y Group

Fluarix–B 6-9Y Group

GSK1562902A–C Lot 3 3-5Y Group

Fluarix–C 3-5Y Group

GSK1562902A–C Lot 3 6-9Y Group

Fluarix–C 6-9Y Group

Total subjects affected by serious adverse events

subjects affected / exposed

0 / 51 (0.00%)

0 / 18 (0.00%)

0 / 51 (0.00%)

1 / 51 (1.96%)

0 / 18 (0.00%)

1 / 17 (5.88%)

0 / 49 (0.00%)

0 / 17 (0.00%)

2 / 49 (4.08%)

0 / 17 (0.00%)

1 / 49 (2.04%)

0 / 18 (0.00%)

number of deaths (all causes)

number of deaths resulting from adverse events

Investigations

Transaminases increased

subjects affected / exposed

0 / 51 (0.00%)

0 / 18 (0.00%)

0 / 51 (0.00%)

1 / 51 (1.96%)

0 / 18 (0.00%)

0 / 17 (0.00%)

0 / 49 (0.00%)

0 / 17 (0.00%)

0 / 49 (0.00%)

0 / 17 (0.00%)

0 / 49 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Injury, poisoning and procedural complications

Wound

subjects affected / exposed

0 / 51 (0.00%)

0 / 18 (0.00%)

0 / 51 (0.00%)

0 / 18 (0.00%)

0 / 17 (0.00%)

0 / 49 (0.00%)

0 / 17 (0.00%)

0 / 49 (0.00%)

0 / 17 (0.00%)

1 / 49 (2.04%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Traumatic brain injury

subjects affected / exposed

0 / 51 (0.00%)

0 / 18 (0.00%)

0 / 51 (0.00%)

0 / 18 (0.00%)

0 / 17 (0.00%)

0 / 49 (0.00%)

0 / 17 (0.00%)

1 / 49 (2.04%)

0 / 17 (0.00%)

0 / 49 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hepatobiliary disorders

Autoimmune hepatitis

subjects affected / exposed

0 / 51 (0.00%)

0 / 18 (0.00%)

0 / 51 (0.00%)

1 / 51 (1.96%)

0 / 18 (0.00%)

0 / 17 (0.00%)

0 / 49 (0.00%)

0 / 17 (0.00%)

0 / 49 (0.00%)

0 / 17 (0.00%)

0 / 49 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infections and infestations

Gastroenteritis

subjects affected / exposed

0 / 51 (0.00%)

0 / 18 (0.00%)

0 / 51 (0.00%)

0 / 18 (0.00%)

0 / 17 (0.00%)

0 / 49 (0.00%)

0 / 17 (0.00%)

1 / 49 (2.04%)

0 / 17 (0.00%)

0 / 49 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metabolism and nutrition disorders

Type 1 diabetes mellitus

subjects affected / exposed

0 / 51 (0.00%)

0 / 18 (0.00%)

0 / 51 (0.00%)

0 / 18 (0.00%)

1 / 17 (5.88%)

0 / 49 (0.00%)

0 / 17 (0.00%)

0 / 49 (0.00%)

0 / 17 (0.00%)

0 / 49 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	GSK1562902A –A Lot 1 3-5Y Group	Fluarix–A 3-5Y Group	GSK1562902A–A Lot 1 6-9Y Group	GSK1562902A–B Lot 2 3-5Y Group	Fluarix–A 6-9Y Group	Fluarix–B 3-5Y Group	GSK1562902A–B Lot 2 6-9Y Group	Fluarix–B 6-9Y Group	GSK1562902A–C Lot 3 3-5Y Group	Fluarix–C 3-5Y Group	GSK1562902A–C Lot 3 6-9Y Group	Fluarix–C 6-9Y Group
Total subjects affected by non serious adverse events
subjects affected / exposed	31 / 51 (60.78%)	7 / 18 (38.89%)	44 / 51 (86.27%)	27 / 51 (52.94%)	12 / 18 (66.67%)	4 / 17 (23.53%)	36 / 49 (73.47%)	9 / 17 (52.94%)	37 / 49 (75.51%)	7 / 17 (41.18%)	44 / 49 (89.80%)	15 / 18 (83.33%)
Investigations
Hepatic enzyme increased
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	1 / 17 (5.88%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Transaminases increased
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	1 / 17 (5.88%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0
Injury, poisoning and procedural complications
Thermal burn
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	1 / 17 (5.88%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0
Tooth injury
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	1 / 17 (5.88%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0
Contusion
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Fibula fracture
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Nervous system disorders
Headache
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	3 / 49 (6.12%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	3	0	0	0
Dizziness
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	1 / 17 (5.88%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0
General disorders and administration site conditions
Injection site reaction
subjects affected / exposed	0 / 51 (0.00%)	1 / 18 (5.56%)	0 / 51 (0.00%)	0 / 51 (0.00%)	1 / 18 (5.56%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	1	0	0	1	0	0	0	0	0	0	0
Pyrexia
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	1 / 17 (5.88%)	0 / 49 (0.00%)	1 / 17 (5.88%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	1	0	0
Influenza like illness
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	3 / 49 (6.12%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	3	0
Ecchymosis
alternative assessment type: Systematic
subjects affected / exposed	9 / 51 (17.65%)	3 / 18 (16.67%)	3 / 51 (5.88%)	4 / 51 (7.84%)	2 / 18 (11.11%)	0 / 17 (0.00%)	4 / 49 (8.16%)	1 / 17 (5.88%)	4 / 49 (8.16%)	0 / 17 (0.00%)	0 / 49 (0.00%)	2 / 18 (11.11%)
occurrences all number	9	3	3	4	2	0	4	1	4	0	0	2
Induration
alternative assessment type: Systematic
subjects affected / exposed	7 / 51 (13.73%)	1 / 18 (5.56%)	12 / 51 (23.53%)	4 / 51 (7.84%)	6 / 18 (33.33%)	1 / 17 (5.88%)	6 / 49 (12.24%)	1 / 17 (5.88%)	14 / 49 (28.57%)	0 / 17 (0.00%)	10 / 49 (20.41%)	1 / 18 (5.56%)
occurrences all number	7	1	12	4	6	1	6	1	14	0	10	1
Pain
alternative assessment type: Systematic
subjects affected / exposed	31 / 51 (60.78%)	7 / 18 (38.89%)	44 / 51 (86.27%)	27 / 51 (52.94%)	12 / 18 (66.67%)	3 / 17 (17.65%)	36 / 49 (73.47%)	9 / 17 (52.94%)	37 / 49 (75.51%)	7 / 17 (41.18%)	44 / 49 (89.80%)	15 / 18 (83.33%)
occurrences all number	31	7	44	27	12	3	36	9	37	7	44	15
Redness
alternative assessment type: Systematic
subjects affected / exposed	10 / 51 (19.61%)	2 / 18 (11.11%)	12 / 51 (23.53%)	6 / 51 (11.76%)	5 / 18 (27.78%)	4 / 17 (23.53%)	6 / 49 (12.24%)	3 / 17 (17.65%)	16 / 49 (32.65%)	2 / 17 (11.76%)	6 / 49 (12.24%)	1 / 18 (5.56%)
occurrences all number	10	2	12	6	5	4	6	3	16	2	6	1
Swelling
alternative assessment type: Systematic
subjects affected / exposed	10 / 51 (19.61%)	1 / 18 (5.56%)	14 / 51 (27.45%)	9 / 51 (17.65%)	7 / 18 (38.89%)	2 / 17 (11.76%)	10 / 49 (20.41%)	2 / 17 (11.76%)	18 / 49 (36.73%)	2 / 17 (11.76%)	14 / 49 (28.57%)	3 / 18 (16.67%)
occurrences all number	10	1	14	9	7	2	10	2	18	2	14	3
Drowsiness ( Symptom assessed in subjects aged 3-5 years.)
alternative assessment type: Systematic
subjects affected / exposed	7 / 51 (13.73%)	1 / 18 (5.56%)	0 / 51 (0.00%)	9 / 51 (17.65%)	0 / 18 (0.00%)	1 / 17 (5.88%)	0 / 49 (0.00%)	0 / 17 (0.00%)	12 / 49 (24.49%)	1 / 17 (5.88%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	7	1	0	9	0	1	0	0	12	1	0	0
Fever (axillary temperature >=37.5°C) (Symptom assessed in subjects aged 3-5 years.)
alternative assessment type: Systematic
subjects affected / exposed	8 / 51 (15.69%)	0 / 18 (0.00%)	0 / 51 (0.00%)	10 / 51 (19.61%)	0 / 18 (0.00%)	2 / 17 (11.76%)	0 / 49 (0.00%)	0 / 17 (0.00%)	18 / 49 (36.73%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	8	0	0	10	0	2	0	0	18	0	0	0
Irritability (Symptom assessed in subjects aged 3-5 years.)
alternative assessment type: Systematic
subjects affected / exposed	9 / 51 (17.65%)	1 / 18 (5.56%)	0 / 51 (0.00%)	13 / 51 (25.49%)	0 / 18 (0.00%)	2 / 17 (11.76%)	0 / 49 (0.00%)	0 / 17 (0.00%)	18 / 49 (36.73%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	9	1	0	13	0	2	0	0	18	0	0	0
Loss of appetite (Symptom assessed in subjects aged 3-5 years.)
subjects affected / exposed	12 / 51 (23.53%)	1 / 18 (5.56%)	0 / 51 (0.00%)	8 / 51 (15.69%)	0 / 18 (0.00%)	1 / 17 (5.88%)	0 / 49 (0.00%)	0 / 17 (0.00%)	15 / 49 (30.61%)	1 / 17 (5.88%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	12	1	0	8	0	1	0	0	15	1	0	0
Shivering (Symptom assessed in subjects aged 3-5 years.)
alternative assessment type: Systematic
subjects affected / exposed	1 / 51 (1.96%)	0 / 18 (0.00%)	0 / 51 (0.00%)	4 / 51 (7.84%)	0 / 18 (0.00%)	1 / 17 (5.88%)	0 / 49 (0.00%)	0 / 17 (0.00%)	10 / 49 (20.41%)	1 / 17 (5.88%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	1	0	0	4	0	1	0	0	10	1	0	0
Sweating (Symptom assessed in subjects aged 3-5 years)
alternative assessment type: Systematic
subjects affected / exposed	4 / 51 (7.84%)	0 / 18 (0.00%)	0 / 51 (0.00%)	1 / 51 (1.96%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	4 / 49 (8.16%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	4	0	0	1	0	0	0	0	4	0	0	0
Vomiting (Symptom assessed in subjects aged 3-5 years)
subjects affected / exposed	7 / 51 (13.73%)	0 / 18 (0.00%)	0 / 51 (0.00%)	6 / 51 (11.76%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	6 / 49 (12.24%)	1 / 17 (5.88%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	7	0	0	6	0	0	0	0	6	1	0	0
Arthralgia (Symptom assessed in subjects aged 6-9 years.)
alternative assessment type: Systematic
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	6 / 51 (11.76%)	0 / 51 (0.00%)	3 / 18 (16.67%)	0 / 17 (0.00%)	7 / 49 (14.29%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	9 / 49 (18.37%)	2 / 18 (11.11%)
occurrences all number	0	0	6	0	3	0	7	0	0	0	9	2
Fatigue (Symptom assessed in subjects aged 6-9 years.)
alternative assessment type: Systematic
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	7 / 51 (13.73%)	0 / 51 (0.00%)	1 / 18 (5.56%)	0 / 17 (0.00%)	6 / 49 (12.24%)	1 / 17 (5.88%)	0 / 49 (0.00%)	0 / 17 (0.00%)	11 / 49 (22.45%)	2 / 18 (11.11%)
occurrences all number	0	0	7	0	1	0	6	1	0	0	11	2
Fever (axillary temperature >= 37.5°C) (Symptom assessed in subjects aged 6-9 years.)
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	7 / 51 (13.73%)	0 / 51 (0.00%)	3 / 18 (16.67%)	0 / 17 (0.00%)	3 / 49 (6.12%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	18 / 49 (36.73%)	0 / 18 (0.00%)
occurrences all number	0	0	7	0	3	0	3	0	0	0	18	0
Gastrointestinal symptoms (Symptom assessed in subjects aged 6-9 years.)
alternative assessment type: Systematic
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	9 / 51 (17.65%)	0 / 51 (0.00%)	5 / 18 (27.78%)	0 / 17 (0.00%)	4 / 49 (8.16%)	5 / 17 (29.41%)	0 / 49 (0.00%)	0 / 17 (0.00%)	16 / 49 (32.65%)	5 / 18 (27.78%)
occurrences all number	0	0	9	0	5	0	4	5	0	0	16	5
Headache (Symptom assessed in subjects aged 6-9 years.)
alternative assessment type: Systematic
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	20 / 51 (39.22%)	0 / 51 (0.00%)	5 / 18 (27.78%)	0 / 17 (0.00%)	11 / 49 (22.45%)	2 / 17 (11.76%)	0 / 49 (0.00%)	0 / 17 (0.00%)	25 / 49 (51.02%)	3 / 18 (16.67%)
occurrences all number	0	0	20	0	5	0	11	2	0	0	25	3
Myalgia
Additional description: Symptom assessed in subjects aged 6-9 years
alternative assessment type: Systematic
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	10 / 51 (19.61%)	0 / 51 (0.00%)	3 / 18 (16.67%)	0 / 17 (0.00%)	11 / 49 (22.45%)	2 / 17 (11.76%)	0 / 49 (0.00%)	0 / 17 (0.00%)	13 / 49 (26.53%)	2 / 18 (11.11%)
occurrences all number	0	0	10	0	3	0	11	2	0	0	13	2
Shivering
Additional description: Symptom assessed in subjects aged 6-9 years.
alternative assessment type: Systematic
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	3 / 51 (5.88%)	0 / 51 (0.00%)	1 / 18 (5.56%)	0 / 17 (0.00%)	7 / 49 (14.29%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	13 / 49 (26.53%)	3 / 18 (16.67%)
occurrences all number	0	0	3	0	1	0	7	0	0	0	13	3
Sweating
Additional description: Symptom assessed in subjects aged 6-9 years.
alternative assessment type: Systematic
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	3 / 51 (5.88%)	0 / 51 (0.00%)	2 / 18 (11.11%)	0 / 17 (0.00%)	3 / 49 (6.12%)	2 / 17 (11.76%)	0 / 49 (0.00%)	0 / 17 (0.00%)	6 / 49 (12.24%)	1 / 18 (5.56%)
occurrences all number	0	0	3	0	2	0	3	2	0	0	6	1
Eye disorders
Conjunctivitis
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	1 / 17 (5.88%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	0 / 51 (0.00%)	1 / 18 (5.56%)	0 / 51 (0.00%)	0 / 51 (0.00%)	1 / 18 (5.56%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	1	0	0	1	0	0	0	0	0	0	0
Vomiting
subjects affected / exposed	1 / 51 (1.96%)	1 / 18 (5.56%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0	0	0	0	0
Nausea
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	1 / 17 (5.88%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0
Diarrhoea
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	6 / 51 (11.76%)	5 / 18 (27.78%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	4 / 49 (8.16%)	0 / 18 (0.00%)
occurrences all number	6	5	0	0	0	0	0	0	0	0	4	0
Rhinorrhoea
subjects affected / exposed	0 / 51 (0.00%)	1 / 18 (5.56%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
Upper respiratory tract inflammation
subjects affected / exposed	0 / 51 (0.00%)	1 / 18 (5.56%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
Herpangina
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	1 / 17 (5.88%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Laryngitis
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 51 (0.00%)	3 / 51 (5.88%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	3	0	0	0	0	0	0	0	0
Nasopharyngitis
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 51 (0.00%)	3 / 51 (5.88%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	3	0	0	0	0	0	0	0	0
Bronchitis chronic
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	1 / 17 (5.88%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Pharyngolaryngeal pain
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	1 / 17 (5.88%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Skin and subcutaneous tissue disorders
Rash
subjects affected / exposed	0 / 51 (0.00%)	1 / 18 (5.56%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	1 / 17 (5.88%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	1	0	0
Acne
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	1 / 17 (5.88%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Dermatitis contact
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	1 / 17 (5.88%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Pityriasis rosea
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Psychiatric disorders
Tic
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Musculoskeletal and connective tissue disorders
Torticollis
subjects affected / exposed	0 / 51 (0.00%)	1 / 18 (5.56%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
Neck pain
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Pain in extremity
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Infections and infestations
Pharyngitis
subjects affected / exposed	3 / 51 (5.88%)	0 / 18 (0.00%)	0 / 51 (0.00%)	6 / 51 (11.76%)	2 / 18 (11.11%)	2 / 17 (11.76%)	3 / 49 (6.12%)	0 / 17 (0.00%)	3 / 49 (6.12%)	0 / 17 (0.00%)	1 / 49 (2.04%)	1 / 18 (5.56%)
occurrences all number	3	0	0	6	2	2	3	0	3	0	1	1
Upper respiratory tract infection
subjects affected / exposed	11 / 51 (21.57%)	3 / 18 (16.67%)	2 / 51 (3.92%)	4 / 51 (7.84%)	1 / 18 (5.56%)	1 / 17 (5.88%)	3 / 49 (6.12%)	0 / 17 (0.00%)	10 / 49 (20.41%)	2 / 17 (11.76%)	6 / 49 (12.24%)	1 / 18 (5.56%)
occurrences all number	11	3	2	4	1	1	3	0	10	2	6	1
Bronchitis
subjects affected / exposed	2 / 51 (3.92%)	2 / 18 (11.11%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	1 / 17 (5.88%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	2	2	0	0	0	0	0	0	0	1	0	0
Folliculitis
subjects affected / exposed	0 / 51 (0.00%)	1 / 18 (5.56%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
Gastroenteritis
subjects affected / exposed	5 / 51 (9.80%)	1 / 18 (5.56%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	3 / 17 (17.65%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	3 / 49 (6.12%)	1 / 18 (5.56%)
occurrences all number	5	1	0	0	0	3	0	0	0	0	3	1
Impetigo
subjects affected / exposed	1 / 51 (1.96%)	1 / 18 (5.56%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0	0	0	0	0
Myringitis
subjects affected / exposed	0 / 51 (0.00%)	1 / 18 (5.56%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
Scarlet fever
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	1 / 17 (5.88%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Acute tonsillitis
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	1 / 17 (5.88%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0
Tonsillitis
subjects affected / exposed	3 / 51 (5.88%)	0 / 18 (0.00%)	0 / 51 (0.00%)	2 / 51 (3.92%)	0 / 18 (0.00%)	3 / 17 (17.65%)	0 / 49 (0.00%)	1 / 17 (5.88%)	4 / 49 (8.16%)	2 / 17 (11.76%)	3 / 49 (6.12%)	1 / 18 (5.56%)
occurrences all number	3	0	0	2	0	3	0	1	4	2	3	1
Otitis media acute
subjects affected / exposed	3 / 51 (5.88%)	0 / 18 (0.00%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	3	0	0	0	0	0	0	0	0	0	0	0
Varicella
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 51 (0.00%)	1 / 51 (1.96%)	0 / 18 (0.00%)	1 / 17 (5.88%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	0	0	0	0
Tooth abscess
subjects affected / exposed	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 51 (0.00%)	0 / 51 (0.00%)	0 / 18 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	0 / 17 (0.00%)	0 / 49 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1

More information

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Were there any global substantial amendments to the protocol? Yes

19 Feb 2007

Amendment 1: Amendment of the study design to include additional age stratification steps with a safety review, following comments by the Medical Research and Ethics Committee (MREC).

17 Apr 2007

Amendment 2: Amendment to distinguish the internal and external safety review process. Inclusion of a description of biochemical analyses.

30 Oct 2007

Amendment 3: Amendment to extend the safety follow-up period to 2 years after the first vaccination.

25 Feb 2009

Amendment 4: Amendment to exclude the neutralizing antibodies analysis (secondary endpoints) for Phase B (study H5N1-022 STG 009 cohort 2) and Phase C (H5N1-023 STG 009 cohort 3). Additionally, recording of AESIs (adverse events of specific interest) for influenza vaccines will be done in a retrospective manner (Day 0-Month 24).

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

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Baseline characteristics

End points

End points

Primary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Primary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Primary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Primary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Primary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Primary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Primary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Primary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Primary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Primary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Primary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Primary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Primary: Number of seroconverted subjects against 2 strains of influenza disease

Primary: Number of seroconverted subjects against 2 strains of influenza disease

Primary: Number of Seroconverted Subjects Against 2 Strains of Influenza Disease

Primary: Number of Seroconverted Subjects Against 2 Strains of Influenza Disease

Primary: Number of Seroconverted Subjects Against 2 Strains of Influenza Disease

Primary: Number of Seroconverted Subjects Against 2 Strains of Influenza Disease

Primary: Number of Seroconverted Subjects Against 2 Strains of Influenza Disease

Primary: Number of Seroconverted Subjects Against 2 Strains of Influenza Disease

Primary: Number of Seroconverted Subjects Against 2 Strains of Influenza Disease

Primary: Number of Seroconverted Subjects Against 2 Strains of Influenza Disease

Primary: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Primary: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Primary: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Primary: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Primary: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Primary: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Primary: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Primary: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Primary: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Primary: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

Primary: Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease

Primary: Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease

Primary: Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease

Primary: Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease

Primary: Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease

Primary: Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease

Primary: Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease

Primary: Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease

Primary: Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease

Primary: Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease

Primary: Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease

Primary: Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease

Primary: Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms

Primary: Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms

Primary: Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms

Primary: Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms

Primary: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Primary: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Primary: Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms

Primary: Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms

Primary: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Primary: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Primary: Number of Subjects With Serious Adverse Events (SAEs)

Primary: Number of Subjects With Serious Adverse Events (SAEs)

Primary: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events

Primary: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events

Primary: Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A

Primary: Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A

Primary: Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A

Primary: Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A

Primary: Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A

Primary: Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A

Primary: Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A

Primary: Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A

Primary: Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A

Primary: Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A

Primary: Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A

Primary: Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A

Primary: Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B