Evaluation of Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Years and Older

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

NCT00760617

Enrollment

526

Registered

2008-09-26

Start date

2008-10-06

Completion date

2009-05-15

Last updated

2018-08-17

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

Conditions

Influenza

Keywords

Influenza, Elderly

Brief summary

The purpose of this study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older. This protocol posting deals with objectives & outcome measures of the extension phase at year 1. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00540592).

Interventions

BIOLOGICALGSK Bio's influenza vaccine GSK2186877A

Intramuscular (IM) administration, 1 dose

BIOLOGICALFluarix

Intramuscular (IM) administration, 1 dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol. * A male or female aged 18-41 years or ≥65 years at the time of the vaccination and who participated in the 110847 study and completed the 6 month follow-up. * Written informed consent obtained from the subject. * Fee of acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study. * Female subjects must be of non-childbearing potential.

Exclusion criteria

* Use of any investigational or non-registered product (drug or vaccine) 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 2008 with a seasonal influenza vaccine. * Chronic administration (defined as more than 14 days) 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 (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) or pre-existing laboratory screening tests. * Acute disease at the time of enrolment. * Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration during the study. * Any medical conditions in which IM injections are contraindicated. * 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 Related Serious Adverse Events (SAEs) From Day 180 to Day 209	Day 180 to Day 209	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 Grade 3 Solicited Local Adverse Events (AEs)	Day 0-6	Grade 3 ecchymosis, redness and swelling was greater than or equal to 100 millimeter (mm) i.e. ≥ 100 mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade.
Duration of Solicited Local AEs	Day 0-6	Duration was defined as number of days with any grade of local symptoms and grade for quantifiable symptoms: ecchymosis, redness and swelling was greater than (\>) 20mm.
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 \>40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to vaccination, grade 3 was defined as a general symptom that prevented normal activity and related was a 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 adverse event (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 possibly related to the study vaccination.
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 0 to 20	Day 0-20	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 possibly related to the study vaccination.
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 21 to 179	Day 21-179	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 possibly related to the study vaccination.
Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Disease (AID)	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 autoiimune 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 possibly related to the study vaccination.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 to Day 20	Day 0-20	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) Between Day 21 to Day 179	Day 21-179	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
Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	At Day 0 and 21	Antibody titers were expressed as Geometric mean titres (GMTs) with separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
HI Antibody Titers at Day 180	Day 180	Antibody titers were expressed as GMTs with separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21	At Day 0 and 21	Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
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 vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
The Number of Subjects Seroconverted to HI Antibodies at Day 21	Day 21	Seroconversion was defined as the percentage of vaccinees who had either a pre-vaccination titre less than (\<) 1:10 and a post-vaccination titre ≥1:40 or a pre-vaccination titre ≥1:10 and at least a 4-fold increase in post-vaccination titre. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
The Number of Subjects Seroconverted to HI Antibodies at Day 180	Day 180	Seroconversion was defined as the percentage of vaccinees who had either a pre-vaccination titre \<1:10 and a post-vaccination titre ≥1:40 or a pre-vaccination titre ≥1:10 and at least a 4-fold increase in post-vaccination titre. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
HI Antibody Seroconversion Factor (SCF) at Day 21	Day 21	SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
HI Antibody SCF at Day 180	Day 180	SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21	At Day 0 and 21	Seroprotection was defined as the percentage of vaccinees with a serum HI titre ≥1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
The Number of Subjects Seroprotected to HI Antibodies at Day 180	Day 180	Seroprotection was defined as the percentage of vaccinees with a serum HI titre ≥1:40 that usually is accepted as indicating protection. The vaccine strains 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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	At Day 0 and 21	The markers assessed were CD4-ALL DOUBLES, CD40 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.

Countries

Germany, Netherlands, Sweden

Participant flow

Participants by arm

Arm	Count
New Generation Influenza Vaccine GSK2186877A Group Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A	266
Fluarix Elderly Group Subjects aged ≥65 years received 1 dose of Fluarix vaccine	144
Fluarix Young Group Subjects aged 18-40 years received 1 dose of Fluarix vaccine	116
Total	526

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	5	2	0
Overall Study	Lost to Follow-up	0	0	5

Baseline characteristics

Characteristic	New Generation Influenza Vaccine GSK2186877A Group	Fluarix Elderly Group	Fluarix Young Group	Total
Age, Continuous	73.5 Years STANDARD_DEVIATION 5.27	73.8 Years STANDARD_DEVIATION 5.54	28.2 Years STANDARD_DEVIATION 6.34	63.59 Years STANDARD_DEVIATION 19.65
Sex: Female, Male Female	143 Participants	68 Participants	53 Participants	264 Participants
Sex: Female, Male Male	123 Participants	76 Participants	63 Participants	262 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	160 / 266	39 / 144	80 / 116
serious Total, serious adverse events	19 / 266	7 / 144	2 / 116

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 only on subjects that reported the specific symptom.

Arm	Measure	Group	Value (MEDIAN)
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	Myalgia	2.0 Days
New Generation Influenza Vaccine GSK2186877A Group	Duration of Solicited General AEs	Headache	1.0 Days
New Generation Influenza Vaccine GSK2186877A Group	Duration of Solicited General AEs	Arthralgia	2.0 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	Gastrointestinal symptoms	1.0 Days
New Generation Influenza Vaccine GSK2186877A Group	Duration of Solicited General AEs	Shivering	1.0 Days
Fluarix Elderly Group	Duration of Solicited General AEs	Headache	1.0 Days
Fluarix Elderly Group	Duration of Solicited General AEs	Arthralgia	1.5 Days
Fluarix Elderly Group	Duration of Solicited General AEs	Fatigue	2.0 Days
Fluarix Elderly Group	Duration of Solicited General AEs	Gastrointestinal symptoms	2.0 Days
Fluarix Elderly Group	Duration of Solicited General AEs	Myalgia	2.0 Days
Fluarix Elderly Group	Duration of Solicited General AEs	Shivering	2.0 Days
Fluarix Elderly Group	Duration of Solicited General AEs	Fever	1.0 Days
Fluarix Young Group	Duration of Solicited General AEs	Myalgia	2.0 Days
Fluarix Young Group	Duration of Solicited General AEs	Fatigue	2.0 Days
Fluarix Young Group	Duration of Solicited General AEs	Fever	1.0 Days
Fluarix Young Group	Duration of Solicited General AEs	Shivering	1.0 Days
Fluarix Young Group	Duration of Solicited General AEs	Headache	1.5 Days
Fluarix Young Group	Duration of Solicited General AEs	Gastrointestinal symptoms	1.0 Days
Fluarix Young Group	Duration of Solicited General AEs	Arthralgia	3.0 Days

Primary

Duration of Solicited Local AEs

Duration was defined as number of days with any grade of local symptoms and grade for quantifiable symptoms: ecchymosis, redness and swelling was greater than (\>) 20mm.

Time frame: Day 0-6

Arm	Measure	Group	Value (MEDIAN)
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	Ecchymosis	6.0 Days
New Generation Influenza Vaccine GSK2186877A Group	Duration of Solicited Local AEs	Swelling	2.0 Days
Fluarix Elderly Group	Duration of Solicited Local AEs	Pain	2.0 Days
Fluarix Elderly Group	Duration of Solicited Local AEs	Swelling	3.0 Days
Fluarix Elderly Group	Duration of Solicited Local AEs	Redness	2.0 Days
Fluarix Elderly Group	Duration of Solicited Local AEs	Ecchymosis	4.0 Days
Fluarix Young Group	Duration of Solicited Local AEs	Redness	2.0 Days
Fluarix Young Group	Duration of Solicited Local AEs	Ecchymosis	7.0 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

Primary

Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Disease (AID)

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 autoiimune 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 possibly 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) Including Autoimmune Disease (AID)	Grade 3 AE(s)	0 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Disease (AID)	Any AE(s)	0 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Disease (AID)	Related AE(s)	0 Participants
Fluarix Elderly Group	Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Disease (AID)	Related AE(s)	0 Participants
Fluarix Elderly Group	Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Disease (AID)	Any AE(s)	0 Participants
Fluarix Elderly Group	Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Disease (AID)	Grade 3 AE(s)	0 Participants
Fluarix Young Group	Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Disease (AID)	Grade 3 AE(s)	0 Participants
Fluarix Young Group	Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Disease (AID)	Related AE(s)	0 Participants
Fluarix Young Group	Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Disease (AID)	Any AE(s)	0 Participants

Primary

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

Grade 3 ecchymosis, redness and swelling was greater than or equal to 100 millimeter (mm) i.e. ≥ 100 mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade.

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)	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 pain	108 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
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Any swelling	20 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 ecchymosis	2 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 redness	43 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Any swelling	7 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Any ecchymosis	2 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)	Grade 3 redness	0 Participants
Fluarix Elderly 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)	Grade 3 ecchymosis	0 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Any pain	18 Participants
Fluarix Elderly 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 pain	0 Participants
Fluarix Young Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Any ecchymosis	1 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 redness	3 Participants
Fluarix Young Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)	Any swelling	1 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 pain	61 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) Between Day 0 to Day 20

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: 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 and Related Serious Adverse Events (SAEs) Between Day 0 to Day 20	Any SAE(s)	4 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 to Day 20	Related SAE(s)	0 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 to Day 20	Any SAE(s)	2 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 to Day 20	Related SAE(s)	0 Participants
Fluarix Young Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 to Day 20	Any SAE(s)	1 Participants
Fluarix Young Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 to Day 20	Related SAE(s)	0 Participants

Primary

Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 to Day 179

Time frame: Day 21-179

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 and Related Serious Adverse Events (SAEs) Between Day 21 to Day 179	Any SAE(s)	19 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 to Day 179	Related SAE(s)	0 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 to Day 179	Any SAE(s)	7 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 to Day 179	Related SAE(s)	0 Participants
Fluarix Young Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 to Day 179	Any SAE(s)	2 Participants
Fluarix Young Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 to Day 179	Related SAE(s)	0 Participants

Primary

Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 180 to Day 209

Time frame: Day 180 to Day 209

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) From Day 180 to Day 209	Any SAE(s)	0 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 180 to Day 209	Related SAE(s)	0 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 180 to Day 209	Any SAE(s)	3 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 180 to Day 209	Related SAE(s)	0 Participants
Fluarix Young Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 180 to Day 209	Any SAE(s)	0 Participants
Fluarix Young Group	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 180 to Day 209	Related SAE(s)	0 Participants

Primary

Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 0 to 20

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 possibly 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 AEs With a Medically Attended Visit Between Day 0 to 20	Grade 3 AE(s)	4 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 0 to 20	Any AE(s)	20 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 0 to 20	Related AE(s)	0 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 0 to 20	Grade 3 AE(s)	1 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 0 to 20	Related AE(s)	0 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 0 to 20	Any AE(s)	8 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 0 to 20	Any AE(s)	9 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 0 to 20	Grade 3 AE(s)	1 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 0 to 20	Related AE(s)	0 Participants

Primary

Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 21 to 179

Time frame: Day 21-179

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 Between Day 21 to 179	Grade 3 AE(s)	26 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 21 to 179	Any AE(s)	103 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 21 to 179	Related AE(s)	0 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 21 to 179	Grade 3 AE(s)	8 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 21 to 179	Any AE(s)	48 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 21 to 179	Related AE(s)	0 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 21 to 179	Any AE(s)	33 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 21 to 179	Related AE(s)	0 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 21 to 179	Grade 3 AE(s)	9 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 \>40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to vaccination, grade 3 was defined as a general symptom that prevented normal activity and related was a 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	Any myalgia	42 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Grade 3 fatigue	1 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related myalgia	31 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Grade 3 shivering	0 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	37 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any gastrointestinal symptoms	24 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Grade 3 myalgia	0 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related shivering	29 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any arthralgia	30 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	Grade 3 gastrointestinal symptoms	0 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related fatigue	39 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related gastrointestinal symptoms	13 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related fever	4 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any headache	39 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related arthralgia	20 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	5 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any fatigue	51 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related headache	24 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related gastrointestinal symptoms	4 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	5 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any fatigue	11 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related fatigue	10 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any headache	7 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	Any myalgia	8 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related myalgia	6 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any shivering	6 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	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 Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any arthralgia	6 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	Any gastrointestinal symptoms	5 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Grade 3 gastrointestinal symptoms	0 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related headache	4 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 shivering	4 Participants
Fluarix Elderly 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 gastrointestinal symptoms	2 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related shivering	7 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any fatigue	27 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related gastrointestinal symptoms	2 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any headache	30 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related fever	3 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related headache	17 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any myalgia	16 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any gastrointestinal symptoms	9 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 myalgia	0 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any shivering	10 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related fatigue	19 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any fever	5 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Grade 3 shivering	1 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Any arthralgia	10 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related myalgia	12 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Related arthralgia	7 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs	Grade 3 headache	4 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	Grade 3 fatigue	2 Participants

Primary

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

Unsolicited adverse event (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 possibly 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)	6 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs	Any AE(s)	49 Participants
New Generation Influenza Vaccine GSK2186877A Group	Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs	Related AE(s)	1 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs	Grade 3 AE(s)	1 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs	Any AE(s)	20 Participants
Fluarix Elderly Group	Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs	Related AE(s)	2 Participants
Fluarix Young Group	Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs	Any AE(s)	18 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)	4 Participants

Secondary

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

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

Time frame: At Day 0 and 21

Population: Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
New Generation Influenza Vaccine GSK2186877A Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	A/Uruguay vaccine strain at Day 0	28.1 titer
New Generation Influenza Vaccine GSK2186877A Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	B/Brisbane vaccine strain at Day 21	519.0 titer
New Generation Influenza Vaccine GSK2186877A Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	B/Brisbane vaccine strain at Day 0	126.5 titer
New Generation Influenza Vaccine GSK2186877A Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	A/Brisbane vaccine strain at Day 0	27.9 titer
New Generation Influenza Vaccine GSK2186877A Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	A/Brisbane vaccine strain at Day 21	74.6 titer
New Generation Influenza Vaccine GSK2186877A Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	A/Uruguay vaccine strain at Day 21	243.9 titer
Fluarix Elderly Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	B/Brisbane vaccine strain at Day 0	159.9 titer
Fluarix Elderly Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	A/Brisbane vaccine strain at Day 0	22.9 titer
Fluarix Elderly Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	A/Uruguay vaccine strain at Day 0	22.8 titer
Fluarix Elderly Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	A/Uruguay vaccine strain at Day 21	134.8 titer
Fluarix Elderly Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	B/Brisbane vaccine strain at Day 21	402.5 titer
Fluarix Elderly Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	A/Brisbane vaccine strain at Day 21	57.5 titer
Fluarix Young Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	A/Brisbane vaccine strain at Day 21	164.7 titer
Fluarix Young Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	B/Brisbane vaccine strain at Day 21	711.5 titer
Fluarix Young Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	A/Brisbane vaccine strain at Day 0	43.2 titer
Fluarix Young Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	A/Uruguay vaccine strain at Day 0	28.9 titer
Fluarix Young Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	B/Brisbane vaccine strain at Day 0	192.7 titer
Fluarix Young Group	Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21	A/Uruguay vaccine strain at Day 21	171.1 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. 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 persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
New Generation Influenza Vaccine GSK2186877A Group	HI Antibody SCF at Day 180	A/Uruguay vaccine strain	3.4 fold increase
New Generation Influenza Vaccine GSK2186877A Group	HI Antibody SCF at Day 180	A/Brisbane vaccine strain	1.3 fold increase
New Generation Influenza Vaccine GSK2186877A Group	HI Antibody SCF at Day 180	B/Brisbane vaccine strain	2.2 fold increase
Fluarix Elderly Group	HI Antibody SCF at Day 180	A/Uruguay vaccine strain	2.9 fold increase
Fluarix Elderly Group	HI Antibody SCF at Day 180	A/Brisbane vaccine strain	1.2 fold increase
Fluarix Elderly Group	HI Antibody SCF at Day 180	B/Brisbane vaccine strain	1.7 fold increase
Fluarix Young Group	HI Antibody SCF at Day 180	A/Brisbane vaccine strain	2.4 fold increase
Fluarix Young Group	HI Antibody SCF at Day 180	B/Brisbane vaccine strain	2.7 fold increase
Fluarix Young Group	HI Antibody SCF at Day 180	A/Uruguay vaccine strain	3.1 fold increase

Secondary

HI Antibody Seroconversion Factor (SCF) at Day 21

SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.

Time frame: Day 21

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
New Generation Influenza Vaccine GSK2186877A Group	HI Antibody Seroconversion Factor (SCF) at Day 21	A/Uruguay vaccine strain	8.7 fold increase
New Generation Influenza Vaccine GSK2186877A Group	HI Antibody Seroconversion Factor (SCF) at Day 21	A/Brisbane vaccine strain	2.7 fold increase
New Generation Influenza Vaccine GSK2186877A Group	HI Antibody Seroconversion Factor (SCF) at Day 21	B/Brisbane vaccine strain	4.1 fold increase
Fluarix Elderly Group	HI Antibody Seroconversion Factor (SCF) at Day 21	A/Uruguay vaccine strain	5.9 fold increase
Fluarix Elderly Group	HI Antibody Seroconversion Factor (SCF) at Day 21	A/Brisbane vaccine strain	2.5 fold increase
Fluarix Elderly Group	HI Antibody Seroconversion Factor (SCF) at Day 21	B/Brisbane vaccine strain	2.5 fold increase
Fluarix Young Group	HI Antibody Seroconversion Factor (SCF) at Day 21	A/Brisbane vaccine strain	3.8 fold increase
Fluarix Young Group	HI Antibody Seroconversion Factor (SCF) at Day 21	B/Brisbane vaccine strain	3.7 fold increase
Fluarix Young Group	HI Antibody Seroconversion Factor (SCF) at Day 21	A/Uruguay vaccine strain	5.9 fold increase

Secondary

HI Antibody Titers at Day 180

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

Time frame: Day 180

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
New Generation Influenza Vaccine GSK2186877A Group	HI Antibody Titers at Day 180	A/Uruguay vaccine strain	90.1 titers
New Generation Influenza Vaccine GSK2186877A Group	HI Antibody Titers at Day 180	A/Brisbane vaccine strain	34.9 titers
New Generation Influenza Vaccine GSK2186877A Group	HI Antibody Titers at Day 180	B/Brisbane vaccine strain	278.7 titers
Fluarix Elderly Group	HI Antibody Titers at Day 180	A/Uruguay vaccine strain	69.9 titers
Fluarix Elderly Group	HI Antibody Titers at Day 180	A/Brisbane vaccine strain	27.7 titers
Fluarix Elderly Group	HI Antibody Titers at Day 180	B/Brisbane vaccine strain	255.7 titers
Fluarix Young Group	HI Antibody Titers at Day 180	A/Brisbane vaccine strain	99.5 titers
Fluarix Young Group	HI Antibody Titers at Day 180	B/Brisbane vaccine strain	463.3 titers
Fluarix Young Group	HI Antibody Titers at Day 180	A/Uruguay vaccine strain	86.1 titers

Secondary

The Geometric Mean (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 Days 0 and 21

The markers assessed were CD4-ALL DOUBLES, CD40 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 21

Population: Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for cell mediated immunity (CMI) which included subjects for whom data concerning immunogenicity CMI outcome measures were available at day 21.

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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Brisbane [CD4-ALL DOUBLES] Day 21	1431.41 cells per million CD4 T-cells	Standard Deviation 679.6
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	B/Brisbane [CD4-IL2] Day 0	711.32 cells per million CD4 T-cells	Standard Deviation 760.06
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Brisbane [CD4-IFN-γ] Day 21	839.94 cells per million CD4 T-cells	Standard Deviation 536.38
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	B/Brisbane [CD4-TNF-α] Day 0	646.27 cells per million CD4 T-cells	Standard Deviation 718.92
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Uruguay [CD4-IL2] Day 21	745.33 cells per million CD4 T-cells	Standard Deviation 428.75
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Uruguay [CD4-IFN-γ] Day 0	282.79 cells per million CD4 T-cells	Standard Deviation 321.42
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Brisbane [CD4-CD40L] Day 0	694.63 cells per million CD4 T-cells	Standard Deviation 452.67
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Uruguay [CD4-IL2] Day 0	385.93 cells per million CD4 T-cells	Standard Deviation 375.33
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Uruguay [CD4-IFN-γ] Day 21	628.36 cells per million CD4 T-cells	Standard Deviation 400.49
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Uruguay [CD4-ALL DOUBLES] Day 0	451.86 cells per million CD4 T-cells	Standard Deviation 419.39
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Brisbane [CD4-IL2] Day 21	1176.29 cells per million CD4 T-cells	Standard Deviation 568.05
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	B/Brisbane [CD4-IFN-γ] Day 0	447.23 cells per million CD4 T-cells	Standard Deviation 708.32
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Uruguay [CD4-TNF-α] Day 21	740.68 cells per million CD4 T-cells	Standard Deviation 448.67
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Brisbane [CD4-IL2] Day 0	645.57 cells per million CD4 T-cells	Standard Deviation 445.17
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	B/Brisbane [CD4-IFN-γ] Day 21	800.89 cells per million CD4 T-cells	Standard Deviation 648.91
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Brisbane [CD4-ALL DOUBLES] Day 0	751.28 cells per million CD4 T-cells	Standard Deviation 492.55
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Brisbane [CD4-CD40L] Day 21	1305.74 cells per million CD4 T-cells	Standard Deviation 622.93
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	B/Brisbane [CD4-ALL DOUBLES] Day 0	828.74 cells per million CD4 T-cells	Standard Deviation 840.19
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Uruguay [CD4-TNF-α] Day 0	405.12 cells per million CD4 T-cells	Standard Deviation 403.06
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Uruguay [CD4-CD40L] Day 0	392.35 cells per million CD4 T-cells	Standard Deviation 368.33
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Uruguay [CD4-ALL DOUBLES] Day 21	912.85 cells per million CD4 T-cells	Standard Deviation 496.53
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Brisbane [CD4-TNF-α] Day 21	1057.44 cells per million CD4 T-cells	Standard Deviation 568.35
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Uruguay [CD4-CD40L] Day 21	803.34 cells per million CD4 T-cells	Standard Deviation 459.33
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	B/Brisbane [CD4-TNF-α] Day 21	1021.43 cells per million CD4 T-cells	Standard Deviation 690.24
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Brisbane [CD4-TNF-α] Day 0	606.82 cells per million CD4 T-cells	Standard Deviation 442.61
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	B/Brisbane [CD4-CD40L] Day 0	775.18 cells per million CD4 T-cells	Standard Deviation 754.9
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	B/Brisbane [CD4-CD40L] Day 21	1230.63 cells per million CD4 T-cells	Standard Deviation 731.08
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	B/Brisbane [CD4-ALL DOUBLES] Day 21	1361.30 cells per million CD4 T-cells	Standard Deviation 799.1
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	B/Brisbane [CD4-IL2] Day 21	1112.52 cells per million CD4 T-cells	Standard Deviation 725.72
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Brisbane [CD4-IFN-γ] Day 0	430.40 cells per million CD4 T-cells	Standard Deviation 373.24
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	B/Brisbane [CD4-IFN-γ] Day 21	478.15 cells per million CD4 T-cells	Standard Deviation 851.02
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Brisbane [CD4-ALL DOUBLES] Day 0	682.47 cells per million CD4 T-cells	Standard Deviation 759.31
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Brisbane [CD4-ALL DOUBLES] Day 21	972.14 cells per million CD4 T-cells	Standard Deviation 1204.18
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Uruguay [CD4-ALL DOUBLES] Day 21	592.66 cells per million CD4 T-cells	Standard Deviation 518.19
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	B/Brisbane [CD4-ALL DOUBLES] Day 0	679.28 cells per million CD4 T-cells	Standard Deviation 702.37
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	B/Brisbane [CD4-ALL DOUBLES] Day 21	935.28 cells per million CD4 T-cells	Standard Deviation 1130.22
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Brisbane [CD4-CD40L] Day 0	616.27 cells per million CD4 T-cells	Standard Deviation 682.26
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Brisbane [CD4-CD40L] Day 21	855.81 cells per million CD4 T-cells	Standard Deviation 974.19
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Uruguay [CD4-CD40L] Day 0	361.18 cells per million CD4 T-cells	Standard Deviation 498.91
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Uruguay [CD4-CD40L] Day 21	543.41 cells per million CD4 T-cells	Standard Deviation 463.96
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	B/Brisbane [CD4-CD40L] Day 21	850.96 cells per million CD4 T-cells	Standard Deviation 901.02
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Brisbane [CD4-IFN-γ] Day 0	338.29 cells per million CD4 T-cells	Standard Deviation 613.41
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Brisbane [CD4-IFN-γ] Day 21	481.04 cells per million CD4 T-cells	Standard Deviation 976.79
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Uruguay [CD4-IFN-γ] Day 0	301.64 cells per million CD4 T-cells	Standard Deviation 426.04
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Uruguay [CD4-IFN-γ] Day 21	399.84 cells per million CD4 T-cells	Standard Deviation 387.97
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	B/Brisbane [CD4-IFN-γ] Day 0	299.25 cells per million CD4 T-cells	Standard Deviation 441.05
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Brisbane [CD4-IL2] Day 0	542.90 cells per million CD4 T-cells	Standard Deviation 700.45
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Brisbane [CD4-IL2] Day 21	816.63 cells per million CD4 T-cells	Standard Deviation 1114.87
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Uruguay [CD4-IL2] Day 0	392.63 cells per million CD4 T-cells	Standard Deviation 488.21
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Uruguay [CD4-IL2] Day 21	505.78 cells per million CD4 T-cells	Standard Deviation 459.04
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	B/Brisbane [CD4-IL2] Day 0	547.71 cells per million CD4 T-cells	Standard Deviation 646.5
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	B/Brisbane [CD4-IL2] Day 21	778.12 cells per million CD4 T-cells	Standard Deviation 1034.69
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Brisbane [CD4-TNF-α] Day 21	749.70 cells per million CD4 T-cells	Standard Deviation 1068.11
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Uruguay [CD4-TNF-α] Day 0	414.27 cells per million CD4 T-cells	Standard Deviation 508.57
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Uruguay [CD4-TNF-α] Day 21	449.51 cells per million CD4 T-cells	Standard Deviation 463.77
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	B/Brisbane [CD4-TNF-α] Day 0	558.87 cells per million CD4 T-cells	Standard Deviation 591.29
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	B/Brisbane [CD4-TNF-α] Day 21	715.45 cells per million CD4 T-cells	Standard Deviation 973.99
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Brisbane [CD4-TNF-α] Day 0	610.09 cells per million CD4 T-cells	Standard Deviation 669.96
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Uruguay [CD4-ALL DOUBLES] Day 0	444.42 cells per million CD4 T-cells	Standard Deviation 578.82
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	B/Brisbane [CD4-CD40L] Day 0	630.27 cells per million CD4 T-cells	Standard Deviation 630.81
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Uruguay [CD4-ALL DOUBLES] Day 0	743.45 cells per million CD4 T-cells	Standard Deviation 552.48
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	B/Brisbane [CD4-IL2] Day 0	852.51 cells per million CD4 T-cells	Standard Deviation 479.69
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	B/Brisbane [CD4-CD40L] Day 21	1275.70 cells per million CD4 T-cells	Standard Deviation 508.4
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	B/Brisbane [CD4-TNF-α] Day 21	1023.28 cells per million CD4 T-cells	Standard Deviation 475.97
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	B/Brisbane [CD4-IL2] Day 21	1156.73 cells per million CD4 T-cells	Standard Deviation 494.36
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Uruguay [CD4-CD40L] Day 21	816.08 cells per million CD4 T-cells	Standard Deviation 447.79
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Brisbane [CD4-TNF-α] Day 0	900.67 cells per million CD4 T-cells	Standard Deviation 914.33
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Uruguay [CD4-CD40L] Day 0	646.92 cells per million CD4 T-cells	Standard Deviation 542.81
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Brisbane [CD4-ALL DOUBLES] Day 0	1179.17 cells per million CD4 T-cells	Standard Deviation 1031.92
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Brisbane [CD4-TNF-α] Day 21	1096.74 cells per million CD4 T-cells	Standard Deviation 689.9
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Brisbane [CD4-CD40L] Day 21	1379.47 cells per million CD4 T-cells	Standard Deviation 735.06
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Brisbane [CD4-ALL DOUBLES] Day 21	1513.30 cells per million CD4 T-cells	Standard Deviation 798.38
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Uruguay [CD4-TNF-α] Day 0	575.28 cells per million CD4 T-cells	Standard Deviation 509.48
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Brisbane [CD4-CD40L] Day 0	1127.82 cells per million CD4 T-cells	Standard Deviation 946.5
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Uruguay [CD4-ALL DOUBLES] Day 21	912.28 cells per million CD4 T-cells	Standard Deviation 476.16
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Uruguay [CD4-TNF-α] Day 21	685.63 cells per million CD4 T-cells	Standard Deviation 429.55
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	B/Brisbane [CD4-IFN-γ] Day 21	934.53 cells per million CD4 T-cells	Standard Deviation 471.32
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	B/Brisbane [CD4-IFN-γ] Day 0	681.49 cells per million CD4 T-cells	Standard Deviation 413.65
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	B/Brisbane [CD4-ALL DOUBLES] Day 21	1403.64 cells per million CD4 T-cells	Standard Deviation 580.53
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Brisbane [CD4-IL2] Day 0	1033.28 cells per million CD4 T-cells	Standard Deviation 884.01
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Uruguay [CD4-IFN-γ] Day 21	638.93 cells per million CD4 T-cells	Standard Deviation 418.36
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	B/Brisbane [CD4-CD40L] Day 0	959.42 cells per million CD4 T-cells	Standard Deviation 465.42
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Brisbane [CD4-IL2] Day 21	1259.69 cells per million CD4 T-cells	Standard Deviation 691.36
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Uruguay [CD4-IFN-γ] Day 0	501.13 cells per million CD4 T-cells	Standard Deviation 482.16
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	B/Brisbane [CD4-TNF-α] Day 0	818.77 cells per million CD4 T-cells	Standard Deviation 441.82
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Uruguay [CD4-IL2] Day 0	599.02 cells per million CD4 T-cells	Standard Deviation 523.72
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Brisbane [CD4-IFN-γ] Day 21	985.11 cells per million CD4 T-cells	Standard Deviation 713.98
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	B/Brisbane [CD4-ALL DOUBLES] Day 0	1045.61 cells per million CD4 T-cells	Standard Deviation 510.95
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Uruguay [CD4-IL2] Day 21	745.61 cells per million CD4 T-cells	Standard Deviation 444.27
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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21	A/Brisbane [CD4-IFN-γ] Day 0	777.72 cells per million CD4 T-cells	Standard Deviation 837.25

Secondary

The Number of Subjects Seroconverted to HI Antibodies at Day 180

Seroconversion was defined as the percentage of vaccinees who had either a pre-vaccination titre \<1:10 and a post-vaccination titre ≥1:40 or a pre-vaccination titre ≥1:10 and at least a 4-fold increase in post-vaccination titre. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.

Time frame: Day 180

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	99 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seroconverted to HI Antibodies at Day 180	A/Brisbane vaccine strain	15 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seroconverted to HI Antibodies at Day 180	B/Brisbane vaccine strain	64 Participants
Fluarix Elderly Group	The Number of Subjects Seroconverted to HI Antibodies at Day 180	A/Uruguay vaccine strain	47 Participants
Fluarix Elderly Group	The Number of Subjects Seroconverted to HI Antibodies at Day 180	A/Brisbane vaccine strain	11 Participants
Fluarix Elderly Group	The Number of Subjects Seroconverted to HI Antibodies at Day 180	B/Brisbane vaccine strain	19 Participants
Fluarix Young Group	The Number of Subjects Seroconverted to HI Antibodies at Day 180	A/Brisbane vaccine strain	31 Participants
Fluarix Young Group	The Number of Subjects Seroconverted to HI Antibodies at Day 180	B/Brisbane vaccine strain	36 Participants
Fluarix Young Group	The Number of Subjects Seroconverted to HI Antibodies at Day 180	A/Uruguay vaccine strain	37 Participants

Secondary

The Number of Subjects Seroconverted to HI Antibodies at Day 21

Seroconversion was defined as the percentage of vaccinees who had either a pre-vaccination titre less than (\<) 1:10 and a post-vaccination titre ≥1:40 or a pre-vaccination titre ≥1:10 and at least a 4-fold increase in post-vaccination titre. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.

Time frame: Day 21

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	209 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seroconverted to HI Antibodies at Day 21	A/Brisbane vaccine strain	77 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seroconverted to HI Antibodies at Day 21	B/Brisbane vaccine strain	130 Participants
Fluarix Elderly Group	The Number of Subjects Seroconverted to HI Antibodies at Day 21	A/Uruguay vaccine strain	97 Participants
Fluarix Elderly Group	The Number of Subjects Seroconverted to HI Antibodies at Day 21	A/Brisbane vaccine strain	46 Participants
Fluarix Elderly Group	The Number of Subjects Seroconverted to HI Antibodies at Day 21	B/Brisbane vaccine strain	47 Participants
Fluarix Young Group	The Number of Subjects Seroconverted to HI Antibodies at Day 21	A/Brisbane vaccine strain	48 Participants
Fluarix Young Group	The Number of Subjects Seroconverted to HI Antibodies at Day 21	B/Brisbane vaccine strain	50 Participants
Fluarix Young Group	The Number of Subjects Seroconverted to HI Antibodies at Day 21	A/Uruguay vaccine strain	67 Participants

Secondary

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

Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.

Time frame: At Day 0 and 21

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21	A/Brisbane vaccine strain at Day 0	226 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21	A/Brisbane vaccine strain at Day 21	251 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21	A/Uruguay vaccine strain at Day 21	253 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21	B/Brisbane vaccine strain at Day 21	253 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21	A/Uruguay vaccine strain at Day 0	212 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21	B/Brisbane vaccine strain at Day 0	253 Participants
Fluarix Elderly Group	The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21	B/Brisbane vaccine strain at Day 0	142 Participants
Fluarix Elderly Group	The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21	A/Brisbane vaccine strain at Day 0	125 Participants
Fluarix Elderly Group	The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21	A/Uruguay vaccine strain at Day 21	140 Participants
Fluarix Elderly Group	The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21	B/Brisbane vaccine strain at Day 21	142 Participants
Fluarix Elderly Group	The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21	A/Brisbane vaccine strain at Day 21	141 Participants
Fluarix Elderly Group	The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21	A/Uruguay vaccine strain at Day 0	116 Participants
Fluarix Young Group	The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21	A/Brisbane vaccine strain at Day 21	108 Participants
Fluarix Young Group	The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21	B/Brisbane vaccine strain at Day 21	108 Participants
Fluarix Young Group	The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21	A/Uruguay vaccine strain at Day 21	108 Participants
Fluarix Young Group	The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21	B/Brisbane vaccine strain at Day 0	108 Participants
Fluarix Young Group	The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21	A/Uruguay vaccine strain at Day 0	90 Participants
Fluarix Young Group	The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21	A/Brisbane vaccine strain at Day 0	97 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. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.

Time frame: Day 180

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	235 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seropositive to HI Antibodies at Day 180	A/Brisbane vaccine strain	226 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seropositive to HI Antibodies at Day 180	B/Brisbane vaccine strain	241 Participants
Fluarix Elderly Group	The Number of Subjects Seropositive to HI Antibodies at Day 180	A/Uruguay vaccine strain	125 Participants
Fluarix Elderly Group	The Number of Subjects Seropositive to HI Antibodies at Day 180	A/Brisbane vaccine strain	123 Participants
Fluarix Elderly Group	The Number of Subjects Seropositive to HI Antibodies at Day 180	B/Brisbane vaccine strain	130 Participants
Fluarix Young Group	The Number of Subjects Seropositive to HI Antibodies at Day 180	A/Uruguay vaccine strain	99 Participants
Fluarix Young Group	The Number of Subjects Seropositive to HI Antibodies at Day 180	B/Brisbane vaccine strain	103 Participants
Fluarix Young Group	The Number of Subjects Seropositive to HI Antibodies at Day 180	A/Brisbane vaccine strain	102 Participants

Secondary

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

Seroprotection was defined as the percentage of vaccinees with a serum HI titre ≥1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.

Time frame: At Day 0 and 21

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21	A/Brisbane vaccine strain at Day 0	124 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21	A/Brisbane vaccine strain at Day 21	222 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21	A/Uruguay vaccine strain at Day 0	121 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21	A/Uruguay vaccine strain at Day 21	248 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21	B/Brisbane vaccine strain at Day 0	236 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21	B/Brisbane vaccine strain at Day 21	253 Participants
Fluarix Elderly Group	The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21	B/Brisbane vaccine strain at Day 21	141 Participants
Fluarix Elderly Group	The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21	A/Brisbane vaccine strain at Day 0	55 Participants
Fluarix Elderly Group	The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21	A/Uruguay vaccine strain at Day 21	123 Participants
Fluarix Elderly Group	The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21	B/Brisbane vaccine strain at Day 0	136 Participants
Fluarix Elderly Group	The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21	A/Brisbane vaccine strain at Day 21	108 Participants
Fluarix Elderly Group	The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21	A/Uruguay vaccine strain at Day 0	58 Participants
Fluarix Young Group	The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21	A/Brisbane vaccine strain at Day 21	101 Participants
Fluarix Young Group	The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21	A/Uruguay vaccine strain at Day 0	53 Participants
Fluarix Young Group	The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21	B/Brisbane vaccine strain at Day 21	108 Participants
Fluarix Young Group	The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21	A/Uruguay vaccine strain at Day 21	104 Participants
Fluarix Young Group	The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21	A/Brisbane vaccine strain at Day 0	68 Participants
Fluarix Young Group	The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21	B/Brisbane vaccine strain at Day 0	101 Participants

Secondary

The Number of Subjects Seroprotected to HI Antibodies at Day 180

Time frame: Day 180

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/Brisbane vaccine strain	143 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seroprotected to HI Antibodies at Day 180	B/Brisbane vaccine strain	241 Participants
New Generation Influenza Vaccine GSK2186877A Group	The Number of Subjects Seroprotected to HI Antibodies at Day 180	A/Uruguay vaccine strain	193 Participants
Fluarix Elderly Group	The Number of Subjects Seroprotected to HI Antibodies at Day 180	A/Brisbane vaccine strain	65 Participants
Fluarix Elderly Group	The Number of Subjects Seroprotected to HI Antibodies at Day 180	A/Uruguay vaccine strain	94 Participants
Fluarix Elderly Group	The Number of Subjects Seroprotected to HI Antibodies at Day 180	B/Brisbane vaccine strain	129 Participants
Fluarix Young Group	The Number of Subjects Seroprotected to HI Antibodies at Day 180	B/Brisbane vaccine strain	103 Participants
Fluarix Young Group	The Number of Subjects Seroprotected to HI Antibodies at Day 180	A/Brisbane vaccine strain	89 Participants
Fluarix Young Group	The Number of Subjects Seroprotected to HI Antibodies at Day 180	A/Uruguay vaccine strain	87 Participants

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

Evaluation of Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Years and Older

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) Including Autoimmune Disease (AID)

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

Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 to Day 20

Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 to Day 179

Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 180 to Day 209

Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 0 to 20

Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 21 to 179

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 Factor (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 Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21

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 0 and 21

The Number of Subjects Seropositive to HI Antibodies at Day 180

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

The Number of Subjects Seroprotected to HI Antibodies at Day 180