Trial Outcomes & Findings for Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' Influenza Vaccine in Elderly People (NCT NCT00992784)

Last Updated: 2018-09-21

Results Overview

Grade 3 ecchymosis, redness and swelling was ≥ 100 millimeter (mm) and grade 3 pain was considerable pain at rest, that prevented normal everyday activities.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

370 participants

Primary outcome timeframe

Day 0-6

Results posted on

2018-09-21

Participant Flow

Participant milestones

Participant milestones
Measure	New Generation Influenza Vaccine GSK2186877A Group Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine	Fluarix Young Group Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
Overall Study STARTED	180	104	86
Overall Study COMPLETED	177	102	85
Overall Study NOT COMPLETED	3	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	New Generation Influenza Vaccine GSK2186877A Group Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine	Fluarix Young Group Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
Overall Study Adverse Event	2	1	0
Overall Study Withdrawal by Subject	1	1	1

Baseline Characteristics

Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' Influenza Vaccine in Elderly People

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	New Generation Influenza Vaccine GSK2186877A Group n=180 Participants Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=104 Participants Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine	Fluarix Young Group n=86 Participants Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine	Total n=370 Participants Total of all reporting groups
Age, Continuous	74.5 Years STANDARD_DEVIATION 5.18 • n=5 Participants	74.8 Years STANDARD_DEVIATION 5.26 • n=7 Participants	29.9 Years STANDARD_DEVIATION 6.55 • n=5 Participants	64.2 Years STANDARD_DEVIATION 19.70 • n=4 Participants
Sex: Female, Male Female	98 Participants n=5 Participants	46 Participants n=7 Participants	35 Participants n=5 Participants	179 Participants n=4 Participants
Sex: Female, Male Male	82 Participants n=5 Participants	58 Participants n=7 Participants	51 Participants n=5 Participants	191 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 0-6

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.

Grade 3 ecchymosis, redness and swelling was ≥ 100 millimeter (mm) and grade 3 pain was considerable pain at rest, that prevented normal everyday activities.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=180 Participants Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=103 Participants Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine	Fluarix Young Group n=85 Participants Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Any ecchymosis	1 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Grade 3 ecchymosis	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Any pain	78 Participants	12 Participants	49 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Grade 3 pain	0 Participants	0 Participants	1 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Any redness	22 Participants	3 Participants	5 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Grade 3 redness	1 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Any swelling	22 Participants	3 Participants	2 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Grade 3 swelling	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 0-6

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented on subjects who experienced the symptom.

Duration was defined as number of days with any grade of local symptoms.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=78 Participants Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=12 Participants Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine	Fluarix Young Group n=49 Participants Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
Duration of Solicited Local AEs Ecchymosis	3.0 Days Interval 3.0 to 3.0	NA Days Information on duration of ecchymosis was missing from these subjects symptom sheets	NA Days Information on duration of ecchymosis was missing from these subjects symptom sheets
Duration of Solicited Local AEs Pain	2.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 4.0	2.0 Days Interval 1.0 to 5.0
Duration of Solicited Local AEs Redness	2.0 Days Interval 1.0 to 5.0	2.0 Days Interval 1.0 to 3.0	3.0 Days Interval 1.0 to 3.0
Duration of Solicited Local AEs Swelling	2.0 Days Interval 1.0 to 4.0	1.0 Days Interval 1.0 to 6.0	2.0 Days Interval 1.0 to 3.0

PRIMARY outcome

Timeframe: Day 0-6

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.

Any fever was defined as oral temperature ≥ 38.0 degree centigrade (°C), grade 3 fever was oral temperature ≥ 39.0°C-≤ 40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade, grade 3 was defined as general symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=180 Participants Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=103 Participants Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine	Fluarix Young Group n=85 Participants Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related gatrointestinal symptoms	6 Participants	2 Participants	4 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any headache	31 Participants	6 Participants	12 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 headache	1 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related headache	25 Participants	6 Participants	8 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any myalgia	37 Participants	7 Participants	15 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 myalgia	1 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related myalgia	29 Participants	5 Participants	15 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any shivering	20 Participants	5 Participants	5 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 shivering	1 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related shivering	16 Participants	4 Participants	3 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any fever	8 Participants	1 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 fever	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related fever	8 Participants	1 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any arthralgia	23 Participants	3 Participants	3 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 arthralgia	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related arthralgia	18 Participants	2 Participants	2 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any fatigue	53 Participants	12 Participants	21 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 fatigue	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related fatigue	41 Participants	9 Participants	17 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any gatrointestinal symptoms	11 Participants	5 Participants	4 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 gatrointestinal symptoms	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 0-6

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.

Duration was defined as number of days with any grade of general symptoms.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=53 Participants Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=12 Participants Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine	Fluarix Young Group n=21 Participants Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
Duration of Solicited General AEs Arthralgia	1.0 Days Interval 1.0 to 7.0	4.0 Days Interval 1.0 to 7.0	1.0 Days Interval 1.0 to 4.0
Duration of Solicited General AEs Fatigue	2.0 Days Interval 1.0 to 7.0	3.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 7.0
Duration of Solicited General AEs Gastrointestinal symptoms	1.0 Days Interval 1.0 to 7.0	3.0 Days Interval 1.0 to 4.0	1.0 Days Interval 1.0 to 1.0
Duration of Solicited General AEs Headache	2.0 Days Interval 1.0 to 3.0	2.5 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 3.0
Duration of Solicited General AEs Myalgia	2.0 Days Interval 1.0 to 6.0	3.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 6.0
Duration of Solicited General AEs Shivering	1.0 Days Interval 1.0 to 4.0	1.0 Days Interval 1.0 to 5.0	2.0 Days Interval 1.0 to 4.0
Duration of Solicited General AEs Fever	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 1.0

PRIMARY outcome

Timeframe: Day 0-20

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

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 was defined as occurrence of any unsolicited symptom regardless of intensity grade, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=180 Participants Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=104 Participants Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine	Fluarix Young Group n=86 Participants Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs Any AE(s)	24 Participants	17 Participants	16 Participants
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs Grade 3 AE(s)	2 Participants	0 Participants	3 Participants
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs Related AE(s)	5 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 0-179

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=180 Participants Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=104 Participants Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine	Fluarix Young Group n=86 Participants Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Any AE(s)	81 Participants	34 Participants	21 Participants
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Grade 3 AE(s)	21 Participants	5 Participants	6 Participants
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Related AE(s)	1 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 0-179

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=180 Participants Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=104 Participants Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine	Fluarix Young Group n=86 Participants Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
Number of Subjects Reporting AEs of Specific Interest (AESI) Any AESI(s)	2 Participants	0 Participants	0 Participants
Number of Subjects Reporting AEs of Specific Interest (AESI) Grade 3 AESI(s)	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting AEs of Specific Interest (AESI) Related AESI(s)	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Day 180

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

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 was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=180 Participants Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=104 Participants Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine	Fluarix Young Group n=86 Participants Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) up to Day 180 Any SAE(s)	19 Participants	6 Participants	3 Participants
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) up to Day 180 Related SAE(s)	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: After Day 180

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=180 Participants Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=104 Participants Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine	Fluarix Young Group n=86 Participants Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) After Day 180 Any SAE(s)	1 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) After Day 180 Related SAE(s)	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 0 and Day 21

Population: Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 21 for whom data concerning immunogenicity at day 21 were available.

Antibody titers were expressed as Geometric mean titers (GMTs) against separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=154 Participants Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=86 Participants Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine	Fluarix Young Group n=78 Participants Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21 A/Brisbane vaccine strain at Day 0	27.8 titer Interval 24.0 to 32.3	25.7 titer Interval 21.3 to 30.9	66.1 titer Interval 50.5 to 86.5
Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21 A/Brisbane vaccine strain at Day 21	57.3 titer Interval 49.8 to 66.0	49.9 titer Interval 41.8 to 59.7	112.1 titer Interval 92.1 to 136.4
Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21 A/Uruguay vaccine strain at Day 0	46.8 titer Interval 38.9 to 56.4	35.3 titer Interval 27.0 to 46.1	48.8 titer Interval 37.3 to 63.9
Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21 A/Uruguay vaccine strain at Day 21	153.7 titer Interval 132.8 to 177.8	107.8 titer Interval 85.8 to 135.3	114.1 titer Interval 92.8 to 140.4
Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21 B/Brisbane vaccine strain at Day 0	80.6 titer Interval 67.8 to 95.7	89.5 titer Interval 71.2 to 112.6	81.4 titer Interval 64.2 to 103.3
Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21 B/Brisbane vaccine strain at Day 21	171.6 titer Interval 148.2 to 198.6	163.9 titer Interval 137.2 to 195.9	157.2 titer Interval 131.6 to 187.7

SECONDARY outcome

Timeframe: Day 180

Population: Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 180 for whom data concerning immunogenicity at day 180 were available.

Antibody titers were expressed as GMTs against separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=134 Participants Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=75 Participants Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine	Fluarix Young Group n=72 Participants Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
HI Antibody Titers at Day 180 A/Brisbane vaccine strain	33.2 titer Interval 28.6 to 38.5	28.7 titer Interval 23.5 to 34.9	73.0 titer Interval 56.2 to 94.8
HI Antibody Titers at Day 180 A/Uruguay vaccine strain	66.9 titer Interval 56.2 to 79.6	52.0 titer Interval 40.1 to 67.5	64.4 titer Interval 49.5 to 83.8
HI Antibody Titers at Day 180 B/Brisbane vaccine strain	97.9 titer Interval 82.2 to 116.6	115.3 titer Interval 91.9 to 144.6	99.9 titer Interval 79.6 to 125.2

SECONDARY outcome

Timeframe: Day 0 and Day 21

Population: Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 21 for whom data concerning immunogenicity at day 21 were available.

Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=154 Participants Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=86 Participants Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine	Fluarix Young Group n=78 Participants Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21 B/Brisbane vaccine strain at Day 21	154 Participants	86 Participants	78 Participants
The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21 A/Brisbane vaccine strain at Day 0	139 Participants	79 Participants	73 Participants
The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21 A/Brisbane vaccine strain at Day 21	150 Participants	86 Participants	78 Participants
The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21 A/Uruguay vaccine strain at Day 0	143 Participants	78 Participants	71 Participants
The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21 A/Uruguay vaccine strain at Day 21	154 Participants	85 Participants	78 Participants
The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21 B/Brisbane vaccine strain at Day 0	151 Participants	86 Participants	75 Participants

SECONDARY outcome

Timeframe: Day 180

Population: Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 180 for whom data concerning immunogenicity at day 180 were available.

Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=134 Participants Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=75 Participants Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine	Fluarix Young Group n=72 Participants Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
The Number of Subjects Seropositive to HI Antibodies at Day 180 A/Brisbane vaccine strain	127 Participants	70 Participants	71 Participants
The Number of Subjects Seropositive to HI Antibodies at Day 180 A/Uruguay vaccine strain	131 Participants	72 Participants	68 Participants
The Number of Subjects Seropositive to HI Antibodies at Day 180 B/Brisbane vaccine strain	132 Participants	75 Participants	70 Participants

SECONDARY outcome

Timeframe: Day 21

Population: Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 21 for whom data concerning immunogenicity at day 21 were available.

A seroconverted subject was defined as a 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 4-fold increase in post-vaccination titer.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=154 Participants Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=86 Participants Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine	Fluarix Young Group n=78 Participants Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
The Number of Subjects Seroconverted to HI Antibodies at Day 21 A/Brisbane vaccine strain	29 Participants	16 Participants	9 Participants
The Number of Subjects Seroconverted to HI Antibodies at Day 21 A/Uruguay vaccine strain	73 Participants	34 Participants	21 Participants
The Number of Subjects Seroconverted to HI Antibodies at Day 21 B/Brisbane vaccine strain	39 Participants	13 Participants	15 Participants

SECONDARY outcome

Timeframe: Day 180

Population: Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 180 for whom data concerning immunogenicity at day 180 were available.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=134 Participants Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=75 Participants Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine	Fluarix Young Group n=72 Participants Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
The Number of Subjects Seroconverted to HI Antibodies at Day 180 A/Brisbane vaccine strain	4 Participants	2 Participants	1 Participants
The Number of Subjects Seroconverted to HI Antibodies at Day 180 A/Uruguay vaccine strain	12 Participants	7 Participants	2 Participants
The Number of Subjects Seroconverted to HI Antibodies at Day 180 B/Brisbane vaccine strain	2 Participants	4 Participants	4 Participants

SECONDARY outcome

Timeframe: At Day 21

Population: Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 21 for whom data concerning immunogenicity at day 21 were available.

SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=154 Participants Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=86 Participants Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine	Fluarix Young Group n=78 Participants Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
HI Antibody Seroconversion Factors (SCF) at Day 21 A/Brisbane vaccine strain	2.1 fold change Interval 1.9 to 2.3	1.9 fold change Interval 1.6 to 2.3	1.7 fold change Interval 1.5 to 2.0
HI Antibody Seroconversion Factors (SCF) at Day 21 A/Uruguay vaccine strain	3.3 fold change Interval 2.9 to 3.7	3.1 fold change Interval 2.5 to 3.8	2.3 fold change Interval 1.9 to 2.9
HI Antibody Seroconversion Factors (SCF) at Day 21 B/Brisbane vaccine strain	2.1 fold change Interval 1.9 to 2.4	1.8 fold change Interval 1.6 to 2.1	1.9 fold change Interval 1.7 to 2.2

SECONDARY outcome

Timeframe: At Day 180

Population: Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 180 for whom data concerning immunogenicity at day 180 were available.

SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=134 Participants Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=75 Participants Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine	Fluarix Young Group n=72 Participants Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
HI Antibody SCF at Day 180 A/Brisbane vaccine strain	1.2 fold change Interval 1.1 to 1.3	1.1 fold change Interval 1.0 to 1.2	1.2 fold change Interval 1.1 to 1.4
HI Antibody SCF at Day 180 A/Uruguay vaccine strain	1.4 fold change Interval 1.3 to 1.6	1.5 fold change Interval 1.3 to 1.7	1.3 fold change Interval 1.2 to 1.5
HI Antibody SCF at Day 180 B/Brisbane vaccine strain	1.2 fold change Interval 1.1 to 1.4	1.2 fold change Interval 1.1 to 1.4	1.2 fold change Interval 1.1 to 1.4

SECONDARY outcome

Timeframe: At Day 0 and Day 21

Population: Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 21 for whom data concerning immunogenicity at day 21 were available.

A seroprotected subject was defined as a subject with a serum HI titer ≥ to 1:40 that usually is accepted as indicating protection.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=154 Participants Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=86 Participants Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine	Fluarix Young Group n=78 Participants Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21 B/Brisbane vaccine strain at Day 21	151 Participants	86 Participants	76 Participants
The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21 A/Brisbane vaccine strain at Day 0	76 Participants	34 Participants	62 Participants
The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21 A/Brisbane vaccine strain at Day 21	124 Participants	64 Participants	72 Participants
The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21 A/Uruguay vaccine strain at Day 0	103 Participants	49 Participants	52 Participants
The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21 A/Uruguay vaccine strain at Day 21	151 Participants	76 Participants	73 Participants
The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21 B/Brisbane vaccine strain at Day 0	131 Participants	75 Participants	67 Participants

SECONDARY outcome

Timeframe: At Day 180

Population: Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 180 for whom data concerning immunogenicity at day 180 were available.

A seroprotected subject was defined as a subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=134 Participants Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=75 Participants Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine	Fluarix Young Group n=72 Participants Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
The Number of Subjects Seroprotected to HI Antibodies at Day 180 A/Brisbane vaccine strain	77 Participants	35 Participants	56 Participants
The Number of Subjects Seroprotected to HI Antibodies at Day 180 A/Uruguay vaccine strain	111 Participants	52 Participants	56 Participants
The Number of Subjects Seroprotected to HI Antibodies at Day 180 B/Brisbane vaccine strain	119 Participants	69 Participants	67 Participants

SECONDARY outcome

Timeframe: At Day 0 and Day 21

Population: Analysis was performed on According-to-Protocol (ATP) cohort for cell mediated immunity (CMI) Day 21 in subjects for whom data concerning immunogenicity were available for at least one test, 21Days after vaccination.

The markers assessed were Cluster of Differentiation 40 Ligand (CD40L), interleukin 2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ) and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens.

Outcome measures

SECONDARY outcome

Timeframe: At Day 180

Population: Analysis was performed on According-to-Protocol (ATP) cohort for cell mediated immunity (CMI) Day 180 in subjects for whom data concerning immunogenicity were available for at least one test, 180 Days after vaccination.

The markers assessed were CD40L, IL-2, TNF-α and IFN-γ and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens.

Outcome measures

Adverse Events

New Generation Influenza Vaccine GSK2186877A Group

Serious events: 19 serious events

Other events: 109 other events

Deaths: 0 deaths

Fluarix Elderly Group

Serious events: 6 serious events

Other events: 25 other events

Deaths: 0 deaths

Fluarix Young Group

Serious events: 3 serious events

Other events: 56 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	New Generation Influenza Vaccine GSK2186877A Group n=180 participants at risk Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=103 participants at risk；n=104 participants at risk Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine	Fluarix Young Group n=85 participants at risk；n=86 participants at risk Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
General disorders Pain	43.3% 78/180 • Serious adverse events were assessed up to day 180 and after day 180. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	11.7% 12/103 • Serious adverse events were assessed up to day 180 and after day 180. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	57.6% 49/85 • Serious adverse events were assessed up to day 180 and after day 180. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Redness	12.2% 22/180 • Serious adverse events were assessed up to day 180 and after day 180. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	2.9% 3/103 • Serious adverse events were assessed up to day 180 and after day 180. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	5.9% 5/85 • Serious adverse events were assessed up to day 180 and after day 180. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Swelling	12.2% 22/180 • Serious adverse events were assessed up to day 180 and after day 180. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	2.9% 3/103 • Serious adverse events were assessed up to day 180 and after day 180. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	2.4% 2/85 • Serious adverse events were assessed up to day 180 and after day 180. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Arthralgia	12.8% 23/180 • Serious adverse events were assessed up to day 180 and after day 180. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	2.9% 3/103 • Serious adverse events were assessed up to day 180 and after day 180. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	3.5% 3/85 • Serious adverse events were assessed up to day 180 and after day 180. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Fatigue	29.4% 53/180 • Serious adverse events were assessed up to day 180 and after day 180. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	11.7% 12/103 • Serious adverse events were assessed up to day 180 and after day 180. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	24.7% 21/85 • Serious adverse events were assessed up to day 180 and after day 180. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Gastrointestinal symptoms	6.1% 11/180 • Serious adverse events were assessed up to day 180 and after day 180. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	4.9% 5/103 • Serious adverse events were assessed up to day 180 and after day 180. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	4.7% 4/85 • Serious adverse events were assessed up to day 180 and after day 180. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Headache	17.2% 31/180 • Serious adverse events were assessed up to day 180 and after day 180. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	5.8% 6/103 • Serious adverse events were assessed up to day 180 and after day 180. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	14.1% 12/85 • Serious adverse events were assessed up to day 180 and after day 180. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Myalgia	20.6% 37/180 • Serious adverse events were assessed up to day 180 and after day 180. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	6.8% 7/103 • Serious adverse events were assessed up to day 180 and after day 180. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	17.6% 15/85 • Serious adverse events were assessed up to day 180 and after day 180. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Shivering	11.1% 20/180 • Serious adverse events were assessed up to day 180 and after day 180. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	4.9% 5/103 • Serious adverse events were assessed up to day 180 and after day 180. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	5.9% 5/85 • Serious adverse events were assessed up to day 180 and after day 180. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	New Generation Influenza Vaccine GSK2186877A Group n=39 Participants Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=25 Participants Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine	Fluarix Young Group n=14 Participants Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Uruguay [CD4-ALL DOUBLES] Day 21	312.78 cells per million CD4+ T-cells Standard Deviation 391.17	181.29 cells per million CD4+ T-cells Standard Deviation 435.61	646.39 cells per million CD4+ T-cells Standard Deviation 529.95
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 B/Brisbane [CD4-ALL DOUBLES] Day 0	579.12 cells per million CD4+ T-cells Standard Deviation 929.73	395.07 cells per million CD4+ T-cells Standard Deviation 401.74	1211.75 cells per million CD4+ T-cells Standard Deviation 589.02
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 B/Brisbane [CD4-ALL DOUBLES] Day 21	833.66 cells per million CD4+ T-cells Standard Deviation 873.42	381.76 cells per million CD4+ T-cells Standard Deviation 708.30	1406.33 cells per million CD4+ T-cells Standard Deviation 663.12
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Brisbane [CD4-CD40L] Day 0	496.13 cells per million CD4+ T-cells Standard Deviation 684.47	404.66 cells per million CD4+ T-cells Standard Deviation 688.08	641.91 cells per million CD4+ T-cells Standard Deviation 595.30
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Brisbane [CD4-ALL DOUBLES] Day 0	505.28 cells per million CD4+ T-cells Standard Deviation 772.80	389.00 cells per million CD4+ T-cells Standard Deviation 856.40	770.48 cells per million CD4+ T-cells Standard Deviation 697.03
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Brisbane [CD4-ALL DOUBLES] Day 21	706.88 cells per million CD4+ T-cells Standard Deviation 505.25	264.58 cells per million CD4+ T-cells Standard Deviation 781.85	1314.16 cells per million CD4+ T-cells Standard Deviation 747.54
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Uruguay [CD4-ALL DOUBLES] Day 0	305.14 cells per million CD4+ T-cells Standard Deviation 457.10	220.40 cells per million CD4+ T-cells Standard Deviation 539.54	423.12 cells per million CD4+ T-cells Standard Deviation 553.25
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Brisbane [CD4-CD40L] Day 21	594.61 cells per million CD4+ T-cells Standard Deviation 444.86	222.79 cells per million CD4+ T-cells Standard Deviation 709.97	1156.09 cells per million CD4+ T-cells Standard Deviation 637.81
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Uruguay [CD4-CD40L] Day 0	288.19 cells per million CD4+ T-cells Standard Deviation 394.53	201.28 cells per million CD4+ T-cells Standard Deviation 331.40	349.47 cells per million CD4+ T-cells Standard Deviation 435.78
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Uruguay [CD4-CD40L] Day 21	236.03 cells per million CD4+ T-cells Standard Deviation 331.31	156.82 cells per million CD4+ T-cells Standard Deviation 359.54	508.67 cells per million CD4+ T-cells Standard Deviation 453.14
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 B/Brisbane [CD4-CD40L] Day 0	532.51 cells per million CD4+ T-cells Standard Deviation 808.78	351.89 cells per million CD4+ T-cells Standard Deviation 341.86	1036.33 cells per million CD4+ T-cells Standard Deviation 578.74
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 B/Brisbane [CD4-CD40L] Day 21	632.53 cells per million CD4+ T-cells Standard Deviation 819.98	337.96 cells per million CD4+ T-cells Standard Deviation 600.56	1173.43 cells per million CD4+ T-cells Standard Deviation 534.19
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Brisbane [CD4-IFN-γ] Day 0	381.48 cells per million CD4+ T-cells Standard Deviation 519.00	155.01 cells per million CD4+ T-cells Standard Deviation 472.80	507.94 cells per million CD4+ T-cells Standard Deviation 575.13
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Brisbane [CD4-IFN-γ] Day 21	389.72 cells per million CD4+ T-cells Standard Deviation 397.50	148.60 cells per million CD4+ T-cells Standard Deviation 575.79	912.64 cells per million CD4+ T-cells Standard Deviation 564.57
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Uruguay [CD4-IFN-γ] Day 0	165.87 cells per million CD4+ T-cells Standard Deviation 395.96	91.55 cells per million CD4+ T-cells Standard Deviation 351.37	245.90 cells per million CD4+ T-cells Standard Deviation 490.89
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Uruguay [CD4-IFN-γ] Day 21	188.82 cells per million CD4+ T-cells Standard Deviation 293.17	85.83 cells per million CD4+ T-cells Standard Deviation 260.52	449.17 cells per million CD4+ T-cells Standard Deviation 407.25
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 B/Brisbane [CD4-IFN-γ] Day 0	252.91 cells per million CD4+ T-cells Standard Deviation 815.43	144.14 cells per million CD4+ T-cells Standard Deviation 286.54	850.80 cells per million CD4+ T-cells Standard Deviation 454.84
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 B/Brisbane [CD4-IFN-γ] Day 21	407.19 cells per million CD4+ T-cells Standard Deviation 746.60	185.93 cells per million CD4+ T-cells Standard Deviation 447.80	1059.08 cells per million CD4+ T-cells Standard Deviation 513.03
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Brisbane [CD4-IL2] Day 0	501.25 cells per million CD4+ T-cells Standard Deviation 632.36	336.49 cells per million CD4+ T-cells Standard Deviation 703.76	641.34 cells per million CD4+ T-cells Standard Deviation 620.52
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Brisbane [CD4-IL2] Day 21	603.99 cells per million CD4+ T-cells Standard Deviation 401.78	231.87 cells per million CD4+ T-cells Standard Deviation 687.91	1119.71 cells per million CD4+ T-cells Standard Deviation 663.02
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Uruguay [CD4-IL2] Day 0	246.44 cells per million CD4+ T-cells Standard Deviation 364.77	159.48 cells per million CD4+ T-cells Standard Deviation 449.91	307.21 cells per million CD4+ T-cells Standard Deviation 428.94
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Uruguay [CD4-IL2] Day 21	223.89 cells per million CD4+ T-cells Standard Deviation 301.93	151.95 cells per million CD4+ T-cells Standard Deviation 362.38	507.44 cells per million CD4+ T-cells Standard Deviation 466.62
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 B/Brisbane [CD4-IL2] Day 0	511.34 cells per million CD4+ T-cells Standard Deviation 843.52	285.96 cells per million CD4+ T-cells Standard Deviation 363.09	980.90 cells per million CD4+ T-cells Standard Deviation 525.94
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 B/Brisbane [CD4-IL2] Day 21	686.04 cells per million CD4+ T-cells Standard Deviation 789.19	318.55 cells per million CD4+ T-cells Standard Deviation 631.64	1119.56 cells per million CD4+ T-cells Standard Deviation 621.33
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Brisbane [CD4-TFN-α] Day 0	354.67 cells per million CD4+ T-cells Standard Deviation 688.18	277.02 cells per million CD4+ T-cells Standard Deviation 793.58	689.52 cells per million CD4+ T-cells Standard Deviation 585.40
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Brisbane [CD4-TFN-α] Day 21	579.83 cells per million CD4+ T-cells Standard Deviation 447.33	279.39 cells per million CD4+ T-cells Standard Deviation 719.36	1083.09 cells per million CD4+ T-cells Standard Deviation 642.04
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Uruguay [CD4-TFN-α] Day 0	268.96 cells per million CD4+ T-cells Standard Deviation 407.82	176.04 cells per million CD4+ T-cells Standard Deviation 464.08	250.20 cells per million CD4+ T-cells Standard Deviation 480.89
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 A/Uruguay [CD4-TFN-α ] Day 21	350.86 cells per million CD4+ T-cells Standard Deviation 329.74	208.35 cells per million CD4+ T-cells Standard Deviation 392.20	575.88 cells per million CD4+ T-cells Standard Deviation 473.30
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 B/Brisbane [CD4-TFN-α] Day 0	390.08 cells per million CD4+ T-cells Standard Deviation 843.99	324.83 cells per million CD4+ T-cells Standard Deviation 342.66	976.64 cells per million CD4+ T-cells Standard Deviation 580.31
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 B/Brisbane [CD4-TFN-α] Day 21	632.14 cells per million CD4+ T-cells Standard Deviation 767.97	367.95 cells per million CD4+ T-cells Standard Deviation 586.79	1126.10 cells per million CD4+ T-cells Standard Deviation 629.66

Measure	New Generation Influenza Vaccine GSK2186877A Group n=25 Participants Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A	Fluarix Elderly Group n=20 Participants Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine	Fluarix Young Group n=12 Participants Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
The GM Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Day 180 Strain A/Brisbane for CD4-ALL DOUBLES	410.98 cells per million CD4+ T-cells Standard Deviation 507.43	395.98 cells per million CD4+ T-cells Standard Deviation 526.39	945.71 cells per million CD4+ T-cells Standard Deviation 669.70
The GM Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Day 180 Strain A/Uruguay for CD4-ALL DOUBLES	160.28 cells per million CD4+ T-cells Standard Deviation 367.49	170.26 cells per million CD4+ T-cells Standard Deviation 295.26	523.37 cells per million CD4+ T-cells Standard Deviation 578.23
The GM Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Day 180 Strain B/Brisbane for CD4-ALL DOUBLES	411.94 cells per million CD4+ T-cells Standard Deviation 885.94	514.93 cells per million CD4+ T-cells Standard Deviation 530.05	1156.78 cells per million CD4+ T-cells Standard Deviation 246.61
The GM Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Day 180 Strain A/Brisbane for CD4-CD40L	330.87 cells per million CD4+ T-cells Standard Deviation 384.52	383.44 cells per million CD4+ T-cells Standard Deviation 485.65	838.17 cells per million CD4+ T-cells Standard Deviation 592.74
The GM Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Day 180 Strain A/Uruguay for CD4-CD40L	117.10 cells per million CD4+ T-cells Standard Deviation 334.47	188.07 cells per million CD4+ T-cells Standard Deviation 251.35	444.32 cells per million CD4+ T-cells Standard Deviation 493.66
The GM Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Day 180 Strain B/Brisbane for CD4-CD40L	367.67 cells per million CD4+ T-cells Standard Deviation 842.20	454.81 cells per million CD4+ T-cells Standard Deviation 488.31	1024.05 cells per million CD4+ T-cells Standard Deviation 242.01
The GM Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Day 180 Strain A/Brisbane for CD4-IFN-γ	311.48 cells per million CD4+ T-cells Standard Deviation 457.12	195.30 cells per million CD4+ T-cells Standard Deviation 449.01	718.48 cells per million CD4+ T-cells Standard Deviation 530.31
The GM Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Day 180 Strain A/Uruguay for CD4-IFN-γ	90.26 cells per million CD4+ T-cells Standard Deviation 326.33	93.12 cells per million CD4+ T-cells Standard Deviation 214.88	344.50 cells per million CD4+ T-cells Standard Deviation 475.04
The GM Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Day 180 Strain B/Brisbane for CD4-IFN-γ	274.24 cells per million CD4+ T-cells Standard Deviation 775.13	191.20 cells per million CD4+ T-cells Standard Deviation 480.62	846.21 cells per million CD4+ T-cells Standard Deviation 187.26
The GM Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Day 180 Strain A/Brisbane for CD4-IL2	257.81 cells per million CD4+ T-cells Standard Deviation 343.17	337.02 cells per million CD4+ T-cells Standard Deviation 491.89	777.60 cells per million CD4+ T-cells Standard Deviation 606.71
The GM Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Day 180 Strain A/Uruguay for CD4-IL2	136.94 cells per million CD4+ T-cells Standard Deviation 259.79	156.64 cells per million CD4+ T-cells Standard Deviation 247.58	364.47 cells per million CD4+ T-cells Standard Deviation 472.06
The GM Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Day 180 Strain B/Brisbane for CD4-IL2	378.41 cells per million CD4+ T-cells Standard Deviation 829.36	357.47 cells per million CD4+ T-cells Standard Deviation 487.00	940.07 cells per million CD4+ T-cells Standard Deviation 268.02
The GM Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Day 180 Strain A/Brisbane for CD4-TFN-α	352.89 cells per million CD4+ T-cells Standard Deviation 489.42	360.15 cells per million CD4+ T-cells Standard Deviation 499.75	833.70 cells per million CD4+ T-cells Standard Deviation 587.76
The GM Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Day 180 Strain A/Uruguay for CD4-TFN-α	162.57 cells per million CD4+ T-cells Standard Deviation 332.69	211.11 cells per million CD4+ T-cells Standard Deviation 261.05	487.90 cells per million CD4+ T-cells Standard Deviation 502.24
The GM Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Day 180 Strain B/Brisbane for CD4-TFN-α	246.41 cells per million CD4+ T-cells Standard Deviation 845.16	414.80 cells per million CD4+ T-cells Standard Deviation 454.02	953.49 cells per million CD4+ T-cells Standard Deviation 224.88