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Clinical Trial Results:
Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) When Administered in Children

Summary
EudraCT number	2010-021073-36
Trial protocol	ES
Global end of trial date	17 Aug 2011

Results information
Results version number	v3(current)
This version publication date	02 Apr 2023
First version publication date	07 Mar 2015
Other versions	v1 , v2
Version creation reason	Correction of full data set Correction of full data set and alignment 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

113314

ISRCTN number

US NCT number

NCT01198756

WHO universal trial number (UTN)

Sponsor organisation name

GlaxoSmithKline Biologicals

Sponsor organisation address

Rue de l'Institut 89, Rixensart, Belgium, 1330

Public contact

GlaxoSmithKline Biologicals, GlaxoSmithKline Biologicals, 044 2089904466, mmd10443@gsk.com

Scientific contact

GlaxoSmithKline Biologicals, GlaxoSmithKline Biologicals, 044 2089904466, mmd10443@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

12 Oct 2011

Is this the analysis of the primary completion data?

Yes

Primary completion date

11 Mar 2011

Global end of trial reached?

Yes

Global end of trial date

17 Aug 2011

Was the trial ended prematurely?

Main objective of the trial

To test the immunogenic non-inferiority (in terms of Geometric Mean Titer [GMT] and Seroconversion Rate [SCR]) for the shared viral strains of FLU Q-QIV versus Fluarix-VB (TIV containing Victoria B strain) and Fluarix-YB (TIV containing Yamagata B strain) in children 3 to 17 years old approximately 28 days after completion of dosing (approximately at Day 28 for primed subjects and approximately at Day 56 for unprimed subjects).

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

01 Oct 2010

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Canada: 379

Country: Number of subjects enrolled

Mexico: 287

Country: Number of subjects enrolled

Taiwan: 295

Country: Number of subjects enrolled

United States: 1638

Country: Number of subjects enrolled

Spain: 510

Worldwide total number of subjects

3109

EEA total number of subjects

510

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)

3109

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

A total of 3109 subjects were enrolled, out of which solely 3094 subjects were vaccinated who constituted the analysed population in this study.

Screening details

Unprimed Subjects – subjects aged 6 months to 8 years with no H1N1 vaccine or H1N1 infection in the last season, or with no seasonal influenza vaccine in the past or who had received only 1 dose for the first time in the last season – received a 2-dose vaccination course. Primed Subjects – all other subjects – received a 1-dose vaccination course.

Number of subjects started

3109

Number of subjects completed

3094

Reason: Number of subjects

Did not receive vaccination: 15

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

GSK2282512A 1 Group

Arm description

Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Arm type

Experimental

Investigational medicinal product name

Quadrivalent seasonal influenza vaccine GSK2282512A

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 17 years of age, single intramuscular dose.

Victoria strain Fluarix Group

Arm description

Subjects, 3 to 17 years old, received 1 dose of Fluarix VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix VB vaccine at Day 0 and Day 28. The Fluarix VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Arm type

Active comparator

Investigational medicinal product name

Fluarix VB

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects of 9 to 17 years of age, single intramuscular dose.

Yamagata strain Fluarix Group

Arm description

Subjects, 3 to 17 years old, received 1 dose of Fluarix YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix YB vaccine at Day 0 and Day 28. The Fluarix YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Arm type

Active comparator

Investigational medicinal product name

Fluarix YB

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects of 9 to 17 years of age, single intramuscular dose

GSK2282512A 2 Group

Arm description

Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.

Arm type

Experimental

Investigational medicinal product name

Quadrivalent seasonal influenza vaccine GSK2282512A

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Single intramuscular dose for primed subjects, two doses for unprimed subjects.

Number of subjects in period 1 ^[1]	GSK2282512A 1 Group	Victoria strain Fluarix Group	Yamagata strain Fluarix Group	GSK2282512A 2 Group
Started	932	929	932	301
Completed	894	889	902	275
Not completed	38	40	30	26
Consent withdrawn by subject	9	-	-	-
Adverse event, non-fatal	-	-	-	1
Withdrawal by Subject	-	4	7	5
Lost to follow-up	29	36	23	18
Protocol deviation	-	-	-	2

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: A total of 3109 subjects were enrolled, out of which solely 3094 subjects were vaccinated who constituted the analysed population in this study.

Baseline characteristics

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Reporting group title

GSK2282512A 1 Group

Reporting group description

Reporting group title

Victoria strain Fluarix Group

Reporting group description

Reporting group title

Yamagata strain Fluarix Group

Reporting group description

Reporting group title

GSK2282512A 2 Group

Reporting group description

Reporting group values	GSK2282512A 1 Group	Victoria strain Fluarix Group	Yamagata strain Fluarix Group	GSK2282512A 2 Group	Total
Number of subjects	932	929	932	301	3094
Age categorical
Units: Subjects
In utero	0	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0	0
Newborns (0-27 days)	0	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	301	301
Children (2-11 years)	932	929	932	0	2793
Adolescents (12-17 years)	0	0	0	0	0
Adults (18-64 years)	0	0	0	0	0
From 65-84 years	0	0	0	0	0
85 years and over	0	0	0	0	0
Age continuous
Units: years
geometric mean (standard deviation)	8.9 ± 4.21	8.9 ± 4.23	8.9 ± 4.17	1.2 ± 0.73	-
Gender categorical
Units: Subjects
Female	434	455	464	143	1496
Male	498	474	468	158	1598

End points

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Reporting group title

GSK2282512A 1 Group

Reporting group description

Reporting group title

Victoria strain Fluarix Group

Reporting group description

Reporting group title

Yamagata strain Fluarix Group

Reporting group description

Reporting group title

GSK2282512A 2 Group

Reporting group description

Subject analysis set title

GSK2282512A 1 (3-8 years) Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subjects, 3 to 8 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Subject analysis set title

GSK2282512A 1 (9-17 years) Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subjects, 9 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Subject analysis set title

Victoria strain Fluarix (3-8 years) Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subjects, 3 to 8 years old, received 1 dose of Fluarix VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix VB vaccine at Day 0 and Day 28. The Fluarix VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Subject analysis set title

Victoria strain Fluarix (9-17 years) Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Victoria strain Fluarix (9-17 years) Group

Subject analysis set title

Yamagata strain Fluarix (3-8 years) Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subjects, 3 to 8 years old, received 1 dose of Fluarix YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix YB vaccine at Day 0 and Day 28. The Fluarix YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Subject analysis set title

Yamagata strain Fluarix (9-17 years) Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subjects, 9 to 17 years old, received 1 dose of Fluarix YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix YB vaccine at Day 0 and Day 28. The Fluarix YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Primary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease

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End point title

Titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease

End point description

Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.

End point type

Primary

End point timeframe

At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

End point values	GSK2282512A 1 Group	Victoria strain Fluarix Group	Yamagata strain Fluarix Group	GSK2282512A 2 Group
Number of subjects analysed	878	871	878	259
Units: titre
geometric mean (confidence interval 95%)
H1N1, POST (N=878;871;878;259)	362.7 (335.3 to 392.3)	429.1 (396.5 to 464.3)	420.2 (388.8 to 454)	200.9 (166.6 to 242.2)
H3N2, POST (N=878;871;878;259)	143.7 (134.2 to 153.9)	139.6 (130.5 to 149.3)	151 (141 to 161.6)	61.4 (53.8 to 70)
Victoria, POST (N=878;871;877;259)	250.5 (230.8 to 272)	245.4 (226.9 to 265.4)	68.1 (61.9 to 74.9)	127.3 (109.4 to 148.1)
Yamagata, POST (N=878;871;878;259)	512.5 (477.6 to 549.9)	197 (180.7 to 214.8)	579 (541.2 to 619.3)	192.7 (172.1 to 215.7)

Adjusted GMT ratio A/California/7/2009 (H1N1)

Statistical analysis description

To assess the non-inferiority in terms of GMTs, the adjusted GMT ratio at post-vaccination with the 2-sided 95% CI for each strain was computed by fitting an Analysis of Covariance (ANCOVA) model including vaccine groups as fixed effect.

Comparison groups

Victoria strain Fluarix Group v GSK2282512A 1 Group v Yamagata strain Fluarix Group

Number of subjects included in analysis

2627

Analysis specification

Pre-specified

Analysis type

non-inferiority

Method

ANCOVA

Parameter type

GMT ratio

Point estimate

1.15

Confidence interval

level

95%

sides

2-sided

lower limit

1.06

upper limit

1.25

Adjusted GMT A/Victoria/210/2009 (H3N2)

Comparison groups

GSK2282512A 1 Group v Victoria strain Fluarix Group v Yamagata strain Fluarix Group

Number of subjects included in analysis

2627

Analysis specification

Pre-specified

Analysis type

non-inferiority

Method

ANCOVA

Parameter type

Adjusted GMT ratio

Point estimate

0.99

Confidence interval

level

95%

sides

2-sided

lower limit

0.92

upper limit

1.07

Adjusted GMT ratio B/Brisbane/60/2008 (Victoria)

Comparison groups

GSK2282512A 1 Group v Victoria strain Fluarix Group

Number of subjects included in analysis

1749

Analysis specification

Pre-specified

Analysis type

non-inferiority

Method

ANCOVA

Parameter type

Adjusted GMT ratio

Point estimate

0.96

Confidence interval

level

95%

sides

2-sided

lower limit

0.87

upper limit

1.07

Adjusted GMT ratio B/Florida/4/2006 (Yamagata)

Comparison groups

GSK2282512A 1 Group v Yamagata strain Fluarix Group

Number of subjects included in analysis

1756

Analysis specification

Pre-specified

Analysis type

non-inferiority

Method

ANCOVA

Parameter type

Adjusted GMT ratio

Point estimate

1.08

Confidence interval

level

95%

sides

2-sided

lower limit

0.99

upper limit

1.16

Difference in SCR A/California/7/2009 (H1N1)

Statistical analysis description

A logistic regression model was fitted for the difference in SCR and the 2-sided 95% CI. The following contrasts were performed: for both A strains (California and Victoria), the SCR difference (Victoria strain Fluarix + Yamagata strains Fluarix pooled groups minus GSK2282512A Group)

Comparison groups

GSK2282512A 1 Group v Victoria strain Fluarix Group v Yamagata strain Fluarix Group

Number of subjects included in analysis

2627

Analysis specification

Pre-specified

Analysis type

non-inferiority

Method

ANCOVA

Parameter type

Difference in SCR (%)

Point estimate

1.79

Confidence interval

level

95%

sides

2-sided

lower limit

-1.04

upper limit

4.77

Difference in SCR A/Victoria/210/2009 (H3N2)

Statistical analysis description

A logistic regression model was fitted for the difference in SCR and the 2-sided 95% CI. The following contrasts were performed: for both A strains (California and Victoria), the SCR difference (Victoris strain Fluarix + Yamagata straing Fluarix pooled groups minus GSK2282512A Group)

Comparison groups

GSK2282512A 1 Group v Victoria strain Fluarix Group v Yamagata strain Fluarix Group

Number of subjects included in analysis

2627

Analysis specification

Pre-specified

Analysis type

non-inferiority

Method

ANCOVA

Parameter type

Difference in SCR (%)

Point estimate

-1.36

Confidence interval

level

95%

sides

2-sided

lower limit

-5.05

upper limit

2.41

Difference in SCR B/Brisbane/60/2008 (Victoria)

Statistical analysis description

A logistic regression model was fitted for the difference in SCR and the 2-sided 95% CI. The following contrasts were performed for the Victoria B strain, the seroconversion rate (SCR) difference (Victoria strain Fluarix Group minus GSK2282512A Group).

Comparison groups

GSK2282512A 1 Group v Victoria strain Fluarix Group

Number of subjects included in analysis

1749

Analysis specification

Pre-specified

Analysis type

non-inferiority

Method

ANCOVA

Parameter type

Difference in SCR (%)

Point estimate

-3.05

Confidence interval

level

95%

sides

2-sided

lower limit

-7.21

upper limit

1.12

Difference in SCR B/Florida/4/2006 (Yamagata)

Statistical analysis description

A logistic regression model was fitted for the difference in SCR and the 2-sided 95% CI. The following contrasts were performed for the Yamagata B strain, the seroconversion rate (SCR) difference (Yamagata strain Fluarix Group minus GSK2282512A Group).

Comparison groups

GSK2282512A 1 Group v Yamagata strain Fluarix Group

Number of subjects included in analysis

1756

Analysis specification

Pre-specified

Analysis type

non-inferiority

Method

ANCOVA

Parameter type

Difference in SCR (%)

Point estimate

-1.8

Confidence interval

level

95%

sides

2-sided

lower limit

-5.89

upper limit

2.3

Primary: Number of subjects seroconverted against 4 strains of influenza disease

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End point title

Number of subjects seroconverted against 4 strains of influenza disease ^[1]

End point description

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains assessed were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.

End point type

Primary

End point timeframe

At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

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.

End point values	GSK2282512A 1 Group	Victoria strain Fluarix Group	Yamagata strain Fluarix Group	GSK2282512A 2 Group
Number of subjects analysed	876	870	877	259
Units: Subjects
H1N1, POST (N=876;870;877;259)	739	755	750	220
H3N2, POST (N=876;870;876;259)	614	590	610	189
Victoria, POST (N=876;870;876;259)	653	622	262	219
Yamagata, POST (N=876;870;877;259)	659	359	644	243

No statistical analyses for this end point

Secondary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease

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End point title

Titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease

End point description

End point type

Secondary

End point timeframe

At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

End point values	GSK2282512A 1 Group	Victoria strain Fluarix Group	Yamagata strain Fluarix Group	GSK2282512A 2 Group
Number of subjects analysed	878	871	878	259
Units: titre
geometric mean (confidence interval 95%)
H1N1, Day 0 (N=876;870;877;259)	29.4 (26.8 to 32.2)	32.2 (29.4 to 35.3)	29.1 (26.6 to 31.8)	16.8 (13.9 to 20.3)
H1N1, POST (N=878;871;878;259)	362.7 (335.3 to 392.3)	429.1 (396.5 to 464.3)	420.2 (388.8 to 454)	200.9 (166.6 to 242.2)
H3N2, Day 0 (N=876;870;876;259)	18.1 (16.7 to 19.7)	19 (17.4 to 20.6)	19.4 (17.8 to 21.1)	5.6 (5.3 to 6)
H3N2, POST (N=878;871;878;259)	143.7 (134.2 to 153.9)	139.6 (130.5 to 149.3)	151 (141 to 161.6)	61.4 (53.8 to 70)
Victoria, Day 0 (N=876;870;877;259)	24.8 (22.5 to 27.3)	25.8 (23.5 to 28.4)	25.8 (23.5 to 28.4)	8.7 (7.5 to 10)
Victoria, POST (N=878;871;877;259)	250.5 (230.8 to 272)	245.4 (226.9 to 265.4)	68.1 (61.9 to 74.9)	127.3 (109.4 to 148.1)
Yamagata, Day 0 (N=876;870;877;259)	57.9 (52 to 64.4)	58.4 (52.6 to 64.9)	65.9 (59.3 to 73.2)	7.7 (7 to 8.6)
Yamagata, POST (N=878;871;878;259)	512.5 (477.6 to 549.9)	197 (180.7 to 214.8)	579 (541.2 to 619.3)	192.7 (172.1 to 215.7)

No statistical analyses for this end point

Secondary: Number of subjects seroprotected against 4 strains of influenza disease

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End point title

Number of subjects seroprotected against 4 strains of influenza disease

End point description

A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 flu strains.

End point type

Secondary

End point timeframe

At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

End point values	GSK2282512A 1 Group	Victoria strain Fluarix Group	Yamagata strain Fluarix Group	GSK2282512A 2 Group
Number of subjects analysed	878	871	878	259
Units: Subjects
H1N1, Day 0 (N=876;870;877;259)	480	496	477	87
H1N1, POST (N=878;871;878;259)	850	848	848	232
H3N2, Day 0 (N=876;870;876;259)	295	301	324	7
H3N2, POST (N=878;871;878;259)	816	808	819	193
Victoria, Day 0 (N=876;870;877;259)	388	404	400	28
Victoria, POST (N=878;871;877;259)	838	839	643	228
Yamagata, Day 0 (N=876;870;877;259)	578	583	622	22
Yamagata, POST (N=878;871;878;259)	869	805	873	250

No statistical analyses for this end point

Secondary: Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease

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End point title

Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease

End point description

The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination (at Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects (POST)) compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer). The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains

End point type

Secondary

End point timeframe

At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

End point values	GSK2282512A 1 Group	Victoria strain Fluarix Group	Yamagata strain Fluarix Group	GSK2282512A 2 Group
Number of subjects analysed	876	870	877	259
Units: fold increase
geometric mean (confidence interval 95%)
H1N1, POST (N=876;870;877;259)	12.31 (11.34 to 13.35)	13.31 (12.28 to 14.43)	14.42 (13.27 to 15.66)	11.95 (10.52 to 13.59)
H3N2, POST (N=876;870;876;259)	7.94 (7.3 to 8.64)	7.37 (6.78 to 8.02)	7.78 (7.16 to 8.46)	10.94 (9.64 to 12.42)
Victoria, POST (N=876;870;876;259)	10.12 (9.23 to 11.09)	9.51 (8.64 to 10.45)	2.63 (2.47 to 2.81)	14.61 (12.84 to 16.63)
Yamagata, POST (N=876;870;877;259)	8.86 (8.12 to 9.66)	3.37 (3.14 to 3.62)	8.78 (8.05 to 9.58)	24.92 (21.98 to 28.26)

No statistical analyses for this end point

Secondary: Number of subjects seroprotected against 4 strains of influenza disease - age strata

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End point title

Number of subjects seroprotected against 4 strains of influenza disease - age strata

End point description

End point type

Secondary

End point timeframe

At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

End point values	GSK2282512A 1 (3-8 years) Group	GSK2282512A 1 (9-17 years) Group	Victoria strain Fluarix (3-8 years) Group	Victoria strain Fluarix (9-17 years) Group	Yamagata strain Fluarix (3-8 years) Group	Yamagata strain Fluarix (9-17 years) Group
Number of subjects analysed	425	453	424	447	424	454
Units: Subjects
H1N1, Day 0 (N=423;453;423;447;424;453)	209	271	218	278	207	270
H1N1, POST (N=425;453;424;447;424;454)	405	445	412	436	405	443
H3N2, Day 0 (N=423;453;423;447;423;453)	161	134	174	127	168	156
H3N2, POST (N=425;453;424;447;424;454)	379	437	390	418	389	430
Victoria, Day 0 (N=423;453;423;447;424;453)	144	244	163	241	150	250
Victoria, POST (N=425;453;424;447;423;454)	398	440	406	433	271	372
Yamagata, Day 0 (N=423;453;423;447;424;453)	205	373	209	374	220	402
Yamagata, POST (N=425;453;424;447;424;454)	419	450	361	444	420	453

No statistical analyses for this end point

Secondary: Number of subjects seroprotected against 4 strains of influenza disease - 6 to 35 Months old

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End point title

Number of subjects seroprotected against 4 strains of influenza disease - 6 to 35 Months old ^[2]

End point description

End point type

Secondary

End point timeframe

At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

Notes
[2] - 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: The analysis was performed only on subjects between 6 and 35 months old, included in the Control Group.

End point values	GSK2282512A 2 Group
Number of subjects analysed	259
Units: Subjects
H1N1, Day 0 (N=423;453;423;447;424;453;259)	87
H1N1, POST (N=425;453;424;447;424;454;259)	232
H3N2, Day 0 (N=423;453;423;447;423;453;259)	7
H3N2, POST (N=425;453;424;447;424;454;259)	193
Victoria, Day 0 (N=423;453;423;447;424;453;259)	28
Victoria, POST (N=425;453;424;447;423;454;259)	228
Yamagata, Day 0 (N=423;453;423;447;424;453;259)	22
Yamagata, POST (N=425;453;424;447;424;454;259)	250

No statistical analyses for this end point

Secondary: Seroconversion factor for Hemagglutination Inhibition antibodies against 4 strains of influenza disease - 6-35 Months

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End point title

Seroconversion factor for Hemagglutination Inhibition antibodies against 4 strains of influenza disease - 6-35 Months ^[3]

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 (i.e. the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer). The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.

End point type

Secondary

End point timeframe

At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

Notes
[3] - 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: The analysis was performed only on subjects between 6 and 35 months old, included in the Control Group.

End point values	GSK2282512A 2 Group
Number of subjects analysed	259
Units: fold increase
geometric mean (confidence interval 95%)
H1N1, POST (N=876;870;877;259)	11.95 (10.52 to 13.59)
H3N2, POST (N=876;870;876;259)	10.94 (9.64 to 12.42)
Victoria, POST (N=876;870;876;259)	14.61 (12.84 to 16.63)
Yamagata, POST (N=876;870;877;259)	24.92 (21.98 to 28.26)

No statistical analyses for this end point

Secondary: Number of subjects with any and grade 3 solicited local symptoms after vaccination

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End point title

Number of subjects with any and grade 3 solicited local symptoms after vaccination

End point description

Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity grade. Grade 3 pain for subjects < 5 years of age = Cried when limb was moved/spontaneously painful; Grade 3 pain for subjects ≥ 5 years of age = Significant pain at rest, pain that preventeded normal everyday activities. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm).

End point type

Secondary

End point timeframe

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

End point values	GSK2282512A 1 Group	Victoria strain Fluarix Group	Yamagata strain Fluarix Group	GSK2282512A 2 Group
Number of subjects analysed	913	912	916	294
Units: Subjects
Any pain	637	538	542	148
Grade 3 pain	35	21	26	6
Any redness	57	38	36	24
Grade 3 redness	1	0	0	2
Any swelling	64	40	39	18
Grade 3 swelling	1	0	0	1

No statistical analyses for this end point

Secondary: Number of days with solicited local symptoms after vaccination

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End point title

Number of days with solicited local symptoms after vaccination

End point description

Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2 respectively. Solicited local symptoms assessed for duration were pain, redness and swelling.

End point type

Secondary

End point timeframe

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

End point values	GSK2282512A 1 Group	Victoria strain Fluarix Group	Yamagata strain Fluarix Group	GSK2282512A 2 Group
Number of subjects analysed	597	497	510	131
Units: Days
median (inter-quartile range (Q1-Q3))
Pain, Dose 1 (N=597;497;510;131)	2 (1 to 3)	2 (1 to 3)	2 (1 to 3)	1 (1 to 2)
Pain, Dose 2 (N=169;151;141;76)	2 (1 to 2)	2 (1 to 2)	2 (1 to 2)	2 (1 to 2)
Redness, Dose 1 (N=48;29;32;13)	2 (1 to 3)	1 (1 to 2)	1 (1 to 2)	1 (1 to 5)
Redness, Dose 2 (N=13;11;10;14)	2 (1 to 3)	1 (1 to 3)	1.5 (1 to 3)	2.5 (1 to 4)
Swelling, Dose 1 (N=57;30;35;10)	2 (1 to 2)	2 (1 to 2)	2 (1 to 2)	1.5 (1 to 3)
Swelling, Dose 2 (N=12;15;7;11)	2.5 (2 to 4)	2 (1 to 2)	2 (1 to 2)	3 (2 to 4)

No statistical analyses for this end point

Secondary: Number of subjects below 5 years of age with any, grade 3 and related solicited general symptoms

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End point title

Number of subjects below 5 years of age with any, grade 3 and related solicited general symptoms

End point description

Symptoms assessed were drowsiness, irritability, loss of appetite and temperature. Any = Incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Any temperature = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 temperature = Axillary temperature ≥ 39.0°C. Grade 3 irritability = Crying that could not be comforted/ preventing normal activity. Grade 3 drowsiness = Drowsiness preventing normal activity. Grade 3 loss of appetite = Not eating at all. Related = A general symptom assessed by the investigator as causally related to vaccination.

End point type

Secondary

End point timeframe

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

End point values	GSK2282512A 1 Group	Victoria strain Fluarix Group	Yamagata strain Fluarix Group	GSK2282512A 2 Group
Number of subjects analysed	185	187	189	292
Units: Subjects
Any drowsiness	46	47	51	102
Grade 3 drowsiness	0	3	1	7
Related drowsiness	34	40	42	93
Any irritability	59	44	48	141
Grade 3 irritability	3	0	3	14
Related irritability	45	36	45	130
Any loss of appetite	40	41	35	93
Grade 3 loss of appetite	0	6	3	5
Related loss of appetite	21	28	24	73
Any temperature	15	16	15	27
Grade 3 temperature	3	5	5	6
Related temperature	6	10	6	18

No statistical analyses for this end point

Secondary: Number of subjects 5 years of age and above with any, grade 3 and related solicited general symptoms

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End point title

Number of subjects 5 years of age and above with any, grade 3 and related solicited general symptoms ^[4]

End point description

Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering and temperature. Any = Incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Any temperature = axillary temperature ≥ 38.0 °C. Grade 3 temperature = axillary temperature ≥ 39.0°C. Grade 3 symptom = Symptom that prevented normal activity. Related = A general symptom assessed by the investigator as causally related to vaccination.

End point type

Secondary

End point timeframe

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

Notes
[4] - 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: The analysis was done only on subjects above 5 years of age from the study pooled groups.

End point values	GSK2282512A 1 Group	Victoria strain Fluarix Group	Yamagata strain Fluarix Group
Number of subjects analysed	727	725	726
Units: Subjects
Any fatigue	173	177	177
Grade 3 fatigue	6	13	8
Related fatigue	143	149	134
Any gastrointestinal symptoms	80	82	72
Grade 3 gastrointestinal symptoms	9	8	6
Related gastrointestinal symptoms	55	51	37
Any headache	170	171	157
Grade 3 headache	8	9	10
Related headache	134	134	116
Any joint pain at other location	103	95	81
Grade 3 joint pain at other location	4	5	1
Related joint pain at other location	82	80	67
Any muscle aches	222	194	193
Grade 3 muscle aches	6	5	9
Related muscle aches	202	178	170
Any shivering	55	51	53
Grade 3 shivering	4	10	4
Related shivering	45	35	41
Any temperature	26	33	20
Grade 3 temperature	5	8	2
Related temperature	16	18	13

No statistical analyses for this end point

Secondary: Number of days with solicited general symptoms after vaccination in subjects below 5 years of age

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End point title

Number of days with solicited general symptoms after vaccination in subjects below 5 years of age

End point description

Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2, respectively. Solicited general symptoms assessed for duration in subjects below 5 years of age were drowsiness, irritability and loss of appetite.

End point type

Secondary

End point timeframe

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

End point values	GSK2282512A 1 Group	Victoria strain Fluarix Group	Yamagata strain Fluarix Group	GSK2282512A 2 Group
Number of subjects analysed	48	37	44	120
Units: Days
median (inter-quartile range (Q1-Q3))
Drowsiness, Dose 1 (N=39;37;44;85)	1 (1 to 2)	2 (1 to 2)	1 (1 to 2)	2 (1 to 3)
Drowsiness, Dose 2 (N=16;18;17;45)	1 (1 to 1.5)	1 (1 to 2)	2 (1 to 3)	2 (1 to 3)
Irritability, Dose 1 (N=48;31;41;120)	1 (1 to 2)	2 (1 to 4)	2 (1 to 3)	2 (1 to 3)
Irritability, Dose 2 (N=25;22;16;74)	1 (1 to 2)	2 (1 to 3)	2 (1 to 3.5)	2 (1 to 3)
Loss of appetite, Dose 1 (N=32;30;25;64)	1 (1 to 2)	2 (1 to 3)	1 (1 to 2)	2 (1 to 3)
Loss of appetite, Dose 2 (N=13;15;14;48)	2 (1 to 3)	2 (1 to 4)	3 (1 to 5)	2 (1 to 3)

No statistical analyses for this end point

Secondary: Number of days with solicited general symptoms after vaccination in subjects 5 years of age and above

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End point title

Number of days with solicited general symptoms after vaccination in subjects 5 years of age and above ^[5]

End point description

Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2, respectively. Solicited general symptoms assessed for duration in subjects 5 years of age and above were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches and shivering.

End point type

Secondary

End point timeframe

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

Notes
[5] - 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: The analysis was done on the four pooled groups of the study.

End point values	GSK2282512A 1 Group	Victoria strain Fluarix Group	Yamagata strain Fluarix Group
Number of subjects analysed	207	180	179
Units: Days
median (inter-quartile range (Q1-Q3))
Fatigue, Dose 1 (N=161;171;167)	2 (1 to 3)	1 (1 to 3)	2 (1 to 3)
Fatigue, Dose 2 (N=27;19;19)	2 (1 to 3)	2 (1 to 3)	2 (1 to 3)
Gastrointestinal symptoms, Dose 1 (N=70;70;65)	1.5 (1 to 3)	1 (1 to 3)	1 (1 to 2)
Gastrointestinal symptoms, Dose 2 (N=17;16;9)	1 (1 to 2)	1.5 (1 to 2)	2 (1 to 2)
Headache, Dose 1 (160;160;146)	2 (1 to 2)	1 (1 to 2)	2 (1 to 3)
Headache, Dose 2 (20;19;17)	1.5 (1 to 2.5)	1 (1 to 2)	1 (1 to 2)
Joint pain at other location, Dose 1 (N=94;86;76)	2 (1 to 2)	2 (1 to 3)	1.5 (1 to 3)
Joint pain at other location, Dose 2 (N=21;13;10)	2 (1 to 2)	1 (1 to 2)	1 (1 to 2)
Muscle aches, Dose 1 (N=207;180;179)	2 (1 to 3)	2 (1 to 3)	2 (1 to 3)
Muscle aches, Dose 2 (N=44;27;30)	1 (1 to 2)	1 (1 to 2)	2 (1 to 2)
Shivering, Dose 1 (N=51;50;50)	1 (1 to 3)	2 (1 to 2)	1 (1 to 3)
Shivering, Dose 2 (N=8;1;4)	1.5 (1 to 2)	1 (1 to 1)	2 (1 to 2)

No statistical analyses for this end point

Secondary: Number of days with fever in all subjects regardless of their age after vaccination

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End point title

Number of days with fever in all subjects regardless of their age after vaccination

End point description

Duration for fever was assessed via tabulation of the number of days with local symptoms of fever (axillary temperature ≥ 38°C) after vaccination with Dose 1 and Dose 2, respectively.

End point type

Secondary

End point timeframe

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

End point values	GSK2282512A 1 Group	Victoria strain Fluarix Group	Yamagata strain Fluarix Group	GSK2282512A 2 Group
Number of subjects analysed	25	43	26	16
Units: Days
median (inter-quartile range (Q1-Q3))
Fever, Dose 1 (N=25;43;26;16)	1 (1 to 1)	1 (1 to 2)	1.5 (1 to 2)	1 (1 to 2)
Fever, Dose 2 (N=17;7;9;12)	2 (1 to 3)	1 (1 to 2)	1 (1 to 2)	1.5 (1 to 2.5)

No statistical analyses for this end point

Secondary: Number of subjects with any, grade 3 and related unsolicited adverse events (AEs)

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End point title

Number of subjects with any, grade 3 and related unsolicited adverse events (AEs)

End point description

Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any unsolicited AE(s) = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE = Occurrence of any unsolicited AE that prevented normal activities. Related unsolicited AE(s) = Occurrence of an unsolicited AE assessed by the investigator to be causally related to vaccination.

End point type

Secondary

End point timeframe

During the 28-day follow-up period (Day 0-27) after vaccination

End point values	GSK2282512A 1 Group	Victoria strain Fluarix Group	Yamagata strain Fluarix Group	GSK2282512A 2 Group
Number of subjects analysed	932	929	932	301
Units: Subjects
Any unsolicited AE(s)	283	291	275	160
Grade 3 unsolicited AE(s)	40	41	35	24
Related unsolicited AE(s)	44	47	44	43

No statistical analyses for this end point

Secondary: Number of subjects with any and related potential immune-mediated diseases (pIMDs) after vaccination

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End point title

Number of subjects with any and related potential immune-mediated diseases (pIMDs) after vaccination

End point description

Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any pIMD(s) = Occurrence of any pIMD(s) regardless of intensity grade or relation to vaccination. Relationship to vaccination was not assessed for pIMDs.

End point type

Secondary

End point timeframe

During the entire study period (from Day 0 to Day 180)

End point values	GSK2282512A 1 Group	Victoria strain Fluarix Group	Yamagata strain Fluarix Group	GSK2282512A 2 Group
Number of subjects analysed	932	929	932	301
Units: Subjects
Any pIMD(s)	0	1	1	0

No statistical analyses for this end point

Secondary: Number of subjects with any and related medically-attended adverse events (MAEs) after vaccination

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End point title

Number of subjects with any and related medically-attended adverse events (MAEs) after vaccination

End point description

Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other criterion for serious adverse event (SAE)), it was reported as SAE. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.Relationship to vaccination was not assessed for MAEs.

End point type

Secondary

End point timeframe

During the entire study period (from Day 0 to Day 180)

End point values	GSK2282512A 1 Group	Victoria strain Fluarix Group	Yamagata strain Fluarix Group	GSK2282512A 2 Group
Number of subjects analysed	932	929	932	301
Units: Subjects
Any MAE(s)	346	335	350	147

No statistical analyses for this end point

Secondary: Number of subjects with any and related serious adverse events (SAEs)

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End point title

Number of subjects with any and related serious adverse events (SAEs)

End point description

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(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s)= Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.

End point type

Secondary

End point timeframe

During the entire study period (from Day 0 to Day 180)

End point values	GSK2282512A 1 Group	Victoria strain Fluarix Group	Yamagata strain Fluarix Group	GSK2282512A 2 Group
Number of subjects analysed	932	929	932	301
Units: Subjects
Any SAE(s)	3	6	5	7
Related SAE(s)	0	0	1	2

No statistical analyses for this end point

Secondary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease - 6 to 35 Months old

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End point title

Titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease - 6 to 35 Months old ^[6]

End point description

End point type

Secondary

End point timeframe

At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

Notes
[6] - 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: The analysis was performed only on subjects between 6 and 35 months old, included in the Control Group.

End point values	GSK2282512A 2 Group
Number of subjects analysed	259
Units: titer
geometric mean (confidence interval 95%)
H1N1, Day 0 (N=423;423;424;259)	16.8 (13.9 to 20.3)
H1N1, POST (N=425;424;424;259)	200.9 (166.6 to 242.2)
H3N2, Day 0 (N=423;423;423;259)	5.6 (5.3 to 6)
H3N2, POST (N=425;424;424;259)	61.4 (53.8 to 70)
Victoria, Day 0 (N=423;423;424;259)	8.7 (7.5 to 10)
Victoria, POST (N=425;424;423;259)	127.3 (109.4 to 148.1)
Yamagata, Day 0 (N=423;423;424;259)	7.7 (7 to 8.6)
Yamagata, POST (N=425;424;424;259)	192.7 (172.1 to 215.7)

No statistical analyses for this end point

Secondary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease - age strata

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End point title

Titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease - age strata

End point description

End point type

Secondary

End point timeframe

At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

End point values	GSK2282512A 1 (3-8 years) Group	GSK2282512A 1 (9-17 years) Group	Victoria strain Fluarix (3-8 years) Group	Victoria strain Fluarix (9-17 years) Group	Yamagata strain Fluarix (3-8 years) Group	Yamagata strain Fluarix (9-17 years) Group
Number of subjects analysed	425	453	424	447	424	454
Units: titre
geometric mean (confidence interval 95%)
H1N1, Day 0 (N=423;453;423;447;424;453)	24.7 (21.6 to 28.3)	34.6 (30.6 to 39.2)	26.9 (23.5 to 30.9)	38.2 (33.8 to 43.1)	24.5 (21.5 to 27.8)	34.2 (30.3 to 38.6)
H1N1, POST (N=425;453;424;447;424;454)	310.5 (274.9 to 350.6)	419.5 (379.8 to 463.4)	382.7 (339.4 to 431.6)	478.2 (431.4 to 530)	356.2 (316.5 to 400.8)	490.3 (443.7 to 541.7)
H3N2, Day 0 (N=423;453;423;447;423;453)	19.7 (17.4 to 22.4)	16.7 (15 to 18.7)	21.2 (18.6 to 24.2)	17 (15.3 to 19)	20.2 (17.8 to 23)	18.6 (16.6 to 20.9)
H3N2, POST (N=425;453;424;447;424;454)	138.2 (123.7 to 154.5)	149.1 (137.3 to 162)	144.4 (130.6 to 159.7)	135.2 (123.5 to 148)	147.9 (133.3 to 164.1)	153.9 (140.7 to 168.4)
Victoria, Day 0 (N=423;453;423;447;424;453)	18.3 (15.8 to 21.1)	32.9 (29 to 37.4)	20.2 (17.6 to 23.3)	32.5 (28.7 to 36.8)	18.4 (16 to 21.1)	35.4 (31.3 to 40.1)
Victoria, POST (N=425;453;424;447;423;454)	194.4 (171.3 to 220.7)	317.8 (287.1 to 351.8)	197.4 (175.9 to 221.6)	301.7 (272.2 to 334.3)	52.6 (45.2 to 61.2)	86.6 (77.4 to 96.9)
Yamagata, Day 0 (N=423;453;423;447;424;453)	27.4 (23.8 to 31.7)	116.2 (102.2 to 132.1)	29.5 (25.6 to 34)	111.6 (98.3 to 126.8)	29.5 (25.5 to 34.1)	139.6 (124.6 to 156.4)
Yamagata, POST (N=425;453;424;447;424;454)	363.4 (327.8 to 402.9)	707.5 (648.7 to 771.5)	103.2 (91.7 to 116.1)	363.7 (330.4 to 400.3)	416.7 (374.5 to 463.7)	787.1 (731.3 to 847.2)

No statistical analyses for this end point

Secondary: Number of subjects seroconverted against 4 strains of influenza disease - 6-35 months old

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End point title

Number of subjects seroconverted against 4 strains of influenza disease - 6-35 months old ^[7]

End point description

End point type

Secondary

End point timeframe

At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

Notes
[7] - 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: The analysis was performed only on subjects between 6 and 35 months old, included in the Control Group.

End point values	GSK2282512A 2 Group
Number of subjects analysed	259
Units: Subjects
H1N1, POST	220
H3N2, POST	189
Victoria, POST	219
Yamagata, POST	243

No statistical analyses for this end point

Secondary: Seroconversion factor for Hemagglutination Inhibition antibodies against 4 strains of influenza disease - age strata

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End point title

Seroconversion factor for Hemagglutination Inhibition antibodies against 4 strains of influenza disease - age strata

End point description

End point type

Secondary

End point timeframe

At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

End point values	GSK2282512A 1 (3-8 years) Group	GSK2282512A 1 (9-17 years) Group	Victoria strain Fluarix (3-8 years) Group	Victoria strain Fluarix (9-17 years) Group	Yamagata strain Fluarix (3-8 years) Group	Yamagata strain Fluarix (9-17 years) Group
Number of subjects analysed	423	453	423	447	424	453
Units: fold increase
geometric mean (confidence interval 95%)
H1N1, POST (N=423;453;423;447;424;453)	12.5 (11.31 to 13.82)	12.12 (10.67 to 13.77)	14.2 (12.83 to 15.71)	12.52 (11.07 to 14.17)	14.56 (13.2 to 16.05)	14.29 (12.52 to 16.31)
H3N2, POST (N=423;453;423;447;423;453)	7.02 (6.3 to 7.84)	8.91 (7.85 to 10.11)	6.82 (6.09 to 7.64)	7.94 (7.02 to 8.97)	7.29 (6.51 to 8.16)	8.27 (7.32 to 9.34)
Victoria, POST (N=423;453;423;447;423;453)	10.64 (9.41 to 12.02)	9.65 (8.42 to 11.07)	9.75 (8.61 to 11.04)	9.28 (8.04 to 10.71)	2.85 (2.58 to 3.16)	2.44 (2.25 to 2.65)
Yamagata, POST (N=423;453;423;447;424;453)	13.23 (11.74 to 14.9)	6.09 (5.42 to 6.84)	3.49 (3.18 to 3.84)	3.26 (2.93 to 3.62)	14.11 (12.57 to 15.84)	5.63 (5.02 to 6.33)

No statistical analyses for this end point

Secondary: Number of subjects seroconverted against 4 strains of influenza disease - age strata

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End point title

Number of subjects seroconverted against 4 strains of influenza disease - age strata

End point description

End point type

Secondary

End point timeframe

At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

End point values	GSK2282512A 1 (3-8 years) Group	GSK2282512A 1 (9-17 years) Group	Victoria strain Fluarix (3-8 years) Group	Victoria strain Fluarix (9-17 years) Group	Yamagata strain Fluarix (3-8 years) Group	Yamagata strain Fluarix (9-17 years) Group
Number of subjects analysed	423	453	423	447	424	453
Units: Subjects
H1N1, POST (N=423;453;423;447;424;453)	374	365	390	365	380	370
H3N2, POST (N=423;453;423;447;423;453)	291	323	282	308	296	314
Victoria, POST (N=423;453;423;447;423;453)	329	324	326	296	133	129
Yamagata, POST (N=423;453;423;447;424;453)	366	293	181	178	372	272

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Serious adverse events were assessed from Day 0 to Day 180. Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during a 7-day and 28-day post-vaccination period, respectively.

Adverse event reporting additional description

For the systematically-assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

Reporting group title

Victoria strain Fluarix Group

Reporting group description

Reporting group title

GSK2282512A 2 Group

Reporting group description

Reporting group title

Yamagata strain Fluarix Group

Reporting group description

Reporting group title

GSK2282512A 1 Group

Reporting group description

Serious adverse events	Victoria strain Fluarix Group	GSK2282512A 2 Group	Yamagata strain Fluarix Group	GSK2282512A 1 Group
Total subjects affected by serious adverse events
subjects affected / exposed	6 / 929 (0.65%)	7 / 301 (2.33%)	5 / 932 (0.54%)	3 / 932 (0.32%)
number of deaths (all causes)	0	0	0	0
number of deaths resulting from adverse events
Injury, poisoning and procedural complications
Accidental overdose
subjects affected / exposed	0 / 929 (0.00%)	0 / 301 (0.00%)	0 / 932 (0.00%)	1 / 932 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Facial bones fracture
subjects affected / exposed	0 / 929 (0.00%)	0 / 301 (0.00%)	1 / 932 (0.11%)	0 / 932 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Foreign body
subjects affected / exposed	0 / 929 (0.00%)	1 / 301 (0.33%)	0 / 932 (0.00%)	0 / 932 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Head injury
subjects affected / exposed	0 / 929 (0.00%)	0 / 301 (0.00%)	1 / 932 (0.11%)	0 / 932 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Joint dislocation
subjects affected / exposed	0 / 929 (0.00%)	0 / 301 (0.00%)	1 / 932 (0.11%)	0 / 932 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Traumatic brain injury
subjects affected / exposed	1 / 929 (0.11%)	0 / 301 (0.00%)	0 / 932 (0.00%)	0 / 932 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital, familial and genetic disorders
Vitello-intestinal duct remnant
subjects affected / exposed	1 / 929 (0.11%)	0 / 301 (0.00%)	0 / 932 (0.00%)	0 / 932 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Hypertension
subjects affected / exposed	0 / 929 (0.00%)	0 / 301 (0.00%)	0 / 932 (0.00%)	1 / 932 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Febrile convulsion
subjects affected / exposed	0 / 929 (0.00%)	1 / 301 (0.33%)	0 / 932 (0.00%)	0 / 932 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Grand mal convulsion
subjects affected / exposed	0 / 929 (0.00%)	1 / 301 (0.33%)	0 / 932 (0.00%)	0 / 932 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Depression
subjects affected / exposed	1 / 929 (0.11%)	0 / 301 (0.00%)	0 / 932 (0.00%)	1 / 932 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Anxiety
subjects affected / exposed	1 / 929 (0.11%)	0 / 301 (0.00%)	0 / 932 (0.00%)	0 / 932 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Suicidal ideation
subjects affected / exposed	1 / 929 (0.11%)	0 / 301 (0.00%)	0 / 932 (0.00%)	0 / 932 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Lymphadenitis
subjects affected / exposed	0 / 929 (0.00%)	0 / 301 (0.00%)	0 / 932 (0.00%)	1 / 932 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Immune system disorders
Anaphylactic reaction
subjects affected / exposed	1 / 929 (0.11%)	0 / 301 (0.00%)	0 / 932 (0.00%)	0 / 932 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypersensitivity
subjects affected / exposed	1 / 929 (0.11%)	0 / 301 (0.00%)	0 / 932 (0.00%)	0 / 932 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Eye disorders
Conjunctivitis
subjects affected / exposed	0 / 929 (0.00%)	0 / 301 (0.00%)	1 / 932 (0.11%)	0 / 932 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Biliary dyskinesia
subjects affected / exposed	1 / 929 (0.11%)	0 / 301 (0.00%)	0 / 932 (0.00%)	0 / 932 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Asthma
subjects affected / exposed	0 / 929 (0.00%)	3 / 301 (1.00%)	0 / 932 (0.00%)	0 / 932 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Angioedema
subjects affected / exposed	0 / 929 (0.00%)	0 / 301 (0.00%)	1 / 932 (0.11%)	0 / 932 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Urticaria
subjects affected / exposed	1 / 929 (0.11%)	0 / 301 (0.00%)	0 / 932 (0.00%)	0 / 932 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Gastroenteritis
subjects affected / exposed	1 / 929 (0.11%)	1 / 301 (0.33%)	0 / 932 (0.00%)	0 / 932 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bronchopneumonia
subjects affected / exposed	0 / 929 (0.00%)	0 / 301 (0.00%)	1 / 932 (0.11%)	0 / 932 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis rotavirus
subjects affected / exposed	0 / 929 (0.00%)	0 / 301 (0.00%)	1 / 932 (0.11%)	0 / 932 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Influenza
subjects affected / exposed	0 / 929 (0.00%)	0 / 301 (0.00%)	1 / 932 (0.11%)	0 / 932 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Lobar pneumonia
subjects affected / exposed	0 / 929 (0.00%)	1 / 301 (0.33%)	0 / 932 (0.00%)	0 / 932 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	1 / 929 (0.11%)	0 / 301 (0.00%)	0 / 932 (0.00%)	0 / 932 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia viral
subjects affected / exposed	0 / 929 (0.00%)	1 / 301 (0.33%)	0 / 932 (0.00%)	0 / 932 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory syncytial virus infection
subjects affected / exposed	0 / 929 (0.00%)	1 / 301 (0.33%)	0 / 932 (0.00%)	0 / 932 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Hypovolaemia
subjects affected / exposed	0 / 929 (0.00%)	0 / 301 (0.00%)	1 / 932 (0.11%)	0 / 932 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	Victoria strain Fluarix Group	GSK2282512A 2 Group	Yamagata strain Fluarix Group	GSK2282512A 1 Group
Total subjects affected by non serious adverse events
subjects affected / exposed	538 / 929 (57.91%)	148 / 301 (49.17%)	542 / 932 (58.15%)	637 / 932 (68.35%)
General disorders and administration site conditions
Pain
alternative assessment type: Systematic
subjects affected / exposed ^[1]	538 / 912 (58.99%)	148 / 294 (50.34%)	542 / 916 (59.17%)	637 / 913 (69.77%)
occurrences all number	538	148	542	637
Swelling
alternative assessment type: Systematic
subjects affected / exposed ^[2]	40 / 912 (4.39%)	18 / 294 (6.12%)	39 / 916 (4.26%)	64 / 913 (7.01%)
occurrences all number	40	18	39	64
Drowsiness
alternative assessment type: Systematic
subjects affected / exposed ^[3]	47 / 187 (25.13%)	102 / 292 (34.93%)	51 / 189 (26.98%)	46 / 185 (24.86%)
occurrences all number	47	102	51	46
Irritability
alternative assessment type: Systematic
subjects affected / exposed ^[4]	44 / 187 (23.53%)	141 / 292 (48.29%)	48 / 189 (25.40%)	59 / 185 (31.89%)
occurrences all number	44	141	48	59
Loss of appetite
alternative assessment type: Systematic
subjects affected / exposed ^[5]	41 / 187 (21.93%)	93 / 292 (31.85%)	35 / 189 (18.52%)	40 / 185 (21.62%)
occurrences all number	41	93	35	40
Temperature
alternative assessment type: Systematic
subjects affected / exposed ^[6]	16 / 187 (8.56%)	27 / 292 (9.25%)	15 / 189 (7.94%)	15 / 185 (8.11%)
occurrences all number	16	27	15	15
Fatigue
alternative assessment type: Systematic
subjects affected / exposed ^[7]	177 / 725 (24.41%)	0 / 301 (0.00%)	177 / 726 (24.38%)	173 / 727 (23.80%)
occurrences all number	177	0	177	173
Gastrointestinal
alternative assessment type: Systematic
subjects affected / exposed ^[8]	82 / 725 (11.31%)	0 / 301 (0.00%)	72 / 726 (9.92%)	80 / 727 (11.00%)
occurrences all number	82	0	72	80
Headache
alternative assessment type: Systematic
subjects affected / exposed ^[9]	171 / 725 (23.59%)	0 / 301 (0.00%)	157 / 726 (21.63%)	170 / 727 (23.38%)
occurrences all number	171	0	157	170
Joint pain at other location
alternative assessment type: Systematic
subjects affected / exposed ^[10]	95 / 725 (13.10%)	0 / 301 (0.00%)	81 / 726 (11.16%)	103 / 727 (14.17%)
occurrences all number	95	0	81	103
Muscle aches
alternative assessment type: Systematic
subjects affected / exposed ^[11]	194 / 725 (26.76%)	0 / 301 (0.00%)	193 / 726 (26.58%)	222 / 727 (30.54%)
occurrences all number	194	0	193	222
Shivering
alternative assessment type: Systematic
subjects affected / exposed ^[12]	51 / 725 (7.03%)	0 / 301 (0.00%)	53 / 726 (7.30%)	55 / 727 (7.57%)
occurrences all number	51	0	53	55
Pyrexia
subjects affected / exposed	16 / 929 (1.72%)	21 / 301 (6.98%)	13 / 932 (1.39%)	19 / 932 (2.04%)
occurrences all number	16	21	13	19
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	10 / 929 (1.08%)	20 / 301 (6.64%)	7 / 932 (0.75%)	11 / 932 (1.18%)
occurrences all number	10	20	7	11
Redness
alternative assessment type: Systematic
subjects affected / exposed ^[13]	38 / 912 (4.17%)	24 / 294 (8.16%)	36 / 916 (3.93%)	57 / 913 (6.24%)
occurrences all number	38	24	36	57
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	38 / 929 (4.09%)	34 / 301 (11.30%)	49 / 932 (5.26%)	53 / 932 (5.69%)
occurrences all number	38	34	49	53
Infections and infestations
Upper respiratory tract infection
subjects affected / exposed	30 / 929 (3.23%)	24 / 301 (7.97%)	33 / 932 (3.54%)	36 / 932 (3.86%)
occurrences all number	30	24	33	36
Nasopharyngitis
subjects affected / exposed	47 / 929 (5.06%)	14 / 301 (4.65%)	43 / 932 (4.61%)	48 / 932 (5.15%)
occurrences all number	47	14	43	48
Rhinorrhoea
subjects affected / exposed	12 / 929 (1.29%)	33 / 301 (10.96%)	19 / 932 (2.04%)	17 / 932 (1.82%)
occurrences all number	12	33	19	17

Notes
[1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: The analysis was performed solely on subjects with symptom sheet completed for the reported specific symptom.
[2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: The analysis was performed solely on subjects with symptom sheet completed for the reported specific symptom.
[3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: The analysis was performed solely on subjects with symptom sheet completed for the reported specific symptom.
[4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: The analysis was performed solely on subjects with symptom sheet completed for the reported specific symptom.
[5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: The analysis was performed solely on subjects with symptom sheet completed for the reported specific symptom.
[6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: The analysis was performed solely on subjects with symptom sheet completed for the reported specific symptom.
[7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: The analysis was performed solely on subjects with symptom sheet completed for the reported specific symptom.
[8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: The analysis was performed solely on subjects with symptom sheet completed for the reported specific symptom.
[9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: The analysis was performed solely on subjects with symptom sheet completed for the reported specific symptom.
[10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: The analysis was performed solely on subjects with symptom sheet completed for the reported specific symptom.
[11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: The analysis was performed solely on subjects with symptom sheet completed for the reported specific symptom.
[12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: The analysis was performed solely on subjects with symptom sheet completed for the reported specific symptom.
[13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: The analysis was performed solely on subjects with symptom sheet completed for the reported specific symptom.

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Were there any global substantial amendments to the protocol? No

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

Clinical Trial Results: Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) When Administered in Children

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease

Primary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease

Primary: Number of subjects seroconverted against 4 strains of influenza disease

Primary: Number of subjects seroconverted against 4 strains of influenza disease

Secondary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease

Secondary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease

Secondary: Number of subjects seroprotected against 4 strains of influenza disease

Secondary: Number of subjects seroprotected against 4 strains of influenza disease

Secondary: Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease

Secondary: Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease

Secondary: Number of subjects seroprotected against 4 strains of influenza disease - age strata

Secondary: Number of subjects seroprotected against 4 strains of influenza disease - age strata

Secondary: Number of subjects seroprotected against 4 strains of influenza disease - 6 to 35 Months old

Secondary: Number of subjects seroprotected against 4 strains of influenza disease - 6 to 35 Months old

Secondary: Seroconversion factor for Hemagglutination Inhibition antibodies against 4 strains of influenza disease - 6-35 Months

Secondary: Seroconversion factor for Hemagglutination Inhibition antibodies against 4 strains of influenza disease - 6-35 Months

Secondary: Number of subjects with any and grade 3 solicited local symptoms after vaccination

Secondary: Number of subjects with any and grade 3 solicited local symptoms after vaccination

Secondary: Number of days with solicited local symptoms after vaccination

Secondary: Number of days with solicited local symptoms after vaccination

Secondary: Number of subjects below 5 years of age with any, grade 3 and related solicited general symptoms

Secondary: Number of subjects below 5 years of age with any, grade 3 and related solicited general symptoms

Secondary: Number of subjects 5 years of age and above with any, grade 3 and related solicited general symptoms

Secondary: Number of subjects 5 years of age and above with any, grade 3 and related solicited general symptoms

Secondary: Number of days with solicited general symptoms after vaccination in subjects below 5 years of age

Secondary: Number of days with solicited general symptoms after vaccination in subjects below 5 years of age

Secondary: Number of days with solicited general symptoms after vaccination in subjects 5 years of age and above

Secondary: Number of days with solicited general symptoms after vaccination in subjects 5 years of age and above

Secondary: Number of days with fever in all subjects regardless of their age after vaccination

Secondary: Number of days with fever in all subjects regardless of their age after vaccination

Secondary: Number of subjects with any, grade 3 and related unsolicited adverse events (AEs)

Secondary: Number of subjects with any, grade 3 and related unsolicited adverse events (AEs)

Secondary: Number of subjects with any and related potential immune-mediated diseases (pIMDs) after vaccination

Secondary: Number of subjects with any and related potential immune-mediated diseases (pIMDs) after vaccination

Secondary: Number of subjects with any and related medically-attended adverse events (MAEs) after vaccination

Secondary: Number of subjects with any and related medically-attended adverse events (MAEs) after vaccination

Secondary: Number of subjects with any and related serious adverse events (SAEs)

Secondary: Number of subjects with any and related serious adverse events (SAEs)

Secondary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease - 6 to 35 Months old

Secondary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease - 6 to 35 Months old

Secondary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease - age strata

Secondary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease - age strata

Secondary: Number of subjects seroconverted against 4 strains of influenza disease - 6-35 months old

Secondary: Number of subjects seroconverted against 4 strains of influenza disease - 6-35 months old

Secondary: Seroconversion factor for Hemagglutination Inhibition antibodies against 4 strains of influenza disease - age strata

Secondary: Seroconversion factor for Hemagglutination Inhibition antibodies against 4 strains of influenza disease - age strata

Secondary: Number of subjects seroconverted against 4 strains of influenza disease - age strata

Secondary: Number of subjects seroconverted against 4 strains of influenza disease - age strata

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical Trial Results:
Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) When Administered in Children