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

Observer-blind Safety and Immunogenicity Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK2186877A When Administered to Elderly Subjects

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00992784

Enrollment

370

Registered

2009-10-09

Start date

2009-10-15

Completion date

2010-05-27

Last updated

2018-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Influenza Vaccines, GSK Bio's influenza vaccine GSK2186877A, influenza infection

Brief summary

The purpose of the study is to evaluate the safety of GSK Biologicals' influenza vaccine. Elderly subjects were randomized in the primary study (NCT00760617) and will now receive the same vaccine for the third time. For this study the masking is observer-blind for elderly subjects and open for young adult subjects.

Interventions

BIOLOGICALGSK investigational vaccine 2186877A

Single dose, intramuscular injection

BIOLOGICALFluarixTM

Single dose, intramuscular injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

All subjects must satisfy ALL the following criteria at study entry: * Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. Specific attention should be given to the compliance potential of subjects with suspected drug or alcohol abuse. * A male or female aged 19-43 years or \>=66 years at the time of the vaccination and who participated in the study NCT00760617 and completed the 6-month follow-up. * Written informed consent obtained from the subject. * Free of an acute aggravation of the health status as established by clinical evaluation before entering into the study. * Female subjects of non-childbearing potential may be enrolled in the study. * Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. * Female subjects of childbearing potential may be enrolled in the study if the subject: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception for 2 months after the vaccination.

Exclusion criteria

The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study: * Use of any investigational or non-registered product other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period. * Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of an influenza vaccine other than the study vaccines or of a vaccine not foreseen in the study protocol during the entire study period. * Vaccination against influenza since January 2009 with a seasonal influenza vaccine. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * History of hypersensivity to a previous dose of influenza vaccine. * History of allergy or reactions likely to be exacerbated by any component of the vaccine(s). * Acute clinically significant pulmonary, cardiovascular, hepatic, renal, neurological and psychiatric disorders, as determined by clinical evaluation or pre-existing laboratory screening tests. * Acute disease and/or fever at the time of enrolment. * Fever is defined as temperature \>=37.5°C on oral setting. * Subjects with a minor illness without fever may be enrolled at the discretion of the investigator. * Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study. * Any medical conditions in which IM injections are contraindicated * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions.

Design outcomes

Primary

Measure	Time frame	Description
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Day 0-6	Grade 3 ecchymosis, redness and swelling was ≥ 100 millimeter (mm) and grade 3 pain was considerable pain at rest, that prevented normal everyday activities.
Duration of Solicited Local AEs	Day 0-6	Duration was defined as number of days with any grade of local symptoms.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Day 0-6	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.
Duration of Solicited General AEs	Day 0-6	Duration was defined as number of days with any grade of general symptoms.
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs	Day 0-20	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.
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit	Day 0-179	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.
Number of Subjects Reporting AEs of Specific Interest (AESI)	Day 0-179	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.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) up to Day 180	Up to Day 180	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.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) After Day 180	After Day 180	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.

Secondary

Measure	Time frame	Description
The Number of Subjects Seroprotected to HI Antibodies at Day 180	At Day 180	A seroprotected subject was defined as a subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection.
Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	Day 0 and Day 21	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.
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	At Day 180	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.
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	At Day 0 and Day 21	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.
HI Antibody Titers at Day 180	Day 180	Antibody titers were expressed as GMTs against separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21	Day 0 and Day 21	Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10.
The Number of Subjects Seropositive to HI Antibodies at Day 180	Day 180	Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10.
The Number of Subjects Seroconverted to HI Antibodies at Day 21	Day 21	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.
The Number of Subjects Seroconverted to HI Antibodies at Day 180	Day 180	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.
HI Antibody Seroconversion Factors (SCF) at Day 21	At Day 21	SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.
HI Antibody SCF at Day 180	At Day 180	SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.
The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21	At Day 0 and Day 21	A seroprotected subject was defined as a subject with a serum HI titer ≥ to 1:40 that usually is accepted as indicating protection.

Countries

Germany, Netherlands, Sweden

Participant flow

Participants by arm

Arm	Count
New Generation Influenza Vaccine GSK2186877A Group Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A	180
Fluarix Elderly Group Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine	104
Fluarix Young Group Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine	86
Total	370

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	2	1	0
Overall Study	Withdrawal by Subject	1	1	1

Baseline characteristics

Characteristic	New Generation Influenza Vaccine GSK2186877A Group	Fluarix Elderly Group	Fluarix Young Group	Total
Age, Continuous	74.5 Years STANDARD_DEVIATION 5.18	74.8 Years STANDARD_DEVIATION 5.26	29.9 Years STANDARD_DEVIATION 6.55	64.2 Years STANDARD_DEVIATION 19.7
Sex: Female, Male Female	98 Participants	46 Participants	35 Participants	179 Participants
Sex: Female, Male Male	82 Participants	58 Participants	51 Participants	191 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	109 / 180	25 / 103	56 / 85
serious Total, serious adverse events	19 / 180	6 / 104	3 / 86

Outcome results

Primary

Duration of Solicited General AEs

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

Time frame: 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.

Arm	Measure	Group	Value (MEDIAN)
New Generation Influenza Vaccine GSK2186877A Group	Duration of Solicited General AEs	Gastrointestinal symptoms	1.0 Days
New Generation Influenza Vaccine GSK2186877A Group	Duration of Solicited General AEs	Fever	1.0 Days
New Generation Influenza Vaccine GSK2186877A Group	Duration of Solicited General AEs	Arthralgia	1.0 Days
New Generation Influenza Vaccine GSK2186877A Group	Duration of Solicited General AEs	Myalgia	2.0 Days
New Generation Influenza Vaccine GSK2186877A Group	Duration of Solicited General AEs	Fatigue	2.0 Days
New Generation Influenza Vaccine GSK2186877A Group	Duration of Solicited General AEs	Shivering	1.0 Days
New Generation Influenza Vaccine GSK2186877A Group	Duration of Solicited General AEs	Headache	2.0 Days
Fluarix Elderly Group	Duration of Solicited General AEs	Fever	1.0 Days
Fluarix Elderly Group	Duration of Solicited General AEs	Gastrointestinal symptoms	3.0 Days
Fluarix Elderly Group	Duration of Solicited General AEs	Myalgia	3.0 Days
Fluarix Elderly Group	Duration of Solicited General AEs	Headache	2.5 Days
Fluarix Elderly Group	Duration of Solicited General AEs	Arthralgia	4.0 Days
Fluarix Elderly Group	Duration of Solicited General AEs	Fatigue	3.0 Days
Fluarix Elderly Group	Duration of Solicited General AEs	Shivering	1.0 Days
Fluarix Young Group	Duration of Solicited General AEs	Fatigue	2.0 Days
Fluarix Young Group	Duration of Solicited General AEs	Myalgia	2.0 Days
Fluarix Young Group	Duration of Solicited General AEs	Gastrointestinal symptoms	1.0 Days
Fluarix Young Group	Duration of Solicited General AEs	Fever	1.0 Days
Fluarix Young Group	Duration of Solicited General AEs	Shivering	2.0 Days
Fluarix Young Group	Duration of Solicited General AEs	Arthralgia	1.0 Days
Fluarix Young Group	Duration of Solicited General AEs	Headache	2.0 Days

Primary

Duration of Solicited Local AEs

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

Time frame: 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.

Arm	Measure	Group	Value (MEDIAN)
New Generation Influenza Vaccine GSK2186877A Group	Duration of Solicited Local AEs	Ecchymosis	3.0 Days
New Generation Influenza Vaccine GSK2186877A Group	Duration of Solicited Local AEs	Pain	2.0 Days
New Generation Influenza Vaccine GSK2186877A Group	Duration of Solicited Local AEs	Redness	2.0 Days
New Generation Influenza Vaccine GSK2186877A Group	Duration of Solicited Local AEs	Swelling	2.0 Days
Fluarix Elderly Group	Duration of Solicited Local AEs	Swelling	1.0 Days
Fluarix Elderly Group	Duration of Solicited Local AEs	Ecchymosis	NA Days
Fluarix Elderly Group	Duration of Solicited Local AEs	Redness	2.0 Days
Fluarix Elderly Group	Duration of Solicited Local AEs	Pain	2.0 Days
Fluarix Young Group	Duration of Solicited Local AEs	Swelling	2.0 Days
Fluarix Young Group	Duration of Solicited Local AEs	Pain	2.0 Days
Fluarix Young Group	Duration of Solicited Local AEs	Redness	3.0 Days
Fluarix Young Group	Duration of Solicited Local AEs	Ecchymosis	NA Days

Primary

Number of Subjects Reporting AEs of Specific Interest (AESI)

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.

Time frame: Day 0-179

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting AEs of Specific Interest (AESI)	Grade 3 AESI(s)	0 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting AEs of Specific Interest (AESI)	Any AESI(s)	2 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting AEs of Specific Interest (AESI)	Related AESI(s)	0 Participants
Fluarix Elderly Group	Number of Subjects Reporting AEs of Specific Interest (AESI)	Grade 3 AESI(s)	0 Participants
Fluarix Elderly Group	Number of Subjects Reporting AEs of Specific Interest (AESI)	Any AESI(s)	0 Participants
Fluarix Elderly Group	Number of Subjects Reporting AEs of Specific Interest (AESI)	Related AESI(s)	0 Participants
Fluarix Young Group	Number of Subjects Reporting AEs of Specific Interest (AESI)	Any AESI(s)	0 Participants
Fluarix Young Group	Number of Subjects Reporting AEs of Specific Interest (AESI)	Related AESI(s)	0 Participants
Fluarix Young Group	Number of Subjects Reporting AEs of Specific Interest (AESI)	Grade 3 AESI(s)	0 Participants

Primary

Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)

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

Time frame: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Any ecchymosis	1 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Grade 3 ecchymosis	0 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Any pain	78 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Grade 3 pain	0 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Any redness	22 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Grade 3 redness	1 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Any swelling	22 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Grade 3 swelling	0 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Any pain	12 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Any swelling	3 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Grade 3 pain	0 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Any redness	3 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Grade 3 redness	0 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Any ecchymosis	0 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Grade 3 ecchymosis	0 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Grade 3 swelling	0 Participants
Fluarix Young Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Any pain	49 Participants
Fluarix Young Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Grade 3 ecchymosis	0 Participants
Fluarix Young Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Any ecchymosis	0 Participants
Fluarix Young Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Grade 3 pain	1 Participants
Fluarix Young Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Any swelling	2 Participants
Fluarix Young Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Grade 3 redness	0 Participants
Fluarix Young Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Any redness	5 Participants
Fluarix Young Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Grade 3 swelling	0 Participants

Primary

Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) After Day 180

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.

Time frame: After Day 180

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) After Day 180	Any SAE(s)	1 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) After Day 180	Related SAE(s)	0 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) After Day 180	Any SAE(s)	0 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) After Day 180	Related SAE(s)	0 Participants
Fluarix Young Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) After Day 180	Any SAE(s)	0 Participants
Fluarix Young Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) After Day 180	Related SAE(s)	0 Participants

Primary

Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) up to Day 180

Time frame: Up to Day 180

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) up to Day 180	Any SAE(s)	19 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) up to Day 180	Related SAE(s)	0 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) up to Day 180	Any SAE(s)	6 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) up to Day 180	Related SAE(s)	0 Participants
Fluarix Young Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) up to Day 180	Any SAE(s)	3 Participants
Fluarix Young Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) up to Day 180	Related SAE(s)	0 Participants

Primary

Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit

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.

Time frame: Day 0-179

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit	Grade 3 AE(s)	21 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit	Any AE(s)	81 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit	Related AE(s)	1 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit	Grade 3 AE(s)	5 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit	Any AE(s)	34 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit	Related AE(s)	1 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit	Any AE(s)	21 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit	Related AE(s)	0 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit	Grade 3 AE(s)	6 Participants

Primary

Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs

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.

Time frame: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Grade 3 gatrointestinal symptoms	0 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any arthralgia	23 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related myalgia	29 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related gatrointestinal symptoms	6 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any fatigue	53 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Grade 3 myalgia	1 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any headache	31 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related fever	8 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any myalgia	37 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Grade 3 headache	1 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any fever	8 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related headache	25 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Grade 3 fatigue	0 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Grade 3 fever	0 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related shivering	16 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related fatigue	41 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related arthralgia	18 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Grade 3 shivering	1 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any gatrointestinal symptoms	11 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Grade 3 arthralgia	0 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any shivering	20 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any fever	1 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any arthralgia	3 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Grade 3 arthralgia	0 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related arthralgia	2 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any fatigue	12 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Grade 3 fatigue	0 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related fatigue	9 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any gatrointestinal symptoms	5 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Grade 3 gatrointestinal symptoms	0 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related gatrointestinal symptoms	2 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any headache	6 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Grade 3 headache	0 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related headache	6 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any myalgia	7 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Grade 3 myalgia	0 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related myalgia	5 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any shivering	5 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Grade 3 shivering	0 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related shivering	4 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Grade 3 fever	0 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related fever	1 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Grade 3 gatrointestinal symptoms	0 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Grade 3 arthralgia	0 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related myalgia	15 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any gatrointestinal symptoms	4 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related fever	1 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any shivering	5 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related fatigue	17 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Grade 3 fever	0 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Grade 3 shivering	0 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Grade 3 fatigue	0 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any arthralgia	3 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related shivering	3 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Grade 3 headache	0 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any fatigue	21 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related headache	8 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any headache	12 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related arthralgia	2 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any myalgia	15 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related gatrointestinal symptoms	4 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any fever	1 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Grade 3 myalgia	0 Participants

Primary

Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs

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.

Time frame: Day 0-20

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs	Grade 3 AE(s)	2 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs	Any AE(s)	24 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs	Related AE(s)	5 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs	Grade 3 AE(s)	0 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs	Any AE(s)	17 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs	Related AE(s)	1 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs	Any AE(s)	16 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs	Related AE(s)	0 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs	Grade 3 AE(s)	3 Participants

Secondary

Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21

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.

Time frame: 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.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
New Generation Influenza Vaccine GSK2186877A Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	A/Brisbane vaccine strain at Day 0	27.8 titer
New Generation Influenza Vaccine GSK2186877A Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	A/Brisbane vaccine strain at Day 21	57.3 titer
New Generation Influenza Vaccine GSK2186877A Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	A/Uruguay vaccine strain at Day 0	46.8 titer
New Generation Influenza Vaccine GSK2186877A Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	A/Uruguay vaccine strain at Day 21	153.7 titer
New Generation Influenza Vaccine GSK2186877A Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	B/Brisbane vaccine strain at Day 0	80.6 titer
New Generation Influenza Vaccine GSK2186877A Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	B/Brisbane vaccine strain at Day 21	171.6 titer
Fluarix Elderly Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	B/Brisbane vaccine strain at Day 21	163.9 titer
Fluarix Elderly Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	A/Brisbane vaccine strain at Day 0	25.7 titer
Fluarix Elderly Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	A/Uruguay vaccine strain at Day 21	107.8 titer
Fluarix Elderly Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	B/Brisbane vaccine strain at Day 0	89.5 titer
Fluarix Elderly Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	A/Brisbane vaccine strain at Day 21	49.9 titer
Fluarix Elderly Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	A/Uruguay vaccine strain at Day 0	35.3 titer
Fluarix Young Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	A/Brisbane vaccine strain at Day 21	112.1 titer
Fluarix Young Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	A/Uruguay vaccine strain at Day 0	48.8 titer
Fluarix Young Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	B/Brisbane vaccine strain at Day 21	157.2 titer
Fluarix Young Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	A/Uruguay vaccine strain at Day 21	114.1 titer
Fluarix Young Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	A/Brisbane vaccine strain at Day 0	66.1 titer
Fluarix Young Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	B/Brisbane vaccine strain at Day 0	81.4 titer

Secondary

HI Antibody SCF at Day 180

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

Time frame: 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.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
New Generation Influenza Vaccine GSK2186877A Group	HI Antibody SCF at Day 180	A/Uruguay vaccine strain	1.4 fold change
New Generation Influenza Vaccine GSK2186877A Group	HI Antibody SCF at Day 180	A/Brisbane vaccine strain	1.2 fold change
New Generation Influenza Vaccine GSK2186877A Group	HI Antibody SCF at Day 180	B/Brisbane vaccine strain	1.2 fold change
Fluarix Elderly Group	HI Antibody SCF at Day 180	A/Uruguay vaccine strain	1.5 fold change
Fluarix Elderly Group	HI Antibody SCF at Day 180	A/Brisbane vaccine strain	1.1 fold change
Fluarix Elderly Group	HI Antibody SCF at Day 180	B/Brisbane vaccine strain	1.2 fold change
Fluarix Young Group	HI Antibody SCF at Day 180	A/Brisbane vaccine strain	1.2 fold change
Fluarix Young Group	HI Antibody SCF at Day 180	B/Brisbane vaccine strain	1.2 fold change
Fluarix Young Group	HI Antibody SCF at Day 180	A/Uruguay vaccine strain	1.3 fold change

Secondary

HI Antibody Seroconversion Factors (SCF) at Day 21

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

Time frame: 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.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
New Generation Influenza Vaccine GSK2186877A Group	HI Antibody Seroconversion Factors (SCF) at Day 21	A/Uruguay vaccine strain	3.3 fold change
New Generation Influenza Vaccine GSK2186877A Group	HI Antibody Seroconversion Factors (SCF) at Day 21	A/Brisbane vaccine strain	2.1 fold change
New Generation Influenza Vaccine GSK2186877A Group	HI Antibody Seroconversion Factors (SCF) at Day 21	B/Brisbane vaccine strain	2.1 fold change
Fluarix Elderly Group	HI Antibody Seroconversion Factors (SCF) at Day 21	A/Uruguay vaccine strain	3.1 fold change
Fluarix Elderly Group	HI Antibody Seroconversion Factors (SCF) at Day 21	A/Brisbane vaccine strain	1.9 fold change
Fluarix Elderly Group	HI Antibody Seroconversion Factors (SCF) at Day 21	B/Brisbane vaccine strain	1.8 fold change
Fluarix Young Group	HI Antibody Seroconversion Factors (SCF) at Day 21	A/Brisbane vaccine strain	1.7 fold change
Fluarix Young Group	HI Antibody Seroconversion Factors (SCF) at Day 21	B/Brisbane vaccine strain	1.9 fold change
Fluarix Young Group	HI Antibody Seroconversion Factors (SCF) at Day 21	A/Uruguay vaccine strain	2.3 fold change

Secondary

HI Antibody Titers at Day 180

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

Time frame: 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.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
New Generation Influenza Vaccine GSK2186877A Group	HI Antibody Titers at Day 180	A/Uruguay vaccine strain	66.9 titer
New Generation Influenza Vaccine GSK2186877A Group	HI Antibody Titers at Day 180	A/Brisbane vaccine strain	33.2 titer
New Generation Influenza Vaccine GSK2186877A Group	HI Antibody Titers at Day 180	B/Brisbane vaccine strain	97.9 titer
Fluarix Elderly Group	HI Antibody Titers at Day 180	A/Uruguay vaccine strain	52.0 titer
Fluarix Elderly Group	HI Antibody Titers at Day 180	A/Brisbane vaccine strain	28.7 titer
Fluarix Elderly Group	HI Antibody Titers at Day 180	B/Brisbane vaccine strain	115.3 titer
Fluarix Young Group	HI Antibody Titers at Day 180	A/Brisbane vaccine strain	73.0 titer
Fluarix Young Group	HI Antibody Titers at Day 180	B/Brisbane vaccine strain	99.9 titer
Fluarix Young Group	HI Antibody Titers at Day 180	A/Uruguay vaccine strain	64.4 titer

Secondary

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

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.

Time frame: 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.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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 397.5
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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 746.6
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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 457.1
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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 772.8
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
Fluarix Elderly Group	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	285.96 cells per million CD4+ T-cells	Standard Deviation 363.09
Fluarix Elderly Group	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	389.00 cells per million CD4+ T-cells	Standard Deviation 856.4
Fluarix Elderly Group	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	264.58 cells per million CD4+ T-cells	Standard Deviation 781.85
Fluarix Elderly Group	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	220.40 cells per million CD4+ T-cells	Standard Deviation 539.54
Fluarix Elderly Group	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	181.29 cells per million CD4+ T-cells	Standard Deviation 435.61
Fluarix Elderly Group	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	395.07 cells per million CD4+ T-cells	Standard Deviation 401.74
Fluarix Elderly Group	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	381.76 cells per million CD4+ T-cells	Standard Deviation 708.3
Fluarix Elderly Group	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	404.66 cells per million CD4+ T-cells	Standard Deviation 688.08
Fluarix Elderly Group	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	222.79 cells per million CD4+ T-cells	Standard Deviation 709.97
Fluarix Elderly Group	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	201.28 cells per million CD4+ T-cells	Standard Deviation 331.4
Fluarix Elderly Group	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	156.82 cells per million CD4+ T-cells	Standard Deviation 359.54
Fluarix Elderly Group	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	351.89 cells per million CD4+ T-cells	Standard Deviation 341.86
Fluarix Elderly Group	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	337.96 cells per million CD4+ T-cells	Standard Deviation 600.56
Fluarix Elderly Group	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	155.01 cells per million CD4+ T-cells	Standard Deviation 472.8
Fluarix Elderly Group	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	148.60 cells per million CD4+ T-cells	Standard Deviation 575.79
Fluarix Elderly Group	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	91.55 cells per million CD4+ T-cells	Standard Deviation 351.37
Fluarix Elderly Group	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	85.83 cells per million CD4+ T-cells	Standard Deviation 260.52
Fluarix Elderly Group	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	144.14 cells per million CD4+ T-cells	Standard Deviation 286.54
Fluarix Elderly Group	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	185.93 cells per million CD4+ T-cells	Standard Deviation 447.8
Fluarix Elderly Group	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	336.49 cells per million CD4+ T-cells	Standard Deviation 703.76
Fluarix Elderly Group	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	231.87 cells per million CD4+ T-cells	Standard Deviation 687.91
Fluarix Elderly Group	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	159.48 cells per million CD4+ T-cells	Standard Deviation 449.91
Fluarix Elderly Group	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	151.95 cells per million CD4+ T-cells	Standard Deviation 362.38
Fluarix Elderly Group	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	318.55 cells per million CD4+ T-cells	Standard Deviation 631.64
Fluarix Elderly Group	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	277.02 cells per million CD4+ T-cells	Standard Deviation 793.58
Fluarix Elderly Group	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	279.39 cells per million CD4+ T-cells	Standard Deviation 719.36
Fluarix Elderly Group	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	176.04 cells per million CD4+ T-cells	Standard Deviation 464.08
Fluarix Elderly Group	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	208.35 cells per million CD4+ T-cells	Standard Deviation 392.2
Fluarix Elderly Group	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	324.83 cells per million CD4+ T-cells	Standard Deviation 342.66
Fluarix Elderly Group	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	367.95 cells per million CD4+ T-cells	Standard Deviation 586.79
Fluarix Young Group	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	1036.33 cells per million CD4+ T-cells	Standard Deviation 578.74
Fluarix Young Group	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	423.12 cells per million CD4+ T-cells	Standard Deviation 553.25
Fluarix Young Group	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	307.21 cells per million CD4+ T-cells	Standard Deviation 428.94
Fluarix Young Group	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	508.67 cells per million CD4+ T-cells	Standard Deviation 453.14
Fluarix Young Group	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	770.48 cells per million CD4+ T-cells	Standard Deviation 697.03
Fluarix Young Group	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	507.44 cells per million CD4+ T-cells	Standard Deviation 466.62
Fluarix Young Group	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	349.47 cells per million CD4+ T-cells	Standard Deviation 435.78
Fluarix Young Group	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	1156.09 cells per million CD4+ T-cells	Standard Deviation 637.81
Fluarix Young Group	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	980.90 cells per million CD4+ T-cells	Standard Deviation 525.94
Fluarix Young Group	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	641.91 cells per million CD4+ T-cells	Standard Deviation 595.3
Fluarix Young Group	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	575.88 cells per million CD4+ T-cells	Standard Deviation 473.3
Fluarix Young Group	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	1119.56 cells per million CD4+ T-cells	Standard Deviation 621.33
Fluarix Young Group	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	1406.33 cells per million CD4+ T-cells	Standard Deviation 663.12
Fluarix Young Group	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	1314.16 cells per million CD4+ T-cells	Standard Deviation 747.54
Fluarix Young Group	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	689.52 cells per million CD4+ T-cells	Standard Deviation 585.4
Fluarix Young Group	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	1211.75 cells per million CD4+ T-cells	Standard Deviation 589.02
Fluarix Young Group	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	1126.10 cells per million CD4+ T-cells	Standard Deviation 629.66
Fluarix Young Group	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	449.17 cells per million CD4+ T-cells	Standard Deviation 407.25
Fluarix Young Group	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	245.90 cells per million CD4+ T-cells	Standard Deviation 490.89
Fluarix Young Group	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	1083.09 cells per million CD4+ T-cells	Standard Deviation 642.04
Fluarix Young Group	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	850.80 cells per million CD4+ T-cells	Standard Deviation 454.84
Fluarix Young Group	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	912.64 cells per million CD4+ T-cells	Standard Deviation 564.57
Fluarix Young Group	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	646.39 cells per million CD4+ T-cells	Standard Deviation 529.95
Fluarix Young Group	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	1059.08 cells per million CD4+ T-cells	Standard Deviation 513.03
Fluarix Young Group	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	507.94 cells per million CD4+ T-cells	Standard Deviation 575.13
Fluarix Young Group	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	976.64 cells per million CD4+ T-cells	Standard Deviation 580.31
Fluarix Young Group	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	641.34 cells per million CD4+ T-cells	Standard Deviation 620.52
Fluarix Young Group	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	1173.43 cells per million CD4+ T-cells	Standard Deviation 534.19
Fluarix Young Group	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	250.20 cells per million CD4+ T-cells	Standard Deviation 480.89
Fluarix Young Group	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	1119.71 cells per million CD4+ T-cells	Standard Deviation 663.02

Secondary

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

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.

Time frame: 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.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
New Generation Influenza Vaccine GSK2186877A Group	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 842.2
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
New Generation Influenza Vaccine GSK2186877A Group	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
Fluarix Elderly Group	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	357.47 cells per million CD4+ T-cells	Standard Deviation 487
Fluarix Elderly Group	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	395.98 cells per million CD4+ T-cells	Standard Deviation 526.39
Fluarix Elderly Group	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	170.26 cells per million CD4+ T-cells	Standard Deviation 295.26
Fluarix Elderly Group	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	514.93 cells per million CD4+ T-cells	Standard Deviation 530.05
Fluarix Elderly Group	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	383.44 cells per million CD4+ T-cells	Standard Deviation 485.65
Fluarix Elderly Group	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	188.07 cells per million CD4+ T-cells	Standard Deviation 251.35
Fluarix Elderly Group	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	454.81 cells per million CD4+ T-cells	Standard Deviation 488.31
Fluarix Elderly Group	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	195.30 cells per million CD4+ T-cells	Standard Deviation 449.01
Fluarix Elderly Group	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	93.12 cells per million CD4+ T-cells	Standard Deviation 214.88
Fluarix Elderly Group	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	191.20 cells per million CD4+ T-cells	Standard Deviation 480.62
Fluarix Elderly Group	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	337.02 cells per million CD4+ T-cells	Standard Deviation 491.89
Fluarix Elderly Group	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	156.64 cells per million CD4+ T-cells	Standard Deviation 247.58
Fluarix Elderly Group	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	360.15 cells per million CD4+ T-cells	Standard Deviation 499.75
Fluarix Elderly Group	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	211.11 cells per million CD4+ T-cells	Standard Deviation 261.05
Fluarix Elderly Group	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	414.80 cells per million CD4+ T-cells	Standard Deviation 454.02
Fluarix Young Group	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	1024.05 cells per million CD4+ T-cells	Standard Deviation 242.01
Fluarix Young Group	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	487.90 cells per million CD4+ T-cells	Standard Deviation 502.24
Fluarix Young Group	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	364.47 cells per million CD4+ T-cells	Standard Deviation 472.06
Fluarix Young Group	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	444.32 cells per million CD4+ T-cells	Standard Deviation 493.66
Fluarix Young Group	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	838.17 cells per million CD4+ T-cells	Standard Deviation 592.74
Fluarix Young Group	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	940.07 cells per million CD4+ T-cells	Standard Deviation 268.02
Fluarix Young Group	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	1156.78 cells per million CD4+ T-cells	Standard Deviation 246.61
Fluarix Young Group	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	945.71 cells per million CD4+ T-cells	Standard Deviation 669.7
Fluarix Young Group	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	833.70 cells per million CD4+ T-cells	Standard Deviation 587.76
Fluarix Young Group	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	344.50 cells per million CD4+ T-cells	Standard Deviation 475.04
Fluarix Young Group	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	523.37 cells per million CD4+ T-cells	Standard Deviation 578.23
Fluarix Young Group	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	846.21 cells per million CD4+ T-cells	Standard Deviation 187.26
Fluarix Young Group	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	718.48 cells per million CD4+ T-cells	Standard Deviation 530.31
Fluarix Young Group	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	953.49 cells per million CD4+ T-cells	Standard Deviation 224.88
Fluarix Young Group	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	777.60 cells per million CD4+ T-cells	Standard Deviation 606.71

Secondary

The Number of Subjects Seroconverted to HI Antibodies at Day 180

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.

Time frame: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seroconverted to HI Antibodies at Day 180	A/Uruguay vaccine strain	12 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seroconverted to HI Antibodies at Day 180	A/Brisbane vaccine strain	4 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seroconverted to HI Antibodies at Day 180	B/Brisbane vaccine strain	2 Participants
Fluarix Elderly Group	The Number of Subjects Seroconverted to HI Antibodies at Day 180	A/Uruguay vaccine strain	7 Participants
Fluarix Elderly Group	The Number of Subjects Seroconverted to HI Antibodies at Day 180	A/Brisbane vaccine strain	2 Participants
Fluarix Elderly Group	The Number of Subjects Seroconverted to HI Antibodies at Day 180	B/Brisbane vaccine strain	4 Participants
Fluarix Young Group	The Number of Subjects Seroconverted to HI Antibodies at Day 180	A/Brisbane vaccine strain	1 Participants
Fluarix Young Group	The Number of Subjects Seroconverted to HI Antibodies at Day 180	B/Brisbane vaccine strain	4 Participants
Fluarix Young Group	The Number of Subjects Seroconverted to HI Antibodies at Day 180	A/Uruguay vaccine strain	2 Participants

Secondary

The Number of Subjects Seroconverted to HI Antibodies at Day 21

Time frame: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seroconverted to HI Antibodies at Day 21	A/Uruguay vaccine strain	73 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seroconverted to HI Antibodies at Day 21	A/Brisbane vaccine strain	29 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seroconverted to HI Antibodies at Day 21	B/Brisbane vaccine strain	39 Participants
Fluarix Elderly Group	The Number of Subjects Seroconverted to HI Antibodies at Day 21	A/Uruguay vaccine strain	34 Participants
Fluarix Elderly Group	The Number of Subjects Seroconverted to HI Antibodies at Day 21	A/Brisbane vaccine strain	16 Participants
Fluarix Elderly Group	The Number of Subjects Seroconverted to HI Antibodies at Day 21	B/Brisbane vaccine strain	13 Participants
Fluarix Young Group	The Number of Subjects Seroconverted to HI Antibodies at Day 21	A/Brisbane vaccine strain	9 Participants
Fluarix Young Group	The Number of Subjects Seroconverted to HI Antibodies at Day 21	B/Brisbane vaccine strain	15 Participants
Fluarix Young Group	The Number of Subjects Seroconverted to HI Antibodies at Day 21	A/Uruguay vaccine strain	21 Participants

Secondary

The Number of Subjects Seropositive to HI Antibodies at Day 180

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

Time frame: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seropositive to HI Antibodies at Day 180	A/Uruguay vaccine strain	131 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seropositive to HI Antibodies at Day 180	A/Brisbane vaccine strain	127 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seropositive to HI Antibodies at Day 180	B/Brisbane vaccine strain	132 Participants
Fluarix Elderly Group	The Number of Subjects Seropositive to HI Antibodies at Day 180	A/Uruguay vaccine strain	72 Participants
Fluarix Elderly Group	The Number of Subjects Seropositive to HI Antibodies at Day 180	A/Brisbane vaccine strain	70 Participants
Fluarix Elderly Group	The Number of Subjects Seropositive to HI Antibodies at Day 180	B/Brisbane vaccine strain	75 Participants
Fluarix Young Group	The Number of Subjects Seropositive to HI Antibodies at Day 180	A/Brisbane vaccine strain	71 Participants
Fluarix Young Group	The Number of Subjects Seropositive to HI Antibodies at Day 180	B/Brisbane vaccine strain	70 Participants
Fluarix Young Group	The Number of Subjects Seropositive to HI Antibodies at Day 180	A/Uruguay vaccine strain	68 Participants

Secondary

The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21

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

Time frame: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21	A/Brisbane vaccine strain at Day 0	139 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21	A/Brisbane vaccine strain at Day 21	150 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21	A/Uruguay vaccine strain at Day 0	143 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21	A/Uruguay vaccine strain at Day 21	154 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21	B/Brisbane vaccine strain at Day 0	151 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21	B/Brisbane vaccine strain at Day 21	154 Participants
Fluarix Elderly Group	The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21	B/Brisbane vaccine strain at Day 21	86 Participants
Fluarix Elderly Group	The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21	A/Brisbane vaccine strain at Day 0	79 Participants
Fluarix Elderly Group	The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21	A/Uruguay vaccine strain at Day 21	85 Participants
Fluarix Elderly Group	The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21	B/Brisbane vaccine strain at Day 0	86 Participants
Fluarix Elderly Group	The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21	A/Brisbane vaccine strain at Day 21	86 Participants
Fluarix Elderly Group	The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21	A/Uruguay vaccine strain at Day 0	78 Participants
Fluarix Young Group	The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21	A/Brisbane vaccine strain at Day 21	78 Participants
Fluarix Young Group	The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21	A/Uruguay vaccine strain at Day 0	71 Participants
Fluarix Young Group	The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21	B/Brisbane vaccine strain at Day 21	78 Participants
Fluarix Young Group	The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21	A/Uruguay vaccine strain at Day 21	78 Participants
Fluarix Young Group	The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21	A/Brisbane vaccine strain at Day 0	73 Participants
Fluarix Young Group	The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21	B/Brisbane vaccine strain at Day 0	75 Participants

Secondary

The Number of Subjects Seroprotected to HI Antibodies at Day 180

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

Time frame: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seroprotected to HI Antibodies at Day 180	A/Uruguay vaccine strain	111 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seroprotected to HI Antibodies at Day 180	A/Brisbane vaccine strain	77 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seroprotected to HI Antibodies at Day 180	B/Brisbane vaccine strain	119 Participants
Fluarix Elderly Group	The Number of Subjects Seroprotected to HI Antibodies at Day 180	A/Uruguay vaccine strain	52 Participants
Fluarix Elderly Group	The Number of Subjects Seroprotected to HI Antibodies at Day 180	A/Brisbane vaccine strain	35 Participants
Fluarix Elderly Group	The Number of Subjects Seroprotected to HI Antibodies at Day 180	B/Brisbane vaccine strain	69 Participants
Fluarix Young Group	The Number of Subjects Seroprotected to HI Antibodies at Day 180	A/Brisbane vaccine strain	56 Participants
Fluarix Young Group	The Number of Subjects Seroprotected to HI Antibodies at Day 180	B/Brisbane vaccine strain	67 Participants
Fluarix Young Group	The Number of Subjects Seroprotected to HI Antibodies at Day 180	A/Uruguay vaccine strain	56 Participants

Secondary

The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21

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

Time frame: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21	B/Brisbane vaccine strain at Day 21	151 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21	A/Uruguay vaccine strain at Day 0	103 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21	B/Brisbane vaccine strain at Day 0	131 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21	A/Brisbane vaccine strain at Day 0	76 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21	A/Uruguay vaccine strain at Day 21	151 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21	A/Brisbane vaccine strain at Day 21	124 Participants
Fluarix Elderly Group	The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21	A/Uruguay vaccine strain at Day 21	76 Participants
Fluarix Elderly Group	The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21	B/Brisbane vaccine strain at Day 0	75 Participants
Fluarix Elderly Group	The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21	A/Brisbane vaccine strain at Day 21	64 Participants
Fluarix Elderly Group	The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21	B/Brisbane vaccine strain at Day 21	86 Participants
Fluarix Elderly Group	The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21	A/Brisbane vaccine strain at Day 0	34 Participants
Fluarix Elderly Group	The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21	A/Uruguay vaccine strain at Day 0	49 Participants
Fluarix Young Group	The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21	A/Uruguay vaccine strain at Day 0	52 Participants
Fluarix Young Group	The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21	A/Brisbane vaccine strain at Day 0	62 Participants
Fluarix Young Group	The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21	A/Brisbane vaccine strain at Day 21	72 Participants
Fluarix Young Group	The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21	B/Brisbane vaccine strain at Day 21	76 Participants
Fluarix Young Group	The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21	A/Uruguay vaccine strain at Day 21	73 Participants
Fluarix Young Group	The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21	B/Brisbane vaccine strain at Day 0	67 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

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

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Duration of Solicited General AEs

Duration of Solicited Local AEs

Number of Subjects Reporting AEs of Specific Interest (AESI)

Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)

Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) After Day 180

Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) up to Day 180

Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit

Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs

Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs

Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21

HI Antibody SCF at Day 180

HI Antibody Seroconversion Factors (SCF) at Day 21

HI Antibody Titers at Day 180

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

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

The Number of Subjects Seroconverted to HI Antibodies at Day 180

The Number of Subjects Seroconverted to HI Antibodies at Day 21

The Number of Subjects Seropositive to HI Antibodies at Day 180

The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21

The Number of Subjects Seroprotected to HI Antibodies at Day 180

The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21