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Clinical Trial Results:
A phase III, double-blind, randomized study to evaluate the immunogenicity and safety of GSK Biologicals’ quadrivalent influenza vaccine compared to GSK Biologicals’ trivalent influenza vaccine administered intramuscularly in children aged 3 to 17 years and to describe the safety and immunogenicity of GSK Biologicals'quadrivalent influenza vaccine in children aged 6 to 35 months.

Summary
EudraCT number	2010-021032-34
Trial protocol	DE FR CZ Outside EU/EEA
Global end of trial date	15 Jun 2011

Results information
Results version number	v2(current)
This version publication date	14 Jul 2022
First version publication date	04 Apr 2015
Other versions	v1
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

113275

ISRCTN number

US NCT number

NCT01196988

WHO universal trial number (UTN)

Sponsor organisation name

GlaxoSmithKline Biologicals

Sponsor organisation address

Rue de l'Institut 89, Rixensart, Belgium,

Public contact

Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.com

Scientific contact

Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.com

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

Yes

EMA paediatric investigation plan number(s)

EMEA-000817-PIP02-11

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

16 Sep 2011

Is this the analysis of the primary completion data?

Yes

Primary completion date

15 Jun 2011

Global end of trial reached?

Yes

Global end of trial date

15 Jun 2011

Was the trial ended prematurely?

Main objective of the trial

•To evaluate the immunological non-inferiority (in terms of Geometric Mean Titre (GMT) and Seroconversion Rate (SCR)) of GSK2321138A vaccine versus Fluarix and GSK2604409A vaccine in children (3 to 17 years) at 28 days (primed subjects) or 56 days (unprimed subjects) following first vaccination (28 days after completion of the immunization series). Criteria to conclude non-inferiority: •The test of non-inferiority will be based on the analysis of the entire age range in each treatment group. Non-inferiority will be concluded if, for the three strains contained in each TIV formulation: •The upper limit of the two-sided 95% confidence interval (CI) of the GMT ratio (TIV-1 (Fluarix) / D-QIV and TIV-2 / D-QIV) after completion of the vaccination series does not exceed 1.5 and •The upper limit of the two-sided 95% CI for the difference in SCR (TIV-1 (Fluarix) minus D-QIV and TIV-2 minus D-QIV) does not exceed 10% for the three strains contained in each TIV formulation

Protection of trial subjects

All subjects were supervised for 30 min after vaccination/product administration with appropriate medical treatment readily available. Vaccines/products were administered by qualified and trained personnel. Vaccines/products were administered only to eligible subjects that had no contraindications to any components of the vaccines/products. Subjects were followed-up for 125 days after the last vaccination/product administration.

Background therapy

Evidence for comparator

Actual start date of recruitment

04 Oct 2010

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 1065

Country: Number of subjects enrolled

Czech Republic: 235

Country: Number of subjects enrolled

France: 183

Country: Number of subjects enrolled

Germany: 707

Country: Number of subjects enrolled

Philippines: 837

Worldwide total number of subjects

3027

EEA total number of subjects

1125

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)

277

Children (2-11 years)

2183

Adolescents (12-17 years)

567

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Subjects were differentiated according to their priming status. Primed subjects had received at least 1 dose of an influenza A (H1N1) 2009 monovalent vaccine and had received 2 doses of seasonal influenza in the last season or had received at least 1 dose prior to last season. Unprimed subjects had not.

Screening details

3015 subjects out of the 3027 who were enrolled in the study were vaccinated. Remaining subjects were not included in the participant flow as started as they failed to meet protocol criteria. The treatment was stratified by age strata: 3-8 and 9-17 years. Another arm evaluates the GSK2321138A vaccine for children aged 6-17 and 18-35 months.

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, Monitor, Data analyst, Carer

Are arms mutually exclusive

Yes

GSK2321138A 1 Group

Arm description

Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.

Arm type

Experimental

Investigational medicinal product name

Influenza vaccine GSK2321138A

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

intramuscular injections

Fluarix Group

Arm description

Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.

Arm type

Active comparator

Investigational medicinal product name

Fluarix

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

intramuscular injections

GSK2604409A Group

Arm description

Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.

Arm type

Active comparator

Investigational medicinal product name

Influenza vaccine GSK2604409A

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

intramuscular injections

GSK2321138A 2 Group

Arm description

Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.

Arm type

Experimental

Investigational medicinal product name

Influenza vaccine GSK2321138A

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular and intravenous use

Dosage and administration details

intramuscular injections

Number of subjects in period 1 ^[1]	GSK2321138A 1 Group	Fluarix Group	GSK2604409A Group	GSK2321138A 2 Group
Started	915	912	911	277
Completed	891	880	886	276
Not completed	24	32	25	1
Consent withdrawn by subject	5	1	4	-
Adverse event, non-fatal	1	2	-	-
Unspecified	2	-	-	-
Lost to follow-up	16	29	21	1

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: 3015 subjects out of the 3027 who were enrolled in the study were vaccinated. Remaining subjects were not included in the participant flow as started as they failed to meet protocol criteria.

Baseline characteristics

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Reporting group title

GSK2321138A 1 Group

Reporting group description

Reporting group title

Fluarix Group

Reporting group description

Reporting group title

GSK2604409A Group

Reporting group description

Reporting group title

GSK2321138A 2 Group

Reporting group description

Reporting group values	GSK2321138A 1 Group	Fluarix Group	GSK2604409A Group	GSK2321138A 2 Group	Total
Number of subjects	915	912	911	277	3015
Age categorical
Units: Subjects
In utero					0
Preterm newborn infants (gestational age < 37 wks)					0
Newborns (0-27 days)					0
Infants and toddlers (28 days-23 months)					0
Children (2-11 years)					0
Adolescents (12-17 years)					0
Adults (18-64 years)					0
From 65-84 years					0
85 years and over					0
Age continuous
Units: months
geometric mean (standard deviation)	98.5 ± 44.4	98.2 ± 45.5	99.6 ± 44.2	22.1 ± 8.02	-
Gender categorical
Units: Subjects
Female	443	439	440	118	1440
Male	472	473	471	159	1575

End points

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Reporting group title

GSK2321138A 1 Group

Reporting group description

Reporting group title

Fluarix Group

Reporting group description

Reporting group title

GSK2604409A Group

Reporting group description

Reporting group title

GSK2321138A 2 Group

Reporting group description

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. ^[1]

End point description

Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).

End point type

Primary

End point timeframe

At Day 0 [PRE] and at Day 28 (for primed subjects) and 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	GSK2321138A 1 Group	Fluarix Group	GSK2604409A Group	GSK2321138A 2 Group
Number of subjects analysed	791	819	801	234
Units: Titers
geometric mean (confidence interval 95%)
FLU A/Cal/7/09, PRE [N=790;819;800;232]	21.6 (19.7 to 23.7)	24.9 (22.8 to 27.3)	22.1 (20.1 to 24.2)	12.3 (10.2 to 14.8)
FLU A/Cal/7/09, POST [N=791;818;801;234]	386.2 (357.3 to 417.4)	433.2 (401 to 468)	422.3 (390.5 to 456.5)	140 (113.7 to 172.3)
FLU A/Vic/210/09, PRE [N=790;819;800;232]	29 (26.6 to 31.6)	31.4 (28.8 to 34.2)	31.2 (28.6 to 34.2)	8.6 (7.4 to 9.9)
FLU A/Vic/210/09, POST [N=791;818;801;234]	228.8 (215 to 243.4)	227.3 (213.3 to 242.3)	234 (219.1 to 249.9)	87.5 (73.8 to 103.7)
FLU B/Bri/60/08, PRE [N=790;819;800;232]	30.9 (28.2 to 33.9)	31 (28.2 to 34)	33.2 (30.2 to 36.6)	9 (7.9 to 10.4)
FLU B/Bri/60/08, POST [N=791;818;801;234]	244.2 (227.5 to 262.1)	245.6 (229.2 to 263.2)	88.4 (81.5 to 95.8)	86.4 (72.6 to 102.9)
FLU B/Bri/3/07, PRE [N=790;819;800;232]	77.3 (70 to 85.3)	77.2 (70 to 85.2)	84.7 (76.6 to 93.6)	13.1 (11.4 to 15.2)
FLU B/Bri/3/07, POST [N=791;818;801;234]	569.6 (533.6 to 608.1)	224.7 (207.9 to 242.9)	643.3 (603.2 to 686.1)	167.7 (144.1 to 195.3)

No statistical analyses for this end point

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

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End point title

Number of seroconverted subjects against 4 strains of influenza disease. ^[2]

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 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).

End point type

Primary

End point timeframe

At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)

Notes
[2] - 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	GSK2321138A 1 Group	Fluarix Group	GSK2604409A Group	GSK2321138A 2 Group
Number of subjects analysed	790	818	800	232
Units: Subjects
FLU A/California/7/09	722	735	733	181
FLU A/Victoria/210/09	571	578	575	159
FLU B/Brisbane/60/08	553	560	237	158
FLU B/Brisbane/3/07	573	303	566	191

No statistical analyses for this end point

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

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End point title

Titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease by age strata. ^[3]

End point description

End point type

Secondary

End point timeframe

At Day 0 [PRE] and at Day 28 (for primed subjects) and 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: Subjects were assessed according to 2 age strata (3-8 years and 9-17 years) in the GSK2321138A 1 Group, the Fluarix Group and the GSK2604409A Group.

End point values	GSK2321138A 1 Group	Fluarix Group	GSK2604409A Group
Number of subjects analysed	791	819	801
Units: Titers
geometric mean (confidence interval 95%)
FLU A/Cal/7/09, PRE, 3-8 years [N=488;511;503]	20.7 (18.3 to 23.3)	22.2 (19.8 to 24.9)	22.4 (19.8 to 25.3)
FLU A/Cal/7/09, POST, 3-8 years [N=489;510;504]	353.4 (319.9 to 390.3)	382.1 (345.4 to 422.7)	381.3 (345 to 421.5)
FLU A/Cal/7/09, PRE, 9-17 years [N=302;308;297]	23.2 (20.2 to 26.6)	30.2 (26.1 to 34.9)	21.5 (18.6 to 24.8)
FLU A/Cal/7/09, POST, 9-17 years [N=302;308;297]	445.8 (393.9 to 504.7)	533.3 (474.9 to 599)	502 (444.1 to 567.5)
FLU A/Vic/210/09, PRE, 3-8 years [N=488;511;503]	29.3 (26.1 to 32.9)	32.9 (29.2 to 37)	31.5 (28 to 35.5)
FLU A/Vic/210/09, POST, 3-8 years [N=489;510;504]	245.5 (226.4 to 266.2)	242 (222.9 to 262.8)	244.4 (224.1 to 266.5)
FLU A/Vic/210/09, PRE, 9-17 years [N=302;308;297]	28.5 (25.1 to 32.3)	29 (25.8 to 32.7)	30.8 (27 to 35.1)
FLU A/Vic/210/09, POST, 9-17 years [N=302;308;297]	204.1 (185.5 to 224.5)	204.9 (185.4 to 226.6)	217.5 (196.9 to 240.2)
FLU B/Bri/60/08, PRE, 3-8 years [N=488;511;503]	27.1 (24 to 30.6)	25.1 (22.3 to 28.3)	27.9 (24.6 to 31.6)
FLU B/Bri/60/08, POST, 3-8 years [N=489;510;504]	236.3 (215.4 to 259.2)	222.3 (202.8 to 243.7)	79.2 (71.2 to 88.2)
FLU B/Bri/60/08, PRE, 9-17 years [N=302;308;297]	38.3 (33.4 to 43.9)	43.9 (38.2 to 50.6)	44.7 (38.6 to 51.7)
FLU B/Bri/60/08, POST, 9-17 years [N=302;308;297]	257.5 (230.7 to 287.5)	289.8 (262.1 to 320.4)	106.4 (94.6 to 119.8)
FLU B/Bri/3/07, PRE, 3-8 years [N=488;511;503]	54.9 (48.7 to 61.9)	51.9 (45.9 to 58.7)	57.6 (50.9 to 65.1)
FLU B/Bri/3/07, POST, 3-8 years [N=489;510;504]	481.3 (443.2 to 522.8)	163.5 (148.4 to 180.1)	566.7 (522.9 to 614.1)
FLU B/Bri/3/07, PRE, 9-17 years [N=302;308;297]	134.3 (115.2 to 156.5)	149.3 (130.3 to 171.1)	162.8 (140.4 to 188.6)
FLU B/Bri/3/07, POST, 9-17 years [N=302;308;297]	748.1 (676.9 to 826.8)	380.6 (342.1 to 423.4)	797.9 (719.5 to 885)

No statistical analyses for this end point

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

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End point title

Titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease by age strata. ^[4]

End point description

End point type

Secondary

End point timeframe

At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

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: Subjects were assessed according to 2 age strata (6-17 months and 18-35 months) in the GSK2321138A 2 Group.

End point values	GSK2321138A 2 Group
Number of subjects analysed	234
Units: Titers
geometric mean (confidence interval 95%)
FLU A/Cal/7/09, PRE, 6-17 months [N=70]	7.1 (5.5 to 9.1)
FLU A/Cal/7/09, POST, 6-17 months [N=71]	56.2 (39.9 to 79.2)
FLU A/Cal/7/09, PRE, 18-35 months [N=162]	15.6 (12.3 to 19.8)
FLU A/Cal/7/09, POST, 18-35 months [N=163]	208.3 (164.6 to 263.4)
FLU A/Vic/210/09, PRE, 6-17 months [N=70]	6.2 (5.1 to 7.6)
FLU A/Vic/210/09, POST, 6-17 months [N=71]	43.8 (33.7 to 57)
FLU A/Vic/210/09, PRE, 18-35 months [N=162]	9.8 (8.1 to 11.9)
FLU A/Vic/210/09, POST, 18-35 months [N=163]	118.2 (96.8 to 144.4)
FLU B/Bri/60/08, PRE, 6-17 months [N=70]	5.9 (5.3 to 6.6)
FLU B/Bri/60/08, POST, 6-17 months [N=71]	40.2 (31.2 to 51.6)
FLU B/Bri/60/08, PRE, 18-35 months [N=162]	10.8 (9 to 13.1)
FLU B/Bri/60/08, POST, 18-35 months [N=163]	120.7 (98.2 to 148.4)
FLU B/Bri/3/07, PRE, 6-17 months [N=70]	10 (7.9 to 12.7)
FLU B/Bri/3/07, POST, 6-17 months [N=71]	93.5 (73.5 to 119)
FLU B/Bri/3/07, PRE, 18-35 months [N=162]	14.8 (12.4 to 17.7)
FLU B/Bri/3/07, POST, 18-35 months [N=163]	216.3 (180.9 to 258.7)

No statistical analyses for this end point

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

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End point title

Number of seroconverted subjects against 4 strains of influenza disease by age strata. ^[5]

End point description

End point type

Secondary

End point timeframe

At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)

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: Subjects were assessed according to 2 age strata (3-8 years and 9-17 years) in the GSK2321138A 1 Group, the Fluarix Group and the GSK2604409A Group.

End point values	GSK2321138A 1 Group	Fluarix Group	GSK2604409A Group
Number of subjects analysed	790	818	800
Units: Subjects
FLU A/California/7/09, 3-8 years [N=488;510;503]	447	468	457
FLU A/California/7/09, 9-17 years [N=302;308;297]	275	267	276
FLU A/Victoria/210/09, 3-8 years [N=488;510;503]	367	365	376
FLU A/Victoria/210/09, 9-17 years [N=302;308;297]	204	213	199
FLU B/Brisbane/60/08, 3-8 years [N=488;510;503]	364	367	154
FLU B/Brisbane/60/08, 9-17 years [N=302;308;297]	189	193	83
FLU B/Brisbane/3/07, 3-8 years [N=488;510;503]	376	203	403
FLU B/Brisbane/3/07, 9-17 years [N=302;308;297]	197	100	163

No statistical analyses for this end point

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

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End point title

Number of seroconverted subjects against 4 strains of influenza disease by age strata. ^[6]

End point description

End point type

Secondary

End point timeframe

At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)

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: Subjects were assessed according to 2 age strata (6-17 months and 18-35 months) in the GSK2321138A 2 Group.

End point values	GSK2321138A 2 Group
Number of subjects analysed	232
Units: Subjects
FLU A/California/7/09, 6-17 months [N=70]	43
FLU A/California/7/09, 18-35 months [N=162]	138
FLU A/Victoria/210/09, 6-17 months [N=70]	37
FLU A/Victoria/210/09, 18-35 months [N=162]	122
FLU B/Brisbane/60/08, 6-17 months [N=70]	36
FLU B/Brisbane/60/08, 18-35 months [N=162]	122
FLU B/Brisbane/3/07, 6-17 months [N=70]	52
FLU B/Brisbane/3/07, 18-35 months [N=162]	139

No statistical analyses for this end point

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

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End point title

Number of seroprotected subjects against 4 strains of influenza disease

End point description

A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).

End point type

Secondary

End point timeframe

At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

End point values	GSK2321138A 1 Group	Fluarix Group	GSK2604409A Group	GSK2321138A 2 Group
Number of subjects analysed	791	819	801	234
Units: Subjects
FLU A/California/7/09, PRE [N=790;819;800;232]	343	404	353	60
FLU A/California/7/09, POST [N=791;818;801;234]	764	793	778	187
FLU A/Victoria/210/09, PRE [N=790;819;800;232]	381	412	409	34
FLU A/Victoria/210/09, POST [N=791;818;801;234]	775	800	773	169
FLU B/Brisbane/60/08, PRE [N=790;819;800;232]	381	396	399	28
FLU B/Brisbane/60/08, POST [N=791;818;801;234]	770	790	639	167
FLU B/Brisbane/3/07, PRE [N=790;819;800;232]	565	575	593	48
FLU B/Brisbane/3/07, POST [N=791;818;801;234]	785	772	798	212

No statistical analyses for this end point

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

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End point title

Number of seroprotected subjects against 4 strains of influenza disease by age strata. ^[7]

End point description

End point type

Secondary

End point timeframe

At Day 0 [PRE] and at Day 28 (for primed subjects) and 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: Subjects were assessed according to 2 age strata (3-8 years and 9-17 years) in the GSK2321138A 1 Group, the Fluarix Group and the GSK2604409A Group.

End point values	GSK2321138A 1 Group	Fluarix Group	GSK2604409A Group
Number of subjects analysed	791	819	801
Units: Subjects
FLU A/Cal/7/09, PRE, 3-8 years [N=488;511;503]	206	234	230
FLU A/Cal/7/09, POST, 3-8 years [N=489;510;504]	469	491	487
FLU A/Cal/7/09, PRE, 9-17 years [N=302;308;297]	137	170	123
FLU A/Cal/7/09, POST, 9-17 years [N=302;308;297]	295	302	291
FLU A/Vic/210/09, PRE, 3-8 years [N=488;511;503]	253	277	269
FLU A/Vic/210/09, POST, 3-8 years [N=489;510;504]	477	496	481
FLU A/Vic/210/09, PRE, 9-17 years [N=302;308;297]	128	135	140
FLU A/Vic/210/09, POST, 9-17 years [N=302;308;297]	298	304	292
FLU B/Bri/60/08, PRE, 3-8 years [N=488;511;503]	217	218	232
FLU B/Bri/60/08, POST, 3-8 years [N=489;510;504]	478	489	378
FLU B/Bri/60/08, PRE, 9-17 years [N=302;308;297]	164	178	167
FLU B/Bri/60/08, POST, 9-17 years [N=302;308;297]	292	301	261
FLU B/Bri/3/07, PRE, 3-8 years [N=488;511;503]	315	309	329
FLU B/Bri/3/07, POST, 3-8 years [N=489;510;504]	485	465	503
FLU B/Bri/3/07, PRE, 9-17 years [N=302;308;297]	250	266	264
FLU B/Bri/3/07, POST, 9-17 years [N=302;308;297]	300	307	295

No statistical analyses for this end point

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

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End point title

Number of seroprotected subjects against 4 strains of influenza disease by age strata. ^[8]

End point description

End point type

Secondary

End point timeframe

At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

Notes
[8] - 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 were assessed according to 2 age strata (6-17 months and 18-35 months) in the GSK2321138A 2 Group.

End point values	GSK2321138A 2 Group
Number of subjects analysed	234
Units: Subjects
FLU A/Cal/7/09, PRE, 6-17 months [N=70]	6
FLU A/Cal/7/09, POST, 6-17 months [N=71]	45
FLU A/Cal/7/09, PRE, 18-35 months [N=162]	54
FLU A/Cal/7/09, POST, 18-35 months [N=163]	142
FLU A/Vic/210/09, PRE, 6-17 months [N=70]	4
FLU A/Vic/210/09, POST, 6-17 months [N=71]	39
FLU A/Vic/210/09, PRE, 18-35 months [N=162]	30
FLU A/Vic/210/09, POST, 18-35 months [N=163]	130
FLU B/Bri/60/08, PRE, 6-17 months [N=70]	1
FLU B/Bri/60/08, POST, 6-17 months [N=71]	38
FLU B/Bri/60/08, PRE, 18-35 months [N=162]	27
FLU B/Bri/60/08, POST, 18-35 months [N=163]	129
FLU B/Bri/3/07, PRE, 6-17 months [N=70]	11
FLU B/Bri/3/07, POST, 6-17 months [N=71]	61
FLU B/Bri/3/07, PRE, 18-35 months [N=162]	37
FLU B/Bri/3/07, POST, 18-35 months [N=163]	151

No statistical analyses for this end point

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

Top of page

End point title

Number of seroprotected subjects against 4 strains of influenza.

End point description

A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:80. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).

End point type

Secondary

End point timeframe

At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

End point values	GSK2321138A 1 Group	Fluarix Group	GSK2604409A Group	GSK2321138A 2 Group
Number of subjects analysed	791	819	801	234
Units: Subjects
FLU A/California/7/09, PRE [N=790;819;800;232]	201	218	202	49
FLU A/California/7/09, POST [N=791;818;801;234]	732	763	744	155
FLU A/Victoria/210/09, PRE [N=790;819;800;232]	228	245	267	27
FLU A/Victoria/210/09, POST [N=791;818;801;234]	721	748	721	125
FLU B/Brisbane/60/08, PRE [N=790;819;800;232]	244	258	269	18
FLU B/Brisbane/60/08, POST [N=791;818;801;234]	708	733	488	140
FLU B/Brisbane/3/07, PRE [N=790;819;800;232]	454	462	476	24
FLU B/Brisbane/3/07, POST [N=791;818;801;234]	779	692	784	175

No statistical analyses for this end point

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

Top of page

End point title

Number of seroprotected subjects against 4 strains of influenza disease by age strata. ^[9]

End point description

End point type

Secondary

End point timeframe

At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

Notes
[9] - 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 were assessed according to 2 age strata (3-8 years and 9-17 years) in the GSK2321138A 1 Group, the Fluarix Group and the GSK2604409A Group.

End point values	GSK2321138A 1 Group	Fluarix Group	GSK2604409A Group
Number of subjects analysed	791	819	801
Units: Subjects
FLU A/Cal/7/09, PRE, 3-8 years [N=488;511;503]	130	128	141
FLU A/Cal/7/09, POST, 3-8 years [N=489;510;504]	453	471	464
FLU A/Cal/7/09, PRE, 9-17 years [N=302;308;297]	71	90	61
FLU A/Cal/7/09, POST, 9-17 years [N=302;308;297]	279	292	280
FLU A/Vic/210/09, PRE, 3-8 years [N=488; 511;503]	156	177	190
FLU A/Vic/210/09, POST, 3-8 years [N=489; 510;504]	446	462	446
FLU A/Vic/210/09, PRE, 9-17 years [N=302;308;297]	72	68	77
FLU A/Vic/210/09, POST, 9-17 years [N=302;308;297]	275	286	275
FLU B/Bri/60/08, PRE, 3-8 years [N=488;511;503]	145	140	150
FLU B/Bri/60/08, POST, 3-8 years [N=489;510;504]	430	441	286
FLU B/Bri/60/08, PRE, 9-17 years [N=302;308;297]	99	118	119
FLU B/Bri/60/08, POST, 9-17 years [N=302;308;297]	278	292	202
FLU B/Bri/3/07, PRE, 3-8 years [N=488;511;503]	233	227	248
FLU B/Bri/3/07, POST, 3-8 years [N=489;510;504]	480	395	493
FLU B/Bri/3/07, PRE, 9-17 years [N=302;308;297]	221	235	228
FLU B/Bri/3/07, POST, 9-17 years [N=302;308;297]	299	297	291

No statistical analyses for this end point

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

Top of page

End point title

Number of seroprotected subjects against 4 strains of influenza disease by age strata. ^[10]

End point description

End point type

Secondary

End point timeframe

At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

Notes
[10] - 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 were assessed according to 2 age strata (6 -17 months and 18-35 months) in the GSK2321138A 2 Group.

End point values	GSK2321138A 2 Group
Number of subjects analysed	234
Units: Subjects
FLU A/California/7/09, PRE, 6-17 months [N=70]	6
FLU A/California/7/09, POST, 6-17 months [N=71]	31
FLU A/California/7/09, PRE, 18-35 months [N=162]	43
FLU A/California/7/09, POST, 18-35 months [N=163]	124
FLU A/Victoria/210/09, PRE, 6-17 months [N=70]	4
FLU A/Victoria/210/09, POST, 6-17 months [N=71]	18
FLU A/Victoria/210/09, PRE, 18-35 months [N=162]	23
FLU A/Victoria/210/09, POST, 18-35 months [N=163]	107
FLU B/Brisbane/60/08, PRE, 6-17 months [N=70]	0
FLU B/Brisbane/60/08, POST, 6-17 months [N=71]	25
FLU B/Brisbane/60/08, PRE, 18-35 months [N=162]	18
FLU B/Brisbane/60/08, POST, 18-35 months [N=163]	115
FLU B/Brisbane/3/07, PRE, 6-17 months [N=70]	4
FLU B/Brisbane/3/07, POST, 6-17 months [N=71]	43
FLU B/Brisbane/3/07, PRE, 18-35 months [N=162]	20
FLU B/Brisbane/3/07, POST, 18-35 months [N=163]	132

No statistical analyses for this end point

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

Top of page

End point title

Number of seroprotected subjects against 4 strains of influenza disease.

End point description

A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:120. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).

End point type

Secondary

End point timeframe

At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

End point values	GSK2321138A 1 Group	Fluarix Group	GSK2604409A Group	GSK2321138A 2 Group
Number of subjects analysed	791	819	801	234
Units: Subjects
FLU A/California/7/09, PRE [N=790;819;800;232]	71	92	79	28
FLU A/California/7/09, POST [N=791;818;801;234]	669	720	690	122
FLU A/Victoria/210/09, PRE [N=790;819;800;232]	103	124	121	15
FLU A/Victoria/210/09, POST [N=791;818;801;234]	597	597	599	82
FLU B/Brisbane/60/08, PRE [N=790;819;800;232]	123	126	148	9
FLU B/Brisbane/60/08, POST [N=791;818;801;234]	578	607	300	83
FLU B/Brisbane/3/07, PRE [N=790;819;800;232]	300	324	327	7
FLU B/Brisbane/3/07, POST [N=791;818;801;234]	730	564	756	129

No statistical analyses for this end point

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

Top of page

End point title

Number of seroprotected subjects against 4 strains of influenza disease by age strata. ^[11]

End point description

End point type

Secondary

End point timeframe

At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

Notes
[11] - 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 were assessed according to 2 age strata (3-8 years and 9-17 years) in the GSK2321138A 1 Group, the Fluarix Group and the GSK2604409A Group.

End point values	GSK2321138A 1 Group	Fluarix Group	GSK2604409A Group
Number of subjects analysed	791	819	801
Units: Subjects
FLU A/Cal/7/09, PRE, 3-8 years [N=488;511;503]	47	56	57
FLU A/Cal/7/09, POST, 3-8 years [N=489;510;504]	410	442	428
FLU A/Cal/7/09, PRE, 9-17 years [N=302;308;297]	24	36	22
FLU A/Cal/7/09, POST, 9-17 years [N=302;308;297]	259	278	262
FLU A/Vic/210/09, PRE, 3-8 years [N=488;511;503]	70	92	87
FLU A/Vic/210/09, POST, 3-8 years [N=489;510;504]	380	385	390
FLU A/Vic/210/09, PRE, 9-17 years [N=302;308;297]	33	32	34
FLU A/Vic/210/09, POST, 9-17 years [N=302;308;297]	271	212	209
FLU B/Bri/60/08, PRE, 3-8 years [N=488;511;503]	75	66	82
FLU B/Bri/60/08, POST, 3-8 years [N=489;510;504]	349	357	174
FLU B/Bri/60/08, PRE, 9-17 years [N=302;308;297]	48	60	66
FLU B/Bri/60/08, POST, 9-17 years [N=302;308;297]	229	250	126
FLU B/Bri/3/07, PRE, 3-8 years [N=488;511;503]	135	155	150
FLU B/Bri/3/07, POST, 3-8 years [N=489;510;504]	444	301	473
FLU B/Bri/3/07, PRE, 9-17 years [N=302;308;297]	165	169	177
FLU B/Bri/3/07, POST, 9-17 years [N=302;308;297]	286	263	283

No statistical analyses for this end point

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

Top of page

End point title

Number of seroprotected subjects against 4 strains of influenza disease by age strata. ^[12]

End point description

End point type

Secondary

End point timeframe

At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

Notes
[12] - 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 were assessed according to 2 age strata (6-17 months and 18-35 months) in the GSK2321138A 2 Group.

End point values	GSK2321138A 2 Group
Number of subjects analysed	234
Units: Subjects
FLU A/California/7/09, PRE, 6-17 months [N=70]	5
FLU A/California/7/09, POST, 6-17 months [N=71]	18
FLU A/California/7/09, PRE, 18-35 months [N=162]	23
FLU A/California/7/09, POST, 18-35 months [N=163]	104
FLU A/Victoria/210/09, PRE, 6-17 months [N=70]	3
FLU A/Victoria/210/09, POST, 6-17 months [N=71]	11
FLU A/Victoria/210/09, PRE, 18-35 months [N=162]	12
FLU A/Victoria/210/09, POST, 18-35 months [N=163]	71
FLU B/Brisbane/60/08, PRE, 6-17 months [N=70]	0
FLU B/Brisbane/60/08, POST, 6-17 months [N=71]	7
FLU B/Brisbane/60/08, PRE, 18-35 months [N=162]	9
FLU B/Brisbane/60/08, POST, 18-35 months [N=163]	76
FLU B/Brisbane/3/07, PRE, 6-17 months [N=70]	1
FLU B/Brisbane/3/07, POST, 6-17 months [N=71]	25
FLU B/Brisbane/3/07, PRE, 18-35 months [N=162]	6
FLU B/Brisbane/3/07, POST, 18-35 months [N=163]	104

No statistical analyses for this end point

Secondary: Mean Geometric Increase (MGI) titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease.

Top of page

End point title

Mean Geometric Increase (MGI) titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease.

End point description

MGI is defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).

End point type

Secondary

End point timeframe

At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)

End point values	GSK2321138A 1 Group	Fluarix Group	GSK2604409A Group	GSK2321138A 2 Group
Number of subjects analysed	790	818	800	232
Units: fold increase
geometric mean (confidence interval 95%)
FLU A/California/7/09	18 (16.6 to 19.5)	17.4 (16 to 18.8)	19.2 (17.7 to 20.9)	11.7 (10.2 to 13.4)
FLU A/Victoria/210/09	7.9 (7.3 to 8.6)	7.2 (6.7 to 7.8)	7.5 (6.9 to 8.1)	10.4 (9 to 11.9)
FLU B/Brisbane/60/08	7.9 (7.3 to 8.6)	7.9 (7.2 to 8.6)	2.7 (2.5 to 2.9)	9.7 (8.5 to 11.2)
FLU B/Brisbane/3/07	7.4 (6.8 to 8)	2.9 (2.7 to 3.1)	7.6 (7 to 8.3)	12.9 (11 to 15.3)

No statistical analyses for this end point

Secondary: Mean Geometric Increase (MGI) titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease by age strata.

Top of page

End point title

Mean Geometric Increase (MGI) titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease by age strata. ^[13]

End point description

End point type

Secondary

End point timeframe

At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)

Notes
[13] - 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 were assessed according to 2 age strata (3-8 years and 9-17 years) in the GSK2321138A 1 Group, the Fluarix Group and the GSK2604409A Group.

End point values	GSK2321138A 1 Group	Fluarix Group	GSK2604409A Group
Number of subjects analysed	790	818	800
Units: fold increase
geometric mean (confidence interval 95%)
FLU A/California/7/09, 3-8 years [N=488;510;503]	17.2 (15.6 to 19)	17.2 (15.6 to 18.9)	17.2 (15.6 to 18.9)
FLU A/California/7/09, 9-17 years [N=302;308;297]	19.2 (16.7 to 22.2)	17.7 (15.2 to 20.5)	23.3 (20.3 to 26.9)
FLU A/Victoria/210/09, 3-8 years [N=488;510;503]	8.4 (7.6 to 9.3)	7.3 (6.6 to 8.1)	7.8 (7.1 to 8.5)
FLU A/Victoria/210/09, 9-17 years [N=302;308;297]	7.2 (6.2 to 8.2)	7.1 (6.2 to 8.1)	7.1 (6.2 to 8.1)
FLU B/Brisbane/60/08, 3-8 years [N=488;510;503]	8.8 (7.9 to 9.8)	8.8 (7.9 to 9.8)	2.8 (2.6 to 3.1)
FLU B/Brisbane/60/08, 9-17 years [N=302;308;297]	6.7 (5.8 to 7.8)	6.6 (5.7 to 7.6)	2.4 (2.1 to 2.7)
FLU B/Brisbane/3/07, 3-8 years [N=488;510;503]	8.8 (7.9 to 9.8)	3.1 (2.9 to 3.4)	9.9 (8.9 to 11)
FLU B/Brisbane/3/07, 9-17 years [N=302;308;297]	5.6 (4.9 to 6.3)	2.5 (2.3 to 2.8)	4.9 (4.3 to 5.6)

No statistical analyses for this end point

Secondary: Mean Geometric Increase (MGI) titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease by age strata.

Top of page

End point title

Mean Geometric Increase (MGI) titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease by age strata. ^[14]

End point description

End point type

Secondary

End point timeframe

At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)

Notes
[14] - 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 were assessed according to 2 age strata (6-17 months and 18-35 months) in the GSK2321138A 2 Group.

End point values	GSK2321138A 2 Group
Number of subjects analysed	232
Units: fold increase
geometric mean (confidence interval 95%)
FLU A/California/7/09, 6-17 months [N=70]	8.2 (6.4 to 10.6)
FLU A/California/7/09, 18-35 months [N=162]	13.7 (11.7 to 16)
FLU A/Victoria/210/09, 6-17 months [N=70]	7.3 (5.9 to 9)
FLU A/Victoria/210/09, 18-35 months [N=162]	12.1 (10.2 to 14.3)
FLU B/Brisbane/60/08, 6-17 months [N=70]	6.9 (5.4 to 8.9)
FLU B/Brisbane/60/08, 18-35 months [N=162]	11.3 (9.6 to 13.2)
FLU B/Brisbane/3/07, 6-17 months [N=70]	9.5 (7 to 12.8)
FLU B/Brisbane/3/07, 18-35 months [N=162]	14.8 (12.2 to 18)

No statistical analyses for this end point

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

Top of page

End point title

Number of subjects with any and grade 3 solicited local symptoms.

End point description

Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful (Child <6 years) or pain that prevented normal activity (Child >6 years). Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of the injection site.

End point type

Secondary

End point timeframe

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

End point values	GSK2321138A 1 Group	Fluarix Group	GSK2604409A Group	GSK2321138A 2 Group
Number of subjects analysed	903	902	906	277
Units: Subjects
Any Pain	444	425	416	116
Grade 3 Pain	20	21	13	5
Any Redness	225	214	206	100
Grade 3 Redness	12	3	6	1
Any Swelling	196	193	160	67
Grade 3 Swelling	11	10	3	0

No statistical analyses for this end point

Secondary: Number of subjects with any, grade 3 and related solicited general symptoms in subjects younger than 6 years old.

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End point title

Number of subjects with any, grade 3 and related solicited general symptoms in subjects younger than 6 years old.

End point description

Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = temperature >39.0°C.

End point type

Secondary

End point timeframe

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

End point values	GSK2321138A 1 Group	Fluarix Group	GSK2604409A Group	GSK2321138A 2 Group
Number of subjects analysed	291	314	280	277
Units: Subjects
Any Drowsiness	67	55	59	84
Grade 3 Drowsiness	5	3	2	7
Related Drowsiness	44	31	36	57
Any Irritability	65	56	53	119
Grade 3 Irritability	4	2	3	11
Related Irritability	44	37	31	81
Any Loss of appetite	59	40	47	83
Grade 3 Loss of appetite	3	3	3	12
Related Loss of appetite	37	24	25	50
Temperature ≥37.5°C	50	51	41	81
Temperature >39°C	4	2	3	18
Related Temperature	24	29	16	37

No statistical analyses for this end point

Secondary: Number of subjects with any, grade 3 and related solicited general symptoms in subjects aged 6 years or older.

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End point title

Number of subjects with any, grade 3 and related solicited general symptoms in subjects aged 6 years or older. ^[15]

End point description

End point type

Secondary

End point timeframe

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

Notes
[15] - 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: Only the following groups had subjects aged 6 years or older: GSK2321138A 1 Group, Fluarix Group and GSK2604409A Group.

End point values	GSK2321138A 1 Group	Fluarix Group	GSK2604409A Group
Number of subjects analysed	613	589	626
Units: Subjects
Any Fatigue	129	118	114
Grade 3 Fatigue	9	8	4
Related Fatigue	95	81	76
Any Gastro.	66	62	52
Grade 3 Gastro.	7	4	2
Related Gastro.	31	29	26
Any Headache	110	125	114
Grade 3 Headache	8	4	5
Related Headache	66	75	71
Any Joint Pain	69	63	51
Grade 3 Joint Pain	2	4	2
Related Joint Pain	44	43	36
Any Muscle aches	116	106	106
Grade 3 Muscle aches	4	8	3
Related Muscle aches	84	81	87
Any Shivering	44	31	37
Grade 3 Shivering	3	3	1
Related Shivering	27	23	22
Temperature ≥37.5°C	48	60	47
Temperature >39°C	7	5	3
Related Temperature	25	30	32

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 = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination.

End point type

Secondary

End point timeframe

During the 28-day (Days 0-27) follow-up period after any vaccination.

End point values	GSK2321138A 1 Group	Fluarix Group	GSK2604409A Group	GSK2321138A 2 Group
Number of subjects analysed	915	912	911	277
Units: Subjects
Subjects with any AE(s)	284	305	308	167
Subjects with grade 3 AE(s)	20	37	26	20
Subjects with related AE(s)	18	19	23	5

No statistical analyses for this end point

Secondary: Number of subjects with any, grade 3 and related medically attended adverse events (MAEs).

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End point title

Number of subjects with any, grade 3 and related medically attended adverse events (MAEs).

End point description

MAEs were defined as AEs that resulted in medical attention (defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason). Any = any MAE regardless of intensity or relationship to vaccination. Grade 3 MAE = MAE which prevented normal, everyday activities. Related = MAE assessed by the investigator as related to the vaccination. Assessment of intensity for MAEs was not performed.

End point type

Secondary

End point timeframe

During the entire study period (Day 0 - Day 180)

End point values	GSK2321138A 1 Group	Fluarix Group	GSK2604409A Group	GSK2321138A 2 Group
Number of subjects analysed	915 ^[16]	912 ^[17]	911 ^[18]	277 ^[19]
Units: Subjects
Subjects with any MAE(s)	271	278	303	171
Subjects with related MAE(s)	2	4	4	2
Subjects with Grade 3 MAE(s)	0	0	0	0

Notes
[16] - Analyses was not performed for Grade 3 MAEs as done in the FDAAA record.
[17] - Analyses was not performed for Grade 3 MAEs as done in the FDAAA record.
[18] - Analyses was not performed for Grade 3 MAEs as done in the FDAAA record.
[19] - Analyses was not performed for Grade 3 MAEs as done in the FDAAA record.

No statistical analyses for this end point

Secondary: Number of subjects with any and related Potential Immune-Mediated Diseases (pIMDs).

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End point title

Number of subjects with any and related Potential Immune-Mediated Diseases (pIMDs).

End point description

pIMDs were defined as a subset of AEs that included both clearly autoimmune diseases (AID) and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.

End point type

Secondary

End point timeframe

During the entire study period (Day 0 - Day 180)

End point values	GSK2321138A 1 Group	Fluarix Group	GSK2604409A Group	GSK2321138A 2 Group
Number of subjects analysed	915	912	911	277
Units: Subjects
Subjects with any pIMD(s)	0	0	2	0
Subjects with related pIMD(s)	0	0	0	0

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

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.

End point type

Secondary

End point timeframe

During the entire study period (Day 0 - Day 180)

End point values	GSK2321138A 1 Group	Fluarix Group	GSK2604409A Group	GSK2321138A 2 Group
Number of subjects analysed	915	912	911	277
Units: Subjects
Subjects with any SAE(s)	8	6	7	9
Subjects with related SAE(s)	0	0	0	0

No statistical analyses for this end point

Secondary: Number of days with solicited local symptoms.

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End point title

Number of days with solicited local symptoms.

End point description

The number of days with any grade of local symptoms after Dose 1 and Dose 2 vaccination respectively was tabulated. Assessed solicited local symptoms for duration were pain, redness and swelling at the injection site.

End point type

Secondary

End point timeframe

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

End point values	GSK2321138A 1 Group	Fluarix Group	GSK2604409A Group	GSK2321138A 2 Group
Number of subjects analysed	395	382	365	94
Units: days
median (inter-quartile range (Q1-Q3))
Pain, Dose 1 [N=395;382;365;94]	2 (1 to 2)	2 (1 to 3)	2 (1 to 3)	1 (1 to 2)
Pain, Dose 2 [N=175;156;160;70]	2 (1 to 2)	2 (1 to 2)	2 (1 to 2)	2 (1 to 2)
Redness, Dose 1 [N=208;192;189;84]	2 (1 to 3)	2 (1 to 3)	2 (1 to 3)	2 (1.5 to 4)
Redness, Dose 2 [N=75;80;76;69]	2 (1 to 3)	2 (1 to 3)	2 (1 to 3)	2 (1 to 3)
Swelling, Dose 1 [N=167;155;135;44]	2 (1 to 3)	2 (1 to 3)	2 (1 to 3)	2 (1 to 3)
Swelling, Dose 2 [N=70;65;59;39]	2 (1 to 2)	2 (1 to 3)	2 (1 to 3)	2 (1 to 4)

No statistical analyses for this end point

Secondary: Number of days with solicited general symptoms

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End point title

Number of days with solicited general symptoms

End point description

The number of days with any grade of local symptoms after Dose 1 and Dose 2 vaccination respectively was tabulated. Assessed solicited general symptoms for duration were drowsiness, fatigue, gastrointestinal symptoms (Gastro.), headache, irritability, loss of appetite, muscle aches, shivering and temperature [axillary temperature equal to or above 37.5 degrees Celsius (°C)].

End point type

Secondary

End point timeframe

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

End point values	GSK2321138A 1 Group	Fluarix Group	GSK2604409A Group	GSK2321138A 2 Group
Number of subjects analysed	121	113	97	79 ^[20]
Units: days
median (inter-quartile range (Q1-Q3))
Drowsiness, Dose 1 [N=50;39;38;66]	1 (1 to 2)	1 (1 to 2)	2 (1 to 3)	1 (1 to 3)
Drowsiness, Dose 2 [N=29;29;32;45]	2 (1 to 3)	1 (1 to 2)	1 (1 to 2)	2 (1 to 3)
Fatigue, Dose 1 [N=121;109;97;0]	2 (1 to 3)	2 (1 to 3)	2 (1 to 3)	0 (0 to 0)
Fatigue, Dose 2 [N=33;25;33,0]	1 (1 to 2)	2 (1 to 2)	1 (1 to 2)	0 (0 to 0)
Gastro., Dose 1 [N=60;56;45;0]	1 (1 to 2)	2 (1 to 2)	2 (1 to 2)	0 (0 to 0)
Gastro., Dose 2 [N=11;9;8;0]	1 (1 to 2)	2 (1 to 2)	1 (1 to 2)	0 (0 to 0)
Headache, Dose 1 [N=100;113;95;0]	1 (1 to 2.5)	1 (1 to 2)	1 (1 to 2)	0 (0 to 0)
Headache, Dose 2 [N=19;21;29;0]	1 (1 to 2)	1 (1 to 2)	1 (1 to 2)	0 (0 to 0)
Irritability, Dose 1 [N=49;42;40;79]	2 (1 to 3)	2 (1 to 3)	2 (1 to 3)	2 (1 to 3)
Irritability, Dose 2 [N=37;33;27;79]	2 (1 to 3)	1 (1 to 3)	2 (1 to 3)	2 (1 to 3)
Joint pain, Dose 1 [N=60;55;46;0]	2 (1 to 3)	2 (1 to 3)	2 (1 to 2)	0 (0 to 0)
Joint pain, Dose 2 [N=18;14;10;0]	1 (1 to 2)	1 (1 to 2)	1.5 (1 to 2)	0 (0 to 0)
Loss of appetite, Dose 1 [N=45;29;25;56]	1 (1 to 4)	2 (1 to 3)	2 (1 to 4)	3 (1 to 4.5)
Loss of appetite, Dose 2 [N=22;26;26;50]	3 (1 to 4)	1 (1 to 3)	2 (1 to 2)	3 (2 to 4)
Muscle aches, Dose 1 [N=107;94;99;0]	2 (1 to 3)	2 (1 to 2)	2 (1 to 2)	0 (0 to 0)
Muscle aches, Dose 2 [N=25;20;19;0]	2 (1 to 3)	2 (1 to 2)	2 (1 to 2)	0 (0 to 0)
Shivering, Dose 1 [N=39;26;31;0]	1 (1 to 2)	2 (1 to 5)	1 (1 to 2)	0 (0 to 0)
Shivering, Dose 2 [N=7;6;7;0]	1 (1 to 3)	1.5 (1 to 3)	2 (1 to 2)	0 (0 to 0)
Temperature, Dose 1 [N=63;78;61;45]	1 (1 to 2)	1.5 (1 to 3)	2 (1 to 3)	1 (1 to 2)
Temperature, Dose 2 [N=40;44;33;53]	1.5 (1 to 2)	1.5 (1 to 2)	2 (1 to 3)	2 (1 to 3)

Notes
[20] - Symptom not assessed in this group.

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.

Adverse event reporting additional description

No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

Reporting group title

GSK2321138A 1 Group

Reporting group description

Reporting group title

Fluarix Group

Reporting group description

Reporting group title

GSK2604409A Group

Reporting group description

Reporting group title

GSK2321138A 2 Group

Reporting group description

Serious adverse events	GSK2321138A 1 Group	Fluarix Group	GSK2604409A Group	GSK2321138A 2 Group
Total subjects affected by serious adverse events
subjects affected / exposed	8 / 915 (0.87%)	6 / 912 (0.66%)	7 / 911 (0.77%)	9 / 277 (3.25%)
number of deaths (all causes)	0	1	0	0
number of deaths resulting from adverse events	0	0	0	0
Injury, poisoning and procedural complications
Abdominal injury
subjects affected / exposed	0 / 915 (0.00%)	1 / 912 (0.11%)	0 / 911 (0.00%)	0 / 277 (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
Concussion
subjects affected / exposed	3 / 915 (0.33%)	0 / 912 (0.00%)	2 / 911 (0.22%)	0 / 277 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	0 / 915 (0.00%)	1 / 912 (0.11%)	0 / 911 (0.00%)	0 / 277 (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 / 1	0 / 0	0 / 0
Cardiac disorders
Atrioventricular block first degree
subjects affected / exposed	1 / 915 (0.11%)	0 / 912 (0.00%)	0 / 911 (0.00%)	0 / 277 (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
Myocarditis
subjects affected / exposed	1 / 915 (0.11%)	0 / 912 (0.00%)	0 / 911 (0.00%)	0 / 277 (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
Nervous system disorders
Epilepsy
subjects affected / exposed	0 / 915 (0.00%)	0 / 912 (0.00%)	0 / 911 (0.00%)	1 / 277 (0.36%)
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
Febrile convulsion
subjects affected / exposed	0 / 915 (0.00%)	0 / 912 (0.00%)	0 / 911 (0.00%)	2 / 277 (0.72%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Lymphadenitis
subjects affected / exposed	1 / 915 (0.11%)	0 / 912 (0.00%)	0 / 911 (0.00%)	0 / 277 (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
Skin and subcutaneous tissue disorders
Rash
subjects affected / exposed	0 / 915 (0.00%)	1 / 912 (0.11%)	1 / 911 (0.11%)	0 / 277 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Suicidal ideation
subjects affected / exposed	1 / 915 (0.11%)	0 / 912 (0.00%)	1 / 911 (0.11%)	0 / 277 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Amoebiasis
subjects affected / exposed	0 / 915 (0.00%)	0 / 912 (0.00%)	0 / 911 (0.00%)	1 / 277 (0.36%)
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
Appendicitis
subjects affected / exposed	0 / 915 (0.00%)	0 / 912 (0.00%)	1 / 911 (0.11%)	0 / 277 (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
Bronchiolitis
subjects affected / exposed	0 / 915 (0.00%)	0 / 912 (0.00%)	0 / 911 (0.00%)	1 / 277 (0.36%)
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
Bronchitis
subjects affected / exposed	0 / 915 (0.00%)	0 / 912 (0.00%)	0 / 911 (0.00%)	3 / 277 (1.08%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bronchopneumonia
subjects affected / exposed	0 / 915 (0.00%)	0 / 912 (0.00%)	0 / 911 (0.00%)	2 / 277 (0.72%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Dengue fever
subjects affected / exposed	0 / 915 (0.00%)	2 / 912 (0.22%)	0 / 911 (0.00%)	0 / 277 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	0 / 915 (0.00%)	0 / 912 (0.00%)	0 / 911 (0.00%)	2 / 277 (0.72%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis bacterial
subjects affected / exposed	1 / 915 (0.11%)	0 / 912 (0.00%)	0 / 911 (0.00%)	0 / 277 (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
Gastroenteritis rotavirus
subjects affected / exposed	0 / 915 (0.00%)	0 / 912 (0.00%)	1 / 911 (0.11%)	0 / 277 (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 viral
subjects affected / exposed	0 / 915 (0.00%)	0 / 912 (0.00%)	0 / 911 (0.00%)	1 / 277 (0.36%)
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
Infectious mononucleosis
subjects affected / exposed	1 / 915 (0.11%)	0 / 912 (0.00%)	0 / 911 (0.00%)	0 / 277 (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
Otitis media acute
subjects affected / exposed	1 / 915 (0.11%)	0 / 912 (0.00%)	0 / 911 (0.00%)	0 / 277 (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
Peritonsillar abscess
subjects affected / exposed	1 / 915 (0.11%)	0 / 912 (0.00%)	0 / 911 (0.00%)	0 / 277 (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
Pneumococcal sepsis
subjects affected / exposed	0 / 915 (0.00%)	0 / 912 (0.00%)	0 / 911 (0.00%)	1 / 277 (0.36%)
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
Pneumonia
subjects affected / exposed	0 / 915 (0.00%)	2 / 912 (0.22%)	0 / 911 (0.00%)	0 / 277 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	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 / 915 (0.00%)	0 / 912 (0.00%)	0 / 911 (0.00%)	1 / 277 (0.36%)
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
Tonsillitis
subjects affected / exposed	1 / 915 (0.11%)	0 / 912 (0.00%)	0 / 911 (0.00%)	1 / 277 (0.36%)
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
Metabolism and nutrition disorders
Diabetic ketoacidosis
subjects affected / exposed	0 / 915 (0.00%)	0 / 912 (0.00%)	1 / 911 (0.11%)	0 / 277 (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
Type 1 diabetes mellitus
subjects affected / exposed	0 / 915 (0.00%)	0 / 912 (0.00%)	1 / 911 (0.11%)	0 / 277 (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	GSK2321138A 1 Group	Fluarix Group	GSK2604409A Group	GSK2321138A 2 Group
Total subjects affected by non serious adverse events
subjects affected / exposed	630 / 915 (68.85%)	616 / 912 (67.54%)	620 / 911 (68.06%)	237 / 277 (85.56%)
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	23 / 915 (2.51%)	23 / 912 (2.52%)	28 / 911 (3.07%)	18 / 277 (6.50%)
occurrences all number	23	23	28	18
Fatigue
alternative assessment type: Systematic
subjects affected / exposed ^[1]	129 / 613 (21.04%)	118 / 589 (20.03%)	114 / 626 (18.21%)	0 / 277 (0.00%)
occurrences all number	129	118	114	0
Gastrointestinal
alternative assessment type: Systematic
subjects affected / exposed ^[2]	66 / 613 (10.77%)	62 / 589 (10.53%)	52 / 626 (8.31%)	0 / 277 (0.00%)
occurrences all number	66	62	52	0
Headache
alternative assessment type: Systematic
subjects affected / exposed ^[3]	110 / 613 (17.94%)	125 / 589 (21.22%)	114 / 626 (18.21%)	0 / 277 (0.00%)
occurrences all number	110	125	114	0
Joint Pain
alternative assessment type: Systematic
subjects affected / exposed ^[4]	69 / 613 (11.26%)	63 / 589 (10.70%)	51 / 626 (8.15%)	0 / 277 (0.00%)
occurrences all number	69	63	51	0
Muscle aches
alternative assessment type: Systematic
subjects affected / exposed ^[5]	116 / 613 (18.92%)	106 / 589 (18.00%)	106 / 626 (16.93%)	0 / 277 (0.00%)
occurrences all number	116	106	106	0
Temperature (Axillary) [subjects 6 years old or older]
alternative assessment type: Systematic
subjects affected / exposed ^[6]	48 / 613 (7.83%)	60 / 589 (10.19%)	47 / 626 (7.51%)	0 / 277 (0.00%)
occurrences all number	48	60	47	0
Irritability
alternative assessment type: Systematic
subjects affected / exposed ^[7]	65 / 291 (22.34%)	56 / 314 (17.83%)	53 / 280 (18.93%)	119 / 277 (42.96%)
occurrences all number	65	56	53	119
Drowsiness
alternative assessment type: Systematic
subjects affected / exposed ^[8]	67 / 291 (23.02%)	55 / 314 (17.52%)	59 / 280 (21.07%)	84 / 277 (30.32%)
occurrences all number	67	55	59	84
Loss of appetite
alternative assessment type: Systematic
subjects affected / exposed ^[9]	59 / 291 (20.27%)	40 / 314 (12.74%)	47 / 280 (16.79%)	83 / 277 (29.96%)
occurrences all number	59	40	47	83
Redness
alternative assessment type: Systematic
subjects affected / exposed ^[10]	225 / 903 (24.92%)	214 / 902 (23.73%)	206 / 906 (22.74%)	100 / 277 (36.10%)
occurrences all number	225	214	206	100
Swelling
alternative assessment type: Systematic
subjects affected / exposed ^[11]	196 / 903 (21.71%)	193 / 902 (21.40%)	160 / 906 (17.66%)	67 / 277 (24.19%)
occurrences all number	196	193	160	67
Temperature (Axillary) [subjects younger than 6 years old]
alternative assessment type: Systematic
subjects affected / exposed ^[12]	50 / 291 (17.18%)	51 / 314 (16.24%)	41 / 280 (14.64%)	81 / 277 (29.24%)
occurrences all number	50	51	41	81
Shivering
alternative assessment type: Systematic
subjects affected / exposed ^[13]	44 / 613 (7.18%)	31 / 589 (5.26%)	37 / 626 (5.91%)	0 / 277 (0.00%)
occurrences all number	44	31	37	0
Pain
alternative assessment type: Systematic
subjects affected / exposed ^[14]	444 / 903 (49.17%)	425 / 902 (47.12%)	416 / 906 (45.92%)	116 / 277 (41.88%)
occurrences all number	444	425	416	116
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	40 / 915 (4.37%)	36 / 912 (3.95%)	45 / 911 (4.94%)	21 / 277 (7.58%)
occurrences all number	40	36	45	21
Infections and infestations
Nasopharyngitis
subjects affected / exposed	49 / 915 (5.36%)	60 / 912 (6.58%)	64 / 911 (7.03%)	37 / 277 (13.36%)
occurrences all number	49	60	64	37
Upper respiratory tract infection
subjects affected / exposed	48 / 915 (5.25%)	51 / 912 (5.59%)	46 / 911 (5.05%)	26 / 277 (9.39%)
occurrences all number	48	51	46	26
Bronchitis
subjects affected / exposed	13 / 915 (1.42%)	5 / 912 (0.55%)	12 / 911 (1.32%)	29 / 277 (10.47%)
occurrences all number	13	5	12	29

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 on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.
[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 on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.
[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 on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.
[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 on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.
[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 on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.
[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 on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.
[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 on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.
[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 on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.
[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 on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.
[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 on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.
[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 on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.
[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 on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.
[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 on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.
[14] - 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 on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.

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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

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 seroconverted subjects against 4 strains of influenza disease.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Secondary: Mean Geometric Increase (MGI) titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease.

Secondary: Mean Geometric Increase (MGI) titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease.

Secondary: Mean Geometric Increase (MGI) titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease by age strata.

Secondary: Mean Geometric Increase (MGI) titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease by age strata.

Secondary: Mean Geometric Increase (MGI) titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease by age strata.

Secondary: Mean Geometric Increase (MGI) titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease by age strata.

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

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

Secondary: Number of subjects with any, grade 3 and related solicited general symptoms in subjects younger than 6 years old.

Secondary: Number of subjects with any, grade 3 and related solicited general symptoms in subjects younger than 6 years old.

Secondary: Number of subjects with any, grade 3 and related solicited general symptoms in subjects aged 6 years or older.

Secondary: Number of subjects with any, grade 3 and related solicited general symptoms in subjects aged 6 years or older.

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, grade 3 and related medically attended adverse events (MAEs).

Secondary: Number of subjects with any, grade 3 and related medically attended adverse events (MAEs).

Secondary: Number of subjects with any and related Potential Immune-Mediated Diseases (pIMDs).

Secondary: Number of subjects with any and related Potential Immune-Mediated Diseases (pIMDs).

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: Number of days with solicited local symptoms.

Secondary: Number of days with solicited local symptoms.

Secondary: Number of days with solicited general symptoms

Secondary: Number of days with solicited general symptoms

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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